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

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Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Media Intervention

Best Practice

Questionnaire Administration

About this trial

This is an interventional health services research trial for Colorectal Carcinoma

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Fred Hutch/University of Washington Cancer ConsortiumRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm 1 (educational video)

Arm 2 (usual care)

Arm 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.

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

Outcomes

Primary Outcome Measures

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.

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.

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).

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.

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.

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.

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.

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).

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT05458986

First Posted

July 1, 2022

Last Updated

May 23, 2023

Sponsor

Fred Hutchinson Cancer Center

Collaborators

American College of Gastroenterology

1. Study Identification

Unique Protocol Identification Number

NCT05458986

Brief Title

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

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 15, 2023 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fred Hutchinson Cancer Center

Collaborators

American College of Gastroenterology

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Carcinoma

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm 1 (educational video)

Arm Type

Experimental

Arm 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.

Arm Title

Arm 2 (usual care)

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Media Intervention

Intervention Description

Watch an educational video

Intervention Type

Other

Intervention Name(s)

Best Practice

Intervention Description

Receive usual care

Intervention Type

Other

Intervention Name(s)

Questionnaire Administration

Intervention Description

Ancillary studies

Primary Outcome Measure Information:

Title

Feasibility as measured by study accrual

Description

Feasibility will be measured by recruitment as the proportion of invited participants who consent and complete the pilot study.

Time Frame

Up to 12 months post-abnormal fecal immunochemical test (FIT) result

Title

Feasibility: number of contacts needed to reach target enrollment

Description

Feasibility will be measured by recruitment as the number of contacts required to reach target enrollment.

Time Frame