Colorectal DisordersNCT02364895
ColonCancerCheck Mailed Invitations: An Evaluation
A study testing Males Group 1: Current CCC invitation letter, Males Group 2: New letter with neutral gender content and Males Group 3: New letter with male-specific content in people with Colorectal Disorders, run by Sunnybrook Health Sciences Centre.
Trial summary
This study evaluates effectiveness of mailed invitations for colorectal cancer screening among screen-eligible Ontarians who are due for screening. The study will evaluate the effectiveness of mailed invitations in general (compared to no invitation) but will also determine if new invitation letters (2 letters for… Read more about this study
- Who is it for?
- Ages 55 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Disorders
- What is being tested?
- Males Group 1: Current CCC invitation letter, Males Group 2: New letter with neutral gender content and Males Group 3: New letter with male-specific content
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75,317 participants
- Where
- No sites listed yet
- Study dates
- Nov 2013to Dec 2014
- 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 55 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 55-74 year old Ontarians with an active OHIP number
Who cannot join
- Death
- Withdrawn from program correspondence
- Prior colorectal cancer diagnosis
- Any FOBT activity within the last two years, including
- Flexible sigmoidoscopy within the last five years.
- Colonoscopy within the last ten years
Show all 11Show fewer
- Other medical history in the last 30 months
- Received a birthday letter, invitation or recall within the last two years
- Inactive primary address
- Missing address
- Address outside Ontario
About this study
This study evaluates effectiveness of mailed invitations for colorectal cancer screening among screen-eligible Ontarians who are due for screening. The study will evaluate the effectiveness of mailed invitations in general (compared to no invitation) but will also determine if new invitation letters (2 letters for male, 1 letter for females) are more effective than current invitation letters used by the ColonCancerCheck program.
Read the detailed description
On April 1 2008, Ontario launched Canada's first organized province-wide CRC screening program, ColonCancerCheck (CCC). CCC has a dual strategy: through the primary care physician, FOBT is offered to people aged 50 to 74 years at average risk for colorectal cancer and colonoscopy to those at increased risk based on family history. In 2010-2011, approximately 30% of Ontarians 50-74 years old were screened for colorectal cancer using the FOBT. An important factor in increasing screening participation is an invitation system.
A central tenet of organized screening programs is that all persons in the target population be invited to participate. In 2010, CCC began implementing a correspondence program in an effort to improve participation in colorectal cancer screening, starting with recall letters to individuals who were due for repeat screening two years after a normal fecal occult blood test (FOBT) and invitation letters to screen-eligible individuals who are due for screening and have not received correspondence from CCO to participate in colorectal cancer screening in the past two years to complete a screening test for colorectal cancer. Individuals who are "due for screening" includes those who have not had a FOBT in the past 2 years, a flexible sigmoidoscopy in the past 5 years, and a colonoscopy in the past 10 years. Currently, CCC sends 10,000 invitation letters monthly to 50-54 year olds only. In October 2013, the CCC correspondence program expanded to also include all eligible Ontarians 55-74 years old.
The current CCC invitation letter includes general information on the benefits of screening for colorectal cancer, the screening test itself (FOBT), and contact information to get more information. It is meant to invite individuals to speak with their primary care provider about colorectal screening. In 2013 Diego Llovet, a lead qualitative researcher at CCO, completed a series of qualitative studies examining the content of current CCC correspondence materials and made recommendations to improve the content of invitation letters. These recommendations were based on four key types of information: a) findings from seven focus groups with screen-eligible Ontarians (men and women, 50-74) who provided feedback on the messages that should be included in these letters, b) input provided by six experts in health communications and health promotion on the content and style of effective cancer screening correspondence, c) evidence from behavioral science studies on barriers to participation in colorectal cancer screening, and d) theories of health behavior change. Based on findings from focus group studies examining the content of the current CCC letter, a unisex and a male-tailored invitation letter were developed. A female-tailored letter was not developed as the focus group studies with females showed that they did not prefer female tailored messaging to a unisex one.
In the current study, we propose to test the effectiveness of mailed invitations for colorectal cancer screening in the real world setting of the CCC program. We will evaluate the effectiveness of mailed invitations in general (i.e., compared to no invitation) but we will also determine whether letters developed based on theories from behavioural science and on the results of qualitative studies with Ontarians in the target population are more effective than those currently used by the program. The findings from this study will be used to inform the CCC program correspondence but will also provide valuable information for the development of correspondence for other screening programs at Cancer Care Ontario and in other jurisdictions engaged in organized screening programs.
- Conditions
- Colorectal Disorders
- Being tested
- Males control group: Deferred letter, Males Group 1: Current CCC invitation letter, Males Group 2: New letter with neutral gender content, Males Group 3: New letter with male-specific content, Females control group: Deferred letter
- Keywords
- Mailed invitation, Fecal Occult Blood Test, Screening
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Males control group: Deferred letterOther
This letter will be sent 6 months after index (mailing) date
Males Group 1: Current CCC invitation letterOther
This letter is currently used by the program in 50-54 year olds
Males Group 2: New letter with neutral gender contentOther
Unisex letter
Males Group 3: New letter with male-specific contentOther
New letter tailored for men
Females control group: Deferred letterOther
This letter will be sent 6 months after index (mailing) date
Females Group 1: Current CCC invitation letterOther
This letter is currently used by the program in 50-54 year olds
Females Group 2: New letter with neutral gender contentOther
Unisex letter
| Study group | Role | What they receive |
|---|---|---|
| Male arm | Experimental | Males control group: Deferred letter Males Group 1: Current CCC invitation letter Males Group 2: New letter with neutral gender content Males Group 3: New letter with male-specific content Receives: Other: Males control group: Deferred letter; Other: Males Group 1: Current CCC invitation letter; Other: Males Group 2: New letter with neutral gender content; Other: Males Group 3: New letter with male-specific content |
| Female arm | Experimental | Females control group: Deferred letter Females Group 1: Current CCC invitation letter Females Group 2: New letter with neutral gender content Receives: Other: Females control group: Deferred letter; Other: Females Group 1: Current CCC invitation letter; Other: Females Group 2: New letter with neutral gender content |
What is being measured
The primary outcome is the main question the study is designed to answer.
fecal occult blood test (FOBT) uptake
Using the administrative databases at CCO, participating individuals will be followed up 6 months after the index date to measure FOBT uptake.
Measured: 6 months after the mailing date
Secondary outcomes (2)
FOBT or colonoscopy uptake
Using the administrative databases at CCO, participating individuals will be followed up 6 months after the index date to measure FOBT of colonoscopy uptake.
Measured: 6 months
Intermediate outcomes
We will mail a simple questionnaire 8-12 weeks after the index date to participants in order to assess intermediate outcomes including (a) recall of letter, (b) knowledge of colorectal cancer screening, (c) intent to be screened for colorectal cancer.
Measured: 8-12 weeks after mailing date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2015 (estimated)
- Study startNov 2013
- Primary completionMay 2014
- Study completionDec 2014
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.
- 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
- Investigator
- Enrolment
- 75,317 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Care Ontario
- Responsible party
- Sponsor
- Investigators
- Jill Tinmouth, MD PhD FRCPC, Principal investigator, Sunnybrook Health Sciences Centre, Cancer Care Ontario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02364895
- Sponsor's protocol ID
- 375-2013
- Status last verified
- Feb 2015
- First submitted
- 19 Dec 2014
- Last updated
- 18 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Tinmouth J, Llovet D, Sutradhar R, Tsiplova K, Roushani J, Lee A, Hader J, Rabeneck L, Paszat L. Two randomized controlled trials for colorectal cancer screening invitations developed using a behavioral science approach. Prev Med. 2022 Feb;155:106918. doi: 10.1016/j.ypmed.2021.106918. Epub 2021 Dec 23.
PubMed 34953810
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ColonCancerCheck Mailed Invitations: An Evaluation
- ClinicalTrials.gov ID
- NCT02364895
- Acronym / sponsor ID
- 375-2013
- Conditions
- Colorectal Disorders
- Keywords
- Mailed invitation, Fecal Occult Blood Test, Screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75,317 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- Cancer Care Ontario
- Study start
- Nov 2013
- Primary completion
- May 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 18 Feb 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 study evaluates effectiveness of mailed invitations for colorectal cancer screening among screen-eligible Ontarians who are due for screening. The study will evaluate the effectiveness of mailed invitations in general (compared to no invitation) but will also determine if new invitation letters (2 letters for male, 1 letter for females) are more effective than current invitation letters used by the ColonCancerCheck program.
Detailed description
On April 1 2008, Ontario launched Canada's first organized province-wide CRC screening program, ColonCancerCheck (CCC). CCC has a dual strategy: through the primary care physician, FOBT is offered to people aged 50 to 74 years at average risk for colorectal cancer and colonoscopy to those at increased risk based on family history. In 2010-2011, approximately 30% of Ontarians 50-74 years old were screened for colorectal cancer using the FOBT. An important factor in increasing screening participation is an invitation system.
A central tenet of organized screening programs is that all persons in the target population be invited to participate. In 2010, CCC began implementing a correspondence program in an effort to improve participation in colorectal cancer screening, starting with recall letters to individuals who were due for repeat screening two years after a normal fecal occult blood test (FOBT) and invitation letters to screen-eligible individuals who are due for screening and have not received correspondence from CCO to participate in colorectal cancer screening in the past two years to complete a screening test for colorectal cancer. Individuals who are "due for screening" includes those who have not had a FOBT in the past 2 years, a flexible sigmoidoscopy in the past 5 years, and a colonoscopy in the past 10 years. Currently, CCC sends 10,000 invitation letters monthly to 50-54 year olds only. In October 2013, the CCC correspondence program expanded to also include all eligible Ontarians 55-74 years old.
