Increasing Colorectal Cancer Screening Uptake With a Patient Navigator

This study has been completed.
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Paul Ritvo, Ph.D., Cancer Care Ontario
ClinicalTrials.gov Identifier:
NCT01506687
First received: June 27, 2011
Last updated: December 2, 2013
Last verified: December 2013

June 27, 2011
December 2, 2013
January 2010
June 2012   (final data collection date for primary outcome measure)
Completion of verified CRC screening event (FOBT;colonoscopy) event in experimental vs. control groups within 48 weeks [ Time Frame: 48 weeks after baseline assessment ] [ Designated as safety issue: No ]
Completion of verified CRC screening events in experimental vs. control patients
Same as current
Complete list of historical versions of study NCT01506687 on ClinicalTrials.gov Archive Site
Screening preferences; predictors of CRC screening and screening preference. [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Increasing Colorectal Cancer Screening Uptake With a Patient Navigator
Increasing Colorectal Cancer Screening Uptake With a Patient Navigator - Phase III Trial

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Colorectal Cancer
  • Behavioral: Health counselling by nurse navigator
    Information on colorectal cancer and screening, assistance in selection of screening option and obtaining kit or colonoscopy referral
    Other Name: Nurse navigator assistance
  • Behavioral: Usual primary care counselling
    Usual care health counselling on colorectal cancer and screening options
    Other Name: Usual primary care
  • Experimental: Navigator intervention
    Intervention: Behavioral: Health counselling by nurse navigator
  • Active Comparator: Usual Care Control
    Usual care
    Intervention: Behavioral: Usual primary care counselling
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
750
June 2012
June 2012   (final data collection date for primary outcome measure)

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.
Both
50 Years to 74 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01506687
10-163
No
Paul Ritvo, Ph.D., Cancer Care Ontario
Cancer Care Ontario
Canadian Institutes of Health Research (CIHR)
Principal Investigator: Paul Ritvo, PHD Cancer Care Ontario
Cancer Care Ontario
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP