- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00483288
Written Educational Information and Phone Calls in Increasing Follow-Up Care in Hispanic Women With Abnormal Pap Smears
Wake Forest University Cervical Screening and Follow Up System for Hispanic Women - A Pilot Study
RATIONALE: Written educational materials and counseling by phone may help promote follow-up care in women with abnormal Pap smears.
PURPOSE: This clinical trial is studying how well written educational information and phone calls work in increasing follow-up care in Hispanic women with abnormal Pap smears.
Study Overview
Status
Conditions
Detailed Description
OBJECTIVES:
Primary
- Determine the reasons for nonadherence to follow-up in Hispanic women with abnormal Pap smear findings.
- Assess the effect of written educational information and phone calls on follow-up rate in these patients.
OUTLINE: This is a pilot, cross-sectional, controlled, multicenter study. Patients are sequentially assigned to 1 of 3 intervention groups.
- Group 1 (control): Patients complete a standardized Spanish survey questionnaire, assessing their demographic information, knowledge, attitudes, behaviors, experiences with cervical screening, past medical history, and prior treatment, either in person (for those who kept their colposcopy appointment) or over the telephone (for those who did not keep their colposcopy appointment). Additional questions are added for patients who did not keep their colposcopy appointment to test for differences and to learn the reasons for not keeping their appointment.
- Group 2 (written educational information): Patients receive notification of their colposcopy appointment and an educational letter about Pap smears, cervical cancer risk, and the purpose and procedure of colposcopy. They complete the standardized Spanish survey questionnaire as in group 1.
- Group 3 (phone call): Patients receive notification of their colposcopy appointment and a personal telephone call educating them about Pap smears, cervical cancer risk, and the purpose and procedure of colposcopy. They complete the standardized Spanish survey questionnaire as in group 1.
All patients are asked to agree to submit residual Pap smear fluid to the Comprehensive Cancer Center of Wake Forest University tumor bank, and be included in a tracking system to insure future follow-up communications.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
North Carolina
-
Winston-Salem, North Carolina, United States, 27157-1096
- Wake Forest University Comprehensive Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
- Abnormal Pap smear findings indicating the need for further treatment at the colposcopy clinic
- Scheduled for colposcopy at the Comprehensive Cancer Center of Wake Forest University
- No history of invasive cervical cancer
PATIENT CHARACTERISTICS:
Must be of Hispanic background, including any of the following:
- Hispanic
- Latino
- Chicano
- Mexican American
- Puerto Rican
- Cuban American
PRIOR CONCURRENT THERAPY:
- Not specified
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Reasons for nonadherence to follow-up
|
Effect of written educational information and phone calls on follow-up rate
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CCCWFU-30104B
- CDR0000547179 (Registry Identifier: PDQ (Physician Data Query))
- CCCWFU-BG04-578
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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