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Increasing Colorectal Cancer Screening Uptake With a Patient Navigator

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ClinicalTrials.gov Identifier: NCT01506687
Recruitment Status : Completed
First Posted : January 10, 2012
Last Update Posted : December 3, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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.


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

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 750 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Increasing Colorectal Cancer Screening Uptake With a Patient Navigator - Phase III Trial
Study Start Date : January 2010
Primary Completion Date : June 2012
Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Screening preferences; predictors of CRC screening and screening preference. [ Time Frame: 48 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 74 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01506687


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

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
First Posted: January 10, 2012    Key Record Dates
Last Update Posted: December 3, 2013
Last Verified: December 2013

Keywords provided by Paul Ritvo, Ph.D., 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