To hear about similar clinical trials, please enter your email below
Trial Title:
Penn Medicine Biobank Return of Results Program
NCT ID:
NCT06089954
Condition:
Genetic Disease
Cancer
Cardiovascular Diseases
Conditions: Official terms:
Cardiovascular Diseases
Genetic Diseases, Inborn
Conditions: Keywords:
Genetic counseling
Return of research results
Genetic testing
Study type:
Interventional
Study phase:
N/A
Overall status:
Enrolling by invitation
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Randomized non-inferiority trial
Primary purpose:
Health Services Research
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
private web-portal eHealth disclosure of genetic results
Description:
The intervention involves delivering actionable genetic research results to participants
via a secure, private web-portal.
Arm group label:
ROR Arm 2
Intervention type:
Other
Intervention name:
eHealth education intervention (web or chatbot)
Description:
The intervention involves pre-disclosure education via an eHealth intervention (web or
chatbot). The intervention will review the types of actionable results being returned,
the method of return, the differences between research and clinical testing, the need for
confirmation testing and the benefits, risks and limitations of receiving actionable
genetic research results and study steps and procedures.
Arm group label:
ROR Arm 1
Arm group label:
ROR Arm 2
Summary:
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.
Detailed description:
The scientific aims of the study are:
Aim 1 (Effectiveness of eHealth return of results): To evaluate in a randomized study
whether disclosure of actionable genetic results by an eHealth intervention (eHealthROR)
provides non-inferior short-term and longitudinal outcomes (knowledge, psychological
distress, health and psychosocial behaviors and costs) compared to phone disclosure by a
GC (e.g. usual care).
Aim 2 (eHealth education and assessing preferences): To evaluate: a) the uptake of
supplemental eHealth (eHealthED) and chatbot education (chatED) among 1250 Penn Biobank
research participants notified of the option to opt-out of receipt of actionable genetic
research results; b) the frequency of opting-out of receipt of actionable genetic
research results; and c) the impact of eHealthED/chatED use on opting out of receipt of
results.
Aim 3 (Implementation): To conduct a multi-stakeholder mixed-methods process evaluation,
to understand: a) potential moderators (e.g. intervention usage, sociodemographic
factors, genetic test result) of short-term and longitudinal outcomes to understand who
benefits more or less from eHealth/chatbot education and eHealth return of result; and b)
facilitators and barriers to implementation of eHealth/chatbot interventions for return
of actionable genetic research results and recommendations for future adaptation and
sustainability.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Pennsylvania
Address:
City:
Philadelphia
Zip:
19104
Country:
United States
Start date:
October 20, 2023
Completion date:
July 1, 2025
Lead sponsor:
Agency:
Abramson Cancer Center at Penn Medicine
Agency class:
Other
Collaborator:
Agency:
Fox Chase Cancer Center
Agency class:
Other
Collaborator:
Agency:
Columbia University
Agency class:
Other
Collaborator:
Agency:
Thomas Jefferson University
Agency class:
Other
Source:
Abramson Cancer Center at Penn Medicine
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06089954
