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Breast Health in Chinese American Women

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
watch DVD and small group discussion
watch DVD
Sponsored by
Georgetown University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Breast Cancer focused on measuring Chinese women, Mammography, Breast Cancer

Eligibility Criteria

42 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • UCLA
  • Georgetown University
  • Temple University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

watch DVD and small group discussion

watch video only

Arm Description

Participants will watch the video in a group and discuss the video.

watch a 22 minutes long video at home by herself.

Outcomes

Primary Outcome Measures

3rd interview about receipt of mammography screening
Measure the effect of small group video discussion on mammography screening adherence.

Secondary Outcome Measures

4th interview about receipt of mammography screening
Measure the effect of small group video discussion on repeated mammography screening adherence.

Full Information

First Posted
February 7, 2011
Last Updated
June 29, 2017
Sponsor
Georgetown University
Collaborators
Temple University, University of California, Los Angeles, National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01292200
Brief Title
Breast Health in Chinese American Women
Official Title
A RCT to Promote Mammography Adherence Among Chinese Immigrant Women
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
December 21, 2016 (Actual)
Study Completion Date
December 21, 2016 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Chinese women, Mammography, Breast Cancer

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
954 (Actual)

8. Arms, Groups, and Interventions

Arm Title
watch DVD and small group discussion
Arm Type
Experimental
Arm Description
Participants will watch the video in a group and discuss the video.
Arm Title
watch video only
Arm Type
Placebo Comparator
Arm Description
watch a 22 minutes long video at home by herself.
Intervention Type
Behavioral
Intervention Name(s)
watch DVD and small group discussion
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
watch DVD
Intervention Description
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.
Primary Outcome Measure Information:
Title
3rd interview about receipt of mammography screening
Description
Measure the effect of small group video discussion on mammography screening adherence.
Time Frame
6-month post-intervention
Secondary Outcome Measure Information:
Title
4th interview about receipt of mammography screening
Description
Measure the effect of small group video discussion on repeated mammography screening adherence.
Time Frame
21-month post-intervention

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: First generation Chinese women Aged 42 and older Have not had a mammogram in the past 2 years Have never had breast cancer Lived in the metropolitan DC, southern CA, and NY suburb; AND Have no mammography screening scheduled in the next 6 month from time of enrollment Exclusion Criteria: Short-term visitors US-born Chinese Americans
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judy (Huei-Yu) Wang, Ph.D.
Organizational Affiliation
Georgetown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Georgetown University
City
Washington, D.C.
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

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
19645031
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.
Results Reference
background
PubMed Identifier
17602099
Citation
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. doi: 10.1177/1090198106296768. Epub 2007 Jun 29.
Results Reference
background

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Breast Health in Chinese American Women

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