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

NCT06684067 | Completed DMC

• 1 other identifier: MREC ID No: 202057-8603
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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

Conditions

Colorectal Cancer Screening; Patient Navigation

Keywords

RCT; colorectal cancer screening; patient navigation; Malaysia; depression; anxiety; HADS; GHQ12

Outcome Measures

Primary Outcomes (1)

• Colonoscopy completion rate

  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 Outcomes (2)

• Mental health - anxiety and depression

  90 days

• Mental health - General psychological distress

  90 days

Study Arms (2)

Patient navigation

EXPERIMENTAL

Participants in the intervention arm will undergo a patient navigation process

Behavioral: Patient navigation

No navigation

NO INTERVENTION

Participants in the control arm will receive standard instructions and not undergo the patient navigation process.

Interventions

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.

Patient navigation

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Malaya: lead
• Ministry of Health, Malaysia: collaborator

Study Sites (1)

Faculty of Medicine, Universiti Malaya

Kuala Lumpur, Kuala Lumpur, 50603, Malaysia

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders

Interventions

Patient Navigation

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Patient-Centered Care; Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• April C Roslani, Master of Surgery

  Universiti Malaya

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2024
• First Posted: November 12, 2024
• Study Start: February 3, 2020
• Primary Completion: February 28, 2022
• Study Completion: March 31, 2022
• Last Updated: November 12, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)