Written Educational Information and Phone Calls in Increasing Follow-Up Care in Hispanic Women With Abnormal Pap Smears
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|ClinicalTrials.gov Identifier: NCT00483288|
Recruitment Status : Completed
First Posted : June 7, 2007
Last Update Posted : January 19, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Cervical Cancer||Other: educational intervention Other: questionnaire administration Other: study of socioeconomic and demographic variables Other: survey administration||Not Applicable|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||238 participants|
|Primary Purpose:||Health Services Research|
|Official Title:||Wake Forest University Cervical Screening and Follow Up System for Hispanic Women - A Pilot Study|
|Study Start Date :||May 2005|
|Actual Primary Completion Date :||September 2006|
- Reasons for nonadherence to follow-up
- Effect of written educational information and phone calls on follow-up rate
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00483288
|United States, North Carolina|
|Wake Forest University Comprehensive Cancer Center|
|Winston-Salem, North Carolina, United States, 27157-1096|
|Study Chair:||Brigitte E. Miller, MD||Wake Forest University Health Sciences|