Choices About Genetic Testing And Learning Your Risk With Smart Technology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Genetic Testing (GT) Uptake
研究概览
简要总结
This study seeks to enhance genetic education and increase the uptake of genetic testing for hereditary cancer risk among cancer survivors. The study will focus on the feasibility and acceptability of a digital intervention designed to improve cancer genomic care.
The study objectives are to:
- Finalize the development and optimize the usability of the CATALYST digital intervention (also known as the relational assistant [RA]).
- Evaluate the feasibility and acceptability of a streamlined cancer genomic care delivery model for cancer survivors. Participants will be randomized to one of two study arms: the RA intervention arm or the enhanced usual care (EUC) arm.
- Assess the uptake of genetic counseling (GC) and genetic testing (GT) and conduct a process evaluation to identify barriers and facilitators to GC, GT, and engagement with the CATALYST intervention and the RA.
详细描述
Research Design and Methods:
This study encompasses refinement of the digital intervention prototype through usability and user interface testing, and subsequent pilot/feasibility testing of a multi-level intervention, CATALYST, that includes a novel digital cancer genetic risk assistant that incorporates education, decision support, interactive smart technology and provides personalized information regarding hereditary cancer risk and genetic testing. The study will be comprised of three intervention testing stages: Phase 1 - User Testing; Phase 2 - Usability Testing, and Phase 3 - Pilot Testing.
User testing and usability testing will be done to refine the intervention prototype by incorporating cancer patients' feedback during each phase. The feasibility and acceptability of the CATALYST intervention will be evaluated in a 2-armed randomized controlled pilot study (Phase 3) of 36 individuals (18 EUC, 18 RA arm) identified as high-risk for a hereditary cancer gene mutation according to NCCN Criteria. The primary outcome of interest is GT uptake.
Data will be collected via guided interviews (televideo or face-to-face in the clinic or other mutually convenient location (community center) for Phase 1 and Phase 2. Phase 3 surveys will be self-administered via the internet or interviewer administered via telephone. Interviews and surveys will be comprised of open-ended and close-ended questions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Care Provider, Outcomes Assessor)
盲法说明
Treating clinicians will be blind to their patient's group assignment. While participants cannot be blinded to the group, they will be blinded to the study's specific hypotheses. Statisticians and outcome assessors will be blinded to allocation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •User/Usability Testing
- •Age 18 or older
- •Diagnosed with ovarian, fallopian tube, peritoneal, breast, pancreatic, colorectal, endometrial or prostate cancer
- •Speak/read and understand English
- •Capable of providing informed consent
- •Have Internet access (via smartphone, tablet, or computer)
- •Randomized Feasibility Trial
- •Age 18 or older
- •Diagnosed with ovarian, fallopian tube, peritoneal, breast, pancreatic, colorectal, endometrial or prostate cancer
- •Meet National Comprehensive Cancer Network (NCCN) criteria for germline GT
- •Speak/read and understand English
- •Capable of providing informed consent
- •Have Internet access (via smartphone, tablet or computer)
排除标准
- •Participants will be 18 years of age or older because germline genetic testing is generally not recommended in children when the test results would not impact clinical management. Participants from the user and usability testing phases are not eligible for the feasibility trial. Feasibility trial participants cannot have previously undergone germline GT for hereditary cancer risk.
研究组 & 干预措施
Relational Agent (RA)
Participants in the RA arm will receive a clinical letter signed by the Medical Director of the institution's clinical genetics program with a link to the HIPAA-compliant RA. The RA will provide educational content equivalent to traditional genetic counseling (GC) in a streamlined format, including videos, decision support, patient testimonials, and real-time Q&A. Participants will be informed that they can consult with a genetic risk specialist at no cost. Those opting for genetic testing (GT) will have a kit mailed to them, with results shared with the participant and their oncologist, tailored to the findings. Participants undecided or unwilling to proceed with GT will be encouraged by the RA to consult their oncology provider and/or schedule a GC appointment.
干预措施: Relational Agent (RA) (Behavioral)
Enhanced Usual Care (EUC)
Participants in the EUC arm will receive a clinical letter signed by the Medical Director of the institution's clinical genetics program. The letter will inform participants of their and their family's potential risk for carrying a pathogenic variant (PV) associated with hereditary cancer. It will emphasize their eligibility for genetic testing (GT), recommend considering a genetic counseling (GC) appointment for further information, and provide a link to the Rutgers Cancer Institute high-risk clinic website. The study team will assist in facilitating GT upon request. Results will be shared with the participant and their oncologist and tailored according to the findings.
干预措施: Enhanced Usual Care (EUC) (Behavioral)
结局指标
主要结局
Genetic Testing (GT) Uptake
时间窗: 1-month, 6-month follow-up
GT uptake will be defined as the proportion of participants who undergo genetic testing within 6 months of the baseline survey (for both the EUC and RA arms). This will be verified through medical record documentation. Self-reported GT will be tracked if verification is not feasible.
次要结局
- Acceptability of the Relational Agent (RA)(1-month follow-up)
- Genetic Testing (GT) Intentions(Baseline, 1-month, 6-month follow-up)
- Informed Decision-Making Indicators(Baseline, 1-month, 6-month follow-up)
- Genetic Counseling (GC) Uptake(1-month, 6-month follow-up)
研究者
Anita Y. Kinney, PhD, RN
Director at Rutgers Cancer Institute
Rutgers, The State University of New Jersey