Community Awareness Resources and Education - Project 1 (CARE)

• ClinicalTrials.gov Identifier: NCT01172561
• Recruitment Status: Completed
• First Posted: July 29, 2010
• Last Update Posted: March 23, 2023
• Sponsor: Ohio State University Comprehensive Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): Electra Paskett, Ohio State University Comprehensive Cancer Center

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
Cervical Cancer	Behavioral: Lay Health Advisor Education Intervention; Behavioral: Usual Care Group	Not Applicable

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 (Clinical Trial)
• 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: March 1, 2005
• Actual Primary Completion Date: May 31, 2008
• Actual Study Completion Date: March 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 [ Time Frame: 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

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes 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

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:

Jamesline 

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

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.

• Responsible Party: Electra Paskett, Professor, Ohio State University Comprehensive Cancer Center
• ClinicalTrials.gov Identifier: NCT01172561
• Other Study ID Numbers: OSU-0488; P50CA105632 ( U.S. NIH Grant/Contract ); NCI-2012-00212 ( Registry Identifier: Clinical Trials Reporting Program (CTRP) )
• First Posted: July 29, 2010
• Last Update Posted: March 23, 2023
• Last Verified: March 2023

Individual Participant Data (IPD) Sharing Statement:

• 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; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases