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Trial record 9 of 319 for:    colon cancer | ( Map: Canada )

Increasing Colorectal Cancer Screening Uptake With a Patient Navigator

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01506687
Recruitment Status : Completed
First Posted : January 10, 2012
Last Update Posted : December 3, 2013
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Paul Ritvo, Ph.D., Cancer Care Ontario

Tracking Information
First Submitted Date  ICMJE June 27, 2011
First Posted Date  ICMJE January 10, 2012
Last Update Posted Date December 3, 2013
Study Start Date  ICMJE January 2010
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 9, 2012)
Completion of verified CRC screening event (FOBT;colonoscopy) event in experimental vs. control groups within 48 weeks [ Time Frame: 48 weeks after baseline assessment ]
Completion of verified CRC screening events in experimental vs. control patients
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01506687 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 9, 2012)
Screening preferences; predictors of CRC screening and screening preference. [ Time Frame: 48 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Increasing Colorectal Cancer Screening Uptake With a Patient Navigator
Official Title  ICMJE Increasing Colorectal Cancer Screening Uptake With a Patient Navigator - Phase III Trial
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Navigator intervention
    Intervention: Behavioral: Health counselling by nurse navigator
  • Active Comparator: Usual Care Control
    Usual care
    Intervention: Behavioral: Usual primary care counselling
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: January 9, 2012)
750
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2012
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 74 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01506687
Other Study ID Numbers  ICMJE 10-163
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Paul Ritvo, Ph.D., Cancer Care Ontario
Study Sponsor  ICMJE Cancer Care Ontario
Collaborators  ICMJE Canadian Institutes of Health Research (CIHR)
Investigators  ICMJE
Principal Investigator: Paul Ritvo, PHD Cancer Care Ontario
PRS Account Cancer Care Ontario
Verification Date December 2013

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