NCT02815436

Brief Summary

Colorectal cancer (CRC) is one of the major global health challenges. CRC is currently the third most common cancer in men and the second common in women worldwide, accounting for approximately 10% of all cancers. Randomized controlled studies have shown that CRC screening using Faecal Occult Blood Testing (FOBT) is effective in reducing cancer mortality by 15-33%. Since yearly testing is recommended to maintain programmatic effectiveness, longitudinal adherence is a critical component of FOBT-based screening programs. The investigators previous study conducted in Hong Kong showed that the rate of compliance with CRC screening was declining since the first year of enrolment. Nevertheless, it remains unknown whether interventions based on reminder systems could effectively enhance longitudinal compliance with FOBT, especially among those who have already enrolled in a CRC screening programme. Current evidence does not adequately compare whether interactive or one-way reminder messages are superior to usual care (i.e. no reminders).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for not_applicable colorectal-cancer

Timeline
Completed

Started Apr 2016

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

April 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 24, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 28, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

July 18, 2018

Status Verified

July 1, 2018

Enrollment Period

1.7 years

First QC Date

June 24, 2016

Last Update Submit

July 16, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Rate of completion of FOBT in the year of receiving the interventions/control

    1 year

Secondary Outcomes (1)

  • Rate of return of FOBT tubes in the year of receiving the interventions/control

    1 year

Study Arms (3)

Telephone reminder

ACTIVE COMPARATOR

subjects in this arm will receive a telephone reminder

Other: Telephone reminder

SMS reminder

ACTIVE COMPARATOR

Subjects in this arm will receive a SMS reminder

Other: SMS reminder

No reminder

NO INTERVENTION

usual care, where no additional intervention will be offered

Interventions

a personal, interactive telephone reminder by a centre colleague to remind return to the centre for taking faecal tubes for screening

Telephone reminder

a one-way, SMS message sent from the centre to the screening participant's mobile phone

SMS reminder

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects who joined the bowel cancer screening programme in the CUHK JC Bowel Cancer Education Centre who are expected to follow-up and return to the centre for annual Fecal Occult Blood Test.

You may not qualify if:

  • Subjects who have medical conditions rendering them unable to understand telephone or SMS messages.
  • Subjects without mobile phone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Martin Wong, MD

    CUHK

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 24, 2016

First Posted

June 28, 2016

Study Start

April 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

July 18, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations