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

May 26, 2026 updated by: Ann & Robert H Lurie Children's Hospital of Chicago
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
Time Frame: 12 months
This will be measured by self-report on a questionnaire given at 12 months.
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
Time Frame: 12 months
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
Time Frame: 14 months
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
Time Frame: 12 months
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
Time Frame: 12 months
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ann & Robert H Lurie Children's Hospital of Chicago

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 14, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 7, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 7, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 20, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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