Clinical trial NCT01292200: Breast Health in Chinese American Women
Official title: A RCT to Promote Mammography Adherence Among Chinese Immigrant Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Chinese women
Mammography
Breast Cancer
Lead sponsor: Georgetown University
Sponsor class: OTHER
Collaborators: name: Temple University
name: University of California, Los Angeles
name: National Cancer Institute (NCI)
First posted: 2011-02-09
Enrollment: 954
Sex: FEMALE
Minimum age (years): 42
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

Eligibility 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

Primary outcomes:
measure: 3rd interview about receipt of mammography screening
timeFrame: 6-month post-intervention
Secondary outcomes:
measure: 4th interview about receipt of mammography screening
timeFrame: 21-month post-intervention
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA
state: California
city: Washington, D.C.
country: United States
facility: Georgetown University
state: District of Columbia
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
Study officials:
affiliation: Georgetown University
name: Judy (Huei-Yu) Wang, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.