Enhancing Information Management for Young Adults After Genetic Cancer Risk Testing
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Acceptability of Intervention Measure (AIM)
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Control Arm
Patients in the control arm will complete a standard genetic counseling or follow-up visit and a post-visit survey.
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.
干预措施: Nest, an electronic medical record (EMR)-integrated software platform to deliver longitudinal, genetics-based care at scale. (Device)
结局指标
主要结局
Acceptability of Intervention Measure (AIM)
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: 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)
时间窗: 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.
次要结局
- Uncertainty of Illness Measures(Baseline, within 7 days of visit)
- Uncertainty of Illness Measures(Baseline, within 7 days of visit)