Telephone Outreach by Navigators to Improve Repeat Fecal Occult Blood Testing

Telephone Outreach by Navigators to Improve Repeat Fecal Occult Blood Testing in Population Colorectal Cancer Screening Programme- a Randomised Control Trial

To conduct a randomised control trial to test the effectiveness of telephone outreach programme to improve the uptake rate of repeat fecal occult blood test in colorectal cancer screening programme.

Study Overview

• Status: Unknown
• Conditions: Colorectal Cancer Screening
• Intervention / Treatment: Behavioral: telephone outreach

Detailed Description

The colorectal cancer screening programme(CRCSP) adopts a two-tier approach, offering faecal occult blood test (FOBT) by FIT as first line screening followed by colonoscopy examination for cases with positive FIT result. Under the CRCSP, participants with negative or uninformative FIT result in the first round should be re-screened after 24 months.

The objective is to conduct a randomised control trial to test the effectiveness of telephone outreach programme to improve the uptake rate of repeat fecal occult blood test in CRCSP.

• Study Type: Interventional
• Enrollment (Anticipated): 1000
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Participants of CRCSP born between 1949 and 1951 with negative or uninformative FIT result in the first screening round who are due for second rescreening round for at least 4 months but did not turn up for rescreening

Exclusion Criteria:

• Nil

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control
Experimental: telephone outreach	Behavioral: telephone outreach; The navigator should make at least five (5) attempts to reach the participants on different days (at least one (1) attempt in weekend) and different time slots (at least one (1) attempt each in am, pm and evening). If the navigator only reached voice mail after the 1-month intervention period, a standard script will be read and a contact number will be provided.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
rescreening of CRC	completion of repeated fecal occult blood test in CRCSP	2 months
rescreening of CRC	completion of repeated fecal occult blood test in CRCSP	5 months

Collaborators and Investigators

• Sponsor: Centre for Health Protection, Hong Kong

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2019
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): February 1, 2020

Study Registration Dates

• First Submitted: May 30, 2019
• First Submitted That Met QC Criteria: June 3, 2019
• First Posted (Actual): June 5, 2019

Study Record Updates

• Last Update Posted (Actual): June 5, 2019
• Last Update Submitted That Met QC Criteria: June 3, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: CRC (NINDS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No