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

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ClinicalTrials.gov Identifier: NCT00519272
Recruitment Status : Active, not recruiting
First Posted : August 22, 2007
Last Update Posted : June 20, 2017
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.

Condition or disease Intervention/treatment
Cervical Cancer Behavioral: Questionnaire

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
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Prospective Study Examining the Barriers to Care for Harris County Cervical Cancer Patients
Actual Study Start Date : July 2006
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer
U.S. FDA Resources

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 Name: Survey



Primary Outcome Measures :
  1. Issues preventing access to early cervical cancer detection and treatment among Harris County cervical cancer patients. [ Time Frame: 3 Years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Criteria

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.


Information from the National Library of Medicine

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): NCT00519272


Locations
United States, Texas
Lyndon B. Johnson General Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Lois M. Ramondetta, MD M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00519272     History of Changes
Other Study ID Numbers: 2006-0530
First Posted: August 22, 2007    Key Record Dates
Last Update Posted: June 20, 2017
Last Verified: June 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Cervical Cancer
Cervix
Precancerous Lesions
Cervical carcinoma in situ
CIS
Early cervical cancer detection and treatment
Barriers to Care
Harris County
Questionnaire

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female