Colorectal CancerNCT04544852
Uncovering and Overcoming the Barriers of Colorectal Cancer Screening Amongst Spouses of Patients With Colorectal Cancer
A study testing Current practice and Targeted intervention programme in people with Colorectal Cancer, run by National University Health System, Singapore at 1 site in Singapore.
Trial summary
To determine amongst spouses of colorectal cancer patients: 1. Screening rates for Colorectal Cancer (CRC) amongst spouses of patients with CRC 2. Barriers to screening based on the Health Belief Model (HBM) 3. Mediators to behaviour change using the transtheoretical model of behavioural change 4. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Current practice and Targeted intervention programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSingapore
- Study dates
- 4 Dec 2017to 30 Jun 2023
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Has a partner who was diagnosed and treated for Colorectal Cancer
- Either Singaporean or Permanent Resident;
- Fulfilled the eligibility to undergo screening for colorectal cancer as stipulated by MOH.
Who cannot join
- Pre-existing family history of FAP, HNPCC or inflammatory bowel disease in the family, as this would place the patient in the high risk group
- Previous personal history of colorectal cancer or colorectal polyps
- Underwent previous FOBT/FIT tests for CRC (this is an exclusion to participate in Stage 2-RCT only. Participants can still take part in Stage 1 and Stage 3 of the study if they fulfilled inclusion criteria 1-3, and did not meet any of the exclusion criteria 1-2)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Uncovering and Overcoming the Barriers of Colorectal Cancer Screening Amongst Spouses of Patients With Colorectal Cancer Through a Randomized Control Trial
To determine amongst spouses of colorectal cancer patients:
- Screening rates for Colorectal Cancer (CRC) amongst spouses of patients with CRC
- Barriers to screening based on the Health Belief Model (HBM)
- Mediators to behaviour change using the transtheoretical model of behavioural change
- If tailored interventions addressing education, convenience and cost would improve screening rates amongst the spouses
Read the detailed description
Stage 1: Randomization into Intervention versus Control
The eligible participants will be randomized into either "Intervention" or "Control" after the study team obtains participants' informed consent and before they begin doing the questionnaires. A randomisation list is generated using a computer procedure using block randomization. Based on the randomisation list, the assigned groups for each study participant's ID are written in a sealed opaque envelope. The envelope will be open at the point of randomisation to find out which group participant is randomised to.
The "Intervention" arm is aimed at specifically addressing gaps in terms of knowledge of colorectal cancer and the importance of screening, as well as targeting cost as well as convenience issues. Spouses who have been randomized into this arm will undergo a session with a trained research assistant who will highlight the following points:
- What is colorectal cancer and what are its risk factors?
- What is the spouse possibly at risk of developing colorectal cancer?
- How can screening help to reduce the risk of colorectal cancer?
- What are the screening modalities for CRC?
- What are FIT kits?
- How to use FIT kits?
- Where to return the FIT kits once they have been used?
All participants who have undergone the counseling session will then be given 2 x FIT kits (as recommended in the guidelines) free of charge, and also advised to mail the FIT kits back to the colorectal clinic in a pre-paid envelope once it has been used. By performing the above targeted interventions, we would have tackled issues relating to education, cost and convenience.
The "Control" arm is the current practice in the community where these participants would be informed that the FIT kits can be obtained from the Singapore Cancer Society (SCS) free of charge if they fulfil the screening criteria as stipulated in the MOH guidelines. The participants will be advised on the various locations to collect these FIT kits.
The endpoint for the "intervention" and the "control" arms is whether the spouses returned the FIT kits within 3 months from date of consent.
Stage 2: Questionnaires
After obtaining informed consent, the spouse would be asked to fill in the baseline demographic form. After that, they will be asked if they have undergone any prior screening as recommended by the MOH screening guidelines as stipulated earlier. Following that, a quantitative questionnaire utilizing the validated Health Belief Model would be administered to study the potential barriers to screening which may be faced by the spouses. This questionnaire is based on the 5 domains of the Health Belief Model which include perceived susceptibility to acquiring CRC, perceived severity of the disease, perceived benefit of going for screening, perceived barriers to action and cues to action. The response options for questions on these domains are categorized into "disagree", "agree" and "unsure".
