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Breast Cancer Screening Intervention

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eunice Lee, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01525264
First received: December 26, 2011
Last updated: February 1, 2012
Last verified: January 2012
History of Changes
  Purpose

Breast cancer is the most commonly occurring cancer and most common cause of cancer mortality among Korean American (KA) women, but mammography utilization among KA women remains suboptimal. Most breast cancer screening studies with KA women have been descriptive and correlational. Therefore, in this 4-year project, the effects of Korean Immigrants & Mammography—Culture-Specific Health Intervention (KIM-CHI) on adherence to recommended breast cancer screening protocols were tested. The specific aims are to: (1) compare the group receiving KIM-CHI with an attention control group on mammogram attainment outcomes including number of mammograms obtained (0, 1, or 2) and if obtained, length of time to obtain the first mammogram, at 15 months using survival analysis; (2) compare the two groups on the mediating variables of health beliefs, knowledge, self-efficacy, and spousal support at 2 weeks, 6 months, and 15 months using repeated measures multivariate analysis of variance; and (3) identify the mediating effects of health beliefs, knowledge, self-efficacy, and spousal support at 2 weeks on mammogram attainment outcomes at 15 months, using structural equation modeling. Data on mammography attainment and the mediating variables were collected at baseline and at 2-weeks, and 6- and 15-months post-baseline.


Condition Intervention Phase
Breast Cancer
 Behavioral: KIM-CHI
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Screening
Official Title: Korean Immigrants & Mammography—Culture-Specific Health Intervention (KIM-CHI)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Change from baseline in mammography uptake at 15 months [ Time Frame: 6- and 15-months post-baseline ] [ Designated as safety issue: No ]
    Non of the participants at baseline had a mammogram within the previous 1 year. The primary outcome was measured by self-report about how many times and when (month and year) mammograms were obtained by women in the study, with follow-up validation by the mammography facility for each woman who reports having had a mammogram in the past 15 months at Time 3. The number of mammograms (o, 1, or 2) and length of time to mammogram were calculated.


Secondary Outcome Measures:
  • Health beliefs [ Time Frame: 6- and 15-months post-baseline ] [ Designated as safety issue: No ]
    health beliefs (perceived seriousness, susceptibility, benefits, barriers, knowledge, self-efficacy about breast cancer and screening) were measured by using Likert-type scale, ranging from strongly disagree = 1 to strongly agree = 5.

  • Spousal Support [ Time Frame: 6- and 15-months post-baseline ] [ Designated as safety issue: No ]
    Women's perceived spousal support received from husbands and husbands' perceived spousal support provided to their wives were measured.


Enrollment: 434
Study Start Date: August 2008
Study Completion Date: October 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Health diet education
Education about improving diet using a DVD with Korean role models and native Korean language. It was an attention control group
 Behavioral: KIM-CHI
The intervention is based on cultural characteristics and context and focuses on changing (1) beliefs about breast cancer and screening, (2) knowledge of breast cancer and screening, (3) self-efficacy of confidence in one's ability to complete all the steps necessary for obtaining a mammogram including requesting a referral for mammogram from a physician. The KIM-CHI program also incorporates strategies for enhancing spousal support (perceived support received from husband). To standardize delivery of culture-relevant health behavior change information related to breast cancer screening to groups of women and their husbands separately, the KIM-CHI program uses a DVD with Korean role models, native Korean language, and male physician authentication as well as inclusion of spouses.
Other Name: Healthy Diet

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  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • For women, criteria for inclusion in the study are

    1. 40 years of age or older
    2. born in Korea but presently living in the U.S.
    3. able to speak and read Korean
    4. married to a KA man who meets inclusion criteria (2) and (3).

Exclusion Criteria:

  • Women who have had a mammogram within the past 1 year or have been diagnosed with breast cancer were excluded.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01525264

Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: Eunice E Lee, PhD UCLA School of Nursing
  More Information

No publications provided

Responsible Party: Eunice Lee, Associate Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01525264     History of Changes
Other Study ID Numbers: KIM-CHI
Study First Received: December 26, 2011
Last Updated: February 1, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:
Mammography

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

ClinicalTrials.gov processed this record on May 23, 2013