Randomized Comparison of Group Versus Individual Genetic Education and Counseling for Familial Breast and/or Ovarian Cancer
http://www.100md.com
《临床肿瘤学》
the Genetics Branch, Center for Cancer Research
Orkand Corporation, Contractor
Center for Cancer Research, Biostatistics and Data Management Section
Center for Cancer Research, Laboratory of Cellular and Molecular Biology
National Cancer Institute, National Institutes of Health
National Center for Complementary and Alternative Medicine, National Institutes of Health
Uniformed Services University, Bethesda, MD
Genentech, Inc, San Francisco, CA
ABSTRACT
PURPOSE: An efficient approach to education and counseling before BRCA1 and BRCA2 mutation testing is necessary for effective utilization of testing in the community. Education and counseling, when delivered individually, are limited by a shortage of trained health care providers as well as by financial and time constraints. The purpose of this study was to determine whether pretest education and counseling for breast cancer genetics in a group setting is equivalent to that provided on an individual basis.
PATIENTS AND METHODS: One hundred forty-two patients at high risk for harboring a BRCA mutation were randomly assigned to group or individual education and counseling sessions. Group education was followed by brief individual counseling. Knowledge and Impact of Events Scales (IES) were administered at baseline and after education and counseling and at 1 week and 3, 6, and 12 months. Satisfaction with education and counseling was measured at completion of the session. Preferred method of education and counseling was solicited at 3 months.
RESULTS: There was no difference in knowledge or IES scores between groups. When stratified by genetic test results, knowledge scores showed no difference. Regardless of group, post-test IES scores in patients with positive results were higher than patients with negative or uninformative results but returned to baseline by 12 months. Participants were equally satisfied with either method they were assigned. Significantly more time was spent per patient in individual sessions (1.25 hours) than in group education (0.74 hours).
CONCLUSION: Our data suggest that group education and counseling may confer similar benefits compared with traditional individual sessions. Additional investigation of this approach in larger numbers of patients is warranted.
INTRODUCTION
Breast cancer is one of the most common forms of cancer in women in the United States, with more than 217,000 new cases diagnosed in 2004.1 Most breast cancer occurs in the absence of a strong family history. However, 5% to 10% of women with breast cancer have an inherited predisposition based on the presence of a germline mutation. Mutations in BRCA1 and BRCA2 are the most common high-penetrance breast cancer susceptibility genes identified to date, accounting for at least half of all genetically predisposed breast cancer.2-4
Although cancer risk management recommendations for individuals known to harbor a mutation in BRCA1 or BRCA2 are not firmly established, there are clear benefits to determining BRCA status for those at high risk. These include options for prophylactic surgery, intensified cancer surveillance, information for other family members, and, for some, the benefit of having an answer regarding the basis of their family’s risk of cancer.5 In addition to the potential benefits of testing in high-risk individuals, direct-to-consumer marketing of BRCA1 and BRCA2 testing has already begun.6 This development challenges the genetic counseling community to develop approaches for the delivery of education and counseling to a broader population of people than might otherwise present for these services.
Genetic counseling, the process of assessment, delivery of education, calculated risk information, and/or genetic information within the context of emotional support are central to informed decision making for predisposition genetic testing.7 Traditionally, genetic education and counseling are delivered in person on a one-on-one basis.8 This approach is limited both by a shortage of qualified health professionals as well as by financial and time constraints associated with this relatively lengthy interaction.
One of the basic goals of pretest genetic counseling for inherited susceptibility to cancer includes facilitating autonomous decision making. This involves the discussion of the risks, benefits, and limitations of testing in the context of an individual’s personal circumstances. Therefore, education is not the only component of genetic test–informed decision making. In fact, one of the strengths of the genetic counseling process includes the individualized psychosocial counseling.9,10 This individual assessment, education, and personalized counseling has been shown to be superior to education alone, resulting in improved understanding of the benefits, risks, and limitations of BRCA genetic testing.11 However, individualized counseling is extremely time and provider intensive and not conducive to large-scale delivery of education and counseling services.
As a consequence, several strategies have been studied as alternatives to traditional one-on-one education and counseling. For instance, individualized print pretest educational materials were found to increase knowledge on breast cancer genetics more than nontailored (general, not personalized) print materials.12 Use of a videotape on inherited susceptibility to breast cancer was used as an adjunct to individual counseling showing improvement in risk recall at 1 month and a reduction in provider counseling time if the video was administered before the session.13 Computer-assisted learning has also been proven to be an effective method of pretest genetic education, resulting in a gain in breast cancer susceptibility knowledge.14 However, this tool was not shown to be a substitute for individual counseling because study participants felt that individual issues and concerns were best addressed with the provider.15
Group education is another approach with proven efficacy in other health care areas.16-20 Group models of education have one distinct advantage over print, video, and computer approaches in that they promote learning with peer contribution and support.18 Preliminary data from our group has suggested that group education sessions delivered by nurses on breast cancer risk may result in knowledge gain while maintaining participant satisfaction.21 Applying this strategy to pretest genetic education and counseling would allow for greater access to genetic services for a larger number of individuals.
Group education has the ultimate advantage of allowing for greater access to genetic education, counseling, and testing in a potentially more cost-efficient method. However, individualized client-centered education and psychosocial counseling has long been considered to be an essential component of the genetic counseling and decision-making process.22 Recognizing this, we compared the outcomes of traditional individualized education and counseling with group education followed by brief individual counseling for BRCA1 and BRCA2 genetic testing. We hypothesized that group education followed by brief individualized counseling would result in equivalent gains in knowledge and no differences in psychological distress measures when compared with individual counseling. We also hypothesized that group education and counseling would be associated with a reduction in provider time and that participants would be equally satisfied with either approach to education and counseling.
PATIENTS AND METHODS
Study Population
Patients were recruited through the clinics at the Breast Care Center at the National Naval Medical Center and the National Cancer Institute. The study was approved by the institutional review boards at both locations. Mechanisms for recruitment included self-referral or referral by a health care provider.
Eligible patients consisted of English-speaking men and women aged 25 to 68 years who met at least one of the following criteria: (1) had a known deleterious BRCA1 or BRCA2 mutation documented in their family; (2) were diagnosed with breast cancer or ductal carcinoma-in-situ at age 45 years or diagnosed with ovarian cancer at age 50 years; (3) were men diagnosed with breast cancer at any age; or (4) were affected with either breast or ovarian cancer and had a family history of cancer consistent with a prior probability of harboring a mutation of at least 10% by any peer-reviewed prior probability model. Eligible men had to have a documentation of deleterious BRCA1 or BRCA mutation in the family or have a documented history of male breast cancer.
