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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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

Eligibility

Primary outcome measure(s)

• 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.

Trial sites (1)