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Increasing Colorectal Cancer Screening Uptake With a Patient Navigator

Increasing Colorectal Cancer Screening Uptake With a Patient Navigator - Phase III Trial

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01506687
Enrollment
750
Registered
2012-01-10
Start date
2010-01-31
Completion date
2012-06-30
Last updated
2013-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Keywords

Colorectal cancer screening, 50 years or older

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.

Interventions

BEHAVIORALHealth counselling by nurse navigator

Information on colorectal cancer and screening, assistance in selection of screening option and obtaining kit or colonoscopy referral

BEHAVIORALUsual primary care counselling

Usual care health counselling on colorectal cancer and screening options

Sponsors

Canadian Institutes of Health Research (CIHR)
CollaboratorOTHER_GOV
Cancer Care Ontario
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to 74 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Completion of verified CRC screening event (FOBT;colonoscopy) event in experimental vs. control groups within 48 weeks48 weeks after baseline assessmentCompletion of verified CRC screening events in experimental vs. control patients

Secondary

MeasureTime frame
Screening preferences; predictors of CRC screening and screening preference.48 weeks

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026