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Community Awareness Resources and Education - Project 1 (CARE)

Primary Purpose

Cervical Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lay Health Advisor Education Intervention
Usual Care Group
Sponsored by
Ohio State University Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Cervical Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • The Ohio State University Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Usual Care Group

Lay Health Advisor Intervention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
July 28, 2010
Last Updated
March 21, 2023
Sponsor
Ohio State University Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01172561
Brief Title
Community Awareness Resources and Education - Project 1
Acronym
CARE
Official Title
Reducing Cervical Cancer in Appalachia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2005 (Actual)
Primary Completion Date
May 31, 2008 (Actual)
Study Completion Date
March 31, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
280 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Lay Health Advisor Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Lay Health Advisor Education Intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Usual Care Group
Intervention Description
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 Measure Information:
Title
Receipt of Cervical Cancer screening via Pap Test
Description
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.
Time Frame
past 12-14 months (yes/no).

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Electra D Paskett, Ph.D.
Organizational Affiliation
The Ohio State University Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43201
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21430302
Citation
Paskett ED, McLaughlin JM, Lehman AM, Katz ML, Tatum CM, Oliveri JM. Evaluating the efficacy of lay health advisors for increasing risk-appropriate Pap test screening: a randomized controlled trial among Ohio Appalachian women. Cancer Epidemiol Biomarkers Prev. 2011 May;20(5):835-43. doi: 10.1158/1055-9965.EPI-10-0880. Epub 2011 Mar 23.
Results Reference
derived
Links:
URL
http://cancer.osu.edu
Description
Jamesline

Learn more about this trial

Community Awareness Resources and Education - Project 1

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