Table 2.

Summary of studies focused on a comparison of counseling strategies

	Title	Samplea: N, Age, Characteristics	Aim	Finding Highlights (Selected Outcomes: Psychological Wellbeing [A], Knowledge [B], Perceived Risk [C], Satisfaction [D], Genetic Testing/Screening Intentions [E] Genetic Testing Uptake [F], Decision Quality [G], Medical Management / Health Behavior [H], Sharing of Information [I], & Informed Choice [J]
Hodgson et al (2015)	32. Outcomes of a randomised controlled trial of a complex genetic counselling intervention to improve family communication	95 probands or parents of probands (mean 47.6y) recruited from genetics clinics in six public hospitals in Victoria, Australia	Evaluate the impact of augmenting standard care with three phone calls from a genetic counselor in terms of family communication about a new genetic diagnosis.	25.6% of intervention group relatives compared with 20.9% of control group relatives made contact with genetic services. [E] Although no major difference was detected overall between the intervention and control groups, there was more contact in the intervention group where the genetic condition conferred a high risk to offspring. [I]
Eijzenga et al (2015)	33. Routine assessment of psychosocial problems after cancer genetic counseling: Results from a randomized controlled trial	118 individuals (mean 49.5y) who underwent diagnostic or pre-symptomatic DNA testing and had their final counseling session prior to 12/15/12 in the Netherlands	Evaluate the impact of augmenting genetic counseling with provision of information about the counselees’ psychosocial problems to genetic counselors as part of a telephone session held 1 month after cancer genetic counseling and testing (CGCT) procedure.	There were no significant differences between groups in regards to cancer worry or distress, problem management, prevalence of CGCT-related problems over time, satisfaction levels, or frequency with which psychosocial issues were discussed. [A, D] Both the intervention group (93%) and the control group (90%) were highly satisfied with the overall genetic counseling process. [D] Counselors’ awareness of problems was higher in the intervention group, but only significantly with “practical issues.” One-third of participants would recommend that all counselees have a session, while 55% would recommend it for only those who express an interest.
Albada et al (2015)	34. Follow-up effects of a tailored pre-counseling website with question prompt in breast cancer genetic counseling	197 women (mean 41.35y) who were the first in their families to seek breast cancer genetic counseling in the Netherlands	Evaluate the immediate and long-term effects of a pre-counseling website with question prompts on patients receiving cancer genetic counseling.	No significant effects were found in regards to recall, knowledge, risk perception, anxiety, cancer worry, or adherence to breast surveillance advice. [A, B, C, H, E] Counselees in the intervention group were significantly more satisfied, had more positive experiences with counseling, and had higher perceived personal control 1 year post-counseling. [A, D]
Nishigaki et al (2014)	35. The effect of genetic counseling for adult offspring of patients with type 2 diabetes on attitudes toward diabetes and its heredity: A randomized controlled trial	216 individuals (mean 45.9y) with a first-degree relative with type 2 diabetes but no personal diagnosis in Tokyo, Japan	Compare a lifestyle intervention with counseling by a genetic counselor (GC + LI) and without (LI) to control (no intervention) in terms of attitudes toward diabetes and its prevention.	More than half of participants indicated feeling anxiety about their potential for developing diabetes, but there were no significant differences between intervention groups. [A] Approximately 40% of participants perceived that their diabetes risk was higher than normal. [C] Significantly more subjects perceived that diabetes onset is controllable in the GC + LI group than in the LI group at both 1-week and 1-year post counseling.
Kuppermann et al (2014)	36. Effect of enhanced information, values clarification, and removal of financial barriers on use of prenatal genetic testing: A randomized clinical trial	710 women (mean 29.25y) who were ≤20wk gestation and had not undergone any prenatal testing for fetal aneuploidy	Evaluate the impact of a decision- support guide and elimination of financial barriers to testing on decision making and prenatal genetic testing uptake.	Knowledge scores were higher in the intervention group. [B] Age-adjusted risk for carrying a fetus with trisomy 21 and risk of miscarriage via amniocentesis were more likely to be correctly reported in the intervention group. [C] Significantly fewer women in the intervention group underwent invasive prenatal diagnostic testing. [F] There were no significant differences found in regards to decisional conflict and decisional regret. [G]
Eijzenga et al (2014)	37. Effect of routine assessment on specific psychosocial problems on personalized communication, counselors’ awareness, and distress levels in cancer genetic counseling practice: A randomized controlled trial	246 participants (mean 48y) referred to genetic counseling at two family cancer clinics in the Netherlands	Evaluate the impact of augmenting genetic counseling with provision of results from the Psychosocial Aspects of Hereditary Cancer (PAHC) as part of a telephone session held 1 month after cancer genetic counseling and testing procedure.	The intervention group had significantly lower levels of cancer worries and distress after counseling. [A] No significant difference was observed in patient satisfaction. [D] Self-reported use of psychosocial services was not statistically significant between groups. The counselors’ awareness of psychosocial problems was significantly increased in the intervention group, as was the frequency with which psychosocial problems were discussed. Counselors who received the patient questionnaire initiated more discussion of psychosocial problems, while the length of the session remained unaffected.
