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

Fred Hutchinson Cancer Center (FHCC) logo

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)

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

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Ari Bell-Brown, MPH

Data sourced from clinicaltrials.gov

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