Breast Health in Chinese American Women
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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 |
- 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.
- 4th interview about receipt of mammography screening [ Time Frame: 24-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 910 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 |
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
Contacts and Locations| Contact: Judy (Huei-Yu) Wang, Ph.D. | 202-687-6306 | jw235@georgetown.edu |
| 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 | Recruiting |
| Philadelphia, Pennsylvania, United States, 19122 | |
| Contact: Grace X. Ma, Ph.D. 215-204-5108 grace.ma@temple.edu | |
| Sub-Investigator: Grace X. Ma, Ph.D. | |
| 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: | February 27, 2013 |
| 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 May 16, 2013