Closing the GAPS: Guideline Adherence, Prevention and Surveillance in Hereditary Cancer
- Conditions
- Hereditary Cancer SyndromesClinical Decision Support
- Registration Number
- NCT06654466
- Lead Sponsor
- Nest Genomics
- 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
- 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 and/or 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 100
- Ages 18-39 years, inclusive
- Has a known pathogenic or likely pathogenic variant in a hereditary cancer syndrome gene and has had these results disclosed to them by a clinician.
- English-speaking and -reading
- Receiving care at Dana Farber Cancer Institute
- Not in active cancer therapy at the time of approach
- Age <18 or >39 years
- Has not had genetic testing for hereditary cancer syndromes or has been tested but no pathogenic or likely pathogenic variant was identified.
- Non-English speaking and reading
- Not receiving care at Dana Farber Cancer Institute
- Active cancer with therapy in progress
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Acceptability of Intervention Measure (AIM) within 7 days of visit A 4-item measure of intervention acceptability on a 5-point Likert response scale designed for a range of stakeholders. Demonstrated to be associated with intervention success.
Gist Comprehension of Genetic Cancer Risk Baseline, within 7 days of visit Modified items from the Gist Comprehension of Genetic Cancer Risk (alpha=.85) ask patients their likelihood of future cancer on a 5-point Likert scale, higher score indicating greater comprehension.
Knowledge of Cancer Screening Baseline, within 7 days of visit An 11-item true-false scale (Cronbach's alpha=.81) will measure knowledge of cancer screening recommendations. Higher score indicates greater knowledge, minimum score=0, maximum score=11. Items will be modified for cancer risk syndromes under study.
Psychosocial Aspects of Hereditary Cancer (PAHC) Baseline, within 7 days of visit A 26-item questionnaire organized into six problem domains: genetics, practical issues, family, living with cancer, emotions, and children. Higher score indicates greater emotional distress. Validated in adults with hereditary cancer risk.
Distress Thermometer (DT) Baseline, within 7 days of visit A visual-analog scale from 0-"no distress" to 10-"extreme distress" to assess general psychological distress. Higher score indicates greater distress. Pairing with the PAHC enhances sensitivity and specificity.
- Secondary Outcome Measures
Name Time Method Uncertainty of Illness Measures Baseline, within 7 days of visit 18-39 self-report - Mischel Illness Uncertainty Scale (Cronbach's α=.74-.92).5-point Likert scale ranging from "Strongly Agree" to "Strongly Disagree". Higher scores indicate greater uncertainty.
Trial Locations
- Locations (1)
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States