Clinical trial NCT01525264: Breast Cancer Screening Intervention
Official title: Korean Immigrants & Mammography-Culture-Specific Health Intervention (KIM-CHI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Mammography
Lead sponsor: Jonsson Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2012-02-02
Enrollment: 434
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

Eligibility 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.

Primary outcomes:
measure: Change from baseline in mammography uptake at 15 months
timeFrame: 6- and 15-months post-baseline
Secondary outcomes:
measure: Health beliefs
timeFrame: 6- and 15-months post-baseline
measure: Spousal Support
timeFrame: 6- and 15-months post-baseline
Other outcomes:
Locations:
Study officials:
affiliation: UCLA School of Nursing
name: Eunice E Lee, PhD
role: PRINCIPAL_INVESTIGATOR
References: