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OpenTrials
Completed

NCT Number: NCT01801059

Patient Activation Intervention in Improving Screening Rates for Colorectal Cancer

This randomized clinical trial focused on activating the patient to ask their health care provider for a colorectal cancer screening test to improve screening rates for colorectal cancer. The patient activation intervention may increase information seeking, number of screening tests ordered and number of completed screening tests for colorectal cancer.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

Columbus, Ohio, 43210, United States

About this study

PRIMARY OBJECTIVES:

I. To test a patient activation intervention to improve colorectal cancer (CRC) screening rates using fecal occult blood test (FOBT) among male and female patients 50 years and older from the East Central Columbus Neighborhood Health Center.

SECONDARY OBJECTIVES:

I. To assess if there is a change in knowledge and attitudes about CRC screening after watching the educational video.

II. To assess the effectiveness of providing communication skills training for improving discussion focusing on CRC screening during the patient-provider visit.

OUTLINE: Patients are randomized to 1 of 2 arms prior to a medical visit.

ARM I (Education only): Patients receive CRC and CRC screening information by an educational video and a brochure with healthy hints to prevent CRC.

ARM II (Education and patient activation): Patients receive CRC and CRC screening information and communication skills training (patient activation) intervention by educational video and brochure and a brochure about healthy hints to prevent CRC.

After the medical visit, patients' medical records are reviewed at 1 month and 2 months after the visit to document CRC screening completion.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patient is 50+ years of age
  • Patient is in need of CRC screening
  • Patient is in good health (e.g. no contraindications to having CRC screening, such as a history of colorectal cancer, congenital heart failure, renal failure, dialysis, dementia, severe arthritis, etc.)
  • Patient is not pregnant
  • Patient is able to speak, read, and understand English

Exclusion criteria

  • Patient is within CRC screening guidelines
  • Patient is at high risk for CRC
  • Patient cannot understand English
  • Patient cannot complete a CRC screening test

Treatment and study plan

Educational Intervention

Other

Receive patient activation intervention by educational video and brochure

Other names: intervention, educational

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. Completion rate of CRC screening

    Time frame: Up to 2 months

    A test of two proportions will be used. If the two groups are different at baseline with respect to key covariates, then a logistic regression model will be used to assess the effect of the intervention on CRC screening controlling for possible confounding variables. The variables that differ between the two groups will be tested as confounders using risk-factor modeling. Summary statistics will be used to describe the time point that subjects receive CRC screening, either after the medical visit or after telephone barriers counseling, and relevant comparisons made.

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Registry information

Official study title

Patient Activation To Increase Colon Cancer Screening (THE CHAT STUDY)

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Feb 28, 2013
Registry last updated
Oct 16, 2014

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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