Ignite Creation Date:
2024-05-06 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06184867
Status:
RECRUITING
Last Update Posted:
2024-01-05
First Post:
2023-11-07
Brief Title:
Choices About Genetic Testing And Learning Your Risk With Smart Technology
Sponsor:
Rutgers The State University of New Jersey
Organization:
Rutgers The State University of New Jersey
Study Overview
Official Title:
Choices About Genetic Testing And Learning Your Risk With Smart Technology
Status:
RECRUITING
Status Verified Date:
2024-01
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:
CATALYST
Brief Summary:
The goal of this observational study is to increase genetic education and genetic testing for hereditary cancer risk among cancer survivors
The study objectives are to
1 Finalize the development and optimize usability of the CATALYST digital intervention ie also known as relational assistant RA
2 Evaluate the feasibility and acceptability of a streamlined cancer genomic care delivery model in cancer survivors Participants will be randomized to one of two study arms the RA intervention vs enhanced usual care EUC
3 Assess GC and GT uptake and conduct a process evaluation to measure barriersfacilitators to GC GT and use of the CATALYST intervention and engagement with the RA
The study objectives are to
1 Finalize the development and optimize usability of the CATALYST digital intervention ie also known as relational assistant RA
2 Evaluate the feasibility and acceptability of a streamlined cancer genomic care delivery model in cancer survivors Participants will be randomized to one of two study arms the RA intervention vs enhanced usual care EUC
3 Assess GC and GT uptake and conduct a process evaluation to measure barriersfacilitators to GC GT and use of the CATALYST intervention and engagement with the RA
Detailed Description:
Research Design and Methods
This study encompasses refinement of the digital intervention prototype through usability and user interface testing and subsequent pilotfeasibility testing of a multi-level intervention CATALYST that includes a novel digital cancer genetic risk assistant that incorporates education decision support interactive smart technology and provides personalized information regarding hereditary cancer risk and genetic testing The study will be comprised of three intervention testing stages Phase 1 - User Testing Phase 2 - Usability Testing and Phase 3 - Pilot Testing
User testing and usability testing will be done to refine the intervention prototype by incorporating cancer patients feedback during each phase The feasibility and acceptability of the CATALYST intervention will be evaluated in a 2-armed randomized controlled pilot study Phase III of 30 individuals 15 in each study arm identified as high-risk for a hereditary cancer gene mutation according to NCCN Criteria The primary outcome of interest is GT uptake Data will be collected via guided interviews televideo or face-to-face in the clinic or other mutually convenient location community center for Phase I and Phase II Phase III surveys will be self-administered via the internet or interviewer administered via telephone Interviews and surveys will be comprised of open-ended and close-ended questions
This study encompasses refinement of the digital intervention prototype through usability and user interface testing and subsequent pilotfeasibility testing of a multi-level intervention CATALYST that includes a novel digital cancer genetic risk assistant that incorporates education decision support interactive smart technology and provides personalized information regarding hereditary cancer risk and genetic testing The study will be comprised of three intervention testing stages Phase 1 - User Testing Phase 2 - Usability Testing and Phase 3 - Pilot Testing
User testing and usability testing will be done to refine the intervention prototype by incorporating cancer patients feedback during each phase The feasibility and acceptability of the CATALYST intervention will be evaluated in a 2-armed randomized controlled pilot study Phase III of 30 individuals 15 in each study arm identified as high-risk for a hereditary cancer gene mutation according to NCCN Criteria The primary outcome of interest is GT uptake Data will be collected via guided interviews televideo or face-to-face in the clinic or other mutually convenient location community center for Phase I and Phase II Phase III surveys will be self-administered via the internet or interviewer administered via telephone Interviews and surveys will be comprised of open-ended and close-ended questions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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 |
|---|---|---|---|
| Pro2023000964 | OTHER | Rutgers The State University of New Jersey | None |