Written Educational Information and Phone Calls in Increasing Follow-Up Care in Hispanic Women With Abnormal Pap Smears

NCT ID: NCT00483288

Last Updated: 2017-01-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 238 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-05-31

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.

Conditions

Cervical Cancer

Study Design

• Primary Study Purpose: HEALTH_SERVICES_RESEARCH

Interventions

educational intervention

Intervention Type: OTHER

questionnaire administration

Intervention Type: OTHER

study of socioeconomic and demographic variables

Intervention Type: OTHER

survey administration

Intervention Type: OTHER

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brigitte E. Miller, MD

Role: STUDY_CHAIR

Wake Forest University Health Sciences

Locations

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, United States

Countries

United States

Other Identifiers

CDR0000547179

Identifier Type: REGISTRY

Identifier Source: secondary_id

CCCWFU-BG04-578

Identifier Type: -

Identifier Source: secondary_id

CCCWFU-30104B

Identifier Type: -

Identifier Source: org_study_id