Penn Medicine Biobank Return of Results Program

Running, not enrolling · Not applicable

Conditions studied: Genetic Disease, Cancer, Cardiovascular Diseases

In brief

The goal of this hybrid type 1 effectiveness-implementation study is to evaluate and compare different ways of delivering genetic research results to participants. The main questions the study aims to answer are: * Is sharing actionable genetic research results with participants through a multimedia patient-informed eHealth intervention (e.g. patient portal) no worse than sharing results by telephone or videoconference with a genetic counselor? * Will research participants access an eHealth educational intervention or chatbot education to learn about research results being offered and the option to decline learning their individual research results and how frequently participants choose to decline actionable research results? * Who benefits less and more from digital intervention with return of actionable research results and what barriers exist to using these tools for return of research results outside this study? Participants in the biobank will be offered digital tools to learn about research results being offered and the option to decline receiving these results. Those who don't decline and have an actionable result will be randomly assigned to receive their results with a genetic counselor or through an eHealth portal. Participants will complete surveys before and after receipt of results to understand patient experiences with these methods of education and return of results to determine if digital tools can be used to help ensure more patients get access to research results which could impact their health.

Key facts

Study ID

NCT06089954

Run by

Abramson Cancer Center at Penn Medicine

People needed

2500

Starts

2023-10-20

Expected to finish

2026-09-30

Last updated by the study team

2026-05-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Potential subjects will include select individuals who participated in Penn Medicine Biobank, Institutional Review Board (IRB) protocol number 813913.
• English speaking
• Age 18 years or older
• Have an actionable genetic mutation (See Appendix A) or have been selected as a control participant
• Agreed to be re-contacted in the future or were not provided the opportunity to indicate a preference

You may not qualify if…

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

Where it is running

• University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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