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Clinical Trials/NCT02594826
NCT02594826
Completed
N/A

Facilitating Cervical Cancer Screening Among Underserved Korean American Women

Fox Chase Cancer Center1 site in 1 country744 target enrollmentFebruary 2009

Overview

Phase
N/A
Intervention
Not specified
Conditions
Cervical Carcinoma
Sponsor
Fox Chase Cancer Center
Enrollment
744
Locations
1
Primary Endpoint
Number of Women Who Receive a Pap Smear Test
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
February 2009
End Date
December 2014
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Carolyn Fang, PhD

Principal Investigator

Fox Chase Cancer Center

Eligibility Criteria

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

Outcomes

Primary Outcomes

Number of Women Who Receive a Pap Smear Test

Time Frame: 12 months

Number of women who receive a Pap smear test in each group

Secondary Outcomes

  • Knowledge About Cervical Cancer(12 months post-program)

Study Sites (1)

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