A Video Intervention to Decrease Patient Fear of Colonoscopy After a Positive Fecal Immunochemical Test

Fred Hutchinson Cancer Center (FHCC)

Status: Completed

Conditions: Colorectal Carcinoma

Treatments: Other: Best Practice; Other: Questionnaire Administration; Other: Media Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05458986

10950 (Other Identifier)

RG1122309

NCI-2022-05223 (Registry Identifier)

Details and patient eligibility

About

This clinical trial compares an educational video intervention versus usual care of no video intervention in decreasing patient fear of a colonoscopy procedure after receiving a positive fecal immunochemical test (FIT). The lack of a follow-up colonoscopy after an abnormal FIT result is associated with an increased risk of colorectal cancer mortality, advanced-stage colorectal cancer, among other complications, compared to the completion of a follow-up colonoscopy. An educational video may reduce patient fear and increase knowledge, self-efficacy, and intent to complete a colonoscopy compared to the usual care of no video intervention.

Full description

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM 1: Patients watch an educational video about the importance of abnormal FIT results, the implications if follow-up colonoscopy is not completed, and demonstrate the steps to complete a colonoscopy.

ARM 2: Patients receive usual care and do not watch the educational video.

After completion of study, patients are followed for 12 months after their abnormal FIT result.

Enrollment: 66 patients

Sex: All

Ages: 45 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 45-75
• Have an assigned primary care provider in our partnering safety-net health system
• Have a billable primary care encounter between 2019-2022
• Have an abnormal FIT result for colorectal cancer (CRC) screening without a colonoscopy within 1 year
• Ability to communicate in English due to initial videos being available in English

Exclusion criteria

• Adults < age 45 or > age 75
• Patients who receive care at other University of Washington (UW) medicine sites (non-safety-net patients)
• Individuals without a primary care encounter between 2019-2022
• Individuals whose primary language is not English

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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66 participants in 2 patient groups

Arm 1 (educational video)

Experimental group

Description:

Patients watch an educational video about the importance of abnormal FIT results, the implications if follow-up colonoscopy is not completed, and demonstrate the steps to complete a colonoscopy.

Treatment:

Other: Media Intervention

Other: Questionnaire Administration

Arm 2 (usual care)

Active Comparator group

Description:

Patients receive usual care and do not watch the educational video.

Treatment:

Other: Questionnaire Administration

Other: Best Practice