Overview

This trial is active, not recruiting.

Condition cervical cancer
Treatments lay health advisor education intervention, usual care group
Phase phase 3
Sponsor Ohio State University Comprehensive Cancer Center
Collaborator National Cancer Institute (NCI)
Start date March 2005
End date May 2008
Trial size 280 participants
Trial identifier NCT01172561, NCI-2012-00212, OSU-0488, P50CA105632

Summary

To increase early detection of cervical cancer by increasing the proportion of Appalachian women, age 18 and older, who receive Pap smears at appropriate intervals and return for follow-up care when necessary.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (caregiver, investigator, outcomes assessor)
Primary purpose screening
Arm
(Active Comparator)
All women over age 18 encouraged to obtain Pap smears appropriate for their risk profile, the comparison arm included a low-literacy brochure to encourage women to receive screening. The brochure was designed to answer basic questions about Pap smears and provide instructions on how to obtain a Pap smear.
usual care group
All women over age 18 encouraged to obtain Pap smears appropriate for their risk profile, the comparison arm included a low-literacy brochure to encourage women to receive screening. The brochure was designed to answer basic questions about Pap smears and provide instructions on how to obtain a Pap smear.
(Experimental)
The Lay Health Advisor education intervention - The intervention consisted of an intensive, reinforced, one on one, interactive ed. program (an initial meeting, then 2 calls and a series of 4 postcards mailed at regular intervals and a 2nd visit. Woman were enrolled for about 12 to 14 months.
lay health advisor education intervention
The individualized health education intervention consisted of an intensive, reinforced, face to face, interactive educational program. The program included an initial meeting of 45 60 minutes, followed by two telephone calls and reinforcement by a series of four postcards mailed at regular intervals and a second visit. Each woman will be enrolled in the intervention program for approximately 12 to 14 months.

Primary Outcomes

Measure
Receipt of Cervical Cancer screening via Pap Test
time frame: past 12-14 months (yes/no).

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: - women age 18 and older - who have visited participating clinics during the last two years and - who consider themselves to be a current patient of that clinic Exclusion Criteria: - Not a resident of the selected Ohio Appalachia county - Under the age of 18

Additional Information

Official title Reducing Cervical Cancer in Appalachia
Principal investigator Electra D Paskett, Ph.D.
Description The overall goal of Project 1 is to increase early detection of cervical cancer by increasing the proportion of Appalachian women, age 18 and older, who receive Pap smears at appropriate intervals and return for follow-up care when necessary. The project was implemented in Appalachian Ohio, a mainly rural and underserved area with a population comprised of 1.5 million adults, aged 18 and older, and used community-based participatory research (CBPR) and community relationships already established in the area by Center investigators.
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Ohio State University Comprehensive Cancer Center.