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Increasing Colorectal Cancer Screening Uptake With a Patient Navigator

This study is currently recruiting participants.
Verified January 2012 by Cancer Care Ontario
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: January 9, 2012
Last verified: January 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Colorectal Cancer
 Behavioral: Health counselling by nurse navigator
Behavioral: Usual primary care counselling
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Increasing Colorectal Cancer Screening Uptake With a Patient Navigator - Phase III Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Cancer Care Ontario:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Screening preferences; predictors of CRC screening and screening preference. [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 750
Study Start Date: January 2010
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Navigator intervention 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
Active Comparator: Usual Care Control
Usual care
 Behavioral: Usual primary care counselling
Usual care health counselling on colorectal cancer and screening options
Other Name: Usual primary care

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.

  Eligibility

Ages Eligible for Study:   50 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01506687

Contacts
Contact: Brian Mitchell, MD 7057595561 Bmitchell@grouphealth.org

Locations
Canada, Ontario
Group Health Centre Recruiting
Sault Ste. Marie, Ontario, Canada
Principal Investigator: Brian Mitchell, MD            
Sponsors and Collaborators
Cancer Care Ontario
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Paul Ritvo, PHD Cancer Care Ontario
  More Information

No publications provided

Responsible Party: Paul Ritvo, Ph.D., Scientist, Research, Prevention and Cancer Control, Cancer Care Ontario
ClinicalTrials.gov Identifier: NCT01506687     History of Changes
Other Study ID Numbers: 10-163
Study First Received: June 27, 2011
Last Updated: January 9, 2012
Health Authority: Canada: Canadian Institutes of Health Research

Keywords provided by Cancer Care Ontario:
Colorectal cancer screening
50 years or older

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on May 19, 2013