Of 170 patients enrolled onto the study, 142 (84%) completed random assignment, an education session, and study follow-up. For those 28 patients who were withdrawn, the majority (n = 19) withdrew before education and counseling. Reasons cited for withdrawal included deciding not to get tested, opting for testing closer to home, and poor health associated with the diagnosis and/or progression of cancer. This finding was not surprising because the decision to pursue genetic testing is a difficult one impacted by personal health status, family concerns, physician input, and the vulnerability associated with learning more about your cancer risk.23-25 Therefore, given the nature of cancer genetic services, it is not uncommon to encounter passive refusers of testing, that is, individuals who initially express an interest in testing then reconsider that decision. After education and counseling, three patients withdrew because of their inability to comply with the protocol follow-up. The remaining six patients excluded from the analysis were individuals found not to meet the eligibility criteria after review of pathology information. Four patients who were randomized did not enter the education arm of the study to which they had been assigned but were analyzed as randomly assigned. These patients included those who were assigned to group education, but when other group members did not show for the session, the patients underwent individual counseling.
For overall between-group comparisons, this study was designed as an equivalence (noninferiority) study, with a sample size of 48 patients per arm with an additional 20% to account for study withdraws, resulting in 60 patients per arm. Sample size calculations were based on change in knowledge at the posteducation and postcounseling knowledge measurement as the primary end point. With 48 patients in a group, a two-sample, 0.10, one-sided t test would have 95% power to reject the null hypothesis that the two groups are not equivalent (the difference in means is 1.5 or farther from 0 in the same direction) in favor of the alternative hypothesis that the means of the two groups are equivalent. This assumed that the expected difference between the groups would be 0 and that the common standard deviation would be 2.5. The parameters were based on hypothesized values that the investigators postulated before conducting the study and were meant to provide an illustration of what magnitude of change could be detectable with at least 48 patients per arm. Additional patients were accrued to meet the minimum sample size for a companion study.
Random Assignment and Study Design
Enrollment, consent, and random assignment. Potential patients were interviewed either by phone or in person to establish preliminary eligibility. If the patient was then interested in the study, verbal consent was obtained. Individuals were told they were participating in a study designed to evaluate different methods of education. They were not told that they were being randomly assigned to group versus individual sessions because this knowledge might influence their expectations and, thus, their experience of the education session. After verbal consent, an enrollment questionnaire consisting of an in-depth personal medical and family history assessment and release for pathology confirmation, if applicable, was mailed to each individual. After the interview, eligible individuals were randomly assigned to either a group or individual pretest education session. The method for random assignment was standard fixed block with no stratification. When the medical and family history packet was obtained, pathologic confirmation of primary cancer was obtained for affected patients. Once eligibility was confirmed, the patient was given an appointment for the group or individual education session to which he or she had been randomly assigned.
On arrival at the education session, patients met with the investigators to review and sign a consent form that described the education and counseling component of the study. At the conclusion of the education and counseling, patients were offered the option of testing or given the option to postpone a testing decision. For those who opted to be tested, their blood was drawn at that session or at a time of their choosing. If an individual at any point chose to undergo germline BRCA1 and BRCA2 testing, he or she reviewed and signed a second consent form describing the risks, benefits, and limitations of testing as well as possible test outcomes. There were no differences between the two arms of the study with regard to recruitment, enrollment, or consent procedures.
Education sessions. Sessions were conducted by genetic advanced-practice nurses who had training in cancer genetics through either their academic preparation and/or through cancer genetic training programs offered at Fox Chase Cancer Center or City of Hope. Genetic nursing is considered a separate clinical nursing specialty, and all the nurses involved in this study were practicing consistent with the established scope and standards of genetics nursing practice.26 To minimize differences in presenters, the education session followed a detailed script with visual aides consisting of slides for group sessions or the same slide reproduced on a flip chart for individual sessions. Specific information regarding risk factors for breast and ovarian cancer and the risks, benefits, and limitations of BRCA testing was discussed in detail during the education session in the same format during both individual and group sessions. Table 1 lists details of the education session content. In circumstances where personal private issues arose during group sessions, patients were told that the concern was important but that it would be discussed when they met privately with the nurse after the education session.
For purposes of this study, group was defined as a combination of unrelated individuals and included both men and women. Group sessions ranged from two to 10 patients (mean, 4.82 patients) and were not fixed in size. Instead, group size was determined based on study enrollment, with larger groups associated with periods corresponding to more intense enrollment. Immediately after the group education session, all participants had a brief individual counseling session with one of the genetic advanced-practice nurses who had conducted and/or attended the education session. To protect confidentiality, patients were informed at the outset of the session that issues of a personal and private nature were important and would be addressed when they met privately with the nurse after the education session. This individual session provided the patient with an opportunity to privately address personal concerns that were not amenable to group discussion, such as sexuality or body image issues. The individual session also reviewed personal risk and family history information and addressed questions as well as any other concerns associated with the education session and/or genetic testing. In addition, personal implications of risk information for the patient and family were reviewed, along with the individual’s potential benefits, risks, and implications of testing. To logistically accommodate the posteducation individual sessions, groups were limited to no more than 10 individuals.
Result sessions. Patients were notified by phone when results were received and given the option of scheduling an appointment for result disclosure or postponing receipt of the results. Result sessions were conducted by the genetic advanced-practice nurses who had participated in the education session and one of the physician investigators. At the start of the session, patients were offered the option of declining their results. For those who opted to learn their results, results and the specific risks for the development of cancer as applicable to the individual were discussed. All patients were provided with risk-specific management options, including a review of available chemoprevention, prophylactic surgery, and surveillance options as well as an overview of available research studies they might consider. Specific implications for family members were also reviewed in detail. Patients were referred to specialists, as indicated, for more detailed discussion of cancer risk management options. Each session was followed by a letter summarizing the details of the result session.
Long-term follow-up. Follow-up phone calls to each patient were completed at 1 week and 3, 6, and 12 months after receiving the results of BRCA testing or after completing the education session for those patients who opted not to be tested. The purpose of these contacts was to identify unresolved psychological or emotional issues and to respond to any questions or concerns that may have developed.
Measures
Sociodemographics. Sex, age, marital status, race, ethnic background, religion, occupation, income, and highest level of education were assessed at baseline as part of the enrollment questionnaire.
Health history. A comprehensive health and cancer risk factor history was assessed at baseline as part of the enrollment questionnaire. Proband cancer diagnosis was confirmed with pathology reports.
Family history. A bilineal three-generation family history was assessed at baseline as part of the enrollment questionnaire and was then further expanded as part of the individualized counseling session. Confirmation of the cancer diagnosis was confirmed with pathology reports on the proband only.
Genetic test results. Genetic testing was performed at the Clincal Laboratory Improvement Amendments (CLIA)–approved laboratory, Myriad Genetics, Inc (Salt Lake City, UT), using full-length sequencing or testing for a site-specific mutation documented in the family. All participants who tested negative or uninformative or had a variant of uncertain significance were then offered the five-mutation large rearrangement panel when it became available. The clinical interpretation of the result for each gene (BRCA1 and BRCA2) was recorded. The five result categories included not done, positive/deleterious mutation, positive/variant of uncertain significance, negative/informative, and negative/uninformative.
