Colorectal DisordersNCT01629004
Increasing Uptake of Colorectal Cancer Screening in Ontario
A study testing FOBT kit and Mailed invitation in people with Colorectal Disorders, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
The investigators hope to determine whether the addition of an FOBT kit and educational materials to a second mailed invitation compared to a second mailed invitation alone increases use of appropriate screening tests (FOBT for average risk or colonoscopy if increased risk) by eligible persons within 6 months of the… Read more about this study
- Who is it for?
- Ages 50 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Disorders
- What is being tested?
- FOBT kit and Mailed invitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,155 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2011to Dec 2013
- 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 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Recipients of a mailed CRC screening invitation through the CCO Invitation Pilot project
- No OHIP record of completion of FOBT since initial mailing (Non-responders arm only)
- No OHIP of 'CRC Cancer Screening Exclusion' tracking code since initial mailing (Non-responders arm only)
- An OHIP record of completion of FOBT 6 months since initial mailing (Recall arm only)
- Negative result according to LRT or if not in LRT, no record of interval colonoscopy in CIRT or OHIP (Recall arm only)
Who cannot join
- Age greater than 74 years at time of mailing
- Interval diagnosis of colorectal cancer
- Interval colonoscopy or flexible sigmoidoscopy
- Interval departure from Pilot physician's practice
- Death
- Presently institutionalized
- Physician has declined participation in the study
- Interval record of repeat FOBT (Recall arm only)
Trial locations and contacts
1 site in 1 country.
About this study
The investigators hope to determine whether the addition of an FOBT kit and educational materials to a second mailed invitation compared to a second mailed invitation alone increases use of appropriate screening tests (FOBT for average risk or colonoscopy if increased risk) by eligible persons within 6 months of the second mailing in: (1)Non-responders to an initial mailed CRC screening invitation from their family physician and, (2)Those who responded to the initial mailed CRC screening invitation and are due for repeat screening (i.e., "recall" patients). In addition, the investigators will also explore the impact of the investigators intervention in likely under-screened groups such as those living in more remote areas of the province and those with low socio-economic status as well as assessing the cost-effectiveness of this strategy.
- Conditions
- Colorectal Disorders
- Being tested
- FOBT kit, Mailed invitation
- Keywords
- colorectal cancer, screening, fecal occult blood testing, mailed invitation
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOBT kitOther
Also called Mailed FOBT kit
Mailed FOBT kit with educational materials and mailed CRC screening invitation on behalf of family physician.
Mailed invitationOther
Also called Mailed invitation alone
Mailed CRC screening invitation alone on behalf of family physician.
| Study group | Role | What they receive |
|---|---|---|
| Non-responders | Other | Non-responders to an initial mailed CRC screening invitation from their family physician.
FOBT kit. Mailed invitation. Receives: Other: FOBT kit; Other: Mailed invitation |
| Recall patients | Other | Those who responded to the initial mailed CRC screening invitation and are now due for repeat screening (i.e., "recall" patients).
FOBT kit. Mailed invitation. Receives: Other: FOBT kit; Other: Mailed invitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uptake of appropriate CRC screening
The primary outcome will be the uptake of appropriate screening (FOBT testing or if there is a positive family history, of colonoscopy) within 6 months of the mailing as determined by from OHIP and CCO data.
Measured: Within 6 months of the mailing
Secondary outcomes (1)
Uptake of lower gastrointestinal investigations
The secondary outcome will be the uptake of lower gastrointestinal investigations (colonoscopy for an indication other than family history or colonoscopy done outside of CIRT, flexible sigmoidoscopy, barium enema) within 12 months, respectively, of the mailing as determined by the administrative data (CIRT, OHIP procedure or radiology code).
Measured: Within 12 months of the mailing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2012 (estimated)
- Study startApr 2011
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal DisordersStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe 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
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 5,155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jill Tinmouth, MD, Principal investigator, Sunnybrook HSC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01629004
- Sponsor's protocol ID
- 308-2010
- Status last verified
- Dec 2014
- First submitted
- 25 Jun 2012
- Last updated
- 23 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Tinmouth J, Patel J, Austin PC, Baxter NN, Brouwers MC, Earle C, Levitt C, Lu Y, Mackinnon M, Paszat L, Rabeneck L. Increasing participation in colorectal cancer screening: results from a cluster randomized trial of directly mailed gFOBT kits to previous nonresponders. Int J Cancer. 2015 Mar 15;136(6):E697-703. doi: 10.1002/ijc.29191. Epub 2014 Sep 23.
