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"Intervention A" depicts current practices by having the research team educate the participants on the Ministry of Health Singapore screening guidelines akin to counselling sessions carried out during the patient's clinical consultation.

"Intervention B" involves a series of proactive engagements in hope to spur patients into contacting their siblings and improve their receptiveness towards colorectal cancer screening.

The engagements would include (1) a sealed envelope containing a cancer information sheet and an invitation letter directed towards siblings for them to contact the research team, (2) weekly phone reminders to the participants for a total of 4 weeks in a bid to remind participants of the need to convey the screening message to their siblings. The envelope will contain information on the various means for the siblings to contact the research team. These include communication means such as electronic mails (emails), telephone, hard copy returned mails through pre-paid envelopes, short messaging services (SMSs) or clinic consult.

Proactive engagement

This intervention depicts current practices by having the research team educate the participants on the Ministry of Health Singapore screening guidelines akin to counselling sessions carried out during the patient's clinical consultation. The research team would highlight that we would be happy to assist if necessary. The research team would then contact the patients in 4 weeks to check if they have communicated with their siblings and if they have gone for screening. We would also find out which method did they adopt to communicate with their siblings.

Current practice

To determine amongst siblings of colorectal cancer patients:1. The knowledge, perception and barriers towards screening colonoscopy. 2. The current screening colonoscopy adoption rate. 3. If patients would engage them through active engagement by healthcare providers in a bid to improve their receptiveness towards and partake in colorectal cancer screening. 4. The method(s) that Colorectal cancer patients adopt to communicate with them. 5. If tailored interventions addressing logistical, psychological and cost barriers could increase the adoption of screening colonoscopy.

Part I: Randomised control trial. Patients will be approached to participate in the study following recovery from their initial operation, after approximately three months, which often corresponds to the initial stages of adjuvant chemotherapy or active disease surveillance. Upon obtaining informed consent for the participant, the number of age appropriate siblings that are eligible for screening colonoscopy will be determined. Only siblings who have fulfilled the study inclusion criteria will be contacted. Siblings who accompany the participant for their follow-up appointment will directly be approached to participate in the qualitative component of the study. The Colorectal cancer patient will then be excluded from the Randomised control trial. However, given the findings of the preliminary study, most of the first degree relatives who came with the patients are the children and not siblings. As such the above mentioned scenario is unlikely. Participants will be enrolled into the randomised control trial and randomised to either "Intervention A" or "Intervention B". "Intervention A" depicts current practices by having the research team educate the participants on the Ministry of Health Singapore screening guidelines akin to counselling sessions carried out during the patient's clinical consultation. The research team would highlight that we would be happy to assist if necessary. The research team would then contact the patients in 4 weeks to check if they have communicated with their siblings and if they have gone for screening. The research team would also find out which method did they adopt to communicate with their siblings."Intervention B" involves a series of proactive engagements in hope to spur patients into contacting their siblings and improve their receptiveness towards colorectal cancer screening. The engagements would include (1) a sealed envelope containing a cancer information sheet and an invitation letter directed towards siblings for them to contact the research team, (2) weekly phone reminders to the participants for a total of 4 weeks in a bid to remind participants of the need to convey the screening message to their siblings. The envelope will contain information on the various means for the siblings to contact the research team. These include communication means such as electronic mails (emails), telephone, hard copy returned mails through pre-paid envelopes, short messaging services (SMSs) or clinic consult. A soft copy can also be given if requested by the patients.Once the participant has successfully contacted their siblings, the research team would inquire about the means of communication and the research team will proceed to invite the siblings to partake in the study. If the participant has yet contacted their siblings, the research team would inquire from participants as to why so. The research team will encourage the participant then to continue attempting to contact their siblings. Failing which at the end of 4 weeks, if the siblings remain not contactable, the participants will not be disturbed henceforth. Siblings who reject invitation to participate in the study will also not be contacted by the research team. Where possible, reasons for not being able to contact the siblings and rejections will be documented.

Siblings response rate will be determined in this study. The research team deem sibling replies as either "active" or "passive" by the way they use to contact the research team. "Active" approach would be for the siblings to contact the study team via the contact information provided to patients. "Passive" approach would be for the siblings to give verbal consent to the patient for the study team to contact them directly. This process is so tedious due to the Personal Data Protection Act (PDPA) that has been passed that prevent random calling of the siblings without informed consent.

Uncovering the Barriers of Colorectal Cancer Screening Amongst Siblings of Colorectal Cancer Patients.

Uncovering the Barriers of Colorectal Cancer Screening Amongst Siblings of Colorectal Cancer Patients Through a Randomised Control Trial.

The research team would like to compare the percentage response rates of siblings amongst the two intervention arms. A positive response would count as a sibling contacting the study team with their interest to undergo education by the research team on the topic of colorectal cancer screening.

The research team would divide the method of positive response via

1. "Active" approach would be for the siblings to contact the study team via the contact information provided to patients.
2. "Passive" approach would be for the siblings to give verbal consent to the patient for the study team to contact them directly.

National University Health System, Singapore

Consultant, Principal Investigator

"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.

"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.

"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.

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.

Targeted intervention programme

Ker Kan Tan

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

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.

Uncovering and Overcoming the Barriers of Colorectal Cancer Screening Amongst Spouses of Patients With Colorectal Cancer

Uncovering and Overcoming the Barriers of Colorectal Cancer Screening Amongst Spouses of Patients With Colorectal Cancer Through a Randomized Control Trial

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Uncovering the Barriers of Colorectal Cancer Screening Amongst Siblings of Colorectal Cancer Patients.	NCT03395938	Colorectal Canc...	Proactive engag... Current practic...	21 Years - 99 Years	National University Health System, Singapore
Uncovering and Overcoming the Barriers of Colorectal Cancer Screening Amongst Spouses of Patients With Colorectal Cancer	NCT04544852	Colorectal Canc...	Current practic... Targeted interv...	50 Years -	National University Health System, Singapore
Uncovering the Barriers of Colorectal Cancer Screening Amongst Siblings of Colorectal Cancer Patients.	NCT03395938	Colorectal Canc...	Proactive engag... Current practic...	21 Years - 99 Years	National University Health System, Singapore
Uncovering the Barriers of Colorectal Cancer Screening Amongst Siblings of Colorectal Cancer Patients.	NCT03395938	Colorectal Canc...	Proactive engag... Current practic...	21 Years - 99 Years	National University Health System, Singapore

Spots Global Cancer Trial Database for current practice