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

NCT05084833 | Completed

• 2 other identifiers: STUDY00000296R01CA255269-01
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 4

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.

Conditions

Colorectal Cancer; Early Detection of Cancer

Keywords

Colorectal cancer; cancer survivor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (3)

Group1: Control (C)

EXPERIMENTAL

Electronic educational materials (C).

Behavioral: Control

Group 2: Patient Activation (PA)

EXPERIMENTAL

C + patient activation (PA) consisting of interactive tailored text messages with links to videos and resources

Behavioral: Control; Behavioral: Patient activation

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

Behavioral: Control; Behavioral: Patient activation; Behavioral: Primary care provider activation

Interventions

Control BEHAVIORAL

Electronic educational materials

Group 2: Patient Activation (PA); Group 3: Patient Activation and PCP Activation (PA + PCP); Group1: Control (C)

Patient activation BEHAVIORAL

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

Group 2: Patient Activation (PA); Group 3: Patient Activation and PCP Activation (PA + PCP)

Primary care provider activation BEHAVIORAL

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

Group 3: Patient Activation and PCP Activation (PA + PCP)

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Do not reside in the United States
• Do not speak English

Sponsors & Collaborators

• Ann & Robert H Lurie Children's Hospital of Chicago: lead
• St. Jude Children's Research Hospital: collaborator
• Memorial Sloan Kettering Cancer Center: collaborator
• Columbia University: collaborator
• The Hospital for Sick Children: collaborator
• Duke University: collaborator
• Penn State University: collaborator
• Hunter College of City University of New York: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (4)

Memorial Sloan Kettering Cancer Center

New York, New York, 10017, United States

Location

Columbia University

New York, New York, 10027, United States

Location

The Pennsylvania State University

University Park, Pennsylvania, 16802, United States

Location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Publications (1)

• 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.

  PMID: 35606736 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Tara O Henderson, MD, MPH

  Ann & Robert H Lurie Children's Hospital of Chicago

  PRINCIPAL INVESTIGATOR

• Karen Kim, MD, MS

  The Pennsylvania State University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2021
• First Posted: October 20, 2021
• Study Start: February 14, 2022
• Primary Completion: July 30, 2025
• Study Completion: September 30, 2025
• Last Updated: December 11, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)