Increasing Colorectal Cancer Screening Uptake With a Patient Navigator
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Health counselling by nurse navigator
Usual primary care counselling
Sponsored by
About this trial
This is an interventional health services research trial for Colorectal Cancer focused on measuring Colorectal cancer screening, 50 years or older
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- FOBT within the last two years
- colonoscopy within five years
- barium enema within five years
- flexible sigmoidoscopy within five years
- Bowel cancer.
Sites / Locations
- Group Health Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Navigator intervention
Usual Care Control
Arm Description
Usual care
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Screening preferences; predictors of CRC screening and screening preference.
Full Information
NCT ID
NCT01506687
First Posted
June 27, 2011
Last Updated
December 2, 2013
Sponsor
Cancer Care Ontario
Collaborators
Canadian Institutes of Health Research (CIHR)
1. Study Identification
Unique Protocol Identification Number
NCT01506687
Brief Title
Increasing Colorectal Cancer Screening Uptake With a Patient Navigator
Official Title
Increasing Colorectal Cancer Screening Uptake With a Patient Navigator - Phase III Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cancer Care Ontario
Collaborators
Canadian Institutes of Health Research (CIHR)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Primary Outcome Measure:
Number of patients who receive a letter and patient navigation services and get screened compared to the control group.
Secondary Outcome Measures:
Proportion (%) of patients preferring FOBT vs.colonoscopy; Predictors of CRC screening and screening preference.
Subjects: Ambulatory patients (men-women aged 50 years and above) recruited from primary care practices at the Group Health Centre, Sault Ste Marie, Ontario. All patients will be screened for eligibility and those who are eligible and agree to participate in the study will be randomized to either of the two study arms: intervention group or control group.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Colorectal cancer screening, 50 years or older
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
750 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Navigator intervention
Arm Type
Experimental
Arm Title
Usual Care Control
Arm Type
Active Comparator
Arm Description
Usual care
Intervention Type
Behavioral
Intervention Name(s)
Health counselling by nurse navigator
Other Intervention Name(s)
Nurse navigator assistance
Intervention Description
Information on colorectal cancer and screening, assistance in selection of screening option and obtaining kit or colonoscopy referral
Intervention Type
Behavioral
Intervention Name(s)
Usual primary care counselling
Other Intervention Name(s)
Usual primary care
Intervention Description
Usual care health counselling on colorectal cancer and screening options
Primary Outcome Measure Information:
Title
Completion of verified CRC screening event (FOBT;colonoscopy) event in experimental vs. control groups within 48 weeks
Description
Completion of verified CRC screening events in experimental vs. control patients
Time Frame
48 weeks after baseline assessment
Secondary Outcome Measure Information:
Title
Screening preferences; predictors of CRC screening and screening preference.
Time Frame
48 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
FOBT within the last two years
colonoscopy within five years
barium enema within five years
flexible sigmoidoscopy within five years
Bowel cancer.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Ritvo, PHD
Organizational Affiliation
Cancer Care Ontario
Official's Role
Principal Investigator
Facility Information:
Facility Name
Group Health Centre
City
Sault Ste. Marie
State/Province
Ontario
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Increasing Colorectal Cancer Screening Uptake With a Patient Navigator
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