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

Primary Purpose

Colorectal Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Decision-aid video
Sponsored by
Universiti Kebangsaan Malaysia Medical Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Colorectal Cancer focused on measuring Screening, Primary care, Video

Eligibility Criteria

50 Years - 74 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • The National University of Malaysia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Usual care

Arm Description

Participants will receive decision-aid video

Participants will receive usual care

Outcomes

Primary Outcome Measures

Number of participants with colorectal cancer screening completion
Number of participants with completion of fecal occult blood test or colonoscopy procedures by participants

Secondary Outcome Measures

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
Period time from intervention to fecal occult blood test uptake
Duration taken after received intervention to screening uptake
Barriers towards the colorectal cancer screening uptake
List of barriers (numbers) towards the colorectal cancer screening uptake

Full Information

First Posted
December 22, 2020
Last Updated
December 30, 2020
Sponsor
Universiti Kebangsaan Malaysia Medical Centre
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1. Study Identification

Unique Protocol Identification Number
NCT04692987
Brief Title
Effectiveness of Decision-aid Video on Colorectal Cancer Screening
Acronym
DAVOCS
Official Title
Effectiveness of Decision-aid Video on Colorectal Cancer Screening in Primary Healthcare Setting: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 2021 (Anticipated)
Primary Completion Date
September 2021 (Anticipated)
Study Completion Date
March 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universiti Kebangsaan Malaysia Medical Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Screening, Primary care, Video

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel randomized controlled trial will be conducted in 3 months duration, with intention-to-treat.
Masking
ParticipantCare Provider
Masking Description
Investigators will designate participants to which arm using random sampling. Participants and care providers are masked to which arm they receive.
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Participants will receive decision-aid video
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Participants will receive usual care
Intervention Type
Other
Intervention Name(s)
Decision-aid video
Intervention Description
Decision-aid video will be developed to disseminate knowledge and to raise awareness on colorectal cancer screening
Primary Outcome Measure Information:
Title
Number of participants with colorectal cancer screening completion
Description
Number of participants with completion of fecal occult blood test or colonoscopy procedures by participants
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Number of participants with colonoscopy completion among those with positive fecal occult blood test
Description
Number of participants who are completed colonoscopy among those positive fecal occult blood test
Time Frame
3 months
Title
Period time from intervention to fecal occult blood test uptake
Description
Duration taken after received intervention to screening uptake
Time Frame
3 months
Title
Barriers towards the colorectal cancer screening uptake
Description
List of barriers (numbers) towards the colorectal cancer screening uptake
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Azmawati Mohammed Nawi, Medical
Phone
+6 03 8921 5555340
Email
azmawati@ppukm.ukm.edu.my
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Azmawati Mohammed Nawi
Organizational Affiliation
The National University of Malaysia
Official's Role
Principal Investigator
Facility Information:
Facility Name
The National University of Malaysia
City
Cheras
State/Province
Kuala Lumpur
ZIP/Postal Code
56000
Country
Malaysia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Azmawati Mohammed Nawi
First Name & Middle Initial & Last Name & Degree
Nur Suhada Ramli
First Name & Middle Initial & Last Name & Degree
Mohd Rohaizat Hassan
First Name & Middle Initial & Last Name & Degree
Zhiqin Wong
First Name & Middle Initial & Last Name & Degree
Muhamad Izwan Ismail
First Name & Middle Initial & Last Name & Degree
Faiz Daud
First Name & Middle Initial & Last Name & Degree
Emma Mirza Wati Mohamad
First Name & Middle Initial & Last Name & Degree
Arina Anis Azlan
First Name & Middle Initial & Last Name & Degree
Noor Azimah Muhammad

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Only three principal investigators will have access to participants' data

Learn more about this trial

Effectiveness of Decision-aid Video on Colorectal Cancer Screening

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