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

Ann & Robert H Lurie Children's Hospital of Chicago

Status: Completed

Conditions: Early Detection of Cancer; Colorectal Cancer

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05084833

R01CA255269-01 (U.S. NIH Grant/Contract)

STUDY00000296

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 3 patient groups

Group1: Control (C)

Experimental group

Description:

Electronic educational materials (C).

Treatment:

Behavioral: Control

Group 2: Patient Activation (PA)

Experimental group

Description:

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

Treatment:

Behavioral: Control

Behavioral: Patient activation

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

Experimental group

Description:

C + PA + PCP activation (PA+PCP) with physician materials about colorectal cancer risk in this population

Treatment:

Behavioral: Control

Behavioral: Patient activation

Behavioral: Primary care provider activation