ASPIRES (Activating Cancer Survivors and Their Primary Care Providers to Increase Colorectal Cancer Screening) Study
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Colorectal Cancer
- Sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
- Enrollment
- 300
- Locations
- 4
- Primary Endpoint
- Proportion of patients who report completing a colonoscopy or Cologuard test (Cologuard test plus colonoscopy if Cologuard is positive) within 12 months of randomization
- Status
- Completed
- Last Updated
- 4 months ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •Do not reside in the United States
- •Do not speak English
Outcomes
Primary Outcomes
Proportion of patients who report completing a colonoscopy or Cologuard test (Cologuard test plus colonoscopy if Cologuard is positive) within 12 months of randomization
Time Frame: 12 months
This will be measured by self-report on a questionnaire given at 12 months.
Secondary Outcomes
- 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)