Community Awareness Resources and Education - Project 1

Cervical Cancer Clinical Trial

— CARE  

Official title:

Reducing Cervical Cancer in Appalachia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01172561
• Other study ID #: OSU-0488
• Secondary ID: P50CA105632NCI-2
• Status: Completed
• Phase: N/A
• Start date: March 1, 2005
• Est. completion date: March 31, 2009

Study information

• Verified date: March 2023
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: March 31, 2009
• Est. primary completion date: May 31, 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
United States	The Ohio State University Comprehensive Cancer Center	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Receipt of Cervical Cancer screening via Pap Test	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.	past 12-14 months (yes/no).

External Links

•   Jamesline