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
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|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||750 participants|
|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|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||June 2012|
|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
Behavioral: Usual primary care counselling
Usual care health counselling on colorectal cancer and screening options
Other Name: Usual primary care
- 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
- Screening preferences; predictors of CRC screening and screening preference. [ Time Frame: 48 weeks ]
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
|Group Health Centre|
|Sault Ste. Marie, Ontario, Canada|
|Principal Investigator:||Paul Ritvo, PHD||Cancer Care Ontario|