NCT04544852

Brief Summary

To determine amongst spouses of colorectal cancer patients:

  1. 1.Screening rates for Colorectal Cancer (CRC) amongst spouses of patients with CRC
  2. 2.Barriers to screening based on the Health Belief Model (HBM)
  3. 3.Mediators to behaviour change using the transtheoretical model of behavioural change
  4. 4.If tailored interventions addressing education, convenience and cost would improve screening rates amongst the spouses

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable colorectal-cancer

Timeline
Completed

Started Dec 2017

Longer than P75 for not_applicable colorectal-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 4, 2017

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

September 5, 2019

Completed
1 year until next milestone

First Posted

Study publicly available on registry

September 10, 2020

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

5.2 years

First QC Date

September 5, 2019

Last Update Submit

April 9, 2026

Conditions

Outcome Measures

Primary Outcomes (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.

    3 months

Study Arms (2)

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.

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.

Behavioral: Targeted intervention programme

Interventions

"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.

Current practice

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

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National University Hospital

Kent Ridge, 119074, Singapore

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor Tan Ker Kan

Study Record Dates

First Submitted

September 5, 2019

First Posted

September 10, 2020

Study Start

December 4, 2017

Primary Completion

February 28, 2023

Study Completion

June 30, 2023

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations