Penn Biobank Return of Research Results Program

Abramson Cancer Center at Penn Medicine

Status: Completed

Conditions: Hereditary Cardiac Amyloidosis; Hereditary Cancer; Cardiovascular Diseases; Cancer

Treatments: Behavioral: e-Health (web-based) disclosure portal; Behavioral: Provider mediated disclosure

Study type: Interventional

Funder types: Other

Identifiers

NCT04242667

833373

UPCC 08021

Details and patient eligibility

About

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.

Enrollment: 260 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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260 participants in 2 patient groups

Actionable gene result for cancer risk

Experimental group

Treatment:

Behavioral: Provider mediated disclosure

Behavioral: e-Health (web-based) disclosure portal

Actionable gene result for cardiovascular disease risk

Experimental group

Treatment:

Behavioral: Provider mediated disclosure

Behavioral: e-Health (web-based) disclosure portal