Ignite Creation Date:
2024-05-06 @ 7:38 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06089954
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-07-01
First Post:
2023-08-21
Brief Title:
Penn Medicine Biobank Return of Results Program
Sponsor:
Abramson Cancer Center at Penn Medicine
Organization:
Abramson Cancer Center at Penn Medicine
Study Overview
Official Title:
A Randomized Study of Web Versus Genetic Counselor Return of Actionable Genetic Research Results to Biobank Participants
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ROR
Brief 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 eg 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 dont 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
Is sharing actionable genetic research results with participants through a multimedia patient-informed eHealth intervention eg 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 dont 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 eg 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 eHealthEDchatED 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 eg intervention usage sociodemographic factors genetic test result of short-term and longitudinal outcomes to understand who benefits more or less from eHealthchatbot education and eHealth return of result and b facilitators and barriers to implementation of eHealthchatbot interventions for return of actionable genetic research results and recommendations for future adaptation and sustainability
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 eg 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 eHealthEDchatED 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 eg intervention usage sociodemographic factors genetic test result of short-term and longitudinal outcomes to understand who benefits more or less from eHealthchatbot education and eHealth return of result and b facilitators and barriers to implementation of eHealthchatbot interventions for return of actionable genetic research results and recommendations for future adaptation and sustainability
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 853617 | OTHER | None | None |