AzTrials
AzTrials

Colorectal CancerNCT03395938

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

A study testing Proactive engagement and Current practice 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
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 21 to 99 years
Conditions the study is for
Colorectal Cancer
What is being tested?
Proactive engagement and Current practice
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
223 participants
Where
1 siteSingapore
Study dates
1 May 2017to 31 May 2021
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 21 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Either Singaporean or Permanent Resident,
  • Has a sibling who has been diagnosed with colorectal cancer
  • Fulfilled the eligibility requirement to undergo screening colonoscopy as stipulated by Ministry of Health Singapore (At least aged 50 year or older or 10 years younger than when the index patient (below aged 60 year) was diagnosed with colorectal cancer)

Who cannot join

  • Pre-existing family history of Familial Adenomatous Polyposis or Hereditary non-polyposis colorectal cancer
  • Personal history of inflammatory bowel disease
  • Personal history of colorectal cancer or colorectal polyps

Trial locations and contacts

1 site in 1 country.

Singapore1 site
  • National University Hospital

    Singapore, 119074

Other trials in Singapore

About this study

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

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.

Read the detailed description

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.

Being tested
Proactive engagement, Current practice
Keywords
SCREENING
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Proactive engagementBehavioural

    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.

  • Current practiceBehavioural

    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.

Study groups in NCT03395938
Study groupRoleWhat they receive
Current practicePlacebo comparator"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.
Receives: Behavioral: Current practice
Proactive engagementActive comparator"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.
Receives: Behavioral: Proactive engagement

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The proportion of siblings that contacted the study team within 4 weeks from point of engagement by the index colorectal cancer patient.

    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.

    Measured: 4 WEEKS

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2018
  2. Study start1 May 2017
  3. Primary completion31 May 2021
  4. Study completion31 May 2021

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
223 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03395938
Sponsor's protocol ID
2017/00172
Other IDs
2017
Status last verified
Sep 2021
First submitted
14 May 2017
Last updated
5 Sep 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Proactive engagement and Current practice 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 5 Sep 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 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 siblings that contacted the study team within 4 weeks from point of engagement by the index colorectal cancer patient. (time frame: 4 WEEKS). 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 Sep 2021.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in