Community Awareness Resources and Education - Project 1

Not Applicable

Completed

• Conditions: Cervical Cancer
• Interventions: Behavioral: Lay Health Advisor Education Intervention; Behavioral: Usual Care Group

• Registration Number: NCT01172561
• Lead Sponsor: Ohio State University Comprehensive Cancer Center

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2005-03-01
• Primary Completion: 2008-05-31
• Study Completion: 2009-03-31
• Study First Submitted: 2010-07-28
• Study First Submitted QC: 2010-07-28
• Study First Posted: 2010-07-29
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-21
• Last Update Posted: 2023-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 280

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lay Health Advisor Intervention	Lay Health Advisor Education Intervention	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.
Usual Care Group	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.

Primary Outcome Measures

Name	Time	Method
Receipt of Cervical Cancer screening via Pap Test	past 12-14 months (yes/no).	the primary outcome of interest for Project 1 intervention will be a dichotomous variable, Pap smear in the past 12-14 months (yes/no). Initially, We will assess the univariate difference between treatment groups (lay health advisor vs. brochure and physician letter) in the proportion of women who received a Pap smear during the past 12 months using design-based logistic regression.

Trial Locations

Locations (1)

The Ohio State University Comprehensive Cancer Center; 🇺🇸 Columbus, Ohio, United States