Back to resultsPenn Biobank Return of Research Results Program
Primary Purpose
Cancer, Cardiovascular Diseases, Hereditary Cancer
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
e-Health (web-based) disclosure portal
Provider mediated disclosure
Sponsored by
About this trial
This is an interventional health services research trial for Cancer
Eligibility Criteria
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
Sites / Locations
- University of Pennsylvania
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Actionable gene result for cancer risk
Actionable gene result for cardiovascular disease risk
Arm Description
Outcomes
Primary Outcome Measures
Completion of surveys
Participant will self-complete surveys to collect psychological and knowledge outcomes
Secondary Outcome Measures
Full Information
NCT ID
NCT04242667
First Posted
January 24, 2020
Last Updated
August 21, 2023
Sponsor
University of Pennsylvania
Collaborators
Fox Chase Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT04242667
Brief Title
Penn Biobank Return of Research Results Program
Official Title
A Randomized Protocol Evaluating Return of Actionable Genetic Research Results to Biobank Participants
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
July 1, 2023 (Actual)
Study Completion Date
September 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
Fox Chase Cancer Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Cardiovascular Diseases, Hereditary Cancer, Hereditary Cardiac Amyloidosis
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Actionable gene result for cancer risk
Arm Type
Experimental
Arm Title
Actionable gene result for cardiovascular disease risk
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
e-Health (web-based) disclosure portal
Intervention Description
Patient uses secure web-based portal to access genetic research results
Intervention Type
Behavioral
Intervention Name(s)
Provider mediated disclosure
Intervention Description
Patient has disclosure of genetic research result by a provider (genetic counselor)
Primary Outcome Measure Information:
Title
Completion of surveys
Description
Participant will self-complete surveys to collect psychological and knowledge outcomes
Time Frame
Baseline survey prior to disclosure of results, and then two post-disclosure surveys at 2-7 days and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angela Bradbury, M.D.
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Penn Biobank Return of Research Results Program
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