CRC ScreeningNCT03197116
Lay Tel Compliance Study
A study testing Telephone reminder and No other in people with CRC Screening and Compliance, Patient, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
This is a randomized controlled study to compare the effectiveness of interactive telephone reminders by a layperson on enhancing compliance with CRC screening by FOBT, when compared with usual care (i.e. no intervention). Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- CRC Screening, Compliance, Patient
- What is being tested?
- Telephone reminder and No other
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- 1 siteHong Kong
- Study dates
- 15 Jun 2017to 31 Dec 2017
- 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 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- (1) had medical conditions rendering them unable to understand telephone; or (2) had no mobile phone were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Telephone Reminders by a Layperson on Compliance With Colorectal Cancer Screening: an Open-label, Randomized Controlled Trial
This is a randomized controlled study to compare the effectiveness of interactive telephone reminders by a layperson on enhancing compliance with CRC screening by FOBT, when compared with usual care (i.e. no intervention).
Read the 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. Our 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 reminder are superior to usual care (i.e. no reminders).
- Conditions
- CRC Screening, Compliance, Patient
- Being tested
- Telephone reminder, No other
- Medical subject headings
- Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone reminderOther
Interactive telephone reminder by a trained layperson with a standard script to remind return to the center for taking fecal tubes for CRC screening
No otherOther
No additional reminder will be offered
| Study group | Role | What they receive |
|---|---|---|
| Telephone reminder | Active comparator | Interactive telephone reminder by a trained layperson with a standard script to remind return to the center for taking fecal tubes for CRC screening Receives: Other: Telephone reminder |
| No reminder | Placebo comparator | No additional reminder will be offered Receives: Other: No other |
What is being measured
The primary outcome is the main question the study is designed to answer.
compliance rate of FOBT completion
Rate of completion of FOBT in the year of receiving the interventions/control
Measured: 6 months
Secondary outcomes (1)
compliance rate of FOBT pick up
Rate of return to the centre for taking FOBT tubes in the year of receiving the interventions/control
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2017
- Study start15 Jun 2017
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CRC ScreeningStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Chi Sang Wong, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03197116
- Sponsor's protocol ID
- Lay Tel Compliance
- Status last verified
- Jul 2018
- First submitted
- 20 Jun 2017
- Last updated
- 18 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- 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 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Telephone Reminders by a Layperson on Compliance With Colorectal Cancer Screening: an Open-label, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03197116
- Acronym / sponsor ID
- Lay Tel Compliance
- Conditions
- CRC Screening, Compliance, Patient
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 15 Jun 2017 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 23 Jun 2017 (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.
This is a randomized controlled study to compare the effectiveness of interactive telephone reminders by a layperson on enhancing compliance with CRC screening by FOBT, when compared with usual care (i.e. no intervention).
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. Our 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 reminder are superior to usual care (i.e. no reminders).
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telephone reminder | Active comparator | Other: Telephone reminderInteractive telephone reminder by a trained layperson with a standard script to remind return to the center for taking fecal tubes for CRC screening |
| No reminder | Placebo comparator | Other: No otherNo additional reminder will be offered |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- (1) had medical conditions rendering them unable to understand telephone; or (2) had no mobile phone were excluded.
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 reminderInteractive telephone reminder by a trained layperson with a standard script to remind return to the center for taking fecal tubes for CRC screening | Other | Telephone reminder |
| No otherNo additional reminder will be offered | Other | No reminder |
Primary outcome
compliance rate of FOBT completion
Time frame: 6 months
Rate of completion of FOBT in the year of receiving the interventions/control
1 secondary outcome
compliance rate of FOBT pick up
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2018.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telephone reminder and No other in people with CRC Screening and Compliance, Patient, run by Chinese University of Hong Kong at 1 site in 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: finished, as of the sponsor's last update on 18 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
compliance rate of FOBT completion (time frame: 6 months). 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 18 Jul 2018.