Clinical trial · Interventional
Penn Medicine Biobank Return of Results Program
A Randomized Study of Web Versus Genetic Counselor Return of Actionable Genetic Research Results to Biobank Participants
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Cardiovascular Diseases | — | UNRESOLVED | — |
| Genetic Disease | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| eHealth education intervention (web or chatbot) | Other | — | UNRESOLVED |
| private web-portal eHealth disclosure of genetic results | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- ROR Arm 1
- description
- Disclosure of results with a Genetic Counselor.
- interventionNames
- Other: eHealth education intervention (web or chatbot)
- type
- EXPERIMENTAL
- label
- ROR Arm 2
- description
- eHealth disclosure of results by private web-portal (with option to speak with a GC).
- interventionNames
- Other: private web-portal eHealth disclosure of genetic results
- Other: eHealth education intervention (web or chatbot)
Primary outcomes (3)
- measure
- Understanding of Genetic Information
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (0)
Data not yet available