A second questionnaire based on the transtheoretical model would then be implemented next. We would determine their stage in the transtheoretical model based on their responses. The basic questionnaire was based on previous published data. This questionnaire will take approximately 5 minutes to complete.
Faecal Occult Blood Test or Colonoscopy:
Never heard: Has not heard of FOBT or colonoscopy. Precontemplation: Never had an FOBT or last FOBT was more than a year ago or last colonoscopy was more than 10 years ago and not thinking about having an FOBT or colonoscopy in the next 2 months.
Contemplation: Never had an FOBT or last FOBT was more than a year ago or last colonoscopy was more than 10 years ago but thinking about having an FOBT or colonoscopy in the next 2 months.
Action: FOBT was within the last year or colonoscopy was within the last year. Maintenance: Has undergone two or more FOBTs in the past 2 years or has undergone at least two or more colonoscopies and would continue to do so in concordance with the schedule
The same questionnaire would be repeated in 3 months and 6-12 months following the initial interview, with at least 3 months between each follow-up. This is in sync with the appointments that the patients themselves would be attending as part of their surveillance for their CRC. This is to document the changes in their responses to the various domains as the impact of the patients' cancers is less felt with time. The responses would guide the research team to determine if the peri-operative period remains the best time to advise the spouses to undergo screening or if we should delay it to a more appropriate and hence receptive period.
- Conditions
- Colorectal Cancer
- Being tested
- Current practice, Targeted intervention programme
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Current practiceBehavioural
"Intervention A" depicts current practices by informing the participants that FIT kits can be obtained from from the Singapore Cancer Society (SCS) or one of their collection point free of charge. Participants will be contacted at 3 months after enrollment to determine whether they have completed the FIT test.
Targeted intervention programmeBehavioural
The targeted intervention programme includes participants undergoing a structured educational program regarding colorectal cancer and the importance of screening in its prevention. The details will be explained to them using the pamphlet from MOH on Colorectal Cancer Screening. They will also be offered two FIT kits free of charge. Research team will educate participants on how to perform the FIT test. A detailed information guide on how to collect stool samples for FIT kit and how to return the completed FIT kit to the NUH Colorectal Centre will be given to them. Participants will be contacted at 3 months after enrollment to determine whether they have completed the FIT test.
| Study group | Role | What they receive |
|---|---|---|
| Current practice | Placebo comparator | "Intervention A" depicts current practices by informing the participants that FIT kits can be obtained from from the Singapore Cancer Society (SCS) or one of their collection point free of charge. Receives: Behavioral: Current practice |
| Targeted intervention programme | Active comparator | "Intervention B" involves a targeted intervention programme tackling issues relating to a lack of education, inconvenience and cost would improve screening rates amongst the spouses. Receives: Behavioral: Targeted intervention programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of participants that completed the FIT test within three months post enrollment.
The research team would like to compare the percentage of FIT kit uptake rates amongst the two intervention arms. A positive outcome would be a higher percentage of FIT uptake seen in the targeted intervention arm.
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 posted10 Sep 2020
- Study start4 Dec 2017
- Primary completion28 Feb 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University Health System, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, KER-KAN TAN, National University Health System, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04544852
- Sponsor's protocol ID
- R-176-000-211-511
- Status last verified
- Apr 2026
- First submitted
- 5 Sep 2019
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lau J, Choe L, Hui Juan Lee D, Khoo AM, Koh WL, Peh C, Ng A, Lim TZ, Lieske B, Lee KC, Chong CS, Seow CS, Keh CHL, Ng JY, Tan KK. Increasing Colorectal Screening Uptake in Spouses of Patients With Colorectal Cancer Using a Randomized Behavioral Trial. J Natl Compr Canc Netw. 2024 Jul 29;22(6):e247018. doi: 10.6004/jnccn.2024.7018.
