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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer; Early Detection of Cancer
• Intervention / Treatment: Behavioral: Control; Behavioral: Patient activation; Behavioral: Primary care provider activation

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.

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10027
      • Columbia University
    • New York, New York, United States, 10017
      • Memorial Sloan Kettering Cancer Center
  • Pennsylvania
    • University Park, Pennsylvania, United States, 16802
      • The Pennsylvania State University
  • Tennessee
    • Memphis, Tennessee, United States, 38105
      • St. Jude Children's Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group1: Control (C); Electronic educational materials (C).	Behavioral: Control; Electronic educational materials
Experimental: Group 2: Patient Activation (PA); C + patient activation (PA) consisting of interactive tailored text messages with links to videos and resources	Behavioral: Control; Electronic educational materials; Behavioral: 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
Experimental: 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	Behavioral: Control; Electronic educational materials; Behavioral: 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; Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
• Collaborators: National Cancer Institute (NCI); The Hospital for Sick Children; Memorial Sloan Kettering Cancer Center; Columbia University; Duke University; St. Jude Children's Research Hospital; Penn State University; Hunter College of City University of New York
• Investigators: Principal Investigator: Tara O Henderson, MD, MPH, Ann & Robert H Lurie Children's Hospital of Chicago; Study Chair: Karen Kim, MD, MS, The Pennsylvania State University

Publications and helpful links

General Publications

• Henderson TO, Bardwell JK, Moskowitz CS, McDonald A, Vukadinovich C, Lam H, Curry M, Oeffinger KC, Ford JS, Elkin EB, Nathan PC, Armstrong GT, Kim K. Implementing a mHealth intervention to increase colorectal cancer screening among high-risk cancer survivors treated with radiotherapy in the Childhood Cancer Survivor Study (CCSS). BMC Health Serv Res. 2022 May 23;22(1):691. doi: 10.1186/s12913-022-08082-3.

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2022
• Primary Completion (Actual): September 30, 2025
• Study Completion (Actual): October 30, 2025

Study Registration Dates

• First Submitted: October 7, 2021
• First Submitted That Met QC Criteria: October 7, 2021
• First Posted (Actual): October 20, 2021

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 26, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Colorectal cancer; cancer survivor
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms
• Other Study ID Numbers: STUDY00000296; R01CA255269-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Participants will be recruited from an established cohort (Childhood Cancer Survivor Study), and therefore individual participant data will not be available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No