Effectiveness of Decision-aid Video on Colorectal Cancer Screening (DAVOCS)

December 30, 2020 updated by: Azmawati, Universiti Kebangsaan Malaysia Medical Centre

Effectiveness of Decision-aid Video on Colorectal Cancer Screening in Primary Healthcare Setting: A Randomized Controlled Trial

Colorectal cancer (CRC) is the second most common cancer in Malaysia. Diagnosing CRC at early stage is crucial to reduce their mortality risk. To achieve this aim, CRC screening promotion intervention is deemed necessary.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

High-quality CRC screening interventions and approaches should be delivered to a large proportion of target population.

To our knowledge, there is no interactive video been developed, that can be used as educational tool for CRC screening in Malaysia. By developing an educational video, we hope that it can be used by health professionals to promote CRC screening, favoring their empowerment for prevention and control of disease.

Study Type

Interventional

Enrollment (Anticipated)

400

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
    • Kuala Lumpur
      • Cheras, Kuala Lumpur, Malaysia, 56000
        • The National University of Malaysia

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

50 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Malaysian aged 50 - 74 years old
  • No previous history or family history of CRC
  • Asymptomatic of CRC
  • Never participated in CRC screening

Exclusion Criteria:

  • Acute patients
  • Patients on aspirin, warfarin or any blood-thinning agent
  • Illiterate or having a significant vision or hearing impairment

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: Intervention
Participants will receive decision-aid video
Other: Decision-aid video
Decision-aid video will be developed to disseminate knowledge and to raise awareness on colorectal cancer screening
No Intervention: Usual care
Participants will receive usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with colorectal cancer screening completion
Time Frame: 3 months
Number of participants with completion of fecal occult blood test or colonoscopy procedures by participants
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with colonoscopy completion among those with positive fecal occult blood test
Time Frame: 3 months
Number of participants who are completed colonoscopy among those positive fecal occult blood test
3 months
Period time from intervention to fecal occult blood test uptake
Time Frame: 3 months
Duration taken after received intervention to screening uptake
3 months
Barriers towards the colorectal cancer screening uptake
Time Frame: 3 months
List of barriers (numbers) towards the colorectal cancer screening uptake
3 months

Collaborators and Investigators

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

Sponsor

Universiti Kebangsaan Malaysia Medical Centre

Investigators

  • Principal Investigator: Azmawati Mohammed Nawi, The National University of Malaysia

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 (Anticipated)

March 1, 2021

Primary Completion (Anticipated)

September 1, 2021

Study Completion (Anticipated)

March 1, 2022

Study Registration Dates

First Submitted

December 22, 2020

First Submitted That Met QC Criteria

December 30, 2020

First Posted (Actual)

January 5, 2021

Study Record Updates

Last Update Posted (Actual)

January 5, 2021

Last Update Submitted That Met QC Criteria

December 30, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FF-2020-155

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Only three principal investigators will have access to participants' data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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