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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
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 moreAwards & 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a woman with unclear genetic test results.I have a known cognitive impairment.I was part of the breast cancer sequencing project in the BWHS.
Research Study Groups:
This trial has the following groups:- Group 1: Conventional modality
- Group 2: Online modality
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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