The current CCC invitation letter includes general information on the benefits of screening for colorectal cancer, the screening test itself (FOBT), and contact information to get more information. It is meant to invite individuals to speak with their primary care provider about colorectal screening. In 2013 Diego Llovet, a lead qualitative researcher at CCO, completed a series of qualitative studies examining the content of current CCC correspondence materials and made recommendations to improve the content of invitation letters. These recommendations were based on four key types of information: a) findings from seven focus groups with screen-eligible Ontarians (men and women, 50-74) who provided feedback on the messages that should be included in these letters, b) input provided by six experts in health communications and health promotion on the content and style of effective cancer screening correspondence, c) evidence from behavioral science studies on barriers to participation in colorectal cancer screening, and d) theories of health behavior change. Based on findings from focus group studies examining the content of the current CCC letter, a unisex and a male-tailored invitation letter were developed. A female-tailored letter was not developed as the focus group studies with females showed that they did not prefer female tailored messaging to a unisex one.
In the current study, we propose to test the effectiveness of mailed invitations for colorectal cancer screening in the real world setting of the CCC program. We will evaluate the effectiveness of mailed invitations in general (i.e., compared to no invitation) but we will also determine whether letters developed based on theories from behavioural science and on the results of qualitative studies with Ontarians in the target population are more effective than those currently used by the program. The findings from this study will be used to inform the CCC program correspondence but will also provide valuable information for the development of correspondence for other screening programs at Cancer Care Ontario and in other jurisdictions engaged in organized screening programs.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Male arm | Experimental | Other: Males control group: Deferred letter, Other: Males Group 1: Current CCC invitation letter, Other: Males Group 2: New letter with neutral gender content, Other: Males Group 3: New letter with male-specific contentMales control group: Deferred letter Males Group 1: Current CCC invitation letter Males Group 2: New letter with neutral gender content Males Group 3: New letter with male-specific content |
| Female arm | Experimental | Other: Females control group: Deferred letter, Other: Females Group 1: Current CCC invitation letter, Other: Females Group 2: New letter with neutral gender contentFemales control group: Deferred letter Females Group 1: Current CCC invitation letter Females Group 2: New letter with neutral gender content |
Who may qualify
- Ages
- 55 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 55-74 year old Ontarians with an active OHIP number
Key exclusion criteria (11 listed)
- Death
- Withdrawn from program correspondence
- Prior colorectal cancer diagnosis
- Any FOBT activity within the last two years, including
- Flexible sigmoidoscopy within the last five years.
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 |
|---|---|---|
| Males control group: Deferred letterThis letter will be sent 6 months after index (mailing) date | Other | Male arm |
| Males Group 1: Current CCC invitation letterThis letter is currently used by the program in 50-54 year olds | Other | Male arm |
| Males Group 2: New letter with neutral gender contentUnisex letter | Other | Male arm |
| Males Group 3: New letter with male-specific contentNew letter tailored for men | Other | Male arm |
| Females control group: Deferred letterThis letter will be sent 6 months after index (mailing) date | Other | Female arm |
| Females Group 1: Current CCC invitation letterThis letter is currently used by the program in 50-54 year olds | Other | Female arm |
| Females Group 2: New letter with neutral gender contentUnisex letter | Other | Female arm |
Primary outcome
fecal occult blood test (FOBT) uptake
Time frame: 6 months after the mailing date
Using the administrative databases at CCO, participating individuals will be followed up 6 months after the index date to measure FOBT uptake.
2 secondary outcomes
FOBT or colonoscopy uptake
Time frame: 6 months
Intermediate outcomes
Time frame: 8-12 weeks after mailing date
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 Feb 2015.
- Derived from this study: PubMed 34953810Tinmouth J, Llovet D, Sutradhar R, Tsiplova K, Roushani J, Lee A, Hader J, Rabeneck L, Paszat L. Two randomized controlled trials for colorectal cancer screening invitations developed using a behavioral science approach. Prev Med. 2022 Feb;155:106918. doi: 10.1016/j.ypmed.2021.106918. Epub 2021 Dec 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 PhD FRCPC principal investigator
Sunnybrook Health Sciences Centre, Cancer Care Ontario
Questions about this trial
What is this clinical trial studying?
A study testing Males Group 1: Current CCC invitation letter, Males Group 2: New letter with neutral gender content and Males Group 3: New letter with male-specific content in people with Colorectal Disorders, run by Sunnybrook Health Sciences Centre.
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 11 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 Feb 2015. 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?
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?
fecal occult blood test (FOBT) uptake (time frame: 6 months after the mailing date). 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 NCT02364895, 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 18 Feb 2015.