Addressing Genomic Disparities in Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 428
- 试验地点
- 4
- 主要终点
- Uptake of Germline Genetic Testing
研究概览
简要总结
The goal of this observational study is to increase genetic education and genetic testing for hereditary cancer risk among Black cancer survivors. The study will:
- Test the effectiveness of a chatbot intervention (also called relational agent, or RA) vs. enhanced usual care (EUC) on engagement in genetic education and requests for genetic testing.
- Evaluate the impact of the chatbot vs. EUC on the process that participants use to make decisions and evaluate effects on well-being (also called psychosocial outcomes).
- Explore the ways (methods) that influence how participants experience the intervention.
- Explore the feasibility of incorporating a Family Sharing Portal (FSP) for participants who receive a positive test result, to facilitate family communication of these test results and genetic testing of first-degree biological relatives after they have received genetic education by the RA.
The main questions this study aims to answer are which group - the chatbot (RA) group or the EUC group - is more likely to request genetic testing and which group is more likely to get (engage with) genetic education.
Participants will be randomly assigned to either the chatbot (RA) group or EUC group. This means each participant has an equal chance of being placed in either group, just like flipping a coin. Each group will receive genetic education and have an opportunity to request genetic testing. Researchers will compare the chatbot (RA) group and the EUC group to see which may request more GT (genetic testing) and which group engages more with genetic education.
详细描述
Research Design and Methods:
This study will employ a 2-arm parallel group randomized controlled trial to evaluate the efficacy of the RA intervention compared to EUC among 428 Black cancer survivors who meet the National Comprehensive Cancer Network's guidelines for genetic referral. Primary outcomes will be engagement with genetic education and uptake of genetic testing (Aim 1). The investigators will also evaluate the impact of the RA intervention on psychosocial and decision quality outcomes (Aim 2) and evaluate mediators and moderators of intervention impact (Aim 3). In response to patient identified needs, we will also explore the feasibility of incorporating a Family Sharing Portal (FSP). All participants who receive a positive test result will be input into the FSP (Aim 4).
Research Procedures:
The design for this study is a 2-arm parallel group trial. Randomization is at the patient level. The investigators will recruit eligible cancer survivors who will be randomized by computer to enhanced usual care (EUC) or RA. Randomization will be balanced in a 1:1 ratio - with 214 participants randomized to each arm. Because this study is designed to address the disparity of low genetic testing utilization in Black cancer patients, all study participants will be Black and approximately 10% will be Hispanic.
The investigators will utilize the EHRs at our participating sites to identify cancer survivors who have not been tested despite meeting GT eligibility criteria. Participants will be ascertained from 1) Georgetown Lombardi Comprehensive Cancer Center (LCCC), MedStar Washington Cancer Institute (MWCI) and MedStar Franklin Square Medical Center in DC and 2) Rutgers' Cancer Institute (in New Brunswick and at University Hospital Newark) including RWJ Barnabas Health community oncology sites. Participants will be women and men who self-identify as Black or African American, have a history of breast, ovarian, uterine, colorectal, prostate, or pancreatic cancer, are at least six-months post-diagnosis, and have received care at one of the participating sites in the prior five years. There is no limit on the years since diagnosis as genetic testing (GT) can guide treatment decisions and provide opportunities for cascade testing to guide screening and prevention in at-risk relatives.
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 their patients group assignment. While participants cannot be blinded to 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-80 years of age
- •Self-identify as Black or African American
- •At least 6-months post diagnosis with any of the following cancers: breast, ovarian, uterine, prostate, colorectal, pancreatic
- •Have not had genetic testing for hereditary cancer
- •Have received care at one of the participating sites in the prior five years
- •Meet National Comprehensive Cancer Network criteria for germline GT
- •Able to read and speak in English
- •Capable of providing informed consent
- •Have internet access (via smartphone, tablet or computer)
- •Comfortable using a computer or mobile phone independently to access information
排除标准
- •Do not speak English
- •Unable to access the Internet
- •Have previously undergone germline genetic testing for hereditary cancer risk or previously had genetic counseling (GC) and declined genetic testing (GT)
- •Are unable to provide informed consent
结局指标
主要结局
Uptake of Germline Genetic Testing
时间窗: 6-months
As captured via internal RedCap form for the number or count of participants who opt for genetic testing, the investigators will test the efficacy of a culturally tailored and interactive electronic relational agent (RA) intervention vs. enhanced usual care (EUC) consisting of clinical letter and genetic recommendation on engagement in genetic testing uptake;
Survey Assessment of Impact of RA vs. EUC
时间窗: 1-month and 6-month survey
Evaluate the impact of the RA vs. EUC on informed decision-making and psychosocial outcomes via survey measures of related constructs at 1-month and 6-month surveys. Multiple scales are used to measure this outcome and each scale has a unique scoring system.
Survey Assessment of Mediators and Moderators of Efficacy
时间窗: Baseline, 1-month and 6-month surveys
Explore potential mechanisms by assessing mediators and moderators of efficacy via survey measures of related constructs at baseline, 1-month and 6-month surveys. Multiple scales are used to measure this outcome and each scale has a unique scoring system.
次要结局
- Survey Assessment of Engagement with Genetic Education(1-month survey)
研究者
Anita Y. Kinney, PhD, RN
Director at Rutgers Cancer Institute
Rutgers, The State University of New Jersey