- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02364895
ColonCancerCheck Mailed Invitations: An Evaluation
Study Overview
Status
Conditions
Intervention / Treatment
- 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
- Other: Females control group: Deferred letter
- Other: Females Group 1: Current CCC invitation letter
- Other: Females Group 2: New letter with neutral gender content
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 55-74 year old Ontarians with an active OHIP number
Exclusion Criteria:
- 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
- Other medical history in the last 30 months
- Exclusion from screening 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Male arm
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
|
This letter will be sent 6 months after index (mailing) date
This letter is currently used by the program in 50-54 year olds
Unisex letter
New letter tailored for men
|
Experimental: Female arm
Females control group: Deferred letter Females Group 1: Current CCC invitation letter Females Group 2: New letter with neutral gender content
|
This letter will be sent 6 months after index (mailing) date
This letter is currently used by the program in 50-54 year olds
Unisex letter
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
6 months after the mailing date
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
FOBT or colonoscopy uptake
Time Frame: 6 months
|
Using the administrative databases at CCO, participating individuals will be followed up 6 months after the index date to measure FOBT of colonoscopy uptake.
|
6 months
|
Intermediate outcomes
Time Frame: 8-12 weeks after mailing date
|
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.
|
8-12 weeks after mailing date
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Jill Tinmouth, MD PhD FRCPC, Sunnybrook Health Sciences Centre, Cancer Care Ontario
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 375-2013
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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