Effect of Patient Navigation on Colonoscopy Completion Screening Rate for Colorectal Cancer.

Not Applicable

Completed

• Conditions: Colorectal Cancer Screening; Patient Navigation

• Registration Number: NCT06684067
• Lead Sponsor: University of Malaya

Brief Summary

The goal of this randomized controlled trial is to evaluate the effectiveness of patient navigation on colonoscopy completion rates in a population screened for colorectal cancer. The main question\[s\] it aims to answer are:

Are colonoscopy completion rates in colorectal cancer screening increased in navigated (intervention arm) compared with non-navigated (control arm) participants?

Is mental well-being, as measured by HADs and GHQ12 scores, better in the intervention arm compared with the control arm?

Participants in the intervention arm will receive:

* standard clinic instructions for the colonoscopy

* phone calls from the patient navigator to discuss the purpose, preparation, and additional information regarding the colonoscopy procedure

* a webpage QR code consist of information on visual image on colonoscopy preparation and procedures, layout and map guidance to navigate in the hospital

* a direct line for phone calls to patient navigators for further guidance on overcoming barriers

Participants in the control arm will only receive:

* standard clinic instructions for the colonoscopy

* one phone call from the patient navigator to discuss the colonoscopy procedure

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-03
• Primary Completion: 2022-02-28
• Study Completion: 2022-03-31
• Status Verified: 2024-10
• Study First Submitted: 2024-10-04
• Study First Submitted QC: 2024-11-10
• Last Update Submitted: 2024-11-10
• Study First Posted: 2024-11-12
• Last Update Posted: 2024-11-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• Average risk for CRC
• More than 50 years of age
• Capacity for informed consent
• IFOBT positive

Exclusion Criteria

• Moderate or high risk CRC
• Previous CRC screening
• Symptomatic

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Colonoscopy completion rate	90 days	The numerator in both arms comprises participants who successfully attended and underwent colonoscopy within 90 days of recruitment. The denominator in both arms comprises all participants randomized to that arm. Colonoscopy completion rate was defined as the percentage of participants who completed colonoscopy within 90 days of randomization.

Secondary Outcome Measures

Name	Time	Method
Mental health - anxiety and depression	90 days	The mental health of participants in both arms was assessed pre- and post-colonoscopy using the Hospital Anxiety \& Depression Scale (HADS). The score may range from 0-21. Scores of 0-7 are normal, 8-10 is mild, 11-14 is moderate and 15-21 is severe anxiety or depression.
Mental health - General psychological distress	90 days	The mental health of participants in both arms was assessed pre- and post-colonoscopy using the General Health Questionnaire 12 (GHQ12) tool as a measure of general psychological distress. Each item in the 12-item questionnaire was scored on a Likert scale of 0-3, for a total score ranging from 0-36. High scores indicate worse health.

Trial Locations

Locations (1)

Faculty of Medicine, Universiti Malaya; 🇲🇾 Kuala Lumpur, Federal Territory, Malaysia