NCT03197116

Brief Summary

This is a randomized controlled study to compare the effectiveness of interactive telephone reminders by a layperson on enhancing compliance with CRC screening by FOBT, when compared with usual care (i.e. no intervention).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2017

Shorter than P25 for not_applicable

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

June 15, 2017

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

June 20, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 23, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

July 18, 2018

Status Verified

July 1, 2018

Enrollment Period

7 months

First QC Date

June 20, 2017

Last Update Submit

July 16, 2018

Conditions

CRC ScreeningCompliance, Patient

Outcome Measures

Primary Outcomes (1)

  • compliance rate of FOBT completion

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

    6 months

Secondary Outcomes (1)

  • compliance rate of FOBT pick up

    6 months

Study Arms (2)

Telephone reminder

ACTIVE COMPARATOR

Interactive telephone reminder by a trained layperson with a standard script to remind return to the center for taking fecal tubes for CRC screening

Other: Telephone reminder

No reminder

PLACEBO COMPARATOR

No additional reminder will be offered

Other: No other

Interventions

Telephone reminderOTHER

Interactive telephone reminder by a trained layperson with a standard script to remind return to the center for taking fecal tubes for CRC screening

Telephone reminder
No otherOTHER

No additional reminder will be offered

No reminder

Eligibility Criteria

Age50 Years - 75 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:

  • (1) had medical conditions rendering them unable to understand telephone; or (2) had no mobile phone were excluded.

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

Patient Compliance

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, CUHK Jocky Club Bowel Cancer Education Centre

Study Record Dates

First Submitted

June 20, 2017

First Posted

June 23, 2017

Study Start

June 15, 2017

Primary Completion

December 31, 2017

Study Completion

December 31, 2017

Last Updated

July 18, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)