Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
2500 participants
INTERVENTIONAL
2023-10-20
2026-03-31
Brief Summary
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* 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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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ROR Arm 1
Disclosure of results with a Genetic Counselor.
eHealth education intervention (web or chatbot)
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.
ROR Arm 2
eHealth disclosure of results by private web-portal (with option to speak with a GC).
private web-portal eHealth disclosure of genetic results
The intervention involves delivering actionable genetic research results to participants via a secure, private web-portal.
eHealth education intervention (web or chatbot)
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.
Interventions
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private web-portal eHealth disclosure of genetic results
The intervention involves delivering actionable genetic research results to participants via a secure, private web-portal.
eHealth education intervention (web or chatbot)
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Evidence in the clinical record that the subject has already received the same actionable result through clinical genetic testing
18 Years
ALL
No
Sponsors
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Fox Chase Cancer Center
OTHER
Columbia University
OTHER
Thomas Jefferson University
OTHER
Abramson Cancer Center at Penn Medicine
OTHER
Responsible Party
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Principal Investigators
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Angela Bradbury, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Locations
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University of Pennsylvania
Philadelphia, Pennsylvania, United States
Countries
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Other Identifiers
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853617
Identifier Type: OTHER
Identifier Source: secondary_id
UPCC 10023
Identifier Type: -
Identifier Source: org_study_id
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