Cervical Cancer Screening Intervention Among Korean American Women

Not Applicable

Completed

Conditions: Cervical Carcinoma

Interventions: Behavioral: Culturally appropriate intervention
Behavioral: General health education control

Registration Number: NCT02594826

Lead Sponsor: Fox Chase Cancer Center

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 744

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Culturally appropriate intervention	Culturally appropriate intervention	Culturally appropriate, church-based intervention focused on cervical cancer and navigation assistance.
General health education control	General health education control	General health and cancer education on nutrition, regular check-ups, tobacco use, and cancer screening.

Primary Outcome Measures

Name	Time	Method
Number of Women Who Receive a Pap Smear Test	12 months	Number of women who receive a Pap smear test in each group

Secondary Outcome Measures

Name	Time	Method
Knowledge About Cervical Cancer	12 months post-program	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.