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出境医 / 临床实验 / Telephone Outreach by Navigators to Improve Repeat Fecal Occult Blood Testing
Telephone Outreach by Navigators to Improve Repeat Fecal Occult Blood Testing
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Colorectal Cancer Screening | Behavioral: telephone outreach | Not Applicable |
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 Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 1000 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Investigator, Outcomes Assessor) |
| Primary Purpose: | Screening |
| Official Title: | Telephone Outreach by Navigators to Improve Repeat Fecal Occult Blood Testing in Population Colorectal Cancer Screening Programme- a Randomised Control Trial |
| Estimated Study Start Date : | October 2019 |
| Estimated Primary Completion Date : | December 2019 |
| Estimated Study Completion Date : | February 2020 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
| 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.
|
| No Intervention: control |
Outcome Measures
Primary Outcome Measures :
- rescreening of CRC [ Time Frame: 2 months ]completion of repeated fecal occult blood test in CRCSP
- rescreening of CRC [ Time Frame: 5 months ]completion of repeated fecal occult blood test in CRCSP
Eligibility Criteria
| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
No Contacts or Locations Provided
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 30, 2019 | ||||
| First Posted Date ICMJE | June 5, 2019 | ||||
| Last Update Posted Date | June 5, 2019 | ||||
| Estimated Study Start Date ICMJE | October 2019 | ||||
| Estimated Primary Completion Date | December 2019 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Telephone Outreach by Navigators to Improve Repeat Fecal Occult Blood Testing | ||||
| Official Title ICMJE | Telephone Outreach by Navigators to Improve Repeat Fecal Occult Blood Testing in Population Colorectal Cancer Screening Programme- a Randomised Control Trial | ||||
| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Investigator, Outcomes Assessor) Primary Purpose: Screening |
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| Condition ICMJE | Colorectal Cancer Screening | ||||
| Intervention ICMJE | 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.
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Unknown status | ||||
| Estimated Enrollment ICMJE |
1000 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | February 2020 | ||||
| Estimated Primary Completion Date | December 2019 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | Child, Adult, Older Adult | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | Not Provided | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03974542 | ||||
| Other Study ID Numbers ICMJE | CRC | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Grace Wong, Centre for Health Protection, Hong Kong | ||||
| Study Sponsor ICMJE | Centre for Health Protection, Hong Kong | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| PRS Account | Centre for Health Protection, Hong Kong | ||||
| Verification Date | June 2019 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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