Colorectal CancerDAVOCSNCT04692987
Effectiveness of Decision-aid Video on Colorectal Cancer Screening
A study testing Decision-aid video in people with Colorectal Cancer, run by Universiti Kebangsaan Malaysia Medical Centre at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Decision-aid video
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteMalaysia
- Study dates
- Mar 2021to Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Malaysian aged 50 - 74 years old
- No previous history or family history of CRC
- Asymptomatic of CRC
- Never participated in CRC screening
Who cannot join
- Acute patients
- Patients on aspirin, warfarin or any blood-thinning agent
- Illiterate or having a significant vision or hearing impairment
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
The National University of Malaysia
Cheras, Kuala Lumpur, 56000
Azmawati Mohammed Nawi
Nur Suhada Ramli
About this study
Official title: 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.
Read the 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.
- Conditions
- Colorectal Cancer
- Being tested
- Decision-aid video
- Keywords
- Screening, Primary care, Video
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision-aid videoOther
Decision-aid video will be developed to disseminate knowledge and to raise awareness on colorectal cancer screening
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants will receive decision-aid video Receives: Other: Decision-aid video |
| Usual care | No intervention | Participants will receive usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with colorectal cancer screening completion
Number of participants with completion of fecal occult blood test or colonoscopy procedures by participants
Measured: 3 months
Secondary outcomes (3)
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
Measured: 3 months
Period time from intervention to fecal occult blood test uptake
Duration taken after received intervention to screening uptake
Measured: 3 months
Barriers towards the colorectal cancer screening uptake
List of barriers (numbers) towards the colorectal cancer screening uptake
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study startMar 2021 (estimated)
- Primary completionSep 2021 (estimated)
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel randomized controlled trial will be conducted in 3 months duration, with intention-to-treat.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Kebangsaan Malaysia Medical Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Azmawati, Universiti Kebangsaan Malaysia Medical Centre
- Investigators
- Azmawati Mohammed Nawi, Principal investigator, The National University of Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04692987
- Sponsor's protocol ID
- FF-2020-155
- Acronym
- DAVOCS
- Status last verified
- Dec 2020
- First submitted
- 22 Dec 2020
- Last updated
- 5 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only three principal investigators will have access to participants' data
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Decision-aid Video on Colorectal Cancer Screening in Primary Healthcare Setting: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04692987
- Acronym / sponsor ID
- DAVOCS / FF-2020-155
- Conditions
- Colorectal Cancer
- Keywords
- Screening, Primary care, Video
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Universiti Kebangsaan Malaysia Medical CentreUniversity, hospital or other
- Study start
- Mar 2021 (estimated)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 5 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Parallel randomized controlled trial will be conducted in 3 months duration, with intention-to-treat.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Decision-aid videoParticipants will receive decision-aid video |
| Usual care | No intervention | –Participants will receive usual care |
Who may qualify
- Ages
- 50 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Malaysian aged 50 - 74 years old
- No previous history or family history of CRC
- Asymptomatic of CRC
- Never participated in CRC screening
Key exclusion criteria (3 listed)
- Acute patients
- Patients on aspirin, warfarin or any blood-thinning agent
- Illiterate or having a significant vision or hearing impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Decision-aid videoDecision-aid video will be developed to disseminate knowledge and to raise awareness on colorectal cancer screening | Other | Intervention |
Primary outcome
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 secondary outcomes
Number of participants with colonoscopy completion among those with positive fecal occult blood test
Time frame: 3 months
Period time from intervention to fecal occult blood test uptake
Time frame: 3 months
Barriers towards the colorectal cancer screening uptake
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- Individual participant dataSharing planned: No. Only three principal investigators will have access to participants' data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Azmawati Mohammed Nawi principal investigator
The National University of Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decision-aid video in people with Colorectal Cancer, run by Universiti Kebangsaan Malaysia Medical Centre at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Azmawati Mohammed Nawi, Medical (+6 03 8921 5555340, azmawati@ppukm.ukm.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with colorectal cancer screening completion (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2021.