Behavioral Intervention Study for Better Breast and Cervical Cancer Control for Korean American Women

Study Overview
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Brief Summary
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The long-term goal of this study is to build a sustainable,community-based outreach program using Korean American community health workers (CHWs) to promote breast and cervical screening among Korean American women, thereby reducing related morbidity and mortality. The study is designed to determine the effectiveness of a health literacy-focused tailored breast and cervical cancer control intervention delivered by CHWs. The investigators hypothesized that, compared to KA women in the delayed intervention group, KA women who receive a health literacy-focused CHW intervention will demonstrate: (1) higher levels of adherence to screening for breast and cervical cancer, (2) greater levels of health literacy, (3) higher levels of breast and cervical cancer knowledge, and (4) improve decisional balance.

Detailed Description
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Despite considerable progress in U.S. cancer control over the past 20 years, certain ethnic minority groups continue to experience significant health disparities. Recent immigrants including Korean Americans (KA), face an unequal cancer burden related to the significant language and cultural barriers they face in attempting to navigate the U.S. healthcare system. KA women have the second highest incidence of cervical cancer nationally and are experiencing rapid increases in breast cancer incidence. Not only are their breast and cervical cancers diagnosed at significantly later stages than those of whites, but they are also the least likely racial/ethnic group to receive early breast and cervical cancer screening. This community-based behavioral intervention is designed 1) to evaluate, in a randomized controlled trial, the effects of our health literacy-focused cancer control intervention, delivered by trained CHWs, on the primary outcomes: mammography and Papanicolaou(Pap)test screening adherence, in a sample of 360 KA women, 2)to test the effects of the proposed intervention on the secondary outcomes: level of health literacy, breast and cervical knowledge, and decisional balance, in the KA sample.

Official Title
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Better Breast and Cervical Cancer Control for Korean American Women

Conditions
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Breast Cancer, Cervical Cancer

Intervention / Treatment
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* Behavioral: Health literacy, health message


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 21-65 years self-identified as a KA woman no mammogram and Pap test within the last 18 months able to read and write Korean or English willing to provide written study consent willingness to provide written consent to allow the researchers to audit medical records for mammography and Pap test use. Exclusion Criteria: Potential participants with a cancer diagnosis, an acute and/or terminal condition Psychiatric diagnosis (e.g., schizophrenia or cognitive impairment), or other conditions Women who have undergone hysterectomy

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Health Literacy<br> | Behavioral: Health literacy, health message<br>* The intervention will consist of three main components: (1) 2-hour in-class health literacy-focused education; (2) tailored telephone counseling; and (3) healthcare system navigation assistance tailored to the woman's specific barriers.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants who adhere to mammography and Papanicolaou(Pap) test screening guidelines | The primary outcome variables are self-reported receipt of, or intention to obtain mammography and/or Pap test. Self-reported intention as an outcome variable has been a common practice in the screening literature, since it has been found to be the best predictor of actual screening behavior.Number of participants who adhere to mammography and Pap test during 6 months period will be the primary outcomes. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health belief score about breast & cervical cancer | Secondary outcome variables include satisfaction with community health worker-led education sessions and follow-up, changes in other screening behaviors including clinical breast exam and breast self-exam, and breast, cervical cancer relevant health beliefs and knowledge. Health belief score will be assessed at baseline, 3, 6 months. | 6 months | 
| Knowledge score about breast & cervical cancer | Secondary outcome variables include satisfaction with community health worker-led education sessions and follow-up, changes in other screening behaviors including clinical breast exam and breast self-exam, and breast, cervical cancer relevant health beliefs and knowledge.Health knowledge score will be assessed at baseline, 3, 6 months. | 6 months | 
| Satisfaction score with community health worker-led intervention activities | Community health worker-led intervention activities include heatlh literacy focused structured education, monthly telephone counselings and other navigation activities to encourage the study participants to have mammogram and pap test. Satisfaction score will be measured at 6 months follow-up. | 6 month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ethnic minority women, Cancer screening, Health literacy, Behavioral intervention, Breast Cancer screening, Cervical Cancer screening