Closing the GAPS: Guideline Adherence, Prevention and Surveillance in Hereditary Cancer
NCT ID: NCT06654466
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2025-12-01
2027-09-30
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Control Arm
Patients in the control arm will complete a standard genetic counseling or follow-up visit and a post-visit survey.
No interventions assigned to this group
Intervention Arm
Patients in the intervention arm will complete a genetic counseling or follow-up visit with a clinician using Nest Clinical Decision Support and a post visit-survey. Intervention arm patients will be given access to the Nest Patient Navigator.
Nest, an electronic medical record (EMR)-integrated software platform to deliver longitudinal, genetics-based care at scale.
The Nest software platform includes the Nest Care Studio, Nest Patient Navigator and the Analytics Dashboard. Nest Care Studio is a clinician facing portal that can be used standalone or electronic medical record (EMR) integrated. Care Studio enables clinicians to effectively manage patients' genetic information over time. Clinicians can see a list of patients that meet criteria for testing, run risk assessment calculations, order genetic tests, manage patients based on results and view education modules.The Nest Patient Navigator is a secure mobile device accessible platform that provides a centralized location for patients to store, manage, and follow-up with their genetic results. The Analytics Dashboard is an interactive dashboard that can track outcomes of genomic programs and trigger interventions to optimize them.
Interventions
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Nest, an electronic medical record (EMR)-integrated software platform to deliver longitudinal, genetics-based care at scale.
The Nest software platform includes the Nest Care Studio, Nest Patient Navigator and the Analytics Dashboard. Nest Care Studio is a clinician facing portal that can be used standalone or electronic medical record (EMR) integrated. Care Studio enables clinicians to effectively manage patients' genetic information over time. Clinicians can see a list of patients that meet criteria for testing, run risk assessment calculations, order genetic tests, manage patients based on results and view education modules.The Nest Patient Navigator is a secure mobile device accessible platform that provides a centralized location for patients to store, manage, and follow-up with their genetic results. The Analytics Dashboard is an interactive dashboard that can track outcomes of genomic programs and trigger interventions to optimize them.
Eligibility Criteria
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Inclusion Criteria
* previous cancer genetic testing with a finding of a pathogenic or likely pathogenic variant resulting in an increased risk of cancer warranting clinical management.
* English-speaking and -reading
* Receiving care at Dana Farber Cancer Institute
* Not in active cancer therapy at the time of approach
Exclusion Criteria
* 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
18 Years
49 Years
ALL
No
Sponsors
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Dana-Farber Cancer Institute
OTHER
National Human Genome Research Institute (NHGRI)
NIH
Nest Genomics
INDUSTRY
Responsible Party
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Principal Investigators
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Huma Q Rana, MD
Role: PRINCIPAL_INVESTIGATOR
Dana-Farber Cancer Institute
Jennifer W Mack, MD
Role: PRINCIPAL_INVESTIGATOR
Dana-Farber Cancer Institute
Locations
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Dana Farber Cancer Institute
Boston, Massachusetts, United States
Countries
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Central Contacts
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Related Links
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Nest Genomics
Other Identifiers
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22-657
Identifier Type: -
Identifier Source: org_study_id