Colorectal Cancer ScreeningNCT03974542
Telephone Outreach by Navigators to Improve Repeat Fecal Occult Blood Testing
A study testing telephone outreach in people with Colorectal Cancer Screening, run by Centre for Health Protection, Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colorectal Cancer Screening
- What is being tested?
- telephone outreach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Oct 2019to Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Nil
About this study
Official title: 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.
Read the 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.
- Conditions
- Colorectal Cancer Screening
- Being tested
- telephone outreach
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telephone outreachBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| telephone outreach | Experimental | Not described Receives: Behavioral: telephone outreach |
| control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
rescreening of CRC
completion of repeated fecal occult blood test in CRCSP
Measured: 2 months
rescreening of CRC
completion of repeated fecal occult blood test in CRCSP
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2019
- Study startOct 2019 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionFeb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer ScreeningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre for Health Protection, Hong Kong
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Grace Wong, Centre for Health Protection, Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03974542
- Sponsor's protocol ID
- CRC
- Status last verified
- Jun 2019
- First submitted
- 30 May 2019
- Last updated
- 5 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telephone Outreach by Navigators to Improve Repeat Fecal Occult Blood Testing in Population Colorectal Cancer Screening Programme- a Randomised Control Trial
- ClinicalTrials.gov ID
- NCT03974542
- Acronym / sponsor ID
- CRC
- Conditions
- Colorectal Cancer Screening
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Centre for Health Protection, Hong KongOther government
- Study start
- Oct 2019 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Feb 2020 (estimated)
- First posted
- 5 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| telephone outreach | Experimental | Behavioral: telephone outreach |
| control | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Nil
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| telephone outreachThe 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. | Behavioural | telephone outreach |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing telephone outreach in people with Colorectal Cancer Screening, run by Centre for Health Protection, Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rescreening of CRC (time frame: 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2019.