Barriers to Care for Patients With Cervical Cancer or Precancerous Lesions

This study is currently recruiting participants.
Verified February 2014 by M.D. Anderson Cancer Center
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00519272
First received: August 20, 2007
Last updated: February 13, 2014
Last verified: February 2014

August 20, 2007
February 13, 2014
July 2006
July 2016   (final data collection date for primary outcome measure)
Issues preventing access to early cervical cancer detection and treatment among Harris County cervical cancer patients. [ Time Frame: 3 Years ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00519272 on ClinicalTrials.gov Archive Site
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Barriers to Care for Patients With Cervical Cancer or Precancerous Lesions
A Prospective Study Examining the Barriers to Care for Harris County Cervical Cancer Patients or Patients With Precancerous Lesions (CIS)

Objectives:

  1. To identify issues preventing access to early cervical cancer detection and treatment among Harris County cervical cancer patients.
  2. To examine correlations between responses on religiosity surveys, locus of control (LOC), education, economics, literacy assessment, and stage of disease at presentation for treatment.
  3. To examine possible changes in responses to surveys after treatment is concluded.
  4. To use this information to design intervention to improve the health status and health outcomes of this patient population.
  5. The objective of Dr. Ramondetta's role as PI for this study is to serve as mentor to the LBJ resident conducting this trial at Lyndon B. Johnson General Hospital (LBJ), review data with him, and advise him as needed as he prepares for publication. She will also inform eligible patients in her LBJ clinic of the opportunity to participate in this study.
  6. The objective of Dr. Milbourne's, Dr. Rhodes', Dr. Bevers', and Dr. Frumovitz' roles is to apprise patients in the LBJ clinics (Colposcopy and Gyn-Onc) of this study, then to contact the resident's research team to complete the consenting and implementation process.

Little is known about what prevents women with cervical cancer or CIS 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, 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 are being asked to take part in this study because you are a patient with newly diagnosed cervical cancer stage IA1 through IVB or CIS and are seen in the gynecologic-oncology or colposcopy clinic at LBJ General Hospital.

This is an investigational study. About 40 patients will be enrolled at Lyndon B. Johnson General Hospital.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

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.

Cervical