Breast Health in Chinese American Women

Breast Cancer Clinical Trial

Official title:

A RCT to Promote Mammography Adherence Among Chinese Immigrant Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01292200
• Other study ID #: 2010-185
• Secondary ID: R01CA142941-01A1
• Status: Completed
• Phase: N/A
• First received: February 7, 2011
• Last updated: June 29, 2017
• Start date: July 2010
• Est. completion date: December 21, 2016

Study information

• Verified date: July 2016
• Source: Georgetown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This four-and-a-half-year study will test the efficacy of viewing a theoretically based and culturally sensitive video followed by group discussion (vs. single viewing) in increasing mammography use. The results of this study will lead cancer control efforts to effectively decrease breast cancer screening disparities experienced by Chinese-America women.

Description:

We will conduct a 4.5-year community-based RCT to study the impact of intervention approaches (small-group video discussion vs. single video mode) on mammography used among Chinese immigrant women. The small-group video discussion will be led by trained Chinese community health educators and trained bilingual research staff using a standardized structured protocol at all sites. In the single video mode, we will mail the intervention materials to women to view and/or read at home. We will recruit 974 Chinese women through our strong and well-established Chinese community partnerships in the metropolitan areas of Washington, DC (Lead PI: Dr. Judy Wang, Georgetown University-GU), New York (Site PI: Dr. Grace Ma at Temple University), and southern California (Site PI: Dr. Annette Maxwell, University of California, Los Angeles-UCLA). Participants' eligibility are listed under "eligibility criteria". We will not enroll US-born Chinese women as they are least likely to face cultural and language barriers to mammography and less likely to engage in our small-group discussion, which will be conducted in Chinese languages. Also, we will not enroll short-term visitors as our study involves four interviews over a 2-year period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 954
• Est. completion date: December 21, 2016
• Est. primary completion date: December 21, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 42 Years and older

Eligibility

Inclusion Criteria:

1. First generation Chinese women

2. Aged 42 and older

3. Have not had a mammogram in the past 2 years

4. Have never had breast cancer

5. Lived in the metropolitan DC, southern CA, and NY suburb; AND

6. Have no mammography screening scheduled in the next 6 month from time of enrollment

Exclusion Criteria:

1. Short-term visitors

2. US-born Chinese Americans

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Behavioral:
• watch DVD and small group discussion
Women in the small-group discussion mode will be called by their community educators to determine possible dates, times, and places for group meetings. The small group sessions will be conducted near the participants' homes. Each small-group will consist of 5-10 participants who will first view a 20-minute video together and then discuss the content of the video as well as their barriers to screening for about 30 minutes. A community educator and an RA at the study site will facilitate the discussion in Chinese languages according to a structured guide.
• watch DVD
Women in the single video mode will receive a cultural video along with an information sheet on local free and low-cost screening programs by mail.

Locations

Country	Name	City	State
United States	UCLA	Los Angeles	California
United States	Temple University	Philadelphia	Pennsylvania
United States	Georgetown University	Washington, D.C.	District of Columbia

Sponsors (4)

Lead Sponsor	Collaborator
Georgetown University	National Cancer Institute (NCI), Temple University, University of California, Los Angeles

Country where clinical trial is conducted

United States, 

References & Publications (2)

Wang JH, Liang W, Schwartz MD, Lee MM, Kreling B, Mandelblatt JS. Development and evaluation of a culturally tailored educational video: changing breast cancer-related behaviors in Chinese women. Health Educ Behav. 2008 Dec;35(6):806-20. Epub 2007 Jun 29. — View Citation

Wang JH, Mandelblatt JS, Liang W, Yi B, Ma IJ, Schwartz MD. Knowledge, cultural, and attitudinal barriers to mammography screening among nonadherent immigrant Chinese women: ever versus never screened status. Cancer. 2009 Oct 15;115(20):4828-38. doi: 10.1002/cncr.24517. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3rd interview about receipt of mammography screening	Measure the effect of small group video discussion on mammography screening adherence.	6-month post-intervention
Secondary	4th interview about receipt of mammography screening	Measure the effect of small group video discussion on repeated mammography screening adherence.	21-month post-intervention