Skip to main content
OpenTrials
Completed

NCT Number: NCT01172561

Community Awareness Resources and Education - Project 1

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cervical Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43201, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lay Health Advisor Education Intervention

Behavioral

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.

Usual Care Group

Behavioral

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 outcomes

  1. Receipt of Cervical Cancer screening via Pap Test

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Reducing Cervical Cancer in Appalachia

Acronym: CARE

Important dates

Study start
2005
Primary completion
2008
Study completion
2009
First posted
Jul 29, 2010
Registry last updated
Mar 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.