An interventional study of Online modality and Genetic counselor follow-up in Hereditary Breast and Ovarian Cancer and Lynch Syndrome, sponsored by Boston University. Completed at 1 site in United States. Open to female participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-04-01.
Sponsored by Boston University · Not applicable, Interventional, and Prevention
Efforts to examine the utility of alternate modalities for genetic results disclosure has widespread implications for how precision medicine research might yield direct health benefits for study participants. This study will examine the efficacy of an online self-guided program to return genetic results to a racial minority cohort population. Study results will provide empirical evidence on the effectiveness of alternate modalities for genetic results return, inform ongoing efforts to establish scalable approaches for effective return of genetic research results, and increase access to personal health information among African American women.
This study is a randomized controlled trial (RCT) within the Black Women's Health Study (BWHS) to test alternate communication modalities for results disclosure. The BWHS is an ongoing prospective cohort study of 59,000 self-identified black women from across the United States who have been followed since 1995. Targeted sequencing of over 4000 women within the cohort for BRCA1/2 and other known or suspected high and moderate penetrance genes opens up the possibility of returning breast cancer genetic results to BWHS participants and examining the clinical utility of genetic results return. The primary aim of the proposed research project is to compare the efficacy of two communication modalities for returning breast cancer genetic research results to African American women: 1) a conventional modality that entails telephone disclosure by a licensed genetic counselor, and 2) an online self-guided modality that entails returning results directly to participants, with optional genetic counselor follow-up via telephone. Secondary aims of this study will examine 1) moderators of the intervention impact and 2) psychosocial, sociodemographic, and clinical predictors of result uptake. This study is uniquely situated to provide critical empirical evidence on the effectiveness of alternate models for genetic results return and provide further insight into the factors influencing uptake of genetic information among African American women.
57 studies on the registry are indexed under Hereditary Breast and Ovarian Cancer Syndrome; 13 are open to participants now.
This study's enrollment of 926 is above the median of 121 across 40 interventional studies indexed under Hereditary Breast and Ovarian Cancer Syndrome.
Browse Hereditary Breast and Ovarian Cancer Syndrome studies →Boston University is the lead sponsor of 266 studies on the registry; 37 are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 24 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
-Women in the BWHS previously included in the targeted breast cancer sequencing project
Exclusion Criteria:
Control arm. Conventional modality entails telephone disclosure of genetic results by a licensed genetic counselor.
Online self-guided modality entails return of genetic results directly to participants, with optional genetic counselor follow-up via telephone.
Behavioral: Online modality · Behavioral: Genetic counselor follow-up
Return of BRCA results directly online or return of printed BRCA results if participant cannot access online or chooses not to
Also known as: Web modality
Optional genetic counselor follow-up over the telephone
Number of participant that decide to learn genetic results at 6 weeks
Decisions about learning genetic results for hereditary breast and ovarian cancer will be monitored and recorded in the electronic study database system.
Time frame: 6 weeks
Number of participant that decide to learn genetic results at 6 months
Decisions about learning genetic results for hereditary breast and ovarian cancer will be monitored and recorded in the electronic study database system.
Time frame: 6 months
Change from baseline in breast cancer genetics knowledge based on questionnaire at responses at 6 weeks
Knowledge about breast cancer genetics will be assessed using an investigator derived questionnaire consisting of 16 items. Higher scores out of ten are associated with more genetics knowledge.
Time frame: Baseline, 6 weeks
Change in baseline depression at 6 weeks
Depression will be assessed using the the 2-item Patient Health Questionnaire (PHQ-2). The 2 questions are: Over the past 2 weeks have you been bothered by: (1) Little interest or pleasure in doing things, and (2) Feeling down, depressed or hopeless. Responses range from 0 to 3 where 0=Not at all, to 3=Nearly everyday. Scores are added and can range from 0 to 6, with higher scores reflecting greater depression.
Time frame: Baseline, 6 weeks
Depression at 6 months
Depression will be assessed using the the 2-item Patient Health Questionnaire (PHQ-2). The 2 questions are: Over the past 2 weeks have you been bothered by: (1) Little interest or pleasure in doing things, and (2) Feeling down, depressed or hopeless. Responses range from 0 to 3 where 0=Not at all, to 3=Nearly everyday. Scores are added and can range from 0 to 6, with higher scores reflecting greater depression.
