Trial record 9 of 17 for:    "Asian Americans" OR "Chinese Americans" OR "Korean Americans" OR "Japanese Americans" OR "Filipino Americans" | Open Studies

Breast Health in Chinese American Women

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Georgetown University
Sponsor:
Collaborators:
Temple University
University of California, Los Angeles
Information provided by (Responsible Party):
Judy Wang, Georgetown University
ClinicalTrials.gov Identifier:
NCT01292200
First received: February 7, 2011
Last updated: March 21, 2014
Last verified: March 2014
  Purpose

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 Intervention
Breast Cancer
Behavioral: watch DVD and small group discussion
Behavioral: watch DVD

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: A RCT to Promote Mammography Adherence Among Chinese Immigrant Women

Resource links provided by NLM:


Further study details as provided by Georgetown University:

Primary Outcome Measures:
  • 3rd interview about receipt of mammography screening [ Time Frame: 6-month post-intervention ] [ Designated as safety issue: No ]
    Measure the effect of small group video discussion on mammography screening adherence.


Secondary Outcome Measures:
  • 4th interview about receipt of mammography screening [ Time Frame: 18-month post-intervention ] [ Designated as safety issue: No ]
    Measure the effect of small group video discussion on repeated mammography screening adherence.


Estimated Enrollment: 954
Study Start Date: July 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   42 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01292200

Contacts
Contact: Judy (Huei-Yu) Wang, Ph.D. 202-687-6306 jw235@georgetown.edu

Locations
United States, California
UCLA Recruiting
Los Angelas, California, United States, 90095
Contact: Annette E. Maxwell, Ph.D.    310-794-9282    amaxwell@ucla.edu   
Sub-Investigator: Annette E. Maxwell, Ph.D.         
United States, District of Columbia
Georgetown University Recruiting
Washington, District of Columbia, United States, 20007
Contact: Judy Wang, PhD    202-687-6306    jw235@georgetown.edu   
Principal Investigator: Judy (Huei_Yu) Wang, Ph.D.         
United States, Pennsylvania
Temple University Active, not recruiting
Philadelphia, Pennsylvania, United States, 19122
Sponsors and Collaborators
Georgetown University
Temple University
University of California, Los Angeles
Investigators
Principal Investigator: Judy (Huei-Yu) Wang, Ph.D. Georgetown University
  More Information

Publications:
Responsible Party: Judy Wang, Assistant professor, Georgetown University
ClinicalTrials.gov Identifier: NCT01292200     History of Changes
Other Study ID Numbers: 2010-185, NCI/ R01CA142941-01A1
Study First Received: February 7, 2011
Last Updated: March 21, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Georgetown University:
Chinese women
Mammography
Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 27, 2014