Knowledge. Knowledge of breast cancer genetics and genetic testing was assessed using a 10-item, true-false scale (see Appendix) modified from the tool developed by the National Human Genome Research Institute Cancer Genetics Studies Consortium. This scale has been used in several cancer genetic studies.11,27,28 Modifications made to the tool were piloted in 51 patients and repeatedly demonstrated adequate internal consistency ( .75). Content validity calculated from assessment by four individual breast cancer genetic experts was 0.93. Construct validity was also conducted using the contrasted groups’ approach, which demonstrated no significant difference between groups (Wilcoxon rank sum test, P = .21). The knowledge scale was administered at baseline and at the conclusion of the education and counseling session. In addition, this tool was administered at 3, 6, and 12 months after results or after education and counseling for those patients who declined testing.
Psychological sequelae. Levels of distress associated with education, counseling, and/or testing were assessed using the Impact of Events Scale (IES).29 This measure is a 15-item self-report scale soliciting information on intrusive thoughts, avoidance, denial, and blocking of thoughts and reminders related to a specific life event or stressor. The measure has a high internal consistency of = .78 for intrusion and = .82 for avoidance.29 The tool has also been validated specifically in cancer survivors,30 which constituted the majority of the patients participating in this study. The IES was administered at baseline and 3, 6, and 12 months after results or after education and counseling for those patients who declined testing.
Patient satisfaction. A satisfaction questionnaire consisting of 10 questions assessing patient’s perceptions of the amount and adequacy of the education session was completed at the conclusion of the education session.
Preferred method of education. At 3 months of follow-up, all patients were asked what method of breast cancer genetic education they preferred, group or individual.
Time analysis. Length of individual sessions was recorded for each patient. For those patients randomly assigned to group sessions, group size, length of the education session, and length of the postgroup individual counseling session were recorded.
Statistical Analysis
The association between the method of education and counseling (individual v group) and variables of interest was tested by univariate methods. Age at baseline was examined as a continuous variable. Continuous data are reported in both means and medians throughout the article because not all the data were normally distributed. A Wilcoxon rank sum test was used to compare the age distribution between the two education and counseling groups. The following were examined as categoric variables: sex, race and ethnicity, religion, education, and cancer diagnosis. For the purposes of analysis, genetic test results were collapsed into the following three ranking categories: negative/informative; positive/variant of uncertain significance and negative/uninformative were combined; and positive/deleterious mutation. For each patient, the most significant final result value was chosen from results of testing in both BRCA1 and BRCA2 to create a final result variable used in the analysis. Fisher’s exact tests were used for 2 x 2 tables, and 2 tests were used for unordered tables. A Cochran-Armitage trend test was used to determine the association between ordered categoric outcomes and the randomized groups.
To analyze both the knowledge scores and IES scores, new variables were created by subtracting the baseline value from each of the postbaseline measurements for each patient. For each of the new knowledge and IES variables, we tested each distribution for a difference from 0 with a Wilcoxon signed rank test, both by method of education and by final genetic test result. To address the primary question regarding the differences between study groups, initially a Wilcoxon rank sum test was used to compare each of the differences from baseline at each time point. Then a Jonckheere-Terpstra trend test was used to compare group distributions within a method of education and across the ordered final genetic test results.31
For analysis of the preferred method of education and satisfaction with education and counseling, we cross-tabulated the preferred method variable with the method of education and used McNemar’s test for paired categoric data to test for discordance between the preference and the method assigned. Last, we cross-tabulated the method of education with the satisfaction variable, and because the responses to the satisfaction variable were ordered and some of the group sizes were small, an exact Cochran-Armitage trend test was used.32
Counseling time was calculated in two ways. For patients randomly assigned to individual counseling, the total time spent per patient reflected the interval between the start and end of the session. For patients randomly assigned to the group arm of the study, three variables were used to calculate the total time spent per patient (group size, length of group session, and length of individual counseling after the group session). Length of the group session was divided by the group size to calculate the time spent per patient in a group session. The time spent per patient in the group session was then added to the time of individual counseling after the group session to establish the total time spent per patient for those in the group arm.
The total time per patient was compared with the four variables of knowledge differences from baseline according to method of education. Because both variables had a continuous distribution, a Spearman rank correlation analysis was used to describe the time spent per patient and the change in knowledge overall and by group. Last, a comparison of the distributions of the total time spent per patient grouped by method of education was performed using the Wilcoxon rank sum test.
RESULTS
Study Population
Random assignment of eligible assessable patients resulted in 71 patients assigned to each of the two arms of the study (group and individual education and counseling sessions). Table 2 provides an overview of the characteristics of the study population. Participants ranged in age from 25 to 68 years; 95% were female; and most were white (89%) and affected with breast cancer (77%). The majority was married (74%), had a college degree or higher level of education (63%), and reported an income of more than $50,000 per year (75%). Overall, there was no statistical difference between the education and counseling groups for the demographic variables tested.
Knowledge
Outcomes from the knowledge scale scores in each group are listed in Table 3. There was a significant gain in knowledge when compared with baseline scores that persisted through the 12-month follow-up period. The median difference in knowledge scores from baseline to after education and counseling was an increase of 1 point, which persisted for each follow-up measurement (3, 6, and 12 months). There was no difference in changes in knowledge scores between the group or individual methods of education and counseling. There was also no difference detected when the knowledge scores were stratified by genetic test results.
Psychological Distress
The mean and median IES scores at baseline and at 3, 6, and 12 months are listed in Table 4. There was no significant difference in IES scores between group and individual education and counseling. There was also no difference in IES scores between the groups when stratified by genetic test results. However, the results demonstrated that post-test IES scores tended to increase as the results of genetic testing degraded from a negative/uninformative result to the result of a positive/deleterious mutation (Table 5).
Genetic Test Results
One hundred thirty-six patients (96%) opted to undergo genetic testing after education and counseling. Those who opted not to pursue genetic testing were equally distributed between group and individual education and counseling sessions. Thirty patients (22%) who were tested were found to have a deleterious mutation, consisting of 21 BRCA1 mutations and nine BRCA2 mutations. Ten patients (7%) were tested for a known mutation in the family and were found to be negative. The remaining 96 patients (71%) were found to be negative/uninformative or to have a variant of uncertain significance in one or both BRCA genes.
Patient Satisfaction
There were no significant differences in self-reported satisfaction comparing individual to group education and counseling. As reviewed in Table 6, the majority of patients felt that both methods of education and counseling provided sufficient information to make a testing decision. Patients also reported that both methods provided information in a format that they could understand and in which they had sufficient time to ask questions.
Preferred Method of Education
Data was collected on patients’ theoretical preferred method of education and counseling. The findings (Table 7) suggest that participants tended to be equally satisfied with whatever method of education and counseling (group or individual) they were assigned (P = .82, by McNemar’s test). In addition, with 115 (86%) of 134 patients satisfied with their assigned method, the 95% CI on this proportion extends from 79% to 91% of patients being satisfied.
Time Analysis
A secondary analysis of provider time per patient was performed. A comparison between the time spent per patient, grouped by method of education, showed significantly more time was spent in individual sessions. The median provider hours per patient in individual sessions was 1.25 hours compared with 0.74 provider hours per patient in group sessions (P < .0001). The median group session length consisted of 1.25 provider hours (range, 0.75 to 2.5 hours). A median of 0.42 hours (range, 0.17 to 1.0 hours) of time was spent on individual counseling after the group education. All correlations between time spent per patient and gain in knowledge were weak for both groups separately (r < 0.30) or both groups considered together (data not shown).
DISCUSSION
As BRCA testing enters the era of direct-to-consumer marketing, a variety of proven strategies for the delivery of education and counseling services are needed for the responsible diffusion of testing services. Group education and counseling already occurs informally with related family members; however, the efficacy of that approach has not been well studied. These data suggest that group education followed by brief individual counseling results in similar knowledge gains when compared with standard individual education and counseling. Additionally, the two education strategies were equivalent with regard to knowledge retention over time.
We did not find any significant psychological distress in either arm of the study, and none of the participants were referred for more extensive psychological counseling. However, we did observe a trend of increased IES scores in patients with positive/deleterious mutations compared with all other result categories, although this study was not powered for detecting changes as a result of mutation status. This trend was present regardless of education and counseling method and declined to baseline over the 12 months of follow-up. This temporary increase in IES scores in individuals found to harbor a BRCA1 or BRCA2 mutation was the same regardless of method of education. This finding was not surprising given the complex medical decisions associated with having a mutation, such as surveillance versus prophylactic breast and/or ovarian surgery. In this setting, an increase in IES scores would be expected because of the increase in thoughts associated with the process of medical decision making surrounding genetic testing. Furthermore, consultations with health care providers reviewing the available medical options would also likely increase the frequency of reminders associated with testing. Both of these influences would be expected to result in an increase in IES scores because this scale is a sensitive measure of active information processing and may not necessarily reflect psychological distress.33,34 Because the data suggest no difference between the two study groups and the increase in IES scores resolved over time, it is unlikely that this increase is associated with the method of education and counseling. However, given the limited numbers of deleterious mutation carriers, interpretation of these findings remains exploratory.
One important finding was that the data suggested significantly more provider time (median, 1.25 provider hours per patient) was spent on each participant in the individual sessions than on participants assigned to group education and counseling (median, 0.74 provider hours per patient). This supports our original hypothesis that group education is more time efficient. It is logical to assume that both demand and access to genetic tests for adult-onset disorders will continue to increase.35 The utilization of groups provides an efficient, high-throughput method for education and counseling that is unlikely to negatively impact knowledge, satisfaction, or psychological distress outcomes when compared with individualized sessions. However, it is important to keep in mind that larger groups result in greater provider time savings. To further streamline the information transfer associated with genetic testing, research focusing on other components of the genetic counseling process, including a randomized comparison of alternatives to in-person result disclosure sessions, is already underway, and those data will be reported separately. Future research in larger numbers of patients might focus on ways to decrease education, counseling, and provider time even further, including further delineation of the minimum components of the education session needed for informed decision making.
The study data that were collected looked at the education and counseling session alone and did not assess the time associated with the coordination of group education sessions or the feasibility of establishing group sessions. Two issues warrant consideration, including the logistics of group sessions. Unless sessions are scheduled at predefined times with no options for modification, the possibility exists that coordination of group sessions could be time consuming for the provider and negate some of the time savings derived by the group education approach. Coordination of individual sessions also uses provider time in settings without clerical support. Second, there is evidence from research on psychosocial groups that small centers with a limited catchment area and/or an extended catchment area (patients coming from greater than 1 hour away from center) may have difficulty recruiting sufficient numbers of people to hold a group.36 Our study was unique in that we paid travel expenses for those living outside the area. Data were not systematically collected on those who declined participation in the study because of travel concerns. Therefore, we are uncertain how significant an issue this is, but it should be a consideration when using the group counseling model in small institutions with an extended catchment area.
The population studied was largely white, female, affected with breast cancer, highly educated, and of a higher socioeconomic bracket than what is representative of the general population.37 There is no reason to believe that this education and counseling approach is not generalizable, and we are not aware of anything that would limit this approach being used with other populations. However, future research might aim to assess the impact of group education and counseling approaches in studies with a larger sample size, more men, and individuals with no cancer history as well as in more diverse populations using culturally sensitive materials.
As cancer predisposition genetic testing becomes more integrated into routine health care, streamlined approaches to education and counseling are needed for greater access to genetic services. These data suggest that group education followed by brief individual counseling results in similar knowledge, psychological, and satisfaction outcomes when compared with individual counseling alone, with less provider time spent per patient. This strategy may also reduce provider burden, resulting in greater availability of these services. Therefore, group education followed by brief individual counseling may be a reasonable alternative to consider for genetic education and counseling for BRCA1 and BRCA2 genetic testing.
Authors' Disclosures of Potential Conflicts of Interest
The following authors or their immediate family members have indicated a financial interest. No conflict exists for drugs or devices used in a study if they are not being evaluated as part of the investigation. Employment: Maria DeCarvalho, Genentech; Pamela Klein, Genentech. Stock Ownership: Pamela Klein, Genentech. For a detailed description of these categories, or for more information about ASCO’s conflict of interest policy, please refer to the Author Disclosure Declaration and Disclosures of Potential Conflicts of Interest found in Information for Contributors in the front of each issue.
Appendix
Acknowledgment
We thank the participants, nurses, physicians, and data managers who worked on the study and/or provided input into the data analysis and manuscript preparation, especially James C. Coyne, PhD, Professor of Psychology, Co-Director, Cancer Care and Outcomes Program, Abramson Cancer Center, University of Pennsylvania.
NOTES
Supported by National Cancer Institute; The Chief, Navy Bureau of Medicine and Surgery, Washington, DC, Clinical Investigation Program No. B99-015.
Authors' disclosures of potential conflicts of interest are found at the end of this article.
