Scalable Communication Modalities for Returning Genetic Research Results

Lynch Syndrome Clinical Trial

— BWHS RoR  

Official title:

Testing Scalable Communication Modalities for Returning Breast Cancer Genetic Research Results to African American Women

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04407611
• Other study ID #: H-40045
• Secondary ID: R01MD014312
• Status: Recruiting
• Phase: N/A
• Start date: March 6, 2023
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Boston University
• Contact: Catharine Wang, PhD
• Phone: 617-358-1475
• Email: clwang[@]bu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2275
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

-Women in the BWHS previously included in the targeted breast cancer sequencing project

Exclusion Criteria:

• Women with known cognitive impairments

• Women with variant of uncertain significance (VUS) results from the sequencing study

Related Conditions & MeSH terms

• Colorectal Neoplasms, Hereditary Nonpolyposis
• Hereditary Breast and Ovarian Cancer
• Hereditary Breast and Ovarian Cancer Syndrome
• Lynch Syndrome

Intervention

Behavioral:
• Online 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-up
Optional genetic counselor follow-up over the telephone

Locations

Country	Name	City	State
United States	BU School of Public Health, the research is being conducted remotely	Boston	Massachusetts

Sponsors (4)

Lead Sponsor	Collaborator
Boston University	MGH Institute of Health Professions, National Institute on Minority Health and Health Disparities (NIMHD), University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 weeks
Primary	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.	6 months
Primary	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.	Baseline, 6 weeks
Primary	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.	Baseline, 6 weeks
Primary	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.	6 months
Primary	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.	12 months
Primary	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.	Baseline, 6 weeks
Primary	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.	6 months
Primary	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.	12 months
Primary	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.	6 weeks
Primary	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.	6 months
Primary	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.	12 months
Primary	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.	6 weeks
Primary	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.	6 months
Primary	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.	12 months