Penn Medicine Biobank Return of Results Program

Summary

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.

Conditions

• Genetic Disease
• Cancer
• Cardiovascular Diseases

Interventions

OTHER

private web-portal eHealth disclosure of genetic results

The intervention involves delivering actionable genetic research results to participants via a secure, private web-portal.

OTHER

eHealth education intervention (web or chatbot)

The intervention involves pre-disclosure education via an eHealth intervention (web or chatbot). The intervention will review the types of actionable results being returned, the method of return, the differences between research and clinical testing, the need for confirmation testing and the benefits, risks and limitations of receiving actionable genetic research results and study steps and procedures.

Sponsors & Collaborators

• Fox Chase Cancer Center

  collaborator OTHER

• Columbia University

  collaborator OTHER

• Thomas Jefferson University

  collaborator OTHER

• Abramson Cancer Center at Penn Medicine

  lead OTHER

Principal Investigators

• Angela Bradbury, MD · University of Pennsylvania

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-10-20

Primary Completion

2026-04-01

Completion

2026-08-31

Countries

• United States

Study Locations