Clinical trial NCT02594826: Cervical Cancer Screening Intervention Among Korean American Women
Official title: Facilitating Cervical Cancer Screening Among Underserved Korean American Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Carcinoma
Lead sponsor: Fox Chase Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: American Cancer Society, Inc.
First posted: 2015-11-03
Enrollment: 744
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

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

Primary outcomes:
measure: Number of Women Who Receive a Pap Smear Test
timeFrame: 12 months
Secondary outcomes:
measure: Knowledge About Cervical Cancer
timeFrame: 12 months post-program
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
Study officials:
affiliation: Fox Chase Cancer Center
name: CAROLYN FANG
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fang CY, Ma GX, Handorf EA, Feng Z, Tan Y, Rhee J, Miller SM, Kim C, Koh HS. Addressing multilevel barriers to cervical cancer screening in Korean American women: A randomized trial of a community-based intervention. Cancer. 2017 May 15;123(6):1018-1026. doi: 10.1002/cncr.30391. Epub 2016 Nov 21.