ColonCancerCheck Mailed Invitations: An Evaluation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75317 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2014-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Increasing Uptake of Colorectal Cancer Screening in Ontario

NCT01629004

Colorectal Disorders

COMPLETED NA

Randomized Trial Evaluating the Effectiveness of the General Practitioner Involvement in Cancer Screening Invitations

NCT02367001

Breast Cancer Colorectal Cancer Cervical Cancer

COMPLETED NA

Information About a Doctor or a Possibility of Choosing Doctor's Gender and Attendance to Screening Colonoscopy

NCT01182922

Colorectal Cancer Screening

COMPLETED EARLY_PHASE1

Time Schedules for Sending Invitations to Colonoscopy Screening

NCT01505972

Colorectal Cancer

COMPLETED NA

Social Media for Colorectal Cancer Screening

NCT04296630

Colorectal Cancer Cancer Screening

ENROLLING_BY_INVITATION NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Colorectal Disorders

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

Males control group: Deferred letter

Intervention Type OTHER

This letter will be sent 6 months after index (mailing) date

Males Group 1: Current CCC invitation letter

Intervention Type OTHER

This letter is currently used by the program in 50-54 year olds

Males Group 2: New letter with neutral gender content

Intervention Type OTHER

Unisex letter

Males Group 3: New letter with male-specific content

Intervention Type OTHER

New letter tailored for men

Female arm

Females control group: Deferred letter Females Group 1: Current CCC invitation letter Females Group 2: New letter with neutral gender content

Group Type EXPERIMENTAL

Females control group: Deferred letter

Intervention Type OTHER

This letter will be sent 6 months after index (mailing) date

Females Group 1: Current CCC invitation letter

Intervention Type OTHER

This letter is currently used by the program in 50-54 year olds

Females Group 2: New letter with neutral gender content

Intervention Type OTHER

Unisex letter

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Males control group: Deferred letter

This letter will be sent 6 months after index (mailing) date

Intervention Type OTHER

Males Group 1: Current CCC invitation letter

This letter is currently used by the program in 50-54 year olds

Intervention Type OTHER

Males Group 2: New letter with neutral gender content

Unisex letter

Intervention Type OTHER

Males Group 3: New letter with male-specific content

New letter tailored for men

Intervention Type OTHER

Females control group: Deferred letter

This letter will be sent 6 months after index (mailing) date

Intervention Type OTHER

Females Group 1: Current CCC invitation letter

This letter is currently used by the program in 50-54 year olds

Intervention Type OTHER

Females Group 2: New letter with neutral gender content

Unisex letter

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

55 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes