NCT00519272

Brief Summary

The goal of this behavioral research study is to look at the reasons that may prevent women from getting early treatment for their cervical cancer.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 21, 2006

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 20, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 22, 2007

Completed
11.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2019

Completed
Last Updated

January 2, 2020

Status Verified

December 1, 2019

Enrollment Period

12.8 years

First QC Date

August 20, 2007

Last Update Submit

December 31, 2019

Conditions

Keywords

Cervical CancerCervixPrecancerous LesionsCervical carcinoma in situCISEarly cervical cancer detection and treatmentBarriers to CareHarris CountyQuestionnaire

Outcome Measures

Primary Outcomes (1)

  • Issues preventing access to early cervical cancer detection and treatment among Harris County cervical cancer patients.

    3 Years

Study Arms (1)

Cervical Cancer Care Questionnaires

New cervical cancer patients through stage IVB presenting to the LBJ Gyn-Onc Clinic.

Behavioral: Questionnaire

Interventions

QuestionnaireBEHAVIORAL

Series of surveys to be completed at the time of diagnosis and within one month after completion of treatment, taking approximately 45 minutes each time.

Also known as: Survey
Cervical Cancer Care Questionnaires

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with newly diagnosed cervical cancer or precancerous lesions (CIS) seen in the Gynecologic-Oncology or Colposcopy Clinic at Lyndon B. Johnson General Hospital in Houston, Texas.

You may qualify if:

  • \) All newly diagnosed cervical cancer patients through Stage IVB presenting to the Lyndon B. Johnson General Hospital (LBJ) Gynecologic Oncology Clinic.

You may not qualify if:

  • \) Patients who are not English or Spanish speaking.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lyndon B. Johnson General Hospital

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Uterine Cervical NeoplasmsUterine Cervical Dysplasia

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Lois M. Ramondetta, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2007

First Posted

August 22, 2007

Study Start

July 21, 2006

Primary Completion

May 15, 2019

Study Completion

May 15, 2019

Last Updated

January 2, 2020

Record last verified: 2019-12

Locations