NCT04407611

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
926

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 21, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 29, 2020

Completed
2.8 years until next milestone

Study Start

First participant enrolled

March 6, 2023

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

April 1, 2026

Status Verified

March 1, 2026

Enrollment Period

3.1 years

First QC Date

May 21, 2020

Last Update Submit

March 31, 2026

Conditions

Hereditary Breast and Ovarian CancerLynch Syndrome

Keywords

BRCA testingReturn of genetic research resultseHealthDigital healthRisk communicationELSI

Outcome Measures

Primary Outcomes (15)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

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.

Behavioral: Online modalityBehavioral: Genetic counselor follow-up

Interventions

Online modalityBEHAVIORAL

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
Online modality
Genetic counselor follow-upBEHAVIORAL

Optional genetic counselor follow-up over the telephone

Online modality

Eligibility Criteria

Age40 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BU School of Public Health, the research is being conducted remotely

Boston, Massachusetts, 02118, United States

Location

Related Publications (1)

  • 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.

    PMID: 37516165DERIVED

MeSH Terms

Conditions

Hereditary Breast and Ovarian Cancer SyndromeColorectal Neoplasms, Hereditary Nonpolyposis

Condition Hierarchy (Ancestors)

Breast NeoplasmsNeoplasms by SiteNeoplasmsOvarian NeoplasmsEndocrine Gland NeoplasmsNeoplastic Syndromes, HereditaryOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesEndocrine System DiseasesGonadal DisordersColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesDNA Repair-Deficiency DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Catharine Wang, PhD

    BU School of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomization to 1 of 2 study arms.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2020

First Posted

May 29, 2020

Study Start

March 6, 2023

Primary Completion

March 31, 2026

Study Completion

March 31, 2026

Last Updated

April 1, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)