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

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Mailed printed materials and in-office training
Sponsored by
Georgetown University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colorectal Cancer focused on measuring colorectal cancer screening, Chinese Americans, patients nonadherent with CRC Screening

Eligibility Criteria

50 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Georgetown University
  • Temple University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Mailed printed materials and in-office training

Control

Arm Description

Usual care

Outcomes

Primary Outcome Measures

Receipt of CRC screening
Nonadherent Chinese American patient's CRC screening rates.

Secondary Outcome Measures

Full Information

First Posted
February 2, 2011
Last Updated
May 20, 2013
Sponsor
Georgetown University
Collaborators
Temple University, National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01289288
Brief Title
A Physician-Based Trial to Increase Colorectal Cancer Screening in Chinese
Acronym
CRC
Official Title
A Physician-Based Trial to Increase Colorectal Cancer Screening in Chinese
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Georgetown University
Collaborators
Temple University, National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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: 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
colorectal cancer screening, Chinese Americans, patients nonadherent with CRC Screening

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
480 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mailed printed materials and in-office training
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Arm Description
Usual care
Intervention Type
Behavioral
Intervention Name(s)
Mailed printed materials and in-office training
Intervention Description
Mailed printed materials including CRC physician guide, patient brochure, flip chart and a poster Two sessions of in-office training with two standardized patients
Primary Outcome Measure Information:
Title
Receipt of CRC screening
Description
Nonadherent Chinese American patient's CRC screening rates.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judy Wang, Ph.D.
Organizational Affiliation
Georgetown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Georgetown University
City
Washington DC
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Temple University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19122
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19183091
Citation
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.
Results Reference
background
PubMed Identifier
17682242
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.
Results Reference
background
PubMed Identifier
29320335
Citation
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.
Results Reference
derived
PubMed Identifier
24567288
Citation
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.
Results Reference
derived

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

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