NCT02594826

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
744

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 31, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 3, 2015

Completed
12 months until next milestone

Results Posted

Study results publicly available

October 13, 2016

Completed
Last Updated

January 26, 2021

Status Verified

January 1, 2021

Enrollment Period

4.6 years

First QC Date

October 31, 2015

Results QC Date

August 22, 2016

Last Update Submit

January 9, 2021

Conditions

Cervical Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Number of Women Who Receive a Pap Smear Test

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

    12 months

Secondary Outcomes (1)

  • Knowledge About Cervical Cancer

    12 months post-program

Study Arms (2)

Culturally appropriate intervention

EXPERIMENTAL

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

Behavioral: Culturally appropriate intervention

General health education control

ACTIVE COMPARATOR

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

Behavioral: General health education control

Interventions

Culturally appropriate interventionBEHAVIORAL

Church-based educational intervention combined with navigation assistance

Culturally appropriate intervention
General health education controlBEHAVIORAL

General health and cancer education

General health education control

Eligibility Criteria

Age21 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • A current diagnosis of cervical cancer
  • Have had a Pap test within the past 12 months
  • Are currently adherent to doctor recommended screening interval

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Related Publications (1)

  • 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.

    PMID: 27869293RESULT

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Results Point of Contact

Title
Dr. Carolyn Fang
Organization
Fox Chase Cancer Center
carolyn.fang@fccc.edu
1-888-369-2427

Study Officials

  • CAROLYN FANG

    Fox Chase Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 31, 2015

First Posted

November 3, 2015

Study Start

February 1, 2009

Primary Completion

September 1, 2013

Study Completion

December 1, 2014

Last Updated

January 26, 2021

Results First Posted

October 13, 2016

Record last verified: 2021-01

Locations

US(1)