- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01289288
A Physician-Based Trial to Increase Colorectal Cancer Screening in Chinese (CRC)
May 20, 2013 updated by: Judy Wang, Georgetown University
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:
- Evaluate the efficacy of a culturally-tailored physician intervention on increasing non-adherent Chinese American's patients' CRC screening rate.
- 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
480
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
District of Columbia
-
Washington DC, District of Columbia, United States, 20007
- Georgetown University
-
-
Pennsylvania
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Philadelphia, Pennsylvania, United States, 19122
- Temple University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 74 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
For Physicians
- are Chinese American,
- practice primary care,
- have a least 75 Chinese patients aged 50 and older in their practice,
- can communicate with patients in Chinese (Mandarin, Cantonese, etc.)
For Patients
- visiting the participating physician at least once in the past 2 years,
- are Chinese Americans,
- are 50 years and older,
- never had any CRC screening or are overdue for screening.
Exclusion Criteria:
For Patients:
- have a colorectal polyp, CRC cancer, or a family history of CRC (first degree relative), and
- 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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
Usual care
|
|
|
Experimental: Mailed printed materials and in-office training
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Receipt of CRC screening
Time Frame: 12 months
|
Nonadherent Chinese American patient's CRC screening rates.
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Judy Wang, Ph.D., Georgetown University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Wang JH, Sheppard VB, Liang W, Ma GX, Maxwell AE. Recruiting Chinese Americans into cancer screening intervention trials: strategies and outcomes. Clin Trials. 2014 Apr;11(2):167-77. doi: 10.1177/1740774513518849. Epub 2014 Feb 24.
- 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.
- 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.
- Huei-Yu Wang J, Ma GX, Liang W, Tan Y, Makambi KH, Dong R, Vernon SW, Tu SP, Mandelblatt JS. Physician Intervention and Chinese Americans' Colorectal Cancer Screening. Am J Health Behav. 2018 Jan 1;42(1):13-26. doi: 10.5993/AJHB.42.1.2.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2007
Primary Completion (Actual)
July 1, 2012
Study Completion (Actual)
July 1, 2012
Study Registration Dates
First Submitted
February 2, 2011
First Submitted That Met QC Criteria
February 2, 2011
First Posted (Estimate)
February 3, 2011
Study Record Updates
Last Update Posted (Estimate)
May 21, 2013
Last Update Submitted That Met QC Criteria
May 20, 2013
Last Verified
May 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2007-297
- R01CA121023 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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