A Physician-Based Trial to Increase Colorectal Cancer Screening in Chinese (CRC)

This study has been completed.
Sponsor:
Collaborators:
Temple University
Information provided by (Responsible Party):
Judy Wang, Georgetown University
ClinicalTrials.gov Identifier:
NCT01289288
First received: February 2, 2011
Last updated: May 20, 2013
Last verified: May 2013
  Purpose

The objective of this study is to test whether a culturally-tailored in-office based intervention have impact on increasing Chinese physician's recommendation of colorectal cancer (CRC) screening to their nonadherent Chinese patients.

Special aims are to:

  1. Evaluate the efficacy of a culturally-tailored physician intervention on increasing non-adherent Chinese American's patients' CRC screening rate.
  2. Identify factors that mediate or moderate the intervention effects. For example, patients who hold an eastern cultural view or are less acculturated will be more likely to benefit from the intervention than patients who hold a western view or who are more acculturated.

Condition Intervention Phase
Colorectal Cancer
Behavioral: Mailed printed materials and in-office training
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Physician-Based Trial to Increase Colorectal Cancer Screening in Chinese

Resource links provided by NLM:


Further study details as provided by Georgetown University:

Primary Outcome Measures:
  • Receipt of CRC screening [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Nonadherent Chinese American patient's CRC screening rates.


Enrollment: 480
Study Start Date: July 2007
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mailed printed materials and in-office training Behavioral: Mailed printed materials and in-office training
  1. Mailed printed materials including CRC physician guide, patient brochure, flip chart and a poster
  2. Two sessions of in-office training with two standardized patients
No Intervention: Control
Usual care

Detailed Description:

This study is a randomized controlled trial aiming to test the effect of the culturally-tailored in-office based intervention on physicians. A total of 24 Chinese physicians in the Washington DC and Philadelphia areas and a total of 24 eligible Chinese patients from each physician will be recruited for this study. Physicians and their patients are randomized into two groups: A and B. Physician in the intervention group (A) will receive mailed printed materials including a CRC physician guide, patient brochure, flip chart and a poster and two sessions of in-office training aimed to reinforce learning of the topic covered by the mailed materials and provide physicians with hands-on experience in using communication skills with standardized patients. Physicians in the control group (B) will receive nothing until the end of the study. Patients will be followed 12-month later after their completion of the baseline survey and their self-reported CRC screening status will be verified by chart audit.

  Eligibility

Ages Eligible for Study:   50 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

For Physicians

  1. are Chinese American,
  2. practice primary care,
  3. have a least 75 Chinese patients aged 50 and older in their practice,
  4. can communicate with patients in Chinese (Mandarin, Cantonese, etc.)

For Patients

  1. visiting the participating physician at least once in the past 2 years,
  2. are Chinese Americans,
  3. are 50 years and older,
  4. never had any CRC screening or are overdue for screening.

Exclusion Criteria:

For Patients:

  1. have a colorectal polyp, CRC cancer, or a family history of CRC (first degree relative), and
  2. had updated CRC screening (FOBT within one year, colonoscopy within 10 years, sigmoidoscopy within 5 years and double-contrast barium enema within 5 years).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01289288

Locations
United States, District of Columbia
Georgetown University
Washington DC, District of Columbia, United States, 20007
United States, Pennsylvania
Temple University
Philadelphia, Pennsylvania, United States, 19122
Sponsors and Collaborators
Georgetown University
Temple University
Investigators
Principal Investigator: Judy Wang, Ph.D. Georgetown University
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Judy Wang, Assistant Professor, Georgetown University
ClinicalTrials.gov Identifier: NCT01289288     History of Changes
Other Study ID Numbers: 2007-297, R01CA121023
Study First Received: February 2, 2011
Last Updated: May 20, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Georgetown University:
colorectal cancer screening
Chinese Americans
patients nonadherent with CRC Screening

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases

ClinicalTrials.gov processed this record on October 22, 2014