Early Detection of CancerNCT02457143
Comparing Methods of Recall for Cancer Screening in Primary Care: a Pragmatic Clinical Trial
A study testing Letter and Phone call in people with Early Detection of Cancer and Cancer, run by Unity Health Toronto at 1 site in Canada.
Trial summary
This randomized trial aims to understand how effective a reminder letter is compared to a reminder phone call in improving breast, cervical and colorectal cancer screening rates and reducing screening disparities. Read more about this study
- Who is it for?
- Ages 21 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Early Detection of Cancer, Cancer, Socioeconomic Status
- What is being tested?
- Letter and Phone call
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,270 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2015to Jul 2016
- 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 21 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The trial will include patients who are rostered to the family practice as of March 31, 2015, are eligible and overdue for cervical, breast and/or colorectal cancer screening and are verified by their primary care physician as needing recall.
Who cannot join
- Patients will be excluded if their primary care physician noted they should not be recalled for screening or if the patient does not have both an address and a phone number on file.
Trial locations and contacts
1 site in 1 country.
Canada1 site
St. Michael's Hospital Academic Family Health Team
Toronto, Ontario, M5B1W8
About this study
Official title: Comparing Methods of Recall for Cancer Screening in Primary Care: a Pragmatic Randomized Clinical Trial
This randomized trial aims to understand how effective a reminder letter is compared to a reminder phone call in improving breast, cervical and colorectal cancer screening rates and reducing screening disparities.
- Conditions
- Early Detection of Cancer, Cancer, Socioeconomic Status
- Being tested
- Letter, Phone call
- Keywords
- recall, income-related disparities, cancer screening
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LetterBehavioural
Phone callBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Letter | Experimental | Patients will receive a reminder letter signed by their family physician which indicates which cancer screening tests they are overdue for and encourages them to book an appointment for screening. Receives: Behavioral: Letter |
| Phone call | Experimental | Patients will receive a phone call from a member of the practice staff. The call will inform them about which cancer screening tests they are overdue for and will encourage them to book an appointment for screening. Receives: Behavioral: Phone call |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients in each arm who go on to receive at least one screening test for which they are due
Measured: 6 months
The proportion of patients in each arm who are due for breast, cervical and colorectal cancer screening who go on to receive those respective screening tests (female patients may be represented in the outcome calculation of more than one cancer screening
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 posted29 May 2015 (estimated)
- Study startJul 2015
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Detection of CancerStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe 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
- None (open label)
- Enrolment
- 5,270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aisha Lofters, MD PhD CCFP, Principal investigator, Unity Health TorontoTara Kiran, MD MSc CCFP, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02457143
- Sponsor's protocol ID
- 15-145
- Status last verified
- Oct 2016
- First submitted
- 27 May 2015
- Last updated
- 17 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Methods of Recall for Cancer Screening in Primary Care: a Pragmatic Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02457143
- Acronym / sponsor ID
- 15-145
- Conditions
- Early Detection of Cancer, Cancer, Socioeconomic Status
- Keywords
- recall, income-related disparities, cancer screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,270 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 29 May 2015 (estimated)
- 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 randomized trial aims to understand how effective a reminder letter is compared to a reminder phone call in improving breast, cervical and colorectal cancer screening rates and reducing screening disparities.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Letter | Experimental | Behavioral: LetterPatients will receive a reminder letter signed by their family physician which indicates which cancer screening tests they are overdue for and encourages them to book an appointment for screening. |
| Phone call | Experimental | Behavioral: Phone callPatients will receive a phone call from a member of the practice staff. The call will inform them about which cancer screening tests they are overdue for and will encourage them to book an appointment for screening. |
Who may qualify
- Ages
- 21 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The trial will include patients who are rostered to the family practice as of March 31, 2015, are eligible and overdue for cervical, breast and/or colorectal cancer screening and are verified by their primary care physician as needing recall.
Key exclusion criteria (1 listed)
- Patients will be excluded if their primary care physician noted they should not be recalled for screening or if the patient does not have both an address and a phone number on file.
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 |
|---|---|---|
| Letter | Behavioural | Letter |
| Phone call | Behavioural | Phone call |
Primary outcome
The proportion of patients in each arm who go on to receive at least one screening test for which they are due
Time frame: 6 months
The proportion of patients in each arm who are due for breast, cervical and colorectal cancer screening who go on to receive those respective screening tests (female patients may be represented in the outcome calculation of more than one cancer screening
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 17 Oct 2016.
Related trials for Early Detection of Cancer
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
RecruitingObservational study
Role of Liquid Biopsies in HPV-associated Cancer Treatment Monitoring
Cervical Cancer, Cervical Dysplasia
Not yet recruiting
Wearable Core Body Temperature Monitoring for Early Detection of Cytokine Release Syndrome in Outpatients Receiving CAR T-Cell Therapy
Myeloma
RecruitingObservational study
Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
Not yet recruiting
POSLUMA PET Imaging for PI-RADS 3 Prostate Lesions
Prostate Cancer, PI-RADS 3 Prostate Lesion
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.
Aisha Lofters, MD PhD CCFP principal investigator
Unity Health Toronto
Tara Kiran, MD MSc CCFP principal investigator
Unity Health Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Letter and Phone call in people with Early Detection of Cancer and Cancer, run by Unity Health Toronto at 1 site in Canada.
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 17 Oct 2016. 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 Canada. 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. 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?
The proportion of patients in each arm who go on to receive at least one screening test for which they are due (time frame: 6 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 17 Oct 2016.