Time frame: 6 months
Depression at 12 months
Depression will be assessed using the the 2-item Patient Health Questionnaire (PHQ-2). The 2 questions are: Over the past 2 weeks have you been bothered by: (1) Little interest or pleasure in doing things, and (2) Feeling down, depressed or hopeless. Responses range from 0 to 3 where 0=Not at all, to 3=Nearly everyday. Scores are added and can range from 0 to 6, with higher scores reflecting greater depression.
Time frame: 12 months
Change in baseline anxiety at 6 weeks
Anxiety will be assessed using the the 2-item Generalized Anxiety Disorder scale (GAD-2). The 2 questions are: Over the past 2 weeks how often have you been bothered by the following problems: (1) Feeling nervous, anxious or on edge, and (2) Not being able to stop or control worrying. Responses range from 0 to 3 where 0=Not at all, to 3=Nearly everyday. Scores are added and can range from 0 to 6, with higher scores reflecting greater anxiety.
Time frame: Baseline, 6 weeks
Anxiety at 6 months
Anxiety will be assessed using the the 2-item Generalized Anxiety Disorder scale (GAD-2). The 2 questions are: Over the past 2 weeks how often have you been bothered by the following problems: (1) Feeling nervous, anxious or on edge, and (2) Not being able to stop or control worrying. Responses range from 0 to 3 where 0=Not at all, to 3=Nearly everyday. Scores are added and can range from 0 to 6, with higher scores reflecting greater anxiety.
Time frame: 6 months
Anxiety at 12 months
Anxiety will be assessed using the the 2-item Generalized Anxiety Disorder scale (GAD-2). The 2 questions are: Over the past 2 weeks how often have you been bothered by the following problems: (1) Feeling nervous, anxious or on edge, and (2) Not being able to stop or control worrying. Responses range from 0 to 3 where 0=Not at all, to 3=Nearly everyday. Scores are added and can range from 0 to 6, with higher scores reflecting greater anxiety.
Time frame: 12 months
Participant distress from cancer risk assessment (test-specific distress) at 6 weeks
Using the Multidimensional Impact of Cancer Risk Assessment (MICRA) distress subscale, the investigators will assess perceptions of distress resulting from learning genetic test results. The distress subscale has 6 items, each scored on a 4 point scale, with higher scores reflecting greater distress.
Time frame: 6 weeks
Participant distress from cancer risk assessment (test-specific distress) at 6 months
Using the Multidimensional Impact of Cancer Risk Assessment (MICRA) distress subscale, the investigators will assess perceptions of distress resulting from learning genetic test results. The distress subscale has 6 items, each scored on a 4 point scale, with higher scores reflecting greater distress.
Time frame: 6 months
Participant distress from cancer risk assessment (test-specific distress) at 12 months
Using the Multidimensional Impact of Cancer Risk Assessment (MICRA) distress subscale, the investigators will assess perceptions of distress resulting from learning genetic test results. The distress subscale has 6 items, each scored on a 4 point scale, with higher scores reflecting greater distress.
Time frame: 12 months
Participant uncertainty from cancer risk assessment at 6 weeks
Using the Multidimensional Impact of Cancer Risk Assessment (MICRA) uncertainty subscale, the investigators will assess perceptions of uncertainty resulting from learning genetic test results. Then uncertainty subscale has 9 items, each scored on a 4 point scale, with higher scores reflecting greater uncertainty.
Time frame: 6 weeks
Participant uncertainty from cancer risk assessment at 6 months
Using the Multidimensional Impact of Cancer Risk Assessment (MICRA) uncertainty subscale, the investigators will assess perceptions of uncertainty resulting from learning genetic test results. Then uncertainty subscale has 9 items, each scored on a 4 point scale, with higher scores reflecting greater uncertainty.
Time frame: 6 months
Participant uncertainty from cancer risk assessment at 12 months
Using the Multidimensional Impact of Cancer Risk Assessment (MICRA) uncertainty subscale, the investigators will assess perceptions of uncertainty resulting from learning genetic test results. Then uncertainty subscale has 9 items, each scored on a 4 point scale, with higher scores reflecting greater uncertainty.
Time frame: 12 months
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Plan to share: No
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Hereditary Breast and Ovarian Cancer Syndrome→
Boston University