Penn Biobank Return of Research Results Program
Not Applicable
Completed
- Conditions
- Hereditary CancerCancerHereditary Cardiac AmyloidosisCardiovascular Diseases
- Registration Number
- NCT04242667
- Lead Sponsor
- Abramson Cancer Center at Penn Medicine
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 260
Inclusion Criteria
- Consented participant in University of Pennsylvania Biobank who previously submitted a DNA sample for research testing
- English speaking
- Aged 18 years or older
- Agreed to be re-contacted in the future or did not indicate a preference on future contact regarding research results
- Have an actionable mutation or have been selected as a control participant
- Have not previously received actionable results of clinical genetic testing
Exclusion Criteria
- Deceased assessed by electronic medical record, death index or identified after contact
- Evidence in the electronic medical record that the subject has already received the same actionable result through clinical genetic testing
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Completion of surveys Baseline survey prior to disclosure of results, and then two post-disclosure surveys at 2-7 days and 6 months Participant will self-complete surveys to collect psychological and knowledge outcomes
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular pathways are targeted by actionable genetic variants in hereditary cancers and TTR-related amyloidosis?
How does e-Health portal delivery of genetic results compare to genetic counseling in patient comprehension and adherence?
Which predictive biomarkers identify Penn Biobank participants most likely to benefit from electronic genetic result disclosure?
What adverse psychological effects arise from electronic disclosure of hereditary cancer risks, and how are they managed?
Are there alternative digital health platforms for returning genetic results in cardiovascular and oncology settings?
Trial Locations
- Locations (1)
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
University of Pennsylvania🇺🇸Philadelphia, Pennsylvania, United States