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

NCT ID: NCT05084833

Last Updated: 2025-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-14

Study Completion Date

2025-09-30

Brief Summary

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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

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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.

Conditions

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Colorectal Cancer Early Detection of Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Group1: Control (C)

Electronic educational materials (C).

Group Type EXPERIMENTAL

Control

Intervention Type BEHAVIORAL

Electronic educational materials

Group 2: Patient Activation (PA)

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

Group Type EXPERIMENTAL

Patient activation

Intervention Type 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

Control

Intervention Type BEHAVIORAL

Electronic educational materials

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

Group Type EXPERIMENTAL

Patient activation

Intervention Type 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

Primary care provider activation

Intervention Type 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

Control

Intervention Type BEHAVIORAL

Electronic educational materials

Interventions

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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

Intervention Type 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

Intervention Type BEHAVIORAL

Control

Electronic educational materials

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Hospital for Sick Children

OTHER

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role collaborator

Penn State University

OTHER

Sponsor Role collaborator

St. Jude Children's Research Hospital

OTHER

Sponsor Role collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role collaborator

Columbia University

OTHER

Sponsor Role collaborator

Hunter College of City University of New York

OTHER

Sponsor Role collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Ann & Robert H Lurie Children's Hospital of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tara O Henderson, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Ann & Robert H Lurie Children's Hospital of Chicago

Karen Kim, MD, MS

Role: STUDY_CHAIR

The Pennsylvania State University

Locations

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Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

Columbia University

New York, New York, United States

Site Status

The Pennsylvania State University

University Park, Pennsylvania, United States

Site Status

St. Jude Children's Research Hospital

Memphis, Tennessee, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 35606736 (View on PubMed)

Other Identifiers

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R01CA255269-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00000296

Identifier Type: -

Identifier Source: org_study_id

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