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

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: Colorectal Cancer
• Intervention / Treatment: Other: Decision-aid video

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

• Study Contact: Name: Azmawati Mohammed Nawi, Medical; Phone Number: +6 03 8921 5555340; Email: azmawati@ppukm.ukm.edu.my

Study Locations

• Malaysia
  • Kuala Lumpur
    • Cheras, Kuala Lumpur, Malaysia, 56000
      • The National University of Malaysia
      • Contact: Azmawati Mohammed Nawi
      • Principal Investigator: Nur Suhada Ramli
      • Principal Investigator: Mohd Rohaizat Hassan
      • Sub-Investigator: Zhiqin Wong
      • Sub-Investigator: Muhamad Izwan Ismail
      • Sub-Investigator: Faiz Daud
      • Sub-Investigator: Emma Mirza Wati Mohamad
      • Sub-Investigator: Arina Anis Azlan
      • Sub-Investigator: Noor Azimah Muhammad

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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	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	Duration taken after received intervention to screening uptake	3 months
Barriers towards the colorectal cancer screening uptake	List of barriers (numbers) towards the colorectal cancer screening uptake	3 months

Collaborators and Investigators

• Sponsor: Universiti Kebangsaan Malaysia Medical Centre
• Investigators: Principal Investigator: Azmawati Mohammed Nawi, The National University of Malaysia

Study record dates

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: Primary care; Screening; Video
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• 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