PubMed 39074504
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uncovering and Overcoming the Barriers of Colorectal Cancer Screening Amongst Spouses of Patients With Colorectal Cancer Through a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04544852
- Acronym / sponsor ID
- R-176-000-211-511
- Conditions
- Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- National University Health System, SingaporeUniversity, hospital or other
- Study start
- 4 Dec 2017 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 10 Sep 2020 (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.
To determine amongst spouses of colorectal cancer patients:
- Screening rates for Colorectal Cancer (CRC) amongst spouses of patients with CRC
- Barriers to screening based on the Health Belief Model (HBM)
- Mediators to behaviour change using the transtheoretical model of behavioural change
- If tailored interventions addressing education, convenience and cost would improve screening rates amongst the spouses
Detailed description
Stage 1: Randomization into Intervention versus Control
The eligible participants will be randomized into either "Intervention" or "Control" after the study team obtains participants' informed consent and before they begin doing the questionnaires. A randomisation list is generated using a computer procedure using block randomization. Based on the randomisation list, the assigned groups for each study participant's ID are written in a sealed opaque envelope. The envelope will be open at the point of randomisation to find out which group participant is randomised to.
The "Intervention" arm is aimed at specifically addressing gaps in terms of knowledge of colorectal cancer and the importance of screening, as well as targeting cost as well as convenience issues. Spouses who have been randomized into this arm will undergo a session with a trained research assistant who will highlight the following points:
- What is colorectal cancer and what are its risk factors?
- What is the spouse possibly at risk of developing colorectal cancer?
- How can screening help to reduce the risk of colorectal cancer?
- What are the screening modalities for CRC?
- What are FIT kits?
- How to use FIT kits?
- Where to return the FIT kits once they have been used?
All participants who have undergone the counseling session will then be given 2 x FIT kits (as recommended in the guidelines) free of charge, and also advised to mail the FIT kits back to the colorectal clinic in a pre-paid envelope once it has been used. By performing the above targeted interventions, we would have tackled issues relating to education, cost and convenience.
The "Control" arm is the current practice in the community where these participants would be informed that the FIT kits can be obtained from the Singapore Cancer Society (SCS) free of charge if they fulfil the screening criteria as stipulated in the MOH guidelines. The participants will be advised on the various locations to collect these FIT kits.
The endpoint for the "intervention" and the "control" arms is whether the spouses returned the FIT kits within 3 months from date of consent.
Stage 2: Questionnaires
After obtaining informed consent, the spouse would be asked to fill in the baseline demographic form. After that, they will be asked if they have undergone any prior screening as recommended by the MOH screening guidelines as stipulated earlier. Following that, a quantitative questionnaire utilizing the validated Health Belief Model would be administered to study the potential barriers to screening which may be faced by the spouses. This questionnaire is based on the 5 domains of the Health Belief Model which include perceived susceptibility to acquiring CRC, perceived severity of the disease, perceived benefit of going for screening, perceived barriers to action and cues to action. The response options for questions on these domains are categorized into "disagree", "agree" and "unsure".
A second questionnaire based on the transtheoretical model would then be implemented next. We would determine their stage in the transtheoretical model based on their responses. The basic questionnaire was based on previous published data. This questionnaire will take approximately 5 minutes to complete.
Faecal Occult Blood Test or Colonoscopy:
Never heard: Has not heard of FOBT or colonoscopy. Precontemplation: Never had an FOBT or last FOBT was more than a year ago or last colonoscopy was more than 10 years ago and not thinking about having an FOBT or colonoscopy in the next 2 months.
Contemplation: Never had an FOBT or last FOBT was more than a year ago or last colonoscopy was more than 10 years ago but thinking about having an FOBT or colonoscopy in the next 2 months.
