NCT03395938

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
223

participants targeted

Target at P50-P75 for not_applicable colorectal-cancer

Timeline
Completed

Started May 2017

Typical duration 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2017

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

May 14, 2017

Completed
8 months until next milestone

First Posted

Study publicly available on registry

January 10, 2018

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2021

Completed
Last Updated

September 5, 2021

Status Verified

September 1, 2021

Enrollment Period

4.1 years

First QC Date

May 14, 2017

Last Update Submit

September 1, 2021

Conditions

Keywords

SCREENING

Outcome Measures

Primary Outcomes (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.

    4 WEEKS

Study Arms (2)

Current practice

PLACEBO 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.

Behavioral: Current practice

Proactive engagement

ACTIVE 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.

Behavioral: Proactive engagement

Interventions

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

Eligibility Criteria

Age21 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National University Hospital

Singapore, 119074, Singapore

Location

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
Consultant, Principal Investigator

Study Record Dates

First Submitted

May 14, 2017

First Posted

January 10, 2018

Study Start

May 1, 2017

Primary Completion

May 31, 2021

Study Completion

May 31, 2021

Last Updated

September 5, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations