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Survivor & Provider Activation for Colorectal Cancer Screening (ASPIRES Trial)
N/A
Waitlist Available
Led By Tara O Henderson, MD, MPH
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have no family history of colorectal cancer
Were treated with radiation to the abdomen, pelvis, spine, or total body irradiation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 months
Awards & highlights
ASPIRES Trial Summary
This trial is testing different ways to get high-risk cancer survivors to get screened for colorectal cancer at the recommended age.
Who is the study for?
This trial is for high-risk cancer survivors without a family history of colorectal cancer, who were treated with certain types of radiation, and haven't had recent colorectal screenings. Participants must have a smartphone, be part of the Childhood Cancer Survivor Study, speak English, and live in the U.S.Check my eligibility
What is being tested?
The ASPIRES study is testing different methods to motivate these survivors to undergo colorectal cancer screening. It compares no intervention (control) with strategies aimed at activating patients directly or through their primary care providers.See study design
What are the potential side effects?
Since this trial focuses on activation methods rather than medical treatments or drugs, there are no direct side effects associated with the interventions being tested.
ASPIRES Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My family has no history of colorectal cancer.
Select...
I have received radiation therapy to my abdomen, pelvis, spine, or whole body.
Select...
I have never had colorectal cancer.
ASPIRES Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 14 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of patients who report completing a colonoscopy or Cologuard test (Cologuard test plus colonoscopy if Cologuard is positive) within 12 months of randomization
Secondary outcome measures
Cost and Cost-Effectiveness Analysis
Interventional procedure
Potential barriers and facilitators to the uptake of the intervention at both the patient and provider level as measured by CFIR questions
+1 moreASPIRES Trial Design
3Treatment groups
Experimental Treatment
Group I: Group1: Control (C)Experimental Treatment1 Intervention
Electronic educational materials (C).
Group II: Group 3: Patient Activation and PCP Activation (PA + PCP)Experimental Treatment3 Interventions
C + PA + PCP activation (PA+PCP) with physician materials about colorectal cancer risk in this population
Group III: Group 2: Patient Activation (PA)Experimental Treatment2 Interventions
C + patient activation (PA) consisting of interactive tailored text messages with links to videos and resources
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Control
2011
Completed Phase 4
~15780
Patient activation
2019
N/A
~320
Find a Location
Who is running the clinical trial?
University of ChicagoLead Sponsor
1,002 Previous Clinical Trials
817,535 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,352 Total Patients Enrolled
St. Jude Children's Research HospitalOTHER
427 Previous Clinical Trials
5,306,262 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My family has no history of colorectal cancer.I have received radiation therapy to my abdomen, pelvis, spine, or whole body.You own a smartphone.I do not speak English.I have never had colorectal cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Group1: Control (C)
- Group 2: Group 2: Patient Activation (PA)
- Group 3: Group 3: Patient Activation and PCP Activation (PA + PCP)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research initiative currently open to new participants?
"This investigation, which was initially posted on February 14th 2022 and last modified one day later, is not currently recruiting patients. Nevertheless, 1069 other clinical trials are presently in search of candidates."
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