Clinical trial NCT06654466: Closing the GAPS: Guideline Adherence, Prevention and Surveillance in Hereditary Cancer
Official title: Enhancing Information Management for Young Adults After Genetic Cancer Risk Testing
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hereditary Cancer Syndromes
Clinical Decision Support
Keywords: Hereditary Cancer Syndromes
Cancer Surveillance
Cancer Prevention
Guideline Adherence
Clinical Decision Support
Adolescent and Young Adult Cancer
Lead sponsor: Nest Genomics
Sponsor class: INDUSTRY
Collaborators: name: Dana-Farber Cancer Institute
name: National Human Genome Research Institute (NHGRI)
First posted: 2024-10-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DEVICE_FEASIBILITY

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Acceptability of Intervention Measure (AIM)
timeFrame: within 7 days of visit
measure: Gist Comprehension of Genetic Cancer Risk
timeFrame: Baseline, within 7 days of visit
measure: Knowledge of Cancer Screening
timeFrame: Baseline, within 7 days of visit
measure: Psychosocial Aspects of Hereditary Cancer (PAHC)
timeFrame: Baseline, within 7 days of visit
measure: Distress Thermometer (DT)
timeFrame: Baseline, within 7 days of visit
Secondary outcomes:
measure: Uncertainty of Illness Measures
timeFrame: Baseline, within 7 days of visit
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Huma Q Rana, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dana-Farber Cancer Institute
name: Jennifer W Mack, MD
role: PRINCIPAL_INVESTIGATOR
References: