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Clinical Trials/NCT03310892
NCT03310892
Completed
Not Applicable

Patient-directed Messaging to Increase Colorectal Cancer Screening

University of Pennsylvania1 site in 1 country600 target enrollmentOctober 9, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Colorectal Cancer
Sponsor
University of Pennsylvania
Enrollment
600
Locations
1
Primary Endpoint
Colonoscopy completion rate
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

This is a randomized controlled trial to to determine whether direct, tailored messaging to patients prior to scheduling colonoscopy will increase patient adherence to provider recommendation for screening colonoscopy.

Detailed Description

The proposed study is a prospective, randomized trial. All eligible subjects (patients identified to be contacted to schedule screening colonoscopy) will be randomized to one of three study arms: usual scheduling process (control), a generic message arm, or a tailored message arm. Patients in the "tailored message" arm will receive a telephone call and be asked a series of questions that will be used to assign patients to one of four messaging cohorts. After these questions have been answered, the patient will then receive a tailored message corresponding to his or her respective messaging cohort, encouraging them to schedule a colonoscopy with a directed script. In the "generic message" arm, patients will receive a telephone call and be asked to answer the same series of questions as the "tailored message" group, then receive a single, standard script encouraging them to schedule a colonoscopy.

Registry
clinicaltrials.gov
Start Date
October 9, 2017
End Date
October 1, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • University of Pennsylvania Health System (UPHS) patients with an active order for screening or surveillance colonoscopy without an existing colonoscopy appointment
  • 50-75 years of age
  • Due for CRC screening or surveillance (defined as no evidence of: colonoscopy in the past 5 years, fecal immunochemical testing in the past 12 months, flexible sigmoidoscopy or CT colonography in the past 5 years, stool DNA test or Cologuard in the last 3 years)

Exclusion Criteria

  • Age \<50 or \>75
  • Pregnant woman
  • Evidence of prior colonoscopy in the past 5 years, fecal immunochemical testing in the past 12 months, flexible sigmoidoscopy or CT colonography in the past 5 years, fecal DNA test or Cologuard in the last 3 years
  • History of colorectal cancer
  • History of inflammatory bowel disease (Crohn's disease or Ulcerative colitis)
  • History of colon surgery or resection
  • History of symptoms concerning for colorectal cancer, such as lower GI bleeding, within the past 6 months
  • Family history of a hereditary colorectal cancer syndrome, such as familial adenomatous polyposis (FAP) or hereditary non-polyposis colon cancer (HNPCC)
  • Current serious medical condition with estimated life expectancy of less than 6 months, such as incurable cancer, end-stage congestive heart failure, decompensated cirrhosis, end stage renal disease, etc.
  • Does not speak English

Outcomes

Primary Outcomes

Colonoscopy completion rate

Time Frame: 120 days

The ratio of the number of participants who complete a colonoscopy to the total number of enrolled participants

Secondary Outcomes

  • Colonoscopy scheduling rate(120 days)

Study Sites (1)

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