Tailored Messaging for CRC Screening

• Sponsor: University of Pennsylvania (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03310892
• Collaborator: (none)
• Enrollment: 600
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 62.7
• Patients Per Site Per Month: 9.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer	Behavioral: Generic message; Behavioral: Tailored message	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 600 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Screening
• Official Title: Patient-directed Messaging to Increase Colorectal Cancer Screening
• Actual Study Start Date: Oct 9, 2017
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Usual Care Participants in this arm will Usual scheduling process without any intervention
Experimental: Generic Message 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.	Behavioral: Generic message; Generic message
Experimental: Tailored Message 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.	Behavioral: Tailored message; Tailored message

Outcome Measures

Primary Outcome Measures

1. Colonoscopy completion rate [120 days]

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

Secondary Outcome Measures

1. Colonoscopy scheduling rate [120 days]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. University of Pennsylvania Health System (UPHS) patients with an active order for screening or surveillance colonoscopy without an existing colonoscopy appointment

2. 50-75 years of age

3. 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:

1. Age <50 or >75

2. Pregnant woman

3. 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

4. History of colorectal cancer

5. History of inflammatory bowel disease (Crohn's disease or Ulcerative colitis)

6. History of colon surgery or resection

7. History of symptoms concerning for colorectal cancer, such as lower GI bleeding, within the past 6 months

8. Family history of a hereditary colorectal cancer syndrome, such as familial adenomatous polyposis (FAP) or hereditary non-polyposis colon cancer (HNPCC)

9. 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.

10. Dementia

11. Does not speak English

12. No telephone number listed in electronic medical record

13. Has any other condition that, in the opinion of the investigator, excludes the patient from participating in this study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pennsylvania Health System	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• University of Pennsylvania

Investigators

• Principal Investigator: Michael L Kochman, MD, University of Pennsylvania

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT03310892
• Other Study ID Numbers: 827866
• First Posted: Oct 16, 2017
• Last Update Posted: Sep 17, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University of Pennsylvania: Colorectal cancer screening
• Additional relevant MeSH terms: Colorectal Neoplasms

Study Results

No Results Posted as of Sep 17, 2021