Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06654466
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-18
Brief Title:
Closing the GAPS Guideline Adherence Prevention and Surveillance in Hereditary Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Enhancing Information Management for Young Adults After Genetic Cancer Risk Testing
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to see if a software platform can improve cancer screening in young adults with genetic risk for cancer
The trial will also help improve the software platform Nest The main questions it aims to answer are
Do Nest users know more about their cancer risks and recommended care than non-users
Do Nest users have less psychological distress than non-users
Do Nest users share cancer risks with family and other doctors more than non-users
Are Nest users more likely than non-users to have up-to-date care plans
Researchers will compare Nest users to non-users to see if the Nest users are more likely to do recommended cancer screening
Participants will
Have a genetic counseling or follow up visit
Take a post-visit survey
Intervention arm only use the Nest Patient Navigator
Complete screening and follow-up care recommended by doctors
The trial will also help improve the software platform Nest The main questions it aims to answer are
Do Nest users know more about their cancer risks and recommended care than non-users
Do Nest users have less psychological distress than non-users
Do Nest users share cancer risks with family and other doctors more than non-users
Are Nest users more likely than non-users to have up-to-date care plans
Researchers will compare Nest users to non-users to see if the Nest users are more likely to do recommended cancer screening
Participants will
Have a genetic counseling or follow up visit
Take a post-visit survey
Intervention arm only use the Nest Patient Navigator
Complete screening and follow-up care recommended by doctors
Detailed Description:
The overall objective of this project is to refine and study Nest a software platform that integrates genetic data into patient care with a goal of improving adherence to recommended care and empowering patients and clinicians to utilize genetic information longitudinally Nest stores structured genetic results in the electronic medical record EMR and provides an interface for clinicians to order guidelines-based personalized care plans with automated charting For patients the mobile friendly platform serves as a secure tool to store results understand risks and recommended care adhere to care and share results with at-risk relatives To facilitate continuity of care patients can share genetic results and care plans with other clinicians For this application the investigators propose two phases During Phase 1 the investigators will pilot the EMR-integrated Nest platform to ensure that the intervention is feasible and acceptable to clinicians and patients Phase 2 will test Nest efficacy to improve patient and clinician experiences and outcomes including patient knowledge of cancer risks and recommended care and will assess implementation outcomes to facilitate future dissemination The investigators will leverage a team with complementary expertise in genomic data business software development and care of young adults with cancer risk This team has already successfully collaborated in development of a patient-facing intervention for adolescents and young adults AYAs with cancer risk syndromes and now seeks to meet the critical need for integrated and coordinated care crossing patients clinicians and health systems The long-term goal of this application is to harness an EMR integrated platform to improve care and outcomes for AYAs with cancer risk syndromes as an initial step toward genomic data integration for an ever-increasing array of conditions with clinical implications
Phase 1 Aims
Aim 1 Pilot Nest among 20 young adult hereditary cancer patients and up to 20 clinicians refining implementation to ensure feasibility and acceptability Our working hypothesis is that the Nest intervention will be feasible and acceptable to patients and clinicians
Phase 2 Aims
In Phase 2 the investigators will Implement the Nest intervention by conducting a randomized trial at a single large cancer center and its associated community-based satellites
Aim 1 Measure the impact of the Nest intervention on patient knowledge of cancer risk and recommended care psychological distress and information sharing with family and clinicians
Our working hypothesis is that patients assigned to the Nest intervention will have increased knowledge of cancer risks and recommended care without increased psychological distress and will have increased frequency of information sharing with family and other clinicians
Aim 2 Examine impact of the Nest intervention on clinician behavior including guideline-concordant orders and referrals as well as EMR documentation Our working hypothesis is that patients assigned to the Nest intervention will have higher rates of guidelines-concordant orders and referrals and Nest Clinical Decision Support CDS summaries in EMR documentation
Aim 3 Evaluate implementation outcomes including patient and clinician utilization of Nest features to facilitate future dissemination The investigators will examine the frequency of utilization of Nest features including patient access and sharing of information and clinician use of orders and documentation templates to assess features that are most useful andor in need of further refinement
Impact At the completion of the proposed research our expected outcomes are to have a refined platform that results in increased knowledge information sharing and guidelines concordant care
Phase 1 Aims
Aim 1 Pilot Nest among 20 young adult hereditary cancer patients and up to 20 clinicians refining implementation to ensure feasibility and acceptability Our working hypothesis is that the Nest intervention will be feasible and acceptable to patients and clinicians
Phase 2 Aims
In Phase 2 the investigators will Implement the Nest intervention by conducting a randomized trial at a single large cancer center and its associated community-based satellites
Aim 1 Measure the impact of the Nest intervention on patient knowledge of cancer risk and recommended care psychological distress and information sharing with family and clinicians
Our working hypothesis is that patients assigned to the Nest intervention will have increased knowledge of cancer risks and recommended care without increased psychological distress and will have increased frequency of information sharing with family and other clinicians
Aim 2 Examine impact of the Nest intervention on clinician behavior including guideline-concordant orders and referrals as well as EMR documentation Our working hypothesis is that patients assigned to the Nest intervention will have higher rates of guidelines-concordant orders and referrals and Nest Clinical Decision Support CDS summaries in EMR documentation
Aim 3 Evaluate implementation outcomes including patient and clinician utilization of Nest features to facilitate future dissemination The investigators will examine the frequency of utilization of Nest features including patient access and sharing of information and clinician use of orders and documentation templates to assess features that are most useful andor in need of further refinement
Impact At the completion of the proposed research our expected outcomes are to have a refined platform that results in increased knowledge information sharing and guidelines concordant care
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None