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OpenTrials
Completed

NCT Number: NCT06684067

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

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

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Key information

Conditions

Colorectal Cancer Screening Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders Patient Navigation

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine, Universiti Malaya

Kuala Lumpur, 50603, Malaysia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patient Navigation

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

University of Malaya

Other

Collaborators

  • Ministry of Health, Malaysia

Registry information

Official study title

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)

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Nov 12, 2024
Registry last updated
Nov 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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