Clinical trial NCT05458986: A Video Intervention to Decrease Patient Fear of Colonoscopy After a Positive Fecal Immunochemical Test
Official title: A Pilot Video Intervention to Decrease Fear of Colonoscopy in a Safety-Net Healthcare System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Carcinoma
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: American College of Gastroenterology
First posted: 2022-07-14
Enrollment: 66
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility as measured by study accrual
timeFrame: Up to 12 months post-abnormal fecal immunochemical test (FIT) result
measure: Feasibility: number of contacts needed to reach target enrollment
timeFrame: Up to 12 months post-abnormal FIT result
measure: Feasibility: time to reach recruitment
timeFrame: Up to 12 months post-abnormal FIT result
measure: Acceptability of the video intervention assessed by a survey
timeFrame: Up to 12 months post-abnormal FIT result
measure: Incidence of fear related to colonoscopy
timeFrame: Up to 12 months post-abnormal FIT result
measure: Knowledge about colonoscopy
timeFrame: Up to 12 months post-abnormal FIT result
measure: Self-efficacy related to colonoscopy
timeFrame: Up to 12 months post-abnormal FIT result
measure: Intent to complete a colonoscopy
timeFrame: Up to 12 months post-abnormal FIT result
Secondary outcomes:
measure: Incidence of completed colonoscopies
timeFrame: At 6 months post randomization
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Rachel Issaka, MD, MAS
role: PRINCIPAL_INVESTIGATOR
References: