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Breast Health in Chinese American Women

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ClinicalTrials.gov Identifier: NCT01292200
Recruitment Status : Completed
First Posted : February 9, 2011
Last Update Posted : July 2, 2017
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
Breast Cancer Behavioral: watch DVD and small group discussion Behavioral: watch DVD

Detailed 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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 954 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: A RCT to Promote Mammography Adherence Among Chinese Immigrant Women
Study Start Date : July 2010
Primary Completion Date : December 21, 2016
Study Completion Date : December 21, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mammography
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: watch DVD and small group discussion
Participants will watch the video in a group and discuss the video.
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.
Placebo Comparator: watch video only
watch a 22 minutes long video at home by herself.
Behavioral: 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.

Outcome Measures

Primary Outcome Measures :
  1. 3rd interview about receipt of mammography screening [ Time Frame: 6-month post-intervention ]
    Measure the effect of small group video discussion on mammography screening adherence.

Secondary Outcome Measures :
  1. 4th interview about receipt of mammography screening [ Time Frame: 21-month post-intervention ]
    Measure the effect of small group video discussion on repeated mammography screening adherence.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   42 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01292200

United States, California
Los Angeles, California, United States, 90095
United States, District of Columbia
Georgetown University
Washington, D.C., District of Columbia, United States, 20007
United States, Pennsylvania
Temple University
Philadelphia, Pennsylvania, United States, 19122
Sponsors and Collaborators
Georgetown University
Temple University
University of California, Los Angeles
National Cancer Institute (NCI)
Principal Investigator: Judy (Huei-Yu) Wang, Ph.D. Georgetown University