Closing the GAPS: Guideline Adherence, Prevention and Surveillance in Hereditary Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-49
SponsorNest Genomics
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Nest, an electronic medical record (EMR)-integrated software platform to deliver longitudinal, genetics-based care at scale.
DeviceThe 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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Control ArmNo intervention 0 interventions
Group B: Intervention ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
within 7 days of visit2
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.
Time frame
Baseline, within 7 days of visit3
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.
Time frame
Baseline, within 7 days of visit4
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.
Time frame
Baseline, within 7 days of visitSecondary outcomes
1
Uncertainty of Illness Measures
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.
Time frame
Baseline, within 7 days of visitSponsors and contacts
Click on the lead sponsor to view all of their trials.
Nest Genomics
Lead sponsor
Dana-Farber Cancer Institute
Collaborator
National Human Genome Research Institute (NHGRI)
Collaborator
Source ClinicalTrials.gov