Text-based Colorectal Cancer Prevention Pilot
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Text Messaging
Sponsored by
About this trial
This is an interventional screening trial for Colorectal Cancer
Eligibility Criteria
Inclusion Criteria:
- Present at Strong Memorial Hospital or Noyes Community Hospital Emergency Departments
- Age 45-75
- English or Spanish speaking
- Capacity to consent
Exclusion Criteria:
- Personal and/or family history of colorectal cancer
- Personal history of inflammatory bowel disease
- History of abdominal or pelvic radiation to treat a prior cancer
- Non-English and Non-Spanish speaking
- Inability to consent
- Lack of text-capable mobile phone and/or inability to use text function
Sites / Locations
- Strong Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Non-adherent control
Non-adherent intervention
Arm Description
Control subjects will receive no text intervention and a 150 day follow-up phone call.
Intervention subjects will receive the text messaging intervention and a 150 day follow-up phone call.
Outcomes
Primary Outcome Measures
Screening
Rates of completed or scheduled screening
Secondary Outcome Measures
Phone Interview for refinement of Intervention
Collect qualitative feedback on perceptions of the intervention to inform its refinement.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05004376
Brief Title
Text-based Colorectal Cancer Prevention Pilot
Official Title
Text-based Intervention to Improve Adherence to Colorectal Cancer Screening Recommendations Among Emergency Department Patients
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
January 3, 2022 (Actual)
Primary Completion Date
May 31, 2022 (Actual)
Study Completion Date
June 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
In this project, we intend to conduct a randomized pilot trial of a structured behavioral intervention, grounded in the Theory of Planned Behavior and Self-Determination Theory, to promote adherence of patients aged 45 - 75 to USPSTF colorectal cancer screening recommendations. We will also collect qualitative feedback on perceptions of the intervention to inform its refinement.
Detailed Description
The investigators propose a pilot randomized controlled trial with a prospectively collected convenience sample of 130 ED patients non-adherent with CRC screening guidelines over a 3-month period. ED Research Associates (EDRAs) will use the EPIC eRecord system to screen adult patients registered in the ED at URMC and Noyes Memorial Hospital (when an EDRA is present in that ED) for eligibility. Inclusion criteria will include: 45-75 years and English or Spanish speaking (costs for interpreting study surveys and patient interactions will be paid for from PI discretionary research funds). Exclusion criteria will include personal and/or family history of colorectal cancer, personal history of inflammatory bowel disease, and a history of abdominal or pelvic radiation to treat a prior cancer. These exclusions were chosen due to their impact on standard colorectal screening recommendations. After consent, subjects will complete a ~10-minute questionnaire administered by the EDRA to determine adherence to current USPSTF guidelines for colorectal cancer screening using validated items in the CDC's National Health Interview Survey16. The enrollment process will categorize study participants into three groups: adherent, uncertain, or non-adherent. Subjects found to be adherent will be notified and their participation will conclude. Subjects found to be in the uncertain or non-adherent groups will be randomized into the treatment or control condition. Following intervention, subjects who were non-adherent will be referred to their usual care provider to discuss options for becoming adherent. Subjects for whom adherence is uncertain will be referred to their usual care provider to confirm their adherence status. Subjects who find through their PCP that they are adherent will be treated as screen failures. Sensitivity analyses will be performed to evaluate estimates of intervention efficacy with and without inclusion of subjects initially determined uncertain and later categorized as non-adherent. Following the initial enrollment, randomization, and recommendation to contact their PCPs, subjects in the intervention condition will receive a series of 6 text messages, sent at approximately 15 day intervals, presenting theory-based messages aimed at encouraging colorectal cancer screening uptake. Subjects without a primary care provider will be given information on how to establish a PCP in Rochester and on cancer screening services subsidized through the Cancer Services Program (CSP) of the Finger Lakes Region (our current R01 includes referrals to the CSP). All subjects in the non-adherent and uncertain groups will receive a follow-up call at 150 days for a ~5-minute survey to determine if they underwent or scheduled screening, if they learned that they did not require screening, and what barriers they perceived in getting screened. Qualitative feedback regarding perceptions of the intervention will also be collected in order to refine the intervention for future study. Medical chart review will also be conducted to confirm patient self-reports, making use of UR records and records from the Rochester Regional Health Information Organization (RHIO; our current R01 has incorporated the RHIO).Completion of a "second-level" consent form for use of the RHIO for chart review will be required for enrollment. In our cervical cancer pilot study, we successfully contacted 68% of participants for follow-up, 11 of whom declined to complete the follow-up interview. Based on lessons learned in our preliminary work, we have developed several strategies (currently employed in our R01 study), in addition to the incentive payment for study completion, which we will employ to maximize retention in this study:
Telephone numbers will be confirmed in the ED during enrollment by the EDRA performing the enrollment by calling the patient's phone to be certain the number is correct.
Up to five calls will be made to each study participant during the follow-up window.
Each participant will be provided with study team contact information and asked to notify us in the event that their phone number changes.
In addition to their primary cell phone number, alternative contact information will be sought from each participant to enable attempts at re-engagement, including: a.Secondary telephone number of participant b.Email address(es) and mailing address.
The EHR will be accessed to check for changes in contact information
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial with a prospectively collected convenience sample
Masking
None (Open Label)
Allocation
Randomized
Enrollment
118 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Non-adherent control
Arm Type
No Intervention
Arm Description
Control subjects will receive no text intervention and a 150 day follow-up phone call.
Arm Title
Non-adherent intervention
Arm Type
Experimental
Arm Description
Intervention subjects will receive the text messaging intervention and a 150 day follow-up phone call.
Intervention Type
Behavioral
Intervention Name(s)
Text Messaging
Intervention Description
Text messages based on behavioral theory to encourage scheduling colorectal cancer screening.
Primary Outcome Measure Information:
Title
Screening
Description
Rates of completed or scheduled screening
Time Frame
150 days
Secondary Outcome Measure Information:
Title
Phone Interview for refinement of Intervention
Description
Collect qualitative feedback on perceptions of the intervention to inform its refinement.
Time Frame
150 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Present at Strong Memorial Hospital or Noyes Community Hospital Emergency Departments
Age 45-75
English or Spanish speaking
Capacity to consent
Exclusion Criteria:
Personal and/or family history of colorectal cancer
Personal history of inflammatory bowel disease
History of abdominal or pelvic radiation to treat a prior cancer
Non-English and Non-Spanish speaking
Inability to consent
Lack of text-capable mobile phone and/or inability to use text function
Facility Information:
Facility Name
Strong Hospital
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Text-based Colorectal Cancer Prevention Pilot
We'll reach out to this number within 24 hrs