Montgomery et al (2013)	38. Preparing individuals to communicate genetic test results to their relatives: Report of a randomized control trial	249 women (mean 48.5y) who had BRCA1/2 testing with at least one first-degree relative with whom to share results	Compare the efficacy of a communication skills-building intervention to wellness education in preparing individuals to communicate results to family members.	There were no differences in distress about sharing results. [A] While there were no significant differences between groups in percentage disclosing results, probands were more likely to share with children, females, and relatives expected to have a favorable opinion about learning results. [I] Sense of control was positively associated with disclosure. [I]
Henneman et al (2013)	39. The effectiveness of a graphical presentation in addition to a frequency format in the context of familial breast cancer risk communication: A multicenter controlled trial	410 unaffected women (mean 41y) with breast cancer family history attending the cancer clinic for the first time in the Netherlands	Evaluate the impact of augmenting the standard frequency format of lifetime breast cancer risk with a graphical presentation (10 × 10 human icons).	Risk estimation accuracy increased and cancer worry decreased in both groups, but no significant differences were found between groups. [A, C] For women with no or slightly increased risk of breast cancer, there were no differences in terms of cancer-prevention intentions (e.g., breast cancer screening or mammography) between the 2 groups. [E]
Voonvinden et al (2012)	40. The introduction of a choice to learn pre-symptomatic DNA test results for BRCA or Lynch syndrome either face-to-face or by letter	198 asymptomatic counselees (mean 44.6y) from families in the Netherlands with a known BRCA1/2 or Lynch syndrome mutation in the Netherlands	Compare traditional test result disclosure to a procedure in which counselees are offered a choice regarding how they receive their results.	The disclosure procedure had no influence on counselees’ emotional problems, cancer worry, knowledge, or risk perception. [A, B, C] The counselees with a favorable test result in the intervention group were the most satisfied. [D] The majority of cases chose for disclosure by letter.
Roberts et al (2012)	41. Effectiveness of a condensed protocol for disclosing APOE genotype and providing risk education for Alzheimer disease	264 participants (mean 58.ly) with only one first-degree relative affected with Alzheimer’s disease (onset ≥60y)	Compare a brief educational model to the standard extended protocol for describing Alzheimer’s disease risk related to APOE allele status.	Alzheimer’s disease knowledge increased from baseline in both groups. [B] No significant differences were observed between groups in patient recall of APOE status and disease risk, or in disease knowledge. [B,] The brief model took, on average, about half as much time as the extended model.
Roussi et al (2010)	42. Enhanced counseling for women undergoing BRCA1/2 testing: Impact on knowledge and psychological distress - Results from a randomized clinical trial	134 women (≥21y) with a family history suggestive of a hereditary pattern of breast and/or ovarian cancer	Evaluate the impact of augmenting standard genetic counseling with a 45-min, enhanced counseling intervention in role-play format from a health educator.	For women who tested positive, the intervention group had significantly lower distress levels 1 week post-disclosure. [A] Women who received the enhanced intervention were significantly more knowledgeable about the heritability of breast and ovarian cancer than those in the control group. [B]
Halbert et al (2010)	43. Effect of genetic counseling and testing for BRCA1 and BRCA2 mutations in African American women: A randomized trial	139 African American and/or black women (59% ≤50y) with ≥5% risk of BRCA1/2 mutation	Compare culturally tailored counseling to standard counseling (both provided by a genetic counselor) across a cohort of randomized and non-randomized women.	Test result acceptors had a greater likelihood of reporting decreased cancer worry. [A] Perceived risk decreased, though there was no difference in perceived risk between the two different types of counseling. [C] BRCA1/2 testing decisions did not have a significant effect on changes in risk perception. [C, F]
Graves et al (2010)	44. Randomized controlled trial of a psychosocial telephone counseling intervention in BRCA1 and BRCA2 mutation carriers	128 women (≥18y) who were BRCA1/2 mutation carriers without metastatic disease or recurrent ovarian cancer in Canada and the USA	Evaluate the impact of augmenting standard genetic counseling with a psychosocial counseling intervention by master’s-level mental health counselors consisting of 5 weekly telephone sessions and a mailed booklet.	Women in the intervention group reported greater reductions in anxiety, depression, and genetic testing distress at the 6-month follow-up compared to women receiving standard genetic counseling, but there were no differences between groups at the 12-month follow-up. [A]
