Clinical trial NCT05084833: ASPIRES (Activating Cancer Survivors and Their Primary Care Providers to Increase Colorectal Cancer Screening) Study
Official title: ASPIRES (Activating Cancer Survivors and Their Primary Care Providers to Increase Colorectal Cancer Screening) Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Colorectal Cancer
Early Detection of Cancer
Keywords: Colorectal cancer
cancer survivor
Lead sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
Sponsor class: OTHER
Collaborators: name: St. Jude Children's Research Hospital
name: Memorial Sloan Kettering Cancer Center
name: Columbia University
name: The Hospital for Sick Children
name: Duke University
name: Penn State University
name: Hunter College of City University of New York
name: National Cancer Institute (NCI)
First posted: 2021-10-20
Enrollment: 300
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients who report completing a colonoscopy or Cologuard test (Cologuard test plus colonoscopy if Cologuard is positive) within 12 months of randomization
timeFrame: 12 months
Secondary outcomes:
measure: 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
timeFrame: 12 months
measure: Potential barriers and facilitators to the uptake of the intervention at both the patient and provider level as measured by CFIR questions
timeFrame: 14 months
measure: Other potential barriers and facilitators to the uptake of the intervention at both the patient and provider level
timeFrame: 12 months
measure: Cost and Cost-Effectiveness Analysis
timeFrame: 12 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: New York
country: United States
facility: Columbia University
state: New York
city: University Park
country: United States
facility: The Pennsylvania State University
state: Pennsylvania
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: Ann & Robert H Lurie Children's Hospital of Chicago
name: Tara O Henderson, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: The Pennsylvania State University
name: Karen Kim, MD, MS
role: STUDY_CHAIR
References:
citation: 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.