Increasing Colorectal Cancer Screening Uptake With a Patient Navigator

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01506687
• Other study ID #: 10-163
• Status: Completed
• Phase: Phase 3
• First received: June 27, 2011
• Last updated: December 2, 2013
• Start date: January 2010
• Est. completion date: June 2012

Study information

• Verified date: December 2013
• Source: Cancer Care Ontario
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Canadian Institutes of Health Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 750
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 74 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

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
• Usual primary care counselling
Usual care health counselling on colorectal cancer and screening options

Locations

Country	Name	City	State
Canada	Group Health Centre	Sault Ste. Marie	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Cancer Care Ontario	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Completion of verified CRC screening event (FOBT;colonoscopy) event in experimental vs. control groups within 48 weeks	Completion of verified CRC screening events in experimental vs. control patients	48 weeks after baseline assessment	No
Secondary	Screening preferences; predictors of CRC screening and screening preference.		48 weeks	No