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

NCT05458986 | Completed

• 3 other identifiers: RG1122309NCI-2022-0522310950
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Carcinoma

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (1)

• Incidence of completed colonoscopies

  At 6 months post randomization

Study Arms (2)

Arm 1 (educational video)

EXPERIMENTAL

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: Media Intervention; Other: Questionnaire Administration

Arm 2 (usual care)

ACTIVE COMPARATOR

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

Other: Best Practice; Other: Questionnaire Administration

Interventions

Media Intervention OTHER

Watch an educational video

Arm 1 (educational video)

Best Practice OTHER

Receive usual care

Arm 2 (usual care)

Questionnaire Administration OTHER

Ancillary studies

Arm 1 (educational video); Arm 2 (usual care)

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• American College of Gastroenterology: collaborator

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Practice Guidelines as Topic

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Rachel Issaka, MD, MAS

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2022
• First Posted: July 14, 2022
• Study Start: May 15, 2023
• Primary Completion: May 3, 2024
• Study Completion: May 3, 2024
• Last Updated: May 30, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)