Community Awareness Resources and Education - Project 1

NCT ID: NCT01172561

Last Updated: 2023-03-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

280 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-01

Study Completion Date

2009-03-31

Brief Summary

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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

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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.

Conditions

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Cervical Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Usual Care Group

Intervention Type BEHAVIORAL

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.

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.

Group Type EXPERIMENTAL

Lay Health Advisor Education Intervention

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Ohio State University Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Electra Paskett

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Electra D Paskett, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

The Ohio State University Comprehensive Cancer Center

Locations

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The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 21430302 (View on PubMed)

Related Links

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Other Identifiers

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P50CA105632

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2012-00212

Identifier Type: REGISTRY

Identifier Source: secondary_id

OSU-0488

Identifier Type: -

Identifier Source: org_study_id

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