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Community Awareness Resources and Education - Project 1 (CARE)

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Electra Paskett, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01172561
First received: July 28, 2010
Last updated: March 29, 2012
Last verified: March 2012
History of Changes
  Purpose

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 Intervention Phase
Cervical Cancer
 Behavioral: Lay Health Advisor Educational Intervention
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Screening
Official Title: Reducing Cervical Cancer in Appalachia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ohio State University Comprehensive Cancer Center:

Primary Outcome Measures:
  • Receipt of Cervical Cancer screening via Pap Test [ Time Frame: past 12-14 months (yes/no). ] [ Designated as safety issue: 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.


Enrollment: 280
Study Start Date: March 2005
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Usual Care Group
All women over age 18 should be encouraged to obtain Pap smears at intervals appropriate for their risk profile, the comparison arm will include a low-literacy brochure which encourages women to receive screening. This low-literacy brochure was designed to answer basic questions about Pap smears and provide women with specific instructions on how to obtain a Pap smear.
Experimental: Intervention - Lay Health Advisor Educational 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.
 Behavioral: Lay Health Advisor Educational 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01172561

Locations
United States, Ohio
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
  More Information

No publications provided by Ohio State University Comprehensive Cancer Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Electra Paskett, Professor, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01172561     History of Changes
Other Study ID Numbers: 2004C0104, 1P50CA105632
Study First Received: July 28, 2010
Last Updated: March 29, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on May 21, 2013