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

NCT ID: NCT06684067

Last Updated: 2024-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-03

Study Completion Date

2022-03-31

Brief Summary

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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

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Conditions

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Colorectal Cancer Screening Patient Navigation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Patient navigation

Participants in the intervention arm will undergo a patient navigation process

Group Type EXPERIMENTAL

Patient navigation

Intervention Type 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.

No navigation

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, Malaysia

OTHER_GOV

Sponsor Role collaborator

University of Malaya

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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April C Roslani, Master of Surgery

Role: PRINCIPAL_INVESTIGATOR

Universiti Malaya

Locations

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Faculty of Medicine, Universiti Malaya

Kuala Lumpur, Kuala Lumpur, Malaysia

Site Status

Countries

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Malaysia

Other Identifiers

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MREC ID No: 202057-8603

Identifier Type: -

Identifier Source: org_study_id

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