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Effectiveness of Tel and SMS Reminder on Compliance With CRC Screening

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Telephone reminder
SMS reminder
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Colorectal Cancer

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Sites / Locations

  • The Chinese University of Hong Kong

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

Telephone reminder

SMS reminder

No reminder

Arm Description

subjects in this arm will receive a telephone reminder

Subjects in this arm will receive a SMS reminder

usual care, where no additional intervention will be offered

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 24, 2016
Last Updated
July 16, 2018
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT02815436
Brief Title
Effectiveness of Tel and SMS Reminder on Compliance With CRC Screening
Official Title
The Effectiveness of Telephone Reminders and SMS Messages on Compliance With Colorectal Cancer Screening: An Open-label, Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).
Detailed Description
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. It leads to 8% of all cancer mortality in the world and it is the fourth most common cause of cancer deaths. There were 4,563 new cases and 3,893 new deaths in Hong Kong in 2012, while 47.4% of the new cases were diagnosed at stage III or above. In the past decades the Asia Pacific countries like China, South Korea, Japan, and Singapore have witnessed a two to three-fold rise in incidence, gradually catching up the figures in Western countries. The direct medical cost for the care of colorectal neoplasia was estimated US$45,115 for stage IV CRC in the initial year of care, bringing a substantial, global public health burden to the healthcare systems. Randomized controlled studies have shown that CRC screening using Faecal Occult Blood Testing (FOBT) is effective in reducing cancer mortality by 15-33%. FOBT as a quick office-based procedure has the advantages of being non-invasive, inexpensive, acceptable, feasible, patient-friendly and devoid of needs for bowel preparation. A 25% relative risk reduction in CRC mortality was found for those attending at least one round of FOBT screening, according to a systematic review conducted in 2007. Guidelines from the US Preventive Services Task Force, the European Nations, the Asia Pacific Consensus statements and other authorities recommended FOBT as one of the first-line screening modalities, especially in resource-limited regions. 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).

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
None (Open Label)
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Telephone reminder
Arm Type
Active Comparator
Arm Description
subjects in this arm will receive a telephone reminder
Arm Title
SMS reminder
Arm Type
Active Comparator
Arm Description
Subjects in this arm will receive a SMS reminder
Arm Title
No reminder
Arm Type
No Intervention
Arm Description
usual care, where no additional intervention will be offered
Intervention Type
Other
Intervention Name(s)
Telephone reminder
Intervention Description
a personal, interactive telephone reminder by a centre colleague to remind return to the centre for taking faecal tubes for screening
Intervention Type
Other
Intervention Name(s)
SMS reminder
Intervention Description
a one-way, SMS message sent from the centre to the screening participant's mobile phone
Primary Outcome Measure Information:
Title
Rate of completion of FOBT in the year of receiving the interventions/control
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Rate of return of FOBT tubes in the year of receiving the interventions/control
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Subjects who have medical conditions rendering them unable to understand telephone or SMS messages. Subjects without mobile phone
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Wong, MD
Organizational Affiliation
CUHK
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Chinese University of Hong Kong
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effectiveness of Tel and SMS Reminder on Compliance With CRC Screening

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