NCT01629004

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5,155

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

April 1, 2011

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 25, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 27, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

December 23, 2014

Status Verified

December 1, 2014

Enrollment Period

2.7 years

First QC Date

June 25, 2012

Last Update Submit

December 19, 2014

Conditions

Colorectal Disorders

Keywords

colorectal cancerscreeningfecal occult blood testingmailed invitation

Outcome Measures

Primary Outcomes (1)

  • 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.

    Within 6 months of the mailing

Secondary Outcomes (1)

  • Uptake of lower gastrointestinal investigations

    Within 12 months of the mailing

Study Arms (2)

Non-responders

OTHER

Non-responders to an initial mailed CRC screening invitation from their family physician. FOBT kit. Mailed invitation.

Other: FOBT kitOther: 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.

Other: FOBT kitOther: Mailed invitation

Interventions

FOBT kitOTHER

Mailed FOBT kit with educational materials and mailed CRC screening invitation on behalf of family physician.

Also known as: Mailed FOBT kit
Non-respondersRecall patients
Mailed invitationOTHER

Mailed CRC screening invitation alone on behalf of family physician.

Also known as: Mailed invitation alone
Non-respondersRecall patients

Eligibility Criteria

Age50 Years - 74 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)
  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sunnybrook HSC

Toronto, Ontario, Canada

Location

Related Publications (1)

  • 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.

    PMID: 25195923DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Jill Tinmouth, MD

    Sunnybrook HSC

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 25, 2012

First Posted

June 27, 2012

Study Start

April 1, 2011

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

December 23, 2014

Record last verified: 2014-12

Locations

CA(1)