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临床试验/NCT05084833
NCT05084833已完成不适用

ASPIRES (Activating Cancer Survivors and Their Primary Care Providers to Increase Colorectal Cancer Screening) Study

Ann & Robert H Lurie Children's Hospital of Chicago8 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2022年2月14日最近更新:
适应症
干预措施

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

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)

Experimental

Electronic educational materials (C).

干预措施: Control (Behavioral)

Group 2: Patient Activation (PA)

Experimental

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)

Experimental

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)

Experimental

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)

Experimental

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)

Experimental

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (8)

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