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| ID | Type | Description | Link |
|---|---|---|---|
| 1R42HG013908-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Dana-Farber Cancer Institute | OTHER |
| National Human Genome Research Institute (NHGRI) | NIH |
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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:
Researchers will compare Nest users to non-users to see if the Nest users are more likely to do recommended cancer screening.
Participants will:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, within 7 days of visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jennifer W Mack, MD | Contact | (617) 632-6622 | Jennifer_Mack@dfci.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Huma Q Rana, MD | Dana-Farber Cancer Institute | Principal Investigator |
| Jennifer W Mack, MD | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana Farber Cancer Institute | Recruiting | Boston | Massachusetts | 02215 | United States |
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| Label | URL |
|---|---|
| Nest Genomics | View source |
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| ID | Term |
|---|---|
| D009386 | Neoplastic Syndromes, Hereditary |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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