Action: FOBT was within the last year or colonoscopy was within the last year. Maintenance: Has undergone two or more FOBTs in the past 2 years or has undergone at least two or more colonoscopies and would continue to do so in concordance with the schedule
The same questionnaire would be repeated in 3 months and 6-12 months following the initial interview, with at least 3 months between each follow-up. This is in sync with the appointments that the patients themselves would be attending as part of their surveillance for their CRC. This is to document the changes in their responses to the various domains as the impact of the patients' cancers is less felt with time. The responses would guide the research team to determine if the peri-operative period remains the best time to advise the spouses to undergo screening or if we should delay it to a more appropriate and hence receptive period.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Current practice | Placebo comparator | Behavioral: Current practice"Intervention A" depicts current practices by informing the participants that FIT kits can be obtained from from the Singapore Cancer Society (SCS) or one of their collection point free of charge. |
| Targeted intervention programme | Active comparator | Behavioral: Targeted intervention programme"Intervention B" involves a targeted intervention programme tackling issues relating to a lack of education, inconvenience and cost would improve screening rates amongst the spouses. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Has a partner who was diagnosed and treated for Colorectal Cancer
- Either Singaporean or Permanent Resident;
- Fulfilled the eligibility to undergo screening for colorectal cancer as stipulated by MOH.
Key exclusion criteria (3 listed)
- Pre-existing family history of FAP, HNPCC or inflammatory bowel disease in the family, as this would place the patient in the high risk group
- Previous personal history of colorectal cancer or colorectal polyps
- Underwent previous FOBT/FIT tests for CRC (this is an exclusion to participate in Stage 2-RCT only. Participants can still take part in Stage 1 and Stage 3 of the study if they fulfilled inclusion criteria 1-3, and did not meet any of the exclusion criteria 1-2)
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 |
|---|---|---|
| Current practice"Intervention A" depicts current practices by informing the participants that FIT kits can be obtained from from the Singapore Cancer Society (SCS) or one of their collection point free of charge. Participants will be contacted at 3 months after enrollment to determine whether they have completed the FIT test. | Behavioural | Current practice |
| Targeted intervention programmeThe targeted intervention programme includes participants undergoing a structured educational program regarding colorectal cancer and the importance of screening in its prevention. The details will be explained to them using the pamphlet from MOH on Colorectal Cancer Screening. They will also be offered two FIT kits free of charge. Research team will educate participants on how to perform the FIT test. A detailed information guide on how to collect stool samples for FIT kit and how to return the completed FIT kit to the NUH Colorectal Centre will be given to them. Participants will be contacted at 3 months after enrollment to determine whether they have completed the FIT test. | Behavioural | Targeted intervention programme |
Primary outcome
The proportion of participants that completed the FIT test within three months post enrollment.
Time frame: 3 months
The research team would like to compare the percentage of FIT kit uptake rates amongst the two intervention arms. A positive outcome would be a higher percentage of FIT uptake seen in the targeted intervention arm.
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 13 Apr 2026.
- Derived from this study: PubMed 39074504Lau J, Choe L, Hui Juan Lee D, Khoo AM, Koh WL, Peh C, Ng A, Lim TZ, Lieske B, Lee KC, Chong CS, Seow CS, Keh CHL, Ng JY, Tan KK. Increasing Colorectal Screening Uptake in Spouses of Patients With Colorectal Cancer Using a Randomized Behavioral Trial. J Natl Compr Canc Netw. 2024 Jul 29;22(6):e247018. doi: 10.6004/jnccn.2024.7018.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Current practice and Targeted intervention programme in people with Colorectal Cancer, run by National University Health System, Singapore at 1 site in Singapore.
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 3 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 13 Apr 2026. 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 Singapore. 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. Some participants in this study may receive a placebo. 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?
The proportion of participants that completed the FIT test within three months post enrollment. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04544852, which also lists 1 linked publication.
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 13 Apr 2026.