Roshanai et al (2009)	45. Does enhanced information at cancer genetic counseling improve counselees’ knowledge, risk perception, satisfaction and negotiation of information to at-risk relatives? - A randomized study	147 men and women (median 56y) who did not suffer from any mental illnesses and read, wrote, and spoke Swedish	Evaluate the impact of augmenting genetic counseling with a subsequent session in which a specialist nurse offered extended cancer genetic information, help identifying important relatives, and an videotape from the counseling session.	Depression and anxiety decreased significantly over time, though there were no differences between groups at any time-point. [A] Knowledge increased significantly at 2-week and 8-month follow-ups, but no significant difference was found between groups. [B] The only significant difference in perceived risk between groups was observed immediately after counseling: the control group gave a more accurate estimation. [C] The only significant difference in satisfaction between groups was the intervention group’s greater satisfaction with the content. [D] Most participants (73%) had shared information with their all their relatives at the 8-month follow-up. [I]
Wakefield et al (2008)	46. A randomized trial of a breast/ovarian cancer genetic testing decision aid used as a communication aid during genetic counseling	148 women (mean 49y) who approached a familial cancer clinic within a two-year period in Australia	Evaluate the impact of a decision aid given during genetic counseling for women considering genetic testing for breast/ovarian cancer risk.	There were no significant differences between groups in anxiety, depression, or psychological distress. [A] Women who received the decision aid had higher levels of knowledge, and felt more informed about genetic testing. [B] No differences were observed in testing uptake, decision quality, or sharing information with family members. [F, G, I] The effect of the decision aid on the measure of informed choice was not significant. [J]
Glanz et al (2007)	47. Effects of colon cancer risk counseling for first-degree relatives	176 siblings and children (mean 54.4y) of colorectal cancer patients living in Hawaii	Compare culturally sensitive Colon Cancer Risk Counseling (CCRC) to General Health Counseling (GHC) by trained health or nurse educators for relatives of colorectal cancer patients.	Knowledge and perceived risk showed change related to treatment group, but were not significant mediators of the treatment effect on adherence. [B, C] The CCRC intervention resulted in a 13% greater increase in screening adherence than GHC at 4 months, but the treatment effect was only 11 % greater at 12 months. [H]
Bennett et al (2007)	48. A randomized controlled trial of a brief self-help coping intervention designed to reduce distress when awaiting genetic risk information	162 women (most >40y) referred to a specific breast and ovarian cancer service in Wales	Evaluate the impact of a distraction-based coping leaflet in women undergoing genetic risk assessment for breast/ovarian cancer.	Among women highly distressed at baseline, only those in the intervention group reported significant reductions in distress. [A] While 95% of participants reported having read the leaflet, significantly fewer reporting having used the distraction strategies exemplified within (but may have used other distraction strategies).
Matloff et al (2006)	49. Healthy women with a family history of breast cancer: Impact of a tailored genetic counseling intervention on risk perception, knowledge, and menopausal therapy decision making	64 women (mean 49y) with at least one first-degree relative with breast cancer	Evaluate the impact of a personalized risk assessment and intervention by a genetic counselor in a cohort of low- and moderate-risk women.	Worry about breast cancer, heart disease, and osteoporosis was correlated with perceived risk, but not actual risk. [A, C] Women in the intervention group gained more knowledge about menopause and menopausal therapy. [B] Participants in the intervention group had lower perceived risk, and reported being very satisfied with the counseling. [C, D] There were no differences between groups in terms of medication usage (hormone therapy, tamoxifen, or raloxifene). [H] Perceived effective decision making was higher for the intervention group at the 6-month follow-up. [G]
Charles et al (2006)	50. Satisfaction with genetic counseling for BRCA1 and BRCA2 mutations among African American women	54 African American women (mean 46y) with moderate to high risk for BRCA1/2 mutation	Compare culturally tailored genetic counseling (CTGC) to standard genetic counseling (SGC), both provided by a genetic counselor.	Women who reported annual household incomes less than $35 K were significantly more likely to report lessened worries than higher income women, and those receiving CTGC were significantly more likely than those receiving SGC to report lessened worry. [A] 96% reported that they were very satisfied with the counseling. [D]
Miller et al. (2005)	51. Enhanced counseling for women undergoing BRCA1/2 testing: Impact on subsequent decision making about risk reduction behaviors	77 high-risk women (most ≤50y) undergoing BRCA1/2 testing	Evaluate the impact of an enhanced counseling intervention by a health educator designed to promote well-informed decision making for risk reduction options for ovarian cancer.	One week after disclosure, women in the enhanced counseling group experienced a greater reduction in avoidant ideation. [A] At the 6-month follow-up, women in the intervention group reported seeking out more information about prophylactic oophorectomy, and were more likely to have actually undergone preventive surgery. [H]
