Hereditary Breast and Ovarian CancerBWHS RoRNCT04407611
Scalable Communication Modalities for Returning Genetic Research Results
A study testing Online modality and Genetic counselor follow-up in people with Hereditary Breast and Ovarian Cancer and Lynch Syndrome, run by Boston University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Hereditary Breast and Ovarian Cancer, Lynch Syndrome
- What is being tested?
- Online modality and Genetic counselor follow-up
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 926 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2023to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -Women in the BWHS previously included in the targeted breast cancer sequencing project
Who cannot join
- Women with known cognitive impairments
- Women with variant of uncertain significance (VUS) results from the sequencing study
Trial locations and contacts
1 site in 1 country.
United States1 site
BU School of Public Health, the research is being conducted remotely
Boston, Massachusetts, 02118
About this study
Official title: Testing Scalable Communication Modalities for Returning Breast Cancer Genetic Research Results to African American Women
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.
Read the detailed description
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.
- Being tested
- Online modality, Genetic counselor follow-up
- Keywords
- BRCA testing, Return of genetic research results, eHealth, Digital health, Risk communication, ELSI
- Medical subject headings
- Hereditary Breast and Ovarian Cancer Syndrome, Colorectal Neoplasms, Hereditary Nonpolyposis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online modalityBehavioural
Also called Web modality
Return of BRCA results directly online or return of printed BRCA results if participant cannot access online or chooses not to
Genetic counselor follow-upBehavioural
Optional genetic counselor follow-up over the telephone
| Study group | Role | What they receive |
|---|---|---|
| Conventional modality | No intervention | Control arm. Conventional modality entails telephone disclosure of genetic results by a licensed genetic counselor. |
| Online modality | Experimental | Online self-guided modality entails return of genetic results directly to participants, with optional genetic counselor follow-up via telephone. Receives: Behavioral: Online modality; Behavioral: Genetic counselor follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2020
- Study start6 Mar 2023
- Primary completion31 Mar 2026
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hereditary Breast and Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization to 1 of 2 study arms.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 926 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington, MGH Institute of Health Professions, National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Catharine Wang, PhD, Principal investigator, BU School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04407611
- Sponsor's protocol ID
- H-40045
- Other IDs
- R01MD014312
- Acronym
- BWHS RoR
- Status last verified
- Mar 2026
- First submitted
- 21 May 2020
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang C, Bertrand KA, Trevino-Talbot M, Flynn M, Ruderman M, Cabral HJ, Bowen DJ, Hughes-Halbert C, Palmer JR. Ethical, legal, and social implications (ELSI) and challenges in the design of a randomized controlled trial to test the online return of cancer genetic research results to U.S. Black women. Contemp Clin Trials. 2023 Sep;132:107309. doi: 10.1016/j.cct.2023.107309. Epub 2023 Jul 27.
PubMed 37516165
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing Scalable Communication Modalities for Returning Breast Cancer Genetic Research Results to African American Women
- ClinicalTrials.gov ID
- NCT04407611
- Acronym / sponsor ID
- BWHS RoR / H-40045
- Keywords
- BRCA testing, Return of genetic research results, eHealth, Digital health, Risk communication, ELSI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 926 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- University of Washington, MGH Institute of Health Professions, National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 6 Mar 2023 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 29 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomization to 1 of 2 study arms.
| Arm | Type | Receives |
|---|---|---|
| Conventional modality | No intervention | –Control arm. Conventional modality entails telephone disclosure of genetic results by a licensed genetic counselor. |
| Online modality | Experimental | Behavioral: Online modality, Behavioral: Genetic counselor follow-upOnline self-guided modality entails return of genetic results directly to participants, with optional genetic counselor follow-up via telephone. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -Women in the BWHS previously included in the targeted breast cancer sequencing project
Key exclusion criteria (2 listed)
- Women with known cognitive impairments
- Women with variant of uncertain significance (VUS) results from the sequencing study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online modalityAlso: Web modalityReturn of BRCA results directly online or return of printed BRCA results if participant cannot access online or chooses not to | Behavioural | Online modality |
| Genetic counselor follow-upOptional genetic counselor follow-up over the telephone | Behavioural | Online modality |
Primary outcome
Number of participant that decide to learn genetic results at 6 weeks
Time frame: 6 weeks
Decisions about learning genetic results for hereditary breast and ovarian cancer will be monitored and recorded in the electronic study database system.
Number of participant that decide to learn genetic results at 6 months
Time frame: 6 months
Decisions about learning genetic results for hereditary breast and ovarian cancer will be monitored and recorded in the electronic study database system.
Change from baseline in breast cancer genetics knowledge based on questionnaire at responses at 6 weeks
Time frame: Baseline, 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.
Change in baseline depression at 6 weeks
Time frame: Baseline, 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.
Depression at 6 months
Time frame: 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.
Depression at 12 months
Time frame: 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.
Change in baseline anxiety at 6 weeks
Time frame: Baseline, 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.
Anxiety at 6 months
Time frame: 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.
Anxiety at 12 months
Time frame: 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.
Participant distress from cancer risk assessment (test-specific distress) at 6 weeks
Time frame: 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.
Participant distress from cancer risk assessment (test-specific distress) at 6 months
Time frame: 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.
Participant distress from cancer risk assessment (test-specific distress) at 12 months
Time frame: 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.
Participant uncertainty from cancer risk assessment at 6 weeks
Time frame: 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.
Participant uncertainty from cancer risk assessment at 6 months
Time frame: 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.
Participant uncertainty from cancer risk assessment at 12 months
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Derived from this study: PubMed 37516165Wang C, Bertrand KA, Trevino-Talbot M, Flynn M, Ruderman M, Cabral HJ, Bowen DJ, Hughes-Halbert C, Palmer JR. Ethical, legal, and social implications (ELSI) and challenges in the design of a randomized controlled trial to test the online return of cancer genetic research results to U.S. Black women. Contemp Clin Trials. 2023 Sep;132:107309. doi: 10.1016/j.cct.2023.107309. Epub 2023 Jul 27.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catharine Wang, PhD principal investigator
BU School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online modality and Genetic counselor follow-up in people with Hereditary Breast and Ovarian Cancer and Lynch Syndrome, run by Boston University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participant that decide to learn genetic results at 6 weeks (time frame: 6 weeks). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04407611, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.