Back to resultsTailored Messaging for CRC Screening
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Generic message
Tailored message
Sponsored by
About this trial
This is an interventional screening trial for Colorectal Cancer focused on measuring Colorectal cancer screening
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.
- Dementia
- Does not speak English
- No telephone number listed in electronic medical record
- Has any other condition that, in the opinion of the investigator, excludes the patient from participating in this study
Sites / Locations
- University of Pennsylvania Health System
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
Usual Care
Generic Message
Tailored Message
Arm Description
Participants in this arm will Usual scheduling process without any intervention
Participants in this arm will receive a telephone call from a study team member, and if no answer, up to two additional attempts will be made. During the telephone call, the study team member will ask the participant a series of 7 questions then receive a "generic" message encouraging colonoscopy scheduling.
Participants in this arm will receive a telephone call from a study team member, and if no answer, up to two additional attempts will be made. During the telephone call, the participant will answer a series of 7 questions then receive a "tailored" message encouraging colonoscopy scheduling, which will be determined by their responses to the preceding questions.
Outcomes
Primary Outcome Measures
Colonoscopy completion rate
The ratio of the number of participants who complete a colonoscopy to the total number of enrolled participants
Secondary Outcome Measures
Colonoscopy scheduling rate
The ratio of the number of participants who schedule a colonoscopy to the total number of enrolled participants
Full Information
NCT ID
NCT03310892
First Posted
October 5, 2017
Last Updated
October 3, 2023
Sponsor
University of Pennsylvania
1. Study Identification
Unique Protocol Identification Number
NCT03310892
Brief Title
Tailored Messaging for CRC Screening
Official Title
Patient-directed Messaging to Increase Colorectal Cancer Screening
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
October 9, 2017 (Actual)
Primary Completion Date
June 30, 2023 (Actual)
Study Completion Date
October 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Colorectal cancer screening
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Participants in this arm will Usual scheduling process without any intervention
Arm Title
Generic Message
Arm Type
Experimental
Arm Description
Participants in this arm will receive a telephone call from a study team member, and if no answer, up to two additional attempts will be made. During the telephone call, the study team member will ask the participant a series of 7 questions then receive a "generic" message encouraging colonoscopy scheduling.
Arm Title
Tailored Message
Arm Type
Experimental
Arm Description
Participants in this arm will receive a telephone call from a study team member, and if no answer, up to two additional attempts will be made. During the telephone call, the participant will answer a series of 7 questions then receive a "tailored" message encouraging colonoscopy scheduling, which will be determined by their responses to the preceding questions.
Intervention Type
Behavioral
Intervention Name(s)
Generic message
Intervention Description
Generic message
Intervention Type
Behavioral
Intervention Name(s)
Tailored message
Intervention Description
Tailored message
Primary Outcome Measure Information:
Title
Colonoscopy completion rate
Description
The ratio of the number of participants who complete a colonoscopy to the total number of enrolled participants
Time Frame
120 days
Secondary Outcome Measure Information:
Title
Colonoscopy scheduling rate
Description
The ratio of the number of participants who schedule a colonoscopy to the total number of enrolled participants
Time Frame
120 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Dementia
Does not speak English
No telephone number listed in electronic medical record
Has any other condition that, in the opinion of the investigator, excludes the patient from participating in this study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael L Kochman, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania Health System
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35357457
Citation
Oyalowo A, Forde KA, Lamanna A, Kochman ML. Effect of Patient-Directed Messaging on Colorectal Cancer Screening: A Randomized Clinical Trial. JAMA Netw Open. 2022 Mar 1;5(3):e224529. doi: 10.1001/jamanetworkopen.2022.4529.
Results Reference
derived
Learn more about this trial
Tailored Messaging for CRC Screening
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