Closing the GAPS: Guideline Adherence, Prevention and Surveillance in Hereditary Cancer

NCT06654466 | Recruiting

• 2 other identifiers: 22-6571R42HG013908-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Clinical Decision Support; Hereditary Cancer Syndromes

Keywords

Hereditary Cancer Syndromes; Cancer Surveillance; Cancer Prevention; Guideline Adherence; Clinical Decision Support; Adolescent and Young Adult Cancer

Outcome Measures

Primary Outcomes (5)

• Acceptability of Intervention Measure (AIM)

  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.

  within 7 days of visit

• Gist Comprehension of Genetic Cancer Risk

  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.

  Baseline, within 7 days of visit

• Knowledge of Cancer Screening

  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.

  Baseline, within 7 days of visit

• Psychosocial Aspects of Hereditary Cancer (PAHC)

  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.

  Baseline, within 7 days of visit

• Distress Thermometer (DT)

  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.

  Baseline, within 7 days of visit

Secondary Outcomes (1)

• Uncertainty of Illness Measures

  Baseline, within 7 days of visit

Study Arms (2)

Control Arm

NO INTERVENTION

Patients in the control arm will complete a standard genetic counseling or follow-up visit and a post-visit survey.

Intervention Arm

EXPERIMENTAL

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.

Device: Nest, an electronic medical record (EMR)-integrated software platform to deliver longitudinal, genetics-based care at scale.

Interventions

Nest, an electronic medical record (EMR)-integrated software platform to deliver longitudinal, genetics-based care at scale. DEVICE

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.

Intervention Arm

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Ages 18-49 years, inclusive
• 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

You may not qualify if:

• Age \<18 or \>49 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

Sponsors & Collaborators

• Nest Genomics: lead
• Dana-Farber Cancer Institute: collaborator
• National Human Genome Research Institute (NHGRI): collaborator

Study Sites (1)

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

Related Links

• Nest Genomics

MeSH Terms

Conditions

Neoplastic Syndromes, Hereditary

Condition Hierarchy (Ancestors)

Neoplasms; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Huma Q Rana, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

• Jennifer W Mack, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer W Mack, MD

CONTACT

(617) 632-6622; Jennifer_Mack@dfci.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2024
• First Posted: October 23, 2024
• Study Start: February 10, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: February 25, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)