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OpenTrials
Completed

NCT Number: NCT01506687

Increasing Colorectal Cancer Screening Uptake With a Patient Navigator

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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

50 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Group Health Centre

Sault Ste. Marie, Ontario, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Health counselling by nurse navigator

Behavioral

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

Other names: Nurse navigator assistance

Usual primary care counselling

Behavioral

Usual care health counselling on colorectal cancer and screening options

Other names: Usual primary care

Primary outcomes

  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 outcomes

  1. Screening preferences; predictors of CRC screening and screening preference.

    Time frame: 48 weeks

Sponsors and collaborators

Lead sponsor

Cancer Care Ontario

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jan 10, 2012
Registry last updated
Dec 3, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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