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Agresti A: Categorical Data Analysis. New York, NY, John Wiley and Sons, Inc, 1990 , pp 79 -129
Lees-Haley P, Price JR, Williams CW, et al: Use of the Impact of Events Scale in the assessment of emotional distress and PTSD may produce misleading results. J Forensic Neuropsychol 2 : 45 -52, 2001
Coyne JC, Kruus L, Racioppo M, et al: What do ratings of cancer-specific distress mean among women at high risk of breast and ovarian cancer Am J Med Genet 116A : 222 -228, 2003
Guttmacher AE, Collins FS: Welcome to the genomic era. N Engl J Med 349 : 996 -998, 2003
Goodwin PJ, Leszcz M, Quirt G, et al: Lessons learned from enrollment in the BEST study: A multicenter, randomized trial of group psychosocial support in metastatic breast cancer. J Clin Epidemiol 53 : 47 -55, 2000
Rimer BK, Schildkraut JM, Lerman C, et al: Participation in a women's breast cancer risk trial: Who participates Who declines Cancer 77 : 2348 -2355, 1996(Kathleen A. Calzone, Shei)
Orkand Corporation, Contractor
Center for Cancer Research, Biostatistics and Data Management Section
Center for Cancer Research, Laboratory of Cellular and Molecular Biology
National Cancer Institute, National Institutes of Health
National Center for Complementary and Alternative Medicine, National Institutes of Health
Uniformed Services University, Bethesda, MD
Genentech, Inc, San Francisco, CA
ABSTRACT
PURPOSE: An efficient approach to education and counseling before BRCA1 and BRCA2 mutation testing is necessary for effective utilization of testing in the community. Education and counseling, when delivered individually, are limited by a shortage of trained health care providers as well as by financial and time constraints. The purpose of this study was to determine whether pretest education and counseling for breast cancer genetics in a group setting is equivalent to that provided on an individual basis.
PATIENTS AND METHODS: One hundred forty-two patients at high risk for harboring a BRCA mutation were randomly assigned to group or individual education and counseling sessions. Group education was followed by brief individual counseling. Knowledge and Impact of Events Scales (IES) were administered at baseline and after education and counseling and at 1 week and 3, 6, and 12 months. Satisfaction with education and counseling was measured at completion of the session. Preferred method of education and counseling was solicited at 3 months.
RESULTS: There was no difference in knowledge or IES scores between groups. When stratified by genetic test results, knowledge scores showed no difference. Regardless of group, post-test IES scores in patients with positive results were higher than patients with negative or uninformative results but returned to baseline by 12 months. Participants were equally satisfied with either method they were assigned. Significantly more time was spent per patient in individual sessions (1.25 hours) than in group education (0.74 hours).
CONCLUSION: Our data suggest that group education and counseling may confer similar benefits compared with traditional individual sessions. Additional investigation of this approach in larger numbers of patients is warranted.
INTRODUCTION
Breast cancer is one of the most common forms of cancer in women in the United States, with more than 217,000 new cases diagnosed in 2004.1 Most breast cancer occurs in the absence of a strong family history. However, 5% to 10% of women with breast cancer have an inherited predisposition based on the presence of a germline mutation. Mutations in BRCA1 and BRCA2 are the most common high-penetrance breast cancer susceptibility genes identified to date, accounting for at least half of all genetically predisposed breast cancer.2-4
Although cancer risk management recommendations for individuals known to harbor a mutation in BRCA1 or BRCA2 are not firmly established, there are clear benefits to determining BRCA status for those at high risk. These include options for prophylactic surgery, intensified cancer surveillance, information for other family members, and, for some, the benefit of having an answer regarding the basis of their family’s risk of cancer.5 In addition to the potential benefits of testing in high-risk individuals, direct-to-consumer marketing of BRCA1 and BRCA2 testing has already begun.6 This development challenges the genetic counseling community to develop approaches for the delivery of education and counseling to a broader population of people than might otherwise present for these services.
Genetic counseling, the process of assessment, delivery of education, calculated risk information, and/or genetic information within the context of emotional support are central to informed decision making for predisposition genetic testing.7 Traditionally, genetic education and counseling are delivered in person on a one-on-one basis.8 This approach is limited both by a shortage of qualified health professionals as well as by financial and time constraints associated with this relatively lengthy interaction.
One of the basic goals of pretest genetic counseling for inherited susceptibility to cancer includes facilitating autonomous decision making. This involves the discussion of the risks, benefits, and limitations of testing in the context of an individual’s personal circumstances. Therefore, education is not the only component of genetic test–informed decision making. In fact, one of the strengths of the genetic counseling process includes the individualized psychosocial counseling.9,10 This individual assessment, education, and personalized counseling has been shown to be superior to education alone, resulting in improved understanding of the benefits, risks, and limitations of BRCA genetic testing.11 However, individualized counseling is extremely time and provider intensive and not conducive to large-scale delivery of education and counseling services.
As a consequence, several strategies have been studied as alternatives to traditional one-on-one education and counseling. For instance, individualized print pretest educational materials were found to increase knowledge on breast cancer genetics more than nontailored (general, not personalized) print materials.12 Use of a videotape on inherited susceptibility to breast cancer was used as an adjunct to individual counseling showing improvement in risk recall at 1 month and a reduction in provider counseling time if the video was administered before the session.13 Computer-assisted learning has also been proven to be an effective method of pretest genetic education, resulting in a gain in breast cancer susceptibility knowledge.14 However, this tool was not shown to be a substitute for individual counseling because study participants felt that individual issues and concerns were best addressed with the provider.15
Group education is another approach with proven efficacy in other health care areas.16-20 Group models of education have one distinct advantage over print, video, and computer approaches in that they promote learning with peer contribution and support.18 Preliminary data from our group has suggested that group education sessions delivered by nurses on breast cancer risk may result in knowledge gain while maintaining participant satisfaction.21 Applying this strategy to pretest genetic education and counseling would allow for greater access to genetic services for a larger number of individuals.
Group education has the ultimate advantage of allowing for greater access to genetic education, counseling, and testing in a potentially more cost-efficient method. However, individualized client-centered education and psychosocial counseling has long been considered to be an essential component of the genetic counseling and decision-making process.22 Recognizing this, we compared the outcomes of traditional individualized education and counseling with group education followed by brief individual counseling for BRCA1 and BRCA2 genetic testing. We hypothesized that group education followed by brief individualized counseling would result in equivalent gains in knowledge and no differences in psychological distress measures when compared with individual counseling. We also hypothesized that group education and counseling would be associated with a reduction in provider time and that participants would be equally satisfied with either approach to education and counseling.
PATIENTS AND METHODS
Study Population
Patients were recruited through the clinics at the Breast Care Center at the National Naval Medical Center and the National Cancer Institute. The study was approved by the institutional review boards at both locations. Mechanisms for recruitment included self-referral or referral by a health care provider.
Eligible patients consisted of English-speaking men and women aged 25 to 68 years who met at least one of the following criteria: (1) had a known deleterious BRCA1 or BRCA2 mutation documented in their family; (2) were diagnosed with breast cancer or ductal carcinoma-in-situ at age 45 years or diagnosed with ovarian cancer at age 50 years; (3) were men diagnosed with breast cancer at any age; or (4) were affected with either breast or ovarian cancer and had a family history of cancer consistent with a prior probability of harboring a mutation of at least 10% by any peer-reviewed prior probability model. Eligible men had to have a documentation of deleterious BRCA1 or BRCA mutation in the family or have a documented history of male breast cancer.
