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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

Singapore1 site
  • National University Hospital

    Kent Ridge, 119074

Other trials in Singapore

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:

  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. 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:

  1. What is colorectal cancer and what are its risk factors?
  2. What is the spouse possibly at risk of developing colorectal cancer?
  3. How can screening help to reduce the risk of colorectal cancer?
  4. What are the screening modalities for CRC?
  5. What are FIT kits?
  6. How to use FIT kits?
  7. 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.

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 groups in NCT04544852
Study groupRoleWhat they receive
Current practicePlacebo 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 programmeActive 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.

  1. 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.

  1. First posted10 Sep 2020
  2. Study start4 Dec 2017
  3. Primary completion28 Feb 2023
  4. Study completion30 Jun 2023

Resources

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)
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

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.

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