Cervical Cancer Screening Intervention Among Korean American Women

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

744 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2014-12-31

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.

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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.

Conditions

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Cervical Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Culturally appropriate intervention

Culturally appropriate, church-based intervention focused on cervical cancer and navigation assistance.

Group Type EXPERIMENTAL

Culturally appropriate intervention

Intervention Type BEHAVIORAL

Church-based educational intervention combined with navigation assistance

General health education control

General health and cancer education on nutrition, regular check-ups, tobacco use, and cancer screening.

Group Type ACTIVE_COMPARATOR

General health education control

Intervention Type BEHAVIORAL

General health and cancer education

Interventions

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Culturally appropriate intervention

Church-based educational intervention combined with navigation assistance

Intervention Type BEHAVIORAL

General health education control

General health and cancer education

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes