Penn Biobank Return of Research Results Program

Not Applicable

Completed

• Conditions: Hereditary Cancer; Cancer; Hereditary Cardiac Amyloidosis; Cardiovascular Diseases
• Interventions: Behavioral: e-Health (web-based) disclosure portal; Behavioral: Provider mediated disclosure

• Registration Number: NCT04242667
• Lead Sponsor: Abramson Cancer Center at Penn Medicine

Brief Summary

The overall goal of the proposed research is to assess the feasibility of a randomized study evaluating the non-inferiority of an electronic Health (e-Health) delivery alternative (e.g. private web portal) as compared to return of actionable genetic research results with a genetic counselor.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-24
• Study First Submitted QC: 2020-01-24
• Study First Posted: 2020-01-27
• Study Start: 2020-03-01
• Primary Completion: 2023-04-11
• Study Completion: 2023-08-01
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-28
• Last Update Posted: 2024-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 260

Inclusion Criteria

1. Consented participant in University of Pennsylvania Biobank who previously submitted a DNA sample for research testing
2. English speaking
3. Aged 18 years or older
4. Agreed to be re-contacted in the future or did not indicate a preference on future contact regarding research results
5. Have an actionable mutation or have been selected as a control participant
6. Have not previously received actionable results of clinical genetic testing

Exclusion Criteria

1. Deceased assessed by electronic medical record, death index or identified after contact
2. Evidence in the electronic medical record that the subject has already received the same actionable result through clinical genetic testing

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Actionable gene result for cancer risk	Provider mediated disclosure	-
Actionable gene result for cardiovascular disease risk	Provider mediated disclosure	-
Actionable gene result for cancer risk	e-Health (web-based) disclosure portal	-
Actionable gene result for cardiovascular disease risk	e-Health (web-based) disclosure portal	-

Primary Outcome Measures

Name	Time	Method
Completion of surveys	Baseline survey prior to disclosure of results, and then two post-disclosure surveys at 2-7 days and 6 months	Participant will self-complete surveys to collect psychological and knowledge outcomes

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States