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Online Communication Modalities for Genetic Results Communication (BWHS RoR Trial)

N/A
Recruiting
Led By Catharine Wang, PhD
Research Sponsored by Boston University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Women with known cognitive impairments
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial examines the efficiency of an online program to provide genetic results to African American women, helping to provide personal health information & increase access to precision medicine.

Who is the study for?
This trial is for African American women who were part of the BWHS breast cancer sequencing project. It's not open to those with uncertain genetic test results or known cognitive impairments.
What is being tested?
The study tests an online self-guided program for returning genetic results related to certain cancers, comparing it with follow-up by a genetic counselor. The goal is to find scalable ways to share health information effectively.
What are the potential side effects?
Since this trial involves informational interventions rather than medical treatments, traditional physical side effects are not applicable. However, participants may experience stress or anxiety from learning about their genetic risks.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a known cognitive impairment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Anxiety at 12 months
Anxiety
Change from baseline in breast cancer genetics knowledge based on questionnaire at responses at 6 weeks
+12 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Online modalityExperimental Treatment2 Interventions
Online self-guided modality entails return of genetic results directly to participants, with optional genetic counselor follow-up via telephone.
Group II: Conventional modalityActive Control1 Intervention
Control arm. Conventional modality entails telephone disclosure of genetic results by a licensed genetic counselor.

Find a Location

Who is running the clinical trial?

National Institute on Minority Health and Health Disparities (NIMHD)NIH
434 Previous Clinical Trials
1,376,558 Total Patients Enrolled
MGH Institute of Health ProfessionsOTHER
16 Previous Clinical Trials
1,348 Total Patients Enrolled
University of WashingtonOTHER
1,820 Previous Clinical Trials
1,912,427 Total Patients Enrolled

Media Library

Online modality Clinical Trial Eligibility Overview. Trial Name: NCT04407611 — N/A
Breast and Ovarian Cancer Research Study Groups: Conventional modality, Online modality
Breast and Ovarian Cancer Clinical Trial 2023: Online modality Highlights & Side Effects. Trial Name: NCT04407611 — N/A
Online modality 2023 Treatment Timeline for Medical Study. Trial Name: NCT04407611 — N/A
~0 spots leftby Dec 2024