Increasing Colorectal Cancer Screening Uptake With a Patient Navigator
1 other identifier
interventional
750
1 country
1
Brief Summary
Patients who receive tailored navigation (consisting of a letter and patient navigation services) and get screened will be significantly greater than the control group who receives treatment as usual. A majority of patients will opt for Fecal Occult Blood Testing (FOBT)as one of their preferred tests, after undergoing the "Patient Navigator" intervention and that proportion will be significantly greater than the group who opt for FOBT in the control group.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 colorectal-cancer
Started Jan 2010
Shorter than P25 for phase_3 colorectal-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 27, 2011
CompletedFirst Posted
Study publicly available on registry
January 10, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedDecember 3, 2013
December 1, 2013
2.4 years
June 27, 2011
December 2, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Completion of verified CRC screening event (FOBT;colonoscopy) event in experimental vs. control groups within 48 weeks
Completion of verified CRC screening events in experimental vs. control patients
48 weeks after baseline assessment
Secondary Outcomes (1)
Screening preferences; predictors of CRC screening and screening preference.
48 weeks
Study Arms (2)
Navigator intervention
EXPERIMENTALUsual Care Control
ACTIVE COMPARATORUsual care
Interventions
Information on colorectal cancer and screening, assistance in selection of screening option and obtaining kit or colonoscopy referral
Usual care health counselling on colorectal cancer and screening options
Eligibility Criteria
You may qualify if:
- Average risk men and women aged 50 - 74
- Unscreened - Defined as no prior CRC screening
- Under-screened - Defined as no FOBT screening within the last two years
- No colonoscopy or barium enema screening within the last five years
- Willing to provide consent to participate in the study.
You may not qualify if:
- FOBT within the last two years
- colonoscopy within five years
- barium enema within five years
- flexible sigmoidoscopy within five years
- Bowel cancer.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cancer Care Ontariolead
- Canadian Institutes of Health Research (CIHR)collaborator
Study Sites (1)
Group Health Centre
Sault Ste. Marie, Ontario, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paul Ritvo, PHD
Cancer Care Ontario
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Scientist, Research, Prevention and Cancer Control
Study Record Dates
First Submitted
June 27, 2011
First Posted
January 10, 2012
Study Start
January 1, 2010
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
December 3, 2013
Record last verified: 2013-12