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Telephone Outreach by Navigators to Improve Repeat Fecal Occult Blood Testing

Primary Purpose

Colorectal Cancer Screening

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
telephone outreach
Sponsored by
Centre for Health Protection, Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Colorectal Cancer Screening

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    telephone outreach

    control

    Arm Description

    Outcomes

    Primary Outcome Measures

    rescreening of CRC
    completion of repeated fecal occult blood test in CRCSP
    rescreening of CRC
    completion of repeated fecal occult blood test in CRCSP

    Secondary Outcome Measures

    Full Information

    First Posted
    May 30, 2019
    Last Updated
    June 3, 2019
    Sponsor
    Centre for Health Protection, Hong Kong
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03974542
    Brief Title
    Telephone Outreach by Navigators to Improve Repeat Fecal Occult Blood Testing
    Official Title
    Telephone Outreach by Navigators to Improve Repeat Fecal Occult Blood Testing in Population Colorectal Cancer Screening Programme- a Randomised Control Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 2019 (Anticipated)
    Primary Completion Date
    December 2019 (Anticipated)
    Study Completion Date
    February 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Centre for Health Protection, Hong Kong

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Colorectal Cancer Screening

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    1000 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    telephone outreach
    Arm Type
    Experimental
    Arm Title
    control
    Arm Type
    No Intervention
    Intervention Type
    Behavioral
    Intervention Name(s)
    telephone outreach
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    rescreening of CRC
    Description
    completion of repeated fecal occult blood test in CRCSP
    Time Frame
    2 months
    Title
    rescreening of CRC
    Description
    completion of repeated fecal occult blood test in CRCSP
    Time Frame
    5 months

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Telephone Outreach by Navigators to Improve Repeat Fecal Occult Blood Testing

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