Tailored Messaging for CRC Screening

NCT ID: NCT03310892

Last Updated: 2023-10-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-09
• Study Completion Date: 2023-10-01

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.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Usual Care

Participants in this arm will Usual scheduling process without any intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Generic message

Intervention Type: BEHAVIORAL

Generic message

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.

Group Type: EXPERIMENTAL

Tailored message

Intervention Type: BEHAVIORAL

Tailored message

Interventions

Generic message

Generic message

Intervention Type: BEHAVIORAL

Tailored message

Tailored message

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael L Kochman, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

University of Pennsylvania Health System

Philadelphia, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 35357457 (View on PubMed)

Other Identifiers

827866

Identifier Type: -

Identifier Source: org_study_id