Of 170 patients enrolled onto the study, 142 (84%) completed random assignment, an education session, and study follow-up. For those 28 patients who were withdrawn, the majority (n = 19) withdrew before education and counseling. Reasons cited for withdrawal included deciding not to get tested, opting for testing closer to home, and poor health associated with the diagnosis and/or progression of cancer. This finding was not surprising because the decision to pursue genetic testing is a difficult one impacted by personal health status, family concerns, physician input, and the vulnerability associated with learning more about your cancer risk.23-25 Therefore, given the nature of cancer genetic services, it is not uncommon to encounter passive refusers of testing, that is, individuals who initially express an interest in testing then reconsider that decision. After education and counseling, three patients withdrew because of their inability to comply with the protocol follow-up. The remaining six patients excluded from the analysis were individuals found not to meet the eligibility criteria after review of pathology information. Four patients who were randomized did not enter the education arm of the study to which they had been assigned but were analyzed as randomly assigned. These patients included those who were assigned to group education, but when other group members did not show for the session, the patients underwent individual counseling.
For overall between-group comparisons, this study was designed as an equivalence (noninferiority) study, with a sample size of 48 patients per arm with an additional 20% to account for study withdraws, resulting in 60 patients per arm. Sample size calculations were based on change in knowledge at the posteducation and postcounseling knowledge measurement as the primary end point. With 48 patients in a group, a two-sample, 0.10, one-sided t test would have 95% power to reject the null hypothesis that the two groups are not equivalent (the difference in means is 1.5 or farther from 0 in the same direction) in favor of the alternative hypothesis that the means of the two groups are equivalent. This assumed that the expected difference between the groups would be 0 and that the common standard deviation would be 2.5. The parameters were based on hypothesized values that the investigators postulated before conducting the study and were meant to provide an illustration of what magnitude of change could be detectable with at least 48 patients per arm. Additional patients were accrued to meet the minimum sample size for a companion study.
Random Assignment and Study Design
Enrollment, consent, and random assignment. Potential patients were interviewed either by phone or in person to establish preliminary eligibility. If the patient was then interested in the study, verbal consent was obtained. Individuals were told they were participating in a study designed to evaluate different methods of education. They were not told that they were being randomly assigned to group versus individual sessions because this knowledge might influence their expectations and, thus, their experience of the education session. After verbal consent, an enrollment questionnaire consisting of an in-depth personal medical and family history assessment and release for pathology confirmation, if applicable, was mailed to each individual. After the interview, eligible individuals were randomly assigned to either a group or individual pretest education session. The method for random assignment was standard fixed block with no stratification. When the medical and family history packet was obtained, pathologic confirmation of primary cancer was obtained for affected patients. Once eligibility was confirmed, the patient was given an appointment for the group or individual education session to which he or she had been randomly assigned.
On arrival at the education session, patients met with the investigators to review and sign a consent form that described the education and counseling component of the study. At the conclusion of the education and counseling, patients were offered the option of testing or given the option to postpone a testing decision. For those who opted to be tested, their blood was drawn at that session or at a time of their choosing. If an individual at any point chose to undergo germline BRCA1 and BRCA2 testing, he or she reviewed and signed a second consent form describing the risks, benefits, and limitations of testing as well as possible test outcomes. There were no differences between the two arms of the study with regard to recruitment, enrollment, or consent procedures.
Education sessions. Sessions were conducted by genetic advanced-practice nurses who had training in cancer genetics through either their academic preparation and/or through cancer genetic training programs offered at Fox Chase Cancer Center or City of Hope. Genetic nursing is considered a separate clinical nursing specialty, and all the nurses involved in this study were practicing consistent with the established scope and standards of genetics nursing practice.26 To minimize differences in presenters, the education session followed a detailed script with visual aides consisting of slides for group sessions or the same slide reproduced on a flip chart for individual sessions. Specific information regarding risk factors for breast and ovarian cancer and the risks, benefits, and limitations of BRCA testing was discussed in detail during the education session in the same format during both individual and group sessions. Table 1 lists details of the education session content. In circumstances where personal private issues arose during group sessions, patients were told that the concern was important but that it would be discussed when they met privately with the nurse after the education session.
For purposes of this study, group was defined as a combination of unrelated individuals and included both men and women. Group sessions ranged from two to 10 patients (mean, 4.82 patients) and were not fixed in size. Instead, group size was determined based on study enrollment, with larger groups associated with periods corresponding to more intense enrollment. Immediately after the group education session, all participants had a brief individual counseling session with one of the genetic advanced-practice nurses who had conducted and/or attended the education session. To protect confidentiality, patients were informed at the outset of the session that issues of a personal and private nature were important and would be addressed when they met privately with the nurse after the education session. This individual session provided the patient with an opportunity to privately address personal concerns that were not amenable to group discussion, such as sexuality or body image issues. The individual session also reviewed personal risk and family history information and addressed questions as well as any other concerns associated with the education session and/or genetic testing. In addition, personal implications of risk information for the patient and family were reviewed, along with the individual’s potential benefits, risks, and implications of testing. To logistically accommodate the posteducation individual sessions, groups were limited to no more than 10 individuals.
Result sessions. Patients were notified by phone when results were received and given the option of scheduling an appointment for result disclosure or postponing receipt of the results. Result sessions were conducted by the genetic advanced-practice nurses who had participated in the education session and one of the physician investigators. At the start of the session, patients were offered the option of declining their results. For those who opted to learn their results, results and the specific risks for the development of cancer as applicable to the individual were discussed. All patients were provided with risk-specific management options, including a review of available chemoprevention, prophylactic surgery, and surveillance options as well as an overview of available research studies they might consider. Specific implications for family members were also reviewed in detail. Patients were referred to specialists, as indicated, for more detailed discussion of cancer risk management options. Each session was followed by a letter summarizing the details of the result session.
Long-term follow-up. Follow-up phone calls to each patient were completed at 1 week and 3, 6, and 12 months after receiving the results of BRCA testing or after completing the education session for those patients who opted not to be tested. The purpose of these contacts was to identify unresolved psychological or emotional issues and to respond to any questions or concerns that may have developed.
Measures
Sociodemographics. Sex, age, marital status, race, ethnic background, religion, occupation, income, and highest level of education were assessed at baseline as part of the enrollment questionnaire.
Health history. A comprehensive health and cancer risk factor history was assessed at baseline as part of the enrollment questionnaire. Proband cancer diagnosis was confirmed with pathology reports.
Family history. A bilineal three-generation family history was assessed at baseline as part of the enrollment questionnaire and was then further expanded as part of the individualized counseling session. Confirmation of the cancer diagnosis was confirmed with pathology reports on the proband only.
