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

November 10, 2024 updated by: University of Malaya

A Prospective Randomized Controlled Trial to Evaluate the Effect of Patient Navigation on Colonoscopy Screening Rate for Colorectal Cancer (CRC) in University Malaya Medical Centre (UMMC)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
    • Federal Territory
      • Kuala Lumpur, Federal Territory, Malaysia, 50603
        • Faculty of Medicine, Universiti Malaya

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patient navigation
Participants in the intervention arm will undergo a patient navigation process
Behavioral: Patient navigation
Participants will receive online educational material, hospital site navigation guidance and direct contact with the patient navigator, in addition to standard instructions on the colonoscopy procedure.
No Intervention: No navigation
Participants in the control arm will receive standard instructions and not undergo the patient navigation process.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Colonoscopy completion rate
Time Frame: 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.
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mental health - anxiety and depression
Time Frame: 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.
90 days
Mental health - General psychological distress
Time Frame: 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.
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Malaya

Collaborators

Ministry of Health, Malaysia

Investigators

  • Principal Investigator: April C Roslani, Master of Surgery, Universiti Malaya

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 3, 2020

Primary Completion (Actual)

February 28, 2022

Study Completion (Actual)

March 31, 2022

Study Registration Dates

First Submitted

October 4, 2024

First Submitted That Met QC Criteria

November 10, 2024

First Posted (Estimated)

November 12, 2024

Study Record Updates

Last Update Posted (Estimated)

November 12, 2024

Last Update Submitted That Met QC Criteria

November 10, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MREC ID No: 202057-8603

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Informed consent was only given for the purposes of this study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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