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

A Pilot Video Intervention to Decrease Fear of Colonoscopy in a Safety-Net Healthcare System

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Carcinoma
• Intervention / Treatment: Other: Questionnaire Administration; Other: Best Practice; Other: Media 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.

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98109
      • Fred Hutch/University of Washington Cancer Consortium

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1 (educational video); 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.	Other: Questionnaire Administration; Ancillary studies; Other: Media Intervention; Watch an educational video
Active Comparator: Arm 2 (usual care); Patients receive usual care and do not watch the educational video.	Other: Questionnaire Administration; Ancillary studies; Other: Best Practice; Receive usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility as measured by study accrual	Feasibility will be measured by recruitment as the proportion of invited participants who consent and complete the pilot study.	Up to 12 months post-abnormal fecal immunochemical test (FIT) result
Feasibility: number of contacts needed to reach target enrollment	Feasibility will be measured by recruitment as the number of contacts required to reach target enrollment.	Up to 12 months post-abnormal FIT result
Feasibility: time to reach recruitment	Feasibility will be measured by recruitment as the time required to reach target enrollment. Time to reach recruitment target will be measured in days and described using medians and interquartile range (IQR).	Up to 12 months post-abnormal FIT result
Acceptability of the video intervention assessed by a survey	Intervention arm patients will complete a post-intervention survey to assess acceptability of the intervention using the Acceptability of Intervention Measure (AIM), a 4-item measure. Items are rated on a 5-point Likert Scale (1, completely disagree; 5, completely agree). Mean scores will be calculated to generate an average AIM score, where higher scores will indicate higher levels of acceptability.	Up to 12 months post-abnormal FIT result
Incidence of fear related to colonoscopy	Intervention arm patients will complete a pre- and post-intervention survey that will include questions about fear of colonoscopy. Usual care patients will complete a baseline survey on the same measures. Fear will be assessed using Manne's 6-item fear of colonoscopy scale. Items are rated on a 5-point Likert scale (1, not at all fearful; 5, extremely fearful). Mean scores will be calculated to generate average fear per participant, with higher scores indicating higher levels of fear.	Up to 12 months post-abnormal FIT result
Knowledge about colonoscopy	Intervention arm patients will complete a pre- and post-intervention survey that will include questions about knowledge about colon cancer screening. Usual care patients will complete a baseline survey on the same measures. Knowledge will be measured using 8 validated questions. Incorrect answers will be scored as 0 and correct answers scored as 1. Higher scores will indicate higher levels of knowledge.	Up to 12 months post-abnormal FIT result
Self-efficacy related to colonoscopy	Intervention arm patients will complete a pre- and post-intervention survey that will include questions about self-efficacy related to a colonoscopy. Usual care patients will complete a baseline survey on the same measures. Self-efficacy will be assessed by adopting an 8-item self-efficacy scale for colonoscopy completion in patients with inflammatory bowel diseases and responses will be recorded on a 5-point scale. Higher scores will indicate higher levels of self-efficacy.	Up to 12 months post-abnormal FIT result
Intent to complete a colonoscopy	Intervention arm patients will complete a pre- and post-intervention survey that will include questions about intent to complete a colonoscopy. Usual care patients will complete a baseline survey on the same measures. Intent will be measured using a single validated question on a nominal scale with 5 options. Responses will be dichotomized to affirmative intent (definitely will do, will do) or uncertain intent (don't know, will not do, and definitely will not do).	Up to 12 months post-abnormal FIT result

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of completed colonoscopies	Through review of the electronic health records (EHR), the investigators will determine rates of completed colonoscopy 6 months after randomization to assess preliminary efficacy.	At 6 months post randomization

Collaborators and Investigators

• Sponsor: Fred Hutchinson Cancer Center
• Collaborators: American College of Gastroenterology
• Investigators: Principal Investigator: Rachel Issaka, MD, MAS, Fred Hutch/University of Washington Cancer Consortium

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2023
• Primary Completion (Actual): May 3, 2024
• Study Completion (Actual): May 3, 2024

Study Registration Dates

• First Submitted: July 1, 2022
• First Submitted That Met QC Criteria: July 11, 2022
• First Posted (Actual): July 14, 2022

Study Record Updates

• Last Update Posted (Actual): May 30, 2024
• Last Update Submitted That Met QC Criteria: May 28, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: RG1122309; NCI-2022-05223 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); 10950 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No