Genetic test results. Genetic testing was performed at the Clincal Laboratory Improvement Amendments (CLIA)–approved laboratory, Myriad Genetics, Inc (Salt Lake City, UT), using full-length sequencing or testing for a site-specific mutation documented in the family. All participants who tested negative or uninformative or had a variant of uncertain significance were then offered the five-mutation large rearrangement panel when it became available. The clinical interpretation of the result for each gene (BRCA1 and BRCA2) was recorded. The five result categories included not done, positive/deleterious mutation, positive/variant of uncertain significance, negative/informative, and negative/uninformative.
Knowledge. Knowledge of breast cancer genetics and genetic testing was assessed using a 10-item, true-false scale (see Appendix) modified from the tool developed by the National Human Genome Research Institute Cancer Genetics Studies Consortium. This scale has been used in several cancer genetic studies.11,27,28 Modifications made to the tool were piloted in 51 patients and repeatedly demonstrated adequate internal consistency ( .75). Content validity calculated from assessment by four individual breast cancer genetic experts was 0.93. Construct validity was also conducted using the contrasted groups’ approach, which demonstrated no significant difference between groups (Wilcoxon rank sum test, P = .21). The knowledge scale was administered at baseline and at the conclusion of the education and counseling session. In addition, this tool was administered at 3, 6, and 12 months after results or after education and counseling for those patients who declined testing.
Psychological sequelae. Levels of distress associated with education, counseling, and/or testing were assessed using the Impact of Events Scale (IES).29 This measure is a 15-item self-report scale soliciting information on intrusive thoughts, avoidance, denial, and blocking of thoughts and reminders related to a specific life event or stressor. The measure has a high internal consistency of = .78 for intrusion and = .82 for avoidance.29 The tool has also been validated specifically in cancer survivors,30 which constituted the majority of the patients participating in this study. The IES was administered at baseline and 3, 6, and 12 months after results or after education and counseling for those patients who declined testing.
Patient satisfaction. A satisfaction questionnaire consisting of 10 questions assessing patient’s perceptions of the amount and adequacy of the education session was completed at the conclusion of the education session.
Preferred method of education. At 3 months of follow-up, all patients were asked what method of breast cancer genetic education they preferred, group or individual.
Time analysis. Length of individual sessions was recorded for each patient. For those patients randomly assigned to group sessions, group size, length of the education session, and length of the postgroup individual counseling session were recorded.
Statistical Analysis
The association between the method of education and counseling (individual v group) and variables of interest was tested by univariate methods. Age at baseline was examined as a continuous variable. Continuous data are reported in both means and medians throughout the article because not all the data were normally distributed. A Wilcoxon rank sum test was used to compare the age distribution between the two education and counseling groups. The following were examined as categoric variables: sex, race and ethnicity, religion, education, and cancer diagnosis. For the purposes of analysis, genetic test results were collapsed into the following three ranking categories: negative/informative; positive/variant of uncertain significance and negative/uninformative were combined; and positive/deleterious mutation. For each patient, the most significant final result value was chosen from results of testing in both BRCA1 and BRCA2 to create a final result variable used in the analysis. Fisher’s exact tests were used for 2 x 2 tables, and 2 tests were used for unordered tables. A Cochran-Armitage trend test was used to determine the association between ordered categoric outcomes and the randomized groups.
To analyze both the knowledge scores and IES scores, new variables were created by subtracting the baseline value from each of the postbaseline measurements for each patient. For each of the new knowledge and IES variables, we tested each distribution for a difference from 0 with a Wilcoxon signed rank test, both by method of education and by final genetic test result. To address the primary question regarding the differences between study groups, initially a Wilcoxon rank sum test was used to compare each of the differences from baseline at each time point. Then a Jonckheere-Terpstra trend test was used to compare group distributions within a method of education and across the ordered final genetic test results.31
For analysis of the preferred method of education and satisfaction with education and counseling, we cross-tabulated the preferred method variable with the method of education and used McNemar’s test for paired categoric data to test for discordance between the preference and the method assigned. Last, we cross-tabulated the method of education with the satisfaction variable, and because the responses to the satisfaction variable were ordered and some of the group sizes were small, an exact Cochran-Armitage trend test was used.32
Counseling time was calculated in two ways. For patients randomly assigned to individual counseling, the total time spent per patient reflected the interval between the start and end of the session. For patients randomly assigned to the group arm of the study, three variables were used to calculate the total time spent per patient (group size, length of group session, and length of individual counseling after the group session). Length of the group session was divided by the group size to calculate the time spent per patient in a group session. The time spent per patient in the group session was then added to the time of individual counseling after the group session to establish the total time spent per patient for those in the group arm.
The total time per patient was compared with the four variables of knowledge differences from baseline according to method of education. Because both variables had a continuous distribution, a Spearman rank correlation analysis was used to describe the time spent per patient and the change in knowledge overall and by group. Last, a comparison of the distributions of the total time spent per patient grouped by method of education was performed using the Wilcoxon rank sum test.
RESULTS
Study Population
Random assignment of eligible assessable patients resulted in 71 patients assigned to each of the two arms of the study (group and individual education and counseling sessions). Table 2 provides an overview of the characteristics of the study population. Participants ranged in age from 25 to 68 years; 95% were female; and most were white (89%) and affected with breast cancer (77%). The majority was married (74%), had a college degree or higher level of education (63%), and reported an income of more than $50,000 per year (75%). Overall, there was no statistical difference between the education and counseling groups for the demographic variables tested.
Knowledge
Outcomes from the knowledge scale scores in each group are listed in Table 3. There was a significant gain in knowledge when compared with baseline scores that persisted through the 12-month follow-up period. The median difference in knowledge scores from baseline to after education and counseling was an increase of 1 point, which persisted for each follow-up measurement (3, 6, and 12 months). There was no difference in changes in knowledge scores between the group or individual methods of education and counseling. There was also no difference detected when the knowledge scores were stratified by genetic test results.
Psychological Distress
The mean and median IES scores at baseline and at 3, 6, and 12 months are listed in Table 4. There was no significant difference in IES scores between group and individual education and counseling. There was also no difference in IES scores between the groups when stratified by genetic test results. However, the results demonstrated that post-test IES scores tended to increase as the results of genetic testing degraded from a negative/uninformative result to the result of a positive/deleterious mutation (Table 5).
Genetic Test Results
One hundred thirty-six patients (96%) opted to undergo genetic testing after education and counseling. Those who opted not to pursue genetic testing were equally distributed between group and individual education and counseling sessions. Thirty patients (22%) who were tested were found to have a deleterious mutation, consisting of 21 BRCA1 mutations and nine BRCA2 mutations. Ten patients (7%) were tested for a known mutation in the family and were found to be negative. The remaining 96 patients (71%) were found to be negative/uninformative or to have a variant of uncertain significance in one or both BRCA genes.
Patient Satisfaction
There were no significant differences in self-reported satisfaction comparing individual to group education and counseling. As reviewed in Table 6, the majority of patients felt that both methods of education and counseling provided sufficient information to make a testing decision. Patients also reported that both methods provided information in a format that they could understand and in which they had sufficient time to ask questions.
Preferred Method of Education
Data was collected on patients’ theoretical preferred method of education and counseling. The findings (Table 7) suggest that participants tended to be equally satisfied with whatever method of education and counseling (group or individual) they were assigned (P = .82, by McNemar’s test). In addition, with 115 (86%) of 134 patients satisfied with their assigned method, the 95% CI on this proportion extends from 79% to 91% of patients being satisfied.
Time Analysis
A secondary analysis of provider time per patient was performed. A comparison between the time spent per patient, grouped by method of education, showed significantly more time was spent in individual sessions. The median provider hours per patient in individual sessions was 1.25 hours compared with 0.74 provider hours per patient in group sessions (P < .0001). The median group session length consisted of 1.25 provider hours (range, 0.75 to 2.5 hours). A median of 0.42 hours (range, 0.17 to 1.0 hours) of time was spent on individual counseling after the group education. All correlations between time spent per patient and gain in knowledge were weak for both groups separately (r < 0.30) or both groups considered together (data not shown).
DISCUSSION
As BRCA testing enters the era of direct-to-consumer marketing, a variety of proven strategies for the delivery of education and counseling services are needed for the responsible diffusion of testing services. Group education and counseling already occurs informally with related family members; however, the efficacy of that approach has not been well studied. These data suggest that group education followed by brief individual counseling results in similar knowledge gains when compared with standard individual education and counseling. Additionally, the two education strategies were equivalent with regard to knowledge retention over time.
We did not find any significant psychological distress in either arm of the study, and none of the participants were referred for more extensive psychological counseling. However, we did observe a trend of increased IES scores in patients with positive/deleterious mutations compared with all other result categories, although this study was not powered for detecting changes as a result of mutation status. This trend was present regardless of education and counseling method and declined to baseline over the 12 months of follow-up. This temporary increase in IES scores in individuals found to harbor a BRCA1 or BRCA2 mutation was the same regardless of method of education. This finding was not surprising given the complex medical decisions associated with having a mutation, such as surveillance versus prophylactic breast and/or ovarian surgery. In this setting, an increase in IES scores would be expected because of the increase in thoughts associated with the process of medical decision making surrounding genetic testing. Furthermore, consultations with health care providers reviewing the available medical options would also likely increase the frequency of reminders associated with testing. Both of these influences would be expected to result in an increase in IES scores because this scale is a sensitive measure of active information processing and may not necessarily reflect psychological distress.33,34 Because the data suggest no difference between the two study groups and the increase in IES scores resolved over time, it is unlikely that this increase is associated with the method of education and counseling. However, given the limited numbers of deleterious mutation carriers, interpretation of these findings remains exploratory.
One important finding was that the data suggested significantly more provider time (median, 1.25 provider hours per patient) was spent on each participant in the individual sessions than on participants assigned to group education and counseling (median, 0.74 provider hours per patient). This supports our original hypothesis that group education is more time efficient. It is logical to assume that both demand and access to genetic tests for adult-onset disorders will continue to increase.35 The utilization of groups provides an efficient, high-throughput method for education and counseling that is unlikely to negatively impact knowledge, satisfaction, or psychological distress outcomes when compared with individualized sessions. However, it is important to keep in mind that larger groups result in greater provider time savings. To further streamline the information transfer associated with genetic testing, research focusing on other components of the genetic counseling process, including a randomized comparison of alternatives to in-person result disclosure sessions, is already underway, and those data will be reported separately. Future research in larger numbers of patients might focus on ways to decrease education, counseling, and provider time even further, including further delineation of the minimum components of the education session needed for informed decision making.
The study data that were collected looked at the education and counseling session alone and did not assess the time associated with the coordination of group education sessions or the feasibility of establishing group sessions. Two issues warrant consideration, including the logistics of group sessions. Unless sessions are scheduled at predefined times with no options for modification, the possibility exists that coordination of group sessions could be time consuming for the provider and negate some of the time savings derived by the group education approach. Coordination of individual sessions also uses provider time in settings without clerical support. Second, there is evidence from research on psychosocial groups that small centers with a limited catchment area and/or an extended catchment area (patients coming from greater than 1 hour away from center) may have difficulty recruiting sufficient numbers of people to hold a group.36 Our study was unique in that we paid travel expenses for those living outside the area. Data were not systematically collected on those who declined participation in the study because of travel concerns. Therefore, we are uncertain how significant an issue this is, but it should be a consideration when using the group counseling model in small institutions with an extended catchment area.
The population studied was largely white, female, affected with breast cancer, highly educated, and of a higher socioeconomic bracket than what is representative of the general population.37 There is no reason to believe that this education and counseling approach is not generalizable, and we are not aware of anything that would limit this approach being used with other populations. However, future research might aim to assess the impact of group education and counseling approaches in studies with a larger sample size, more men, and individuals with no cancer history as well as in more diverse populations using culturally sensitive materials.
As cancer predisposition genetic testing becomes more integrated into routine health care, streamlined approaches to education and counseling are needed for greater access to genetic services. These data suggest that group education followed by brief individual counseling results in similar knowledge, psychological, and satisfaction outcomes when compared with individual counseling alone, with less provider time spent per patient. This strategy may also reduce provider burden, resulting in greater availability of these services. Therefore, group education followed by brief individual counseling may be a reasonable alternative to consider for genetic education and counseling for BRCA1 and BRCA2 genetic testing.
Authors' Disclosures of Potential Conflicts of Interest
The following authors or their immediate family members have indicated a financial interest. No conflict exists for drugs or devices used in a study if they are not being evaluated as part of the investigation. Employment: Maria DeCarvalho, Genentech; Pamela Klein, Genentech. Stock Ownership: Pamela Klein, Genentech. For a detailed description of these categories, or for more information about ASCO’s conflict of interest policy, please refer to the Author Disclosure Declaration and Disclosures of Potential Conflicts of Interest found in Information for Contributors in the front of each issue.
Appendix
Acknowledgment
We thank the participants, nurses, physicians, and data managers who worked on the study and/or provided input into the data analysis and manuscript preparation, especially James C. Coyne, PhD, Professor of Psychology, Co-Director, Cancer Care and Outcomes Program, Abramson Cancer Center, University of Pennsylvania.
NOTES
Supported by National Cancer Institute; The Chief, Navy Bureau of Medicine and Surgery, Washington, DC, Clinical Investigation Program No. B99-015.
Authors' disclosures of potential conflicts of interest are found at the end of this article.
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