PubMed 25195923
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Uptake of Colorectal Cancer Screening in Ontario
- ClinicalTrials.gov ID
- NCT01629004
- Acronym / sponsor ID
- 308-2010
- Conditions
- Colorectal Disorders
- Keywords
- colorectal cancer, screening, fecal occult blood testing, mailed invitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,155 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 27 Jun 2012 (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.
The investigators hope to determine whether the addition of an FOBT kit and educational materials to a second mailed invitation compared to a second mailed invitation alone increases use of appropriate screening tests (FOBT for average risk or colonoscopy if increased risk) by eligible persons within 6 months of the second mailing in: (1)Non-responders to an initial mailed CRC screening invitation from their family physician and, (2)Those who responded to the initial mailed CRC screening invitation and are due for repeat screening (i.e., "recall" patients). In addition, the investigators will also explore the impact of the investigators intervention in likely under-screened groups such as those living in more remote areas of the province and those with low socio-economic status as well as assessing the cost-effectiveness of this strategy.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-responders | Other | Other: FOBT kit, Other: Mailed invitationNon-responders to an initial mailed CRC screening invitation from their family physician. FOBT kit. Mailed invitation. |
| Recall patients | Other | Other: FOBT kit, Other: Mailed invitationThose who responded to the initial mailed CRC screening invitation and are now due for repeat screening (i.e., "recall" patients). FOBT kit. Mailed invitation. |
Who may qualify
- Ages
- 50 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Recipients of a mailed CRC screening invitation through the CCO Invitation Pilot project
- No OHIP record of completion of FOBT since initial mailing (Non-responders arm only)
- No OHIP of 'CRC Cancer Screening Exclusion' tracking code since initial mailing (Non-responders arm only)
- An OHIP record of completion of FOBT 6 months since initial mailing (Recall arm only)
- Negative result according to LRT or if not in LRT, no record of interval colonoscopy in CIRT or OHIP (Recall arm only)
Key exclusion criteria (8 listed)
- Age greater than 74 years at time of mailing
- Interval diagnosis of colorectal cancer
- Interval colonoscopy or flexible sigmoidoscopy
- Interval departure from Pilot physician's practice
- Death
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 |
|---|---|---|
| FOBT kitAlso: Mailed FOBT kitMailed FOBT kit with educational materials and mailed CRC screening invitation on behalf of family physician. | Other | Non-responders, Recall patients |
| Mailed invitationAlso: Mailed invitation aloneMailed CRC screening invitation alone on behalf of family physician. | Other | Non-responders, Recall patients |
Primary outcome
Uptake of appropriate CRC screening
Time frame: Within 6 months of the mailing
The primary outcome will be the uptake of appropriate screening (FOBT testing or if there is a positive family history, of colonoscopy) within 6 months of the mailing as determined by from OHIP and CCO data.
1 secondary outcome
Uptake of lower gastrointestinal investigations
Time frame: Within 12 months of the mailing
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 23 Dec 2014.
- Derived from this study: PubMed 25195923Tinmouth J, Patel J, Austin PC, Baxter NN, Brouwers MC, Earle C, Levitt C, Lu Y, Mackinnon M, Paszat L, Rabeneck L. Increasing participation in colorectal cancer screening: results from a cluster randomized trial of directly mailed gFOBT kits to previous nonresponders. Int J Cancer. 2015 Mar 15;136(6):E697-703. doi: 10.1002/ijc.29191. Epub 2014 Sep 23.
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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.
Jill Tinmouth, MD principal investigator
Sunnybrook HSC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FOBT kit and Mailed invitation in people with Colorectal Disorders, run by Sunnybrook Health Sciences Centre 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 5 inclusion and 8 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 23 Dec 2014. 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?
Uptake of appropriate CRC screening (time frame: Within 6 months of the mailing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01629004, which also lists 1 linked publication.
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 23 Dec 2014.