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Completed

NCT Number: NCT00483288

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157-1096, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Educational Intervention

Other

Questionnaire Administration

Other

study of socioeconomic and demographic variables

Other

Survey Administration

Other

Primary outcomes

  1. Reasons for nonadherence to follow-up

  2. Effect of written educational information and phone calls on follow-up rate

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Wake Forest University Cervical Screening and Follow Up System for Hispanic Women - A Pilot Study

Important dates

Study start
2005
Primary completion
2006
First posted
Jun 7, 2007
Registry last updated
Jan 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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