Breast Health in Chinese American Women

June 29, 2017 updated by: Judy Wang, Georgetown University

A RCT to Promote Mammography Adherence Among Chinese Immigrant Women

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

954

Phase

  • Not Applicable

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

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • UCLA
    • District of Columbia
      • Washington, D.C., District of Columbia, United States, 20007
        • Georgetown University
    • Pennsylvania
      • 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

42 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

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: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6-month post-intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
21-month post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Georgetown University

Collaborators

National Cancer Institute (NCI)
University of California, Los Angeles
Temple University

Investigators

  • Principal Investigator: Judy (Huei-Yu) 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

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, 2010

Primary Completion (Actual)

December 21, 2016

Study Completion (Actual)

December 21, 2016

Study Registration Dates

First Submitted

February 7, 2011

First Submitted That Met QC Criteria

February 8, 2011

First Posted (Estimate)

February 9, 2011

Study Record Updates

Last Update Posted (Actual)

July 2, 2017

Last Update Submitted That Met QC Criteria

June 29, 2017

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010-185
  • R01CA142941-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

Clinical Trials on Breast Cancer

Clinical Trials on watch DVD and small group discussion

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Japan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe