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Community Awareness Resources and Education - Project 1 (CARE)

This study is ongoing, but not recruiting participants.
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: September 29, 2016
Last verified: September 2016
  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 Education Intervention
Behavioral: Usual Care Group
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:


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
Estimated Study Completion Date: December 2017
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
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: OSU-0488  P50CA105632  NCI-2012-00212 
Study First Received: July 28, 2010
Last Updated: September 29, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

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 December 09, 2016