Written Educational Information and Phone Calls in Increasing Follow-Up Care in Hispanic Women With Abnormal Pap Smears
Primary Purpose
Cervical Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
educational intervention
questionnaire administration
study of socioeconomic and demographic variables
survey administration
Sponsored by
About this trial
This is an interventional health services research trial for Cervical Cancer focused on measuring cervical cancer
Eligibility Criteria
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
Sites / Locations
- Wake Forest University Comprehensive Cancer Center
Outcomes
Primary Outcome Measures
Reasons for nonadherence to follow-up
Effect of written educational information and phone calls on follow-up rate
Secondary Outcome Measures
Full Information
NCT ID
NCT00483288
First Posted
June 6, 2007
Last Updated
January 17, 2017
Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00483288
Brief Title
Written Educational Information and Phone Calls in Increasing Follow-Up Care in Hispanic Women With Abnormal Pap Smears
Official Title
Wake Forest University Cervical Screening and Follow Up System for Hispanic Women - A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
September 2006 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)
4. Oversight
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
Keywords
cervical cancer
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Enrollment
238 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
educational intervention
Intervention Type
Other
Intervention Name(s)
questionnaire administration
Intervention Type
Other
Intervention Name(s)
study of socioeconomic and demographic variables
Intervention Type
Other
Intervention Name(s)
survey administration
Primary Outcome Measure Information:
Title
Reasons for nonadherence to follow-up
Title
Effect of written educational information and phone calls on follow-up rate
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brigitte E. Miller, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Wake Forest University Comprehensive Cancer Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1096
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Written Educational Information and Phone Calls in Increasing Follow-Up Care in Hispanic Women With Abnormal Pap Smears
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