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

Wake Forest University (WFU) logo

Wake Forest University (WFU)

Status

Completed

Conditions

Cervical Cancer

Treatments

Other: survey administration
Other: study of socioeconomic and demographic variables
Other: educational intervention
Other: questionnaire administration

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00483288
CCCWFU-BG04-578
CCCWFU-30104B
CDR0000547179 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

238 estimated patients

Sex

Female

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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