Cancer, Cardiovascular Diseases, Hereditary Cancer, Hereditary Cardiac Amyloidosis
Conditions
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.
Interventions
BEHAVIORALe-Health (web-based) disclosure portal
Patient uses secure web-based portal to access genetic research results
BEHAVIORALProvider mediated disclosure
Patient has disclosure of genetic research result by a provider (genetic counselor)
Sponsors
Fox Chase Cancer Center
Abramson Cancer Center at Penn Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Consented participant in University of Pennsylvania Biobank who previously submitted a DNA sample for research testing 2. English speaking 3. Aged 18 years or older 4. Agreed to be re-contacted in the future or did not indicate a preference on future contact regarding research results 5. Have an actionable mutation or have been selected as a control participant 6. Have not previously received actionable results of clinical genetic testing
Exclusion criteria
1. Deceased assessed by electronic medical record, death index or identified after contact 2. Evidence in the electronic medical record that the subject has already received the same actionable result through clinical genetic testing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed