NCT02364895

Brief 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 male, 1 letter for females) are more effective than current invitation letters used by the ColonCancerCheck program.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75,317

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2013

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

December 19, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 18, 2015

Completed
Last Updated

February 18, 2015

Status Verified

February 1, 2015

Enrollment Period

6 months

First QC Date

December 19, 2014

Last Update Submit

February 10, 2015

Conditions

Colorectal Disorders

Keywords

Mailed invitationFecal Occult Blood TestScreening

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 months after the mailing date

Secondary Outcomes (2)

  • FOBT or colonoscopy uptake

    6 months

  • Intermediate outcomes

    8-12 weeks after mailing date

Study Arms (2)

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

Other: Males control group: Deferred letterOther: Males Group 1: Current CCC invitation letterOther: Males Group 2: New letter with neutral gender contentOther: 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

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

Interventions

Males control group: Deferred letterOTHER

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

Male arm
Males Group 1: Current CCC invitation letterOTHER

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

Male arm
Males Group 2: New letter with neutral gender contentOTHER

Unisex letter

Male arm
Males Group 3: New letter with male-specific contentOTHER

New letter tailored for men

Male arm
Females control group: Deferred letterOTHER

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

Female arm
Females Group 1: Current CCC invitation letterOTHER

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

Female arm
Females Group 2: New letter with neutral gender contentOTHER

Unisex letter

Female arm

Eligibility Criteria

Age55 Years - 74 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • year old Ontarians with an active OHIP number

You may not qualify if:

  • 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
  • Received a birthday letter, invitation or recall within the last two years
  • Inactive primary address
  • Missing address
  • Address outside Ontario

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 34953810DERIVED

Study Officials

  • Jill Tinmouth, MD PhD FRCPC

    Sunnybrook Health Sciences Centre, Cancer Care Ontario

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SCREENING
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2014

First Posted

February 18, 2015

Study Start

November 1, 2013

Primary Completion

May 1, 2014

Study Completion

December 1, 2014

Last Updated

February 18, 2015

Record last verified: 2015-02