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Breast Cancer Screening Intervention

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
KIM-CHI
Healthy Wife Control Group
Sponsored by
Jonsson Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Breast Cancer focused on measuring Mammography

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Culturally Relavent Education

    Healthy Wife Intervention

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Health beliefs
    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
    Women's perceived spousal support received from husbands and husbands' perceived spousal support provided to their wives were measured.

    Full Information

    First Posted
    December 26, 2011
    Last Updated
    August 17, 2016
    Sponsor
    Jonsson Comprehensive Cancer Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01525264
    Brief Title
    Breast Cancer Screening Intervention
    Official Title
    Korean Immigrants & Mammography-Culture-Specific Health Intervention (KIM-CHI)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2008 (undefined)
    Primary Completion Date
    September 2010 (Actual)
    Study Completion Date
    October 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Jonsson Comprehensive Cancer Center

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed Description
    In this two-group cluster randomized, longitudinal, controlled design, the KIM-CHI and control activities were delivered immediately after baseline data collection at 50 KA religious organizations. Participants in the attention control group followed the same study procedures as participants in the KIM-CHI group, except for the content of the educational films. The baseline and longitudinal data were collected from August 2008 to September 2010 in Cook County, Illinois. The KIM-CHI group slogan was "Healthy Family, Healthy Wife," and the control group slogan was "Healthy Family, Healthy Diet," emphasizing the importance of the husband's support in promoting family health by improving breast cancer screening or diet in the KIM-CHI and attention control groups, respectively. The KIM-CHI program consisted of (1) showing a project team-designed 30-minute Korean language film (in DVD format) on breast cancer screening to change health beliefs; (2) holding a brief group discussion session immediately after the film showing; and (3) requiring each couple to complete a discussion activity together at home to enhance spousal support for the women. A total of 516 women were assessed for eligibility for this study from August 2008 to June 2009. 428 KA women were recruited at baseline. The response rates for returning homework activity in intervention and control groups were 98.1% (207/211) and 98.6% (214/217), respectively. All the variables reported are from KA women, but socio-demographic variables are from both KA women and their husbands. Mammography uptake was measured by self-report at 6- months and 15-months post-baseline, based on the ACS guideline recommending that women 40 and older receive a mammogram every year. Predictor variables measured were age, education, employment, and level of acculturation. Level of acculturation was measured by the Suinn-Lew Asian Self-Identity Acculturation Scale (SL-ASIA). The SL-ASIA was modified slightly by deleting one item about generation because it was not relevant for first-generation KAs. The words "Asian" and "Oriental" in the original instrument were also changed to "Korean." Scoring for the revised SL-ASIA was the same as the original SL-ASIA, using a 5-point Likert scale with a final score ranging from 1.00 (low acculturation) to 5.00 (high acculturation). Questions on health care resources and utilization, health insurance status, usual source of care (a regular place or doctor to visit), and physical examinations in the past 2 years without sickness or for health problems were measured. Family history of breast cancer and history of mammography (when the last mammogram was, if they ever had one) were also measured. After Human Subjects Review Approval was obtained, invitation letters were mailed to all 210 religious organizations listed in the Korean language Chicago Korean Business Directory 2006. One hundred KA organizations were contacted to request participation in the study and 110 KA religious organizations were treated as "unable to reach." Of those 100 contacted organizations, 32 were ineligible (e.g., they were younger KAs, students, multi-ethnics, or disabled persons). Eighteen of the remaining 68 eligible organizations (26.5%) refused to participate. The 50 organizations were randomly assigned to either the KIM-CHI or attention control group. After random assignment, the characteristics of religious organizations (location and size) were not statistically significantly different between the two groups. A total of 428 couples participated in this study at baseline; 211 wife-husband dyads from 26 KIM-CHI organizations and 217 wife-husband dyads from 24 attention control organizations. KA women and their husbands who were interested in participating in our study signed two copies of an informed consent form. Next, each completed a self-administered baseline questionnaire which took 30-45 minutes. Then they received the KIM-CHI or control education. Six- and 15-month post-baseline data were collected via phone by telephone surveyors who were blind to the study group assignment. At 6-months, 414 women participated in the telephone survey in Korean, with 3.3% lost to follow-up. At 15-months post-baseline, 395 women participated in the telephone survey, with 7.7% lost to follow-up, for the entire study period. The reasons for lost to follow-up were death, refused to participate, or unable to contract. KA women included at the 15 months' data collection (n = 395) and those who dropped out (n = 33) did not differ in demographic or other major variables in this study.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Cancer
    Keywords
    Mammography

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    434 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Culturally Relavent Education
    Arm Type
    Experimental
    Arm Description
    Education about improving diet using a DVD with Korean role models and native Korean language.
    Arm Title
    Healthy Wife Intervention
    Arm Type
    Active Comparator
    Arm Description
    Intervention group of couples who received education about importance of a Healthy Diet. It was an attention control group
    Intervention Type
    Behavioral
    Intervention Name(s)
    KIM-CHI
    Other Intervention Name(s)
    Culturally relavent intervention
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Healthy Wife Control Group
    Other Intervention Name(s)
    Healthy Diet
    Intervention Description
    Intervention group of couples who received education about importance of Healthy diet
    Primary Outcome Measure Information:
    Title
    Change from baseline in mammography uptake at 15 months
    Description
    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.
    Time Frame
    6- and 15-months post-baseline
    Secondary Outcome Measure Information:
    Title
    Health beliefs
    Description
    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.
    Time Frame
    6- and 15-months post-baseline
    Title
    Spousal Support
    Description
    Women's perceived spousal support received from husbands and husbands' perceived spousal support provided to their wives were measured.
    Time Frame
    6- and 15-months post-baseline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: For women, criteria for inclusion in the study are 40 years of age or older born in Korea but presently living in the U.S. able to speak and read Korean 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Eunice E Lee, PhD
    Organizational Affiliation
    UCLA School of Nursing
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Breast Cancer Screening Intervention

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