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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00483288
First received: June 6, 2007
Last updated: May 9, 2009
Last verified: August 2007

June 6, 2007
May 9, 2009
May 2007
Not Provided
  • Reasons for nonadherence to follow-up [ Designated as safety issue: No ]
  • Effect of written educational information and phone calls on follow-up rate [ Designated as safety issue: No ]
  • Reasons for nonadherence to follow-up
  • Effect of written educational information and phone calls on follow-up rate
Complete list of historical versions of study NCT00483288 on ClinicalTrials.gov Archive Site
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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 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.

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.

Interventional
Not Provided
Primary Purpose: Health Services Research
Cervical Cancer
  • Other: educational intervention
  • Other: questionnaire administration
  • Other: study of socioeconomic and demographic variables
  • Other: survey administration
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
238
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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
Female
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00483288
CDR0000547179, CCCWFU-30104B, CCCWFU-BG04-578
Not Provided
Not Provided
Wake Forest University
National Cancer Institute (NCI)
Study Chair: Brigitte E. Miller, MD Comprehensive Cancer Center of Wake Forest University
National Cancer Institute (NCI)
August 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP