Cervical Cancer Screening Intervention Among Korean American Women

Study Overview
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Brief Summary
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This is a randomized trial to evaluate the effects of a community-based intervention on increasing cervical cancer screening rates in underserved Korean American women. Due to the multiple factors that contribute to screening uptake, an educational program customized to Korean culture combined with navigation assistance may be effective in increasing the number of Korean American women who can access cervical cancer screening.

Detailed Description
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PRIMARY OBJECTIVES: I. To evaluate the efficacy of a culturally-appropriate educational intervention compared to a general cancer health education program in increasing cervical cancer screening among Korean American women. SECONDARY OBJECTIVES: I. To examine the effects of a culturally-appropriate intervention on women's knowledge, psychosocial beliefs about cervical cancer and screening, and barriers to screening compared to a general cancer health education program. II. To examine the extent to which changes in knowledge, psychosocial beliefs, and barriers mediate the effects of the intervention on screening behavior. OUTLINE: Participants are randomized to 1 of 2 arms. ARM I (INTERVENTION CONDITION): Participants undergo a culturally appropriate, church-based intervention comprised of four components: 2-hour small group education sessions delivered at church sites by professional, bilingual community health educators (CHEs) that include culturally appropriate visual aids and print materials in Korean; navigation assistance, including language services, appointment scheduling, and transportation assistance from CHEs and church health workers (CHWs); referrals to Pap test sites; and a 6-month reminder letter for screening. ARM II (CONTROL CONDITION): Participants undergo 2-hour general health and cancer education by bilingual CHEs, which covers nutrition, regular check-ups, tobacco use, and cancer screening. Participants also receive pre-existing written material produced by the American Cancer Society (ACS), National Institutes of Health (NIH), and Centers for Disease Control (CDC)., and are advised to seek regular preventive health services. After completion of study, participants are followed up post-intervention and at 12 months.

Official Title
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Facilitating Cervical Cancer Screening Among Underserved Korean American Women

Conditions
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Cervical Carcinoma

Intervention / Treatment
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* Behavioral: Culturally appropriate intervention
* Behavioral: General health education control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Self-identified Korean ethnicity Possessing a functional telephone in the home or on person Anticipated presence in this geographic region for a period of one year Exclusion Criteria: A current diagnosis of cervical cancer Have had a Pap test within the past 12 months Are currently adherent to doctor recommended screening interval

Ages Eligible for Study
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Minimum Age: 21 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: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Culturally appropriate intervention<br>Culturally appropriate, church-based intervention focused on cervical cancer and navigation assistance. | Behavioral: Culturally appropriate intervention<br>* Church-based educational intervention combined with navigation assistance<br>|
| Active Comparator: General health education control<br>General health and cancer education on nutrition, regular check-ups, tobacco use, and cancer screening. | Behavioral: General health education control<br>* General health and cancer education<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Women Who Receive a Pap Smear Test | Number of women who receive a Pap smear test in each group | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knowledge About Cervical Cancer | Women's knowledge was assessed using 10 items. For each item, women responded whether the statement was true (Yes, No, or Don't know). Don't know responses were scored as incorrect. Each item that was answered correctly was scored as '1'. Correct responses were summed across all 10 items. Therefore, women's knowledge scores could range from 0 (no correct responses) to 10 (all correct responses), where higher scores represent greater knowledge. | 12 months post-program |