Colorectal Cancer ScreeningNCT06684067
Effect of Patient Navigation on Colonoscopy Completion Screening Rate for Colorectal Cancer.
A study testing Patient navigation in people with Colorectal Cancer Screening and Patient Navigation, run by University of Malaya at 1 site in Malaysia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Colorectal Cancer Screening, Patient Navigation
- What is being tested?
- Patient navigation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteMalaysia
- Study dates
- 3 Feb 2020to 31 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Average risk for CRC
- More than 50 years of age
- Capacity for informed consent
- IFOBT positive
Who cannot join
- Moderate or high risk CRC
- Previous CRC screening
- Symptomatic
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Faculty of Medicine, Universiti Malaya
Kuala Lumpur, Kuala Lumpur, 50603
About this study
Official title: A Prospective Randomized Controlled Trial to Evaluate the Effect of Patient Navigation on Colonoscopy Screening Rate for Colorectal Cancer (CRC) in University Malaya Medical Centre (UMMC)
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?
Read more
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
- Conditions
- Colorectal Cancer Screening, Patient Navigation
- Being tested
- Patient navigation
- Keywords
- RCT, colorectal cancer screening, patient navigation, Malaysia, depression, anxiety, HADS, GHQ12
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient navigationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Patient navigation | Experimental | Participants in the intervention arm will undergo a patient navigation process Receives: Behavioral: Patient navigation |
| No navigation | No intervention | Participants in the control arm will receive standard instructions and not undergo the patient navigation process. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colonoscopy completion rate
The numerator in both arms comprises participants who successfully attended and underwent colonoscopy within 90 days of recruitment. The denominator in both arms comprises all participants randomized to that arm. Colonoscopy completion rate was defined as the percentage of participants who completed colonoscopy within 90 days of randomization.
Measured: 90 days
Secondary outcomes (2)
Mental health - anxiety and depression
The mental health of participants in both arms was assessed pre- and post-colonoscopy using the Hospital Anxiety \& Depression Scale (HADS). The score may range from 0-21. Scores of 0-7 are normal, 8-10 is mild, 11-14 is moderate and 15-21 is severe anxiety or depression.
Measured: 90 days
Mental health - General psychological distress
The mental health of participants in both arms was assessed pre- and post-colonoscopy using the General Health Questionnaire 12 (GHQ12) tool as a measure of general psychological distress. Each item in the 12-item questionnaire was scored on a Likert scale of 0-3, for a total score ranging from 0-36. High scores indicate worse health.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start3 Feb 2020
- Primary completion28 Feb 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer ScreeningStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Malaysia
- Responsible party
- Sponsor
- Investigators
- April C Roslani, Master of Surgery, Principal investigator, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06684067
- Sponsor's protocol ID
- MREC ID No: 202057-8603
- Status last verified
- Oct 2024
- First submitted
- 4 Oct 2024
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Informed consent was only given for the purposes of this study.
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Trial to Evaluate the Effect of Patient Navigation on Colonoscopy Screening Rate for Colorectal Cancer (CRC) in University Malaya Medical Centre (UMMC)
- ClinicalTrials.gov ID
- NCT06684067
- Acronym / sponsor ID
- MREC ID No: 202057-8603
- Conditions
- Colorectal Cancer Screening, Patient Navigation
- Keywords
- RCT, colorectal cancer screening, patient navigation, Malaysia, depression, anxiety, HADS, GHQ12
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Collaborators
- Ministry of Health, Malaysia
- Study start
- 3 Feb 2020 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 12 Nov 2024 (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.
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
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient navigation | Experimental | Behavioral: Patient navigationParticipants in the intervention arm will undergo a patient navigation process |
| No navigation | No intervention | –Participants in the control arm will receive standard instructions and not undergo the patient navigation process. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Average risk for CRC
- More than 50 years of age
- Capacity for informed consent
- IFOBT positive
Key exclusion criteria (3 listed)
- Moderate or high risk CRC
- Previous CRC screening
- Symptomatic
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 |
|---|---|---|
| Patient navigationParticipants 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. | Behavioural | Patient navigation |
Primary outcome
Colonoscopy completion rate
Time frame: 90 days
The numerator in both arms comprises participants who successfully attended and underwent colonoscopy within 90 days of recruitment. The denominator in both arms comprises all participants randomized to that arm. Colonoscopy completion rate was defined as the percentage of participants who completed colonoscopy within 90 days of randomization.
2 secondary outcomes
Mental health - anxiety and depression
Time frame: 90 days
Mental health - General psychological distress
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Individual participant dataSharing planned: No. Informed consent was only given for the purposes of this study.
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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.
April C Roslani, Master of Surgery principal investigator
University of Malaya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient navigation in people with Colorectal Cancer Screening and Patient Navigation, run by University of Malaya 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: finished, as of the sponsor's last update on 12 Nov 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Colonoscopy completion rate (time frame: 90 days). 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 12 Nov 2024.