Braithwaite et al (2005)	52. Development of a risk assessment tool for women with a family history of breast cancer	72 women (≥18y) with a first- or second-degree relative with breast cancer in the UK	Compare the genetic risk assessment in the clinical environment (GRACE) prototype to standard risk counseling from a clinical nurse specialist.	There were no significant differences between groups in risk perception or cancer-related worry. [A, C] Patient satisfaction was higher in the group receiving nurse counseling than in the GRACE product group. [D]
Brain et al (2005)	53. An exploratory comparison of genetic counselling protocols for HNPCC predictive testing	14 women and 12 men (mean 41y) currently unaffected individuals from families with an HNPCC-related mutation in Wales	Compare an extended genetic nurse specialist counseling protocol (2 sessions of education and reflection) to shortened protocol (1 session of education).	The effect of counseling protocol on knowledge and psychological distress was not significant. [A, B] No differences were found in satisfaction between groups. [D] All participants reported intentions to pursue testing prior to counseling, which did not change after counseling in either group. [E]
McInerney-Leo et al (2004)	54. BRCA1/2 testing in hereditary breast and ovarian cancer families: Effectiveness of problem-solving training as a counseling intervention	212 men and women (≥18y) with a BRCA1/2 mutation	Compare a problem-solving training intervention to a client-centered intervention, including assessment of changes at follow-up 6–9 months later.	A greater decrease in breast cancer worry was observed in those who chose testing than those who did not. [A, F] Depressive symptoms decreased more in the problem-solving training group than the client-centered counseling group. [A] Cancer worry was higher in participants with a personal history of breast cancer, regardless of decision to test. [A]
Brain et al (2000)	55. A randomized trial of specialist genetic assessment: Psychological impact on women at different levels of familial breast cancer risk	740 women (mean 42.6y) referred for a family history of breast cancer in Wales	Evaluate the impact of augmenting a surgical consultation with a multidisciplinary specialist risk assessment by a clinical geneticist.	Breast cancer worry and perceived risk decreased from baseline in low- and moderate-risk women, but not in high-risk women. [A, C] Women at high risk reported significantly lower instrumental satisfaction than women at low or moderate risk. [D] The effect of risk information on interest in genetic testing was not significant. [E]
Lerman et al (1999)	56. Racial differences in testing motivation and psychological distress following pretest education for BRCA1 gene testing	228 Caucasian and 70 African American women (18–75y) with at least one first-degree relative affected by breast or ovarian cancer	Compare a standard education model (E) to an education plus counseling model (E + C) in terms of racial differences.	All groups evidenced a reduction in distress. This decrease, although not significantly different, was smallest among African American women who received E + C. [A] In African American women E + C led to greater increases than E in intentions to be tested and provision of a blood sample. In Caucasian women there were no differential effects of the interventions on these outcomes. [E]
Watson et aL (1998)	57. Family history of breast cancer: What do women understand and recall about their genetic risk?	115 women (28–7ly) with a family history of breast cancer referred for genetic counseling in London	Evaluate the impact of augmenting standard clinical geneticist consultation with provision of an audiotape of the encounter.	Cancer worry was reduced in participants who received a tape. [A] Recall of the risk figure was more accurate when the clinical geneticist had given this to the woman as an odds ratio rather than in other formats. However, it was not affected by provision of a tape. [C] Overall, participants were satisfied with the service offered. [D] Increases in clinical breast examinations and mammograms were seen between 1- and 6-month follow-ups. [H]
Lerman et al (1997)	58. Controlled trial of pretest education approaches to enhance informed decision-making for BRCA1 gene testing	400 women (18–75y) with one first-degree relative affected by breast or ovarian cancer	Compare education only and education plus counseling to control (waiting list) for decision-making regarding BRCA1 testing.	Participants in both the educationaland counseling interventions showed increases in knowledge, while participants in the control group showed decreases. [B] The education alone, but not education plus counseling, resulted in significantly greater decreases in perceived risk of a BRCA1 mutation compared to controls. [C] Neither approach led to changes in intentions to pursue testing. [E]

^aUnless otherwise noted in this Sample column, the study was conducted in the United States of America