ASPIRES (Activating Cancer Survivors and Their Primary Care Providers to Increase Colorectal Cancer Screening) Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 8
- 主要终点
- Proportion of patients who report completing a colonoscopy or Cologuard test (Cologuard test plus colonoscopy if Cologuard is positive) within 12 months of randomization
研究概览
简要总结
The primary purpose of this study is to assess the best method for encouraging high-risk cancer survivors to get screened for colorectal cancer at the recommended age.
详细描述
This is a 12-month, 3-arm randomized controlled trial of 315 Childhood Cancer Survivor Study (CCSS) survivors using a text message intervention with data collected at baseline and 12 months through patient and provider surveys and interviews and a medical record review. Participants will be randomly assigned to one of three groups: control, patient activation (PA) using a text message/video intervention, or patient activation + primary care provider activation (PA + PCP) which will include providing primary care providers with resources about colorectal cancer risk in this population. All participants will receive electronic resources about their previous cancer treatment and colorectal cancer screening recommendations.
The primary outcome is the proportion of patients who complete the colonoscopy or Cologuard test (Cologuard test plus colonoscopy if the Cologuard is positive) within 12 months of enrolling on the study, as measured via self-report questions in the end of study questionnaire. The study will test the hypothesis that, compared to controls, survivors randomized to the PA and PA + PCP activation groups will have significantly higher rates of completion of colorectal cancer screening.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible participants will include people who:
- •Enrolled on the Childhood Cancer Survivor Study
- •Were treated with radiation to the abdomen, pelvis, spine, or total body irradiation
- •Have no history of colorectal cancer
- •Have not had a colonoscopy in the last 5 years or Cologuard in the last 3 years
- •Have a smartphone
排除标准
- •Do not reside in the United States
- •Do not speak English
研究组 & 干预措施
Group1: Control (C)
Electronic educational materials (C).
干预措施: Control (Behavioral)
Group 2: Patient Activation (PA)
C + patient activation (PA) consisting of interactive tailored text messages with links to videos and resources
干预措施: Control (Behavioral)
Group 2: Patient Activation (PA)
C + patient activation (PA) consisting of interactive tailored text messages with links to videos and resources
干预措施: Patient activation (Behavioral)
Group 3: Patient Activation and PCP Activation (PA + PCP)
C + PA + PCP activation (PA+PCP) with physician materials about colorectal cancer risk in this population
干预措施: Control (Behavioral)
Group 3: Patient Activation and PCP Activation (PA + PCP)
C + PA + PCP activation (PA+PCP) with physician materials about colorectal cancer risk in this population
干预措施: Patient activation (Behavioral)
Group 3: Patient Activation and PCP Activation (PA + PCP)
C + PA + PCP activation (PA+PCP) with physician materials about colorectal cancer risk in this population
干预措施: Primary care provider activation (Behavioral)
结局指标
主要结局
Proportion of patients who report completing a colonoscopy or Cologuard test (Cologuard test plus colonoscopy if Cologuard is positive) within 12 months of randomization
时间窗: 12 months
This will be measured by self-report on a questionnaire given at 12 months.
次要结局
- Proportion of patients who complete the colonoscopy or Cologuard test (Cologuard test plus colonoscopy if Cologuard is positive) within 12 months of randomization as measured in medical record reports(12 months)
- Potential barriers and facilitators to the uptake of the intervention at both the patient and provider level as measured by CFIR questions(14 months)
- Other potential barriers and facilitators to the uptake of the intervention at both the patient and provider level(12 months)
- Cost and Cost-Effectiveness Analysis(12 months)
