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

Colorectal Cancer Clinical Trial

— CRC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01289288
• Other study ID #: 2007-297
• Secondary ID: R01CA121023
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: February 2, 2011
• Last updated: May 20, 2013
• Start date: July 2007
• Est. completion date: July 2012

Study information

• Verified date: May 2013
• Source: Georgetown University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 480
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 74 Years

Eligibility

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).

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Behavioral:
• Mailed printed materials and in-office training
Mailed printed materials including CRC physician guide, patient brochure, flip chart and a poster Two sessions of in-office training with two standardized patients

Locations

Country	Name	City	State
United States	Temple University	Philadelphia	Pennsylvania
United States	Georgetown University	Washington DC	District of Columbia

Sponsors (3)

Lead Sponsor	Collaborator
Georgetown University	National Cancer Institute (NCI), Temple University

Country where clinical trial is conducted

United States, 

References & Publications (2)

Liang W, Wang JH, Chen MY, Mandelblatt JS. Language use and the receipt of cancer screening recommendations by immigrant Chinese American women. J Womens Health (Larchmt). 2009 Feb;18(2):201-7. doi: 10.1089/jwh.2007.0709. — View Citation

Wang JH, Liang W, Chen MY, Cullen J, Feng S, Yi B, Schwartz MD, Mandelblatt JS. The influence of culture and cancer worry on colon cancer screening among older Chinese-American women. Ethn Dis. 2006 Spring;16(2):404-11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Receipt of CRC screening	Nonadherent Chinese American patient's CRC screening rates.	12 months	No