Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma

Uterine Cervical Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

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

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

Church-based educational intervention combined with navigation assistance

Culturally appropriate intervention

General health education control

CAROLYN FANG

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.

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.

Cervical Cancer Screening Intervention Among Korean American Women

Facilitating Cervical Cancer Screening Among Underserved Korean American Women

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

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.

National Cancer Institute (NCI)

American Cancer Society, Inc.

Fox Chase Cancer Center

Principal Investigator

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

Culturally appropriate intervention: Church-based educational intervention combined with navigation assistance

Culturally Appropriate Intervention

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

General health education control: General health and cancer education

General Health Education Control

Total

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Carolyn Fang

Number of Women Who Receive a Pap Smear Test

The null hypothesis is that the two conditions would not differ in their knowledge following program participation. The study biostatistician conducted full regression models to examine change in knowledge (from pre- to post-program) within each group and across groups over time. The models controlled for relevant covariates.

Preliminary data cleaning revealed that of the 705 participants who were included in the primary analysis, 29 participants had failed to answer 1/3 or more of the items on the questionnaire. Therefore, due to extensive missing data, these participants were excluded from the analysis of the secondary outcomes.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Cervical Cancer Screening Intervention Among Korean American Women	NCT02594826	Cervical Carcin...	Culturally appr... General health ...	21 Years -	Fox Chase Cancer Center
Cervical Cancer Screening Intervention Among Korean American Women	NCT02594826	Cervical Carcin...	Culturally appr... General health ...	21 Years -	Fox Chase Cancer Center

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