NCT00483288

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
238

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 7, 2007

Completed
Last Updated

January 19, 2017

Status Verified

June 1, 2013

Enrollment Period

1.3 years

First QC Date

June 6, 2007

Last Update Submit

January 17, 2017

Conditions

Cervical Cancer

Keywords

cervical cancer

Outcome Measures

Primary Outcomes (2)

  • Reasons for nonadherence to follow-up

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

Interventions

educational interventionOTHER
questionnaire administrationOTHER
study of socioeconomic and demographic variablesOTHER
survey administrationOTHER

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Wake Forest University Comprehensive Cancer Center

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

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health Services

Study Officials

  • Brigitte E. Miller, MD

    Wake Forest University Health Sciences

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Purpose
HEALTH SERVICES RESEARCH
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2007

First Posted

June 7, 2007

Study Start

May 1, 2005

Primary Completion

September 1, 2006

Last Updated

January 19, 2017

Record last verified: 2013-06

Locations

US(1)