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Breast Cancer Screening Intervention

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ClinicalTrials.gov Identifier: NCT01525264
Recruitment Status : Completed
First Posted : February 2, 2012
Last Update Posted : August 18, 2016
Sponsor:
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

Brief Summary:
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 or disease Intervention/treatment Phase
Breast Cancer Behavioral: KIM-CHI Behavioral: Healthy Wife Control Group Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 434 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Korean Immigrants & Mammography—Culture-Specific Health Intervention (KIM-CHI)
Study Start Date : August 2008
Actual Primary Completion Date : September 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Culturally Relavent Education
Education about improving diet using a DVD with Korean role models and native Korean language.
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: Culturally relavent intervention
Active Comparator: Healthy Wife Intervention
Intervention group of couples who received education about importance of a Healthy Diet. It was an attention control group
Behavioral: Healthy Wife Control Group
Intervention group of couples who received education about importance of Healthy diet
Other Name: Healthy Diet



Primary Outcome Measures :
  1. Change from baseline in mammography uptake at 15 months [ Time Frame: 6- and 15-months post-baseline ]
    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 :
  1. Health beliefs [ Time Frame: 6- and 15-months post-baseline ]
    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.

  2. Spousal Support [ Time Frame: 6- and 15-months post-baseline ]
    Women's perceived spousal support received from husbands and husbands' perceived spousal support provided to their wives were measured.



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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01525264


Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
Principal Investigator: Eunice E Lee, PhD UCLA School of Nursing

Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01525264     History of Changes
Other Study ID Numbers: 10-000204
Kim-CHi ( Other Grant/Funding Number: Jonsson Comprehensive Cancer Center )
First Posted: February 2, 2012    Key Record Dates
Last Update Posted: August 18, 2016
Last Verified: February 2012

Keywords provided by Jonsson Comprehensive Cancer Center:
Mammography

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