CARE: Community Awareness Resources and Education - Project 1

Sponsor
Ohio State University Comprehensive Cancer Center (Other)
Overall Status
Completed
CT.gov ID
NCT01172561
Collaborator
National Cancer Institute (NCI) (NIH)
280
1
2
49
5.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Lay Health Advisor Education Intervention
  • Behavioral: Usual Care Group
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
280 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Screening
Official Title:
Reducing Cervical Cancer in Appalachia
Actual Study Start Date :
Mar 1, 2005
Actual Primary Completion Date :
May 31, 2008
Actual Study Completion Date :
Mar 31, 2009

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 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.

Behavioral: 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: Lay Health Advisor 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.

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.

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Ohio State University Comprehensive Cancer Center Columbus Ohio United States 43201

Sponsors and Collaborators

  • Ohio State University Comprehensive Cancer Center
  • National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Electra D Paskett, Ph.D., The Ohio State University Comprehensive Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Electra Paskett, Professor, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01172561
Other Study ID Numbers:
  • OSU-0488
  • P50CA105632
  • NCI-2012-00212
First Posted:
Jul 29, 2010
Last Update Posted:
Apr 28, 2020
Last Verified:
Apr 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 28, 2020