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

Primary Purpose

Colorectal Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Current practice
Targeted intervention programme
Sponsored by
National University Health System, Singapore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Colorectal Cancer

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Has a partner who was diagnosed and treated for Colorectal Cancer
  2. Either Singaporean or Permanent Resident;
  3. Fulfilled the eligibility to undergo screening for colorectal cancer as stipulated by MOH.

Exclusion Criteria:

  1. 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
  2. Previous personal history of colorectal cancer or colorectal polyps
  3. 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)

Sites / Locations

  • National University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Current practice

Targeted intervention programme

Arm Description

"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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 5, 2019
Last Updated
June 30, 2023
Sponsor
National University Health System, Singapore
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1. Study Identification

Unique Protocol Identification Number
NCT04544852
Brief Title
Uncovering and Overcoming the Barriers of Colorectal Cancer Screening Amongst Spouses of Patients With Colorectal Cancer
Official Title
Uncovering and Overcoming the Barriers of Colorectal Cancer Screening Amongst Spouses of Patients With Colorectal Cancer Through a Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 4, 2017 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National University Health System, Singapore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Current practice
Arm Type
Placebo Comparator
Arm Description
"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.
Arm Title
Targeted intervention programme
Arm Type
Active Comparator
Arm Description
"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 Type
Behavioral
Intervention Name(s)
Current practice
Intervention Description
"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.
Intervention Type
Behavioral
Intervention Name(s)
Targeted intervention programme
Intervention Description
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.
Primary Outcome Measure Information:
Title
The proportion of participants that completed the FIT test within three months post enrollment.
Description
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.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ker Kan Tan
Phone
67722230
Email
ker_kan_tan@nuhs.edu.sg
Facility Information:
Facility Name
National University Hospital
City
Kent Ridge
ZIP/Postal Code
119074
Country
Singapore
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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