NCT01525264

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
434

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Aug 2008

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 26, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 2, 2012

Completed
Last Updated

August 18, 2016

Status Verified

February 1, 2012

Enrollment Period

2.1 years

First QC Date

December 26, 2011

Last Update Submit

August 17, 2016

Conditions

Keywords

Mammography

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in mammography uptake at 15 months

    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.

    6- and 15-months post-baseline

Secondary Outcomes (2)

  • Health beliefs

    6- and 15-months post-baseline

  • Spousal Support

    6- and 15-months post-baseline

Study Arms (2)

Culturally Relavent Education

EXPERIMENTAL

Education about improving diet using a DVD with Korean role models and native Korean language.

Behavioral: KIM-CHI

Healthy Wife Intervention

ACTIVE COMPARATOR

Intervention group of couples who received education about importance of a Healthy Diet. It was an attention control group

Behavioral: Healthy Wife Control Group

Interventions

KIM-CHIBEHAVIORAL

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.

Also known as: Culturally relavent intervention
Culturally Relavent Education

Intervention group of couples who received education about importance of Healthy diet

Also known as: Healthy Diet
Healthy Wife Intervention

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older
  • born in Korea but presently living in the U.S.
  • able to speak and read Korean

You may not qualify if:

  • Women who have had a mammogram within the past 1 year or have been diagnosed with breast cancer were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Diet, Healthy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

DietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Eunice E Lee, PhD

    UCLA School of Nursing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 26, 2011

First Posted

February 2, 2012

Study Start

August 1, 2008

Primary Completion

September 1, 2010

Study Completion

October 1, 2010

Last Updated

August 18, 2016

Record last verified: 2012-02