Patient Activation Intervention in Improving Screening Rates for Colorectal Cancer

NCT01801059 | Completed DMC

• 2 other identifiers: OSU-07104NCI-2012-01922
• Study Type: interventional
• Target: 284
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colon Cancer; Rectal Cancer

Keywords

colon cancer; Colorectal Cancer Screening

Outcome Measures

Primary Outcomes (1)

• Completion rate of CRC screening

  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.

  Up to 2 months

Study Arms (2)

Arm I education CRC and CRC screening

ACTIVE COMPARATOR

Educational intervention: Patients receive CRC and CRC screening information from an educational video and received a brochure focused on healthy hints to prevent CRC. Questionnaire administration prior to and after the intervention.

Other: educational intervention; Other: questionnaire administration

Arm II education and patient activation intervention

EXPERIMENTAL

Educational intervention administered: Patients receive patient activation intervention comprising CRC and CRC screening information and communication skills training intervention by educational video and brochure, and they also receive a brochure focused on healthy hints to prevent CRC. Questionnaire administration prior to and after the intervention.

Other: educational intervention; Other: questionnaire administration

Interventions

educational intervention OTHER

Receive patient activation intervention by educational video and brochure

Also known as: intervention, educational

Arm I education CRC and CRC screening; Arm II education and patient activation intervention

questionnaire administration OTHER

Ancillary studies

Arm I education CRC and CRC screening; Arm II education and patient activation intervention

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

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

Columbus, Ohio, 43210, United States

Location

Related Links

• Jamesline

MeSH Terms

Conditions

Colonic Neoplasms; Rectal Neoplasms

Interventions

Early Intervention, Educational; Methods

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Investigative Techniques

Study Officials

• Mira Katz

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 26, 2013
• First Posted: February 28, 2013
• Study Start: September 1, 2007
• Primary Completion: August 1, 2010
• Study Completion: December 1, 2010
• Last Updated: October 16, 2014

Record last verified: 2014-10

Locations

US (1)