A Prospective Study Examining the Barriers to Care for Harris County Cervical Cancer Patients

December 31, 2019 updated by: M.D. Anderson Cancer Center
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Little is known about what prevents women with cervical cancer from getting early and possibly curative treatment. This study consists of a series of questionnaires that ask questions about religion; coping; access to health care; physical, emotional, and spiritual well-being; understanding of health questions; control; fear; anxiety; and other health beliefs to determine why some women delay coming in for check-ups and why some women do not complete their treatments. It is thought that health beliefs influence behavior practices and that by identifying these issues, things can be done to improve the health condition and results for these patients.

You will be asked to complete a series of questionnaires at 2 specific time points: The first time point will be before treatment begins and the second time point will be within a month following completion of treatment.

Filling out the questionnaires should take about 45 minutes each time. You should have adequate time to complete these questionnaires during your clinic appointment.

If you want to take part but are too ill to complete the questionnaires, you will be provided a pre-addressed, stamped envelope, so that you can mail them back to the study staff at your earliest convenience.

This is an investigational study. This is an investigational study. Up to 150 patients will be enrolled at Lyndon B. Johnson General Hospital.

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Lyndon B. Johnson General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

1) Patients who are not English or Spanish speaking.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cervical Cancer Care Questionnaires
New cervical cancer patients through stage IVB presenting to the LBJ Gyn-Onc Clinic.
Behavioral: Questionnaire
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.
Other Names:
  • Survey

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Issues preventing access to early cervical cancer detection and treatment among Harris County cervical cancer patients.
Time Frame: 3 Years
3 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 21, 2006

Primary Completion (Actual)

May 15, 2019

Study Completion (Actual)

May 15, 2019

Study Registration Dates

First Submitted

August 20, 2007

First Submitted That Met QC Criteria

August 21, 2007

First Posted (Estimate)

August 22, 2007

Study Record Updates

Last Update Posted (Actual)

January 2, 2020

Last Update Submitted That Met QC Criteria

December 31, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2006-0530

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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