eHealth Disclosure for Genetic Disorder Results

(ROR Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Angela Bradbury, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Pennsylvania

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Angela Bradbury, MD

Principal Investigator

University of Pennsylvania

Eligibility Criteria

This trial is for English-speaking adults over 18 who are part of the Penn Medicine Biobank and have an actionable genetic mutation or are control participants. They must be willing to be re-contacted. Those already aware of their genetic results through clinical testing cannot join.

Inclusion Criteria

English speaking

I am 18 years old or older.

I am open to future contact or wasn't asked about my preference.

Exclusion Criteria

This criterion is not applicable to a living patient's perspective.

Evidence in the clinical record that the subject has already received the same actionable result through clinical genetic testing

Treatment Details

Interventions

• eHealth Education Intervention (Web or Chatbot) (Behavioural Intervention)
• Private Web-Portal eHealth Disclosure of Genetic Results (Behavioural Intervention)

Trial Overview The study compares two methods of delivering genetic research results: via a multimedia eHealth intervention (like a patient portal) or directly from a genetic counselor by phone/video. It will assess participant engagement with digital tools and willingness to learn about their genetics.

Participant Groups

Group I: ROR Arm 2 Experimental Treatment 2 Interventions

eHealth disclosure of results by private web-portal (with option to speak with a GC).

Group II: ROR Arm 1 Experimental Treatment 1 Intervention

Disclosure of results with a Genetic Counselor.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Pennsylvania Philadelphia, PA

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2118

Patients Recruited

45,270,000+

Abramson Cancer Center at Penn Medicine

Lead Sponsor

Trials

425

Patients Recruited

464,000+

Thomas Jefferson University

Collaborator

Trials

475

Patients Recruited

189,000+

Fox Chase Cancer Center

Collaborator

Trials

236

Patients Recruited

39,300+

Columbia University

Collaborator

Trials

1529

Patients Recruited

2,832,000+