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

Colorectal Cancer Clinical Trial

— ASPIRES  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05084833
• Other study ID #: IRB20-1247
• Secondary ID: R01CA255269-01
• Status: Enrolling by invitation
• Phase: N/A
• Start date: February 14, 2022
• Est. completion date: November 1, 2025

Study information

• Verified date: May 2024
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 315
• Est. completion date: November 1, 2025
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Early Detection of Cancer

Intervention

Behavioral:
• Control
Electronic educational materials
• Patient activation
Interactive text messages with links to videos (e.g. colorectal cancer screening options, cost of colorectal cancer screening, perspective from a cancer survivor, why regular appointments are important for cancer survivors) and resources (e.g. helpful websites) are sent to participants
• Primary care provider activation
Faxed educational materials (e.g. current colorectal cancer screening recommendations, frequently asked questions, insurance letter template, cover letter with overview of patient's cancer treatment history) sent to primary care providers

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois
United States	St. Jude Children's Research Hospital	Memphis	Tennessee
United States	Columbia University	New York	New York
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (8)

Lead Sponsor	Collaborator
University of Chicago	Columbia University, Duke University, Hunter College of City University of New York, Memorial Sloan Kettering Cancer Center, National Cancer Institute (NCI), St. Jude Children's Research Hospital, The Hospital for Sick Children

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients who report completing a colonoscopy or Cologuard test (Cologuard test plus colonoscopy if Cologuard is positive) within 12 months of randomization	This will be measured by self-report on a questionnaire given at 12 months.	12 months
Secondary	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	The study team will confirm if participants had a colonoscopy or cologuard test by reaching out to the medical site where the participant was screened, and requesting the medical record confirmation.	12 months
Secondary	Potential barriers and facilitators to the uptake of the intervention at both the patient and provider level as measured by CFIR questions	Consolidated Framework for Implementation Research (CFIR) questions are included in the 12-month questionnaire for participants, the 12-month questionnaire for their primary care providers, and the end of study interviews for the participants, primary care providers, and other medical office staff. CFIR questions are meant to measure 5 domains: intervention characteristics, outer setting, inner setting, characteristics of individuals, and process.	14 months
Secondary	Other potential barriers and facilitators to the uptake of the intervention at both the patient and provider level	In this study, the potential moderators include patient characteristics, such as age, gender, educational attainment, health insurance coverage, types of insurance, chronic health conditions, and race/ethnicity as well as PCP factors such as knowledge, years in practice, and practice setting. The potential mediators in this study may include the patient's perception of involvement in decision making, health insurance coverage, and whether the patient reviewed the study resources and videos. This will be measured through data collected via the baseline and 12 month questionnaires as well as data previously collected via the St. Jude Childhood Cancer Survivor Study.	12 months
Secondary	Cost and Cost-Effectiveness Analysis	We will collect data on the replication costs of the intervention and health services from the intervention per participant. The costs of the intervention (e.g. intervention materials, personnel time, and texting costs) will be collected by the University of Chicago team via a cost spreadsheet. The cost of the health services will be collected via the 12-month questionnaire; participants will be asked to share information about the types of medical visits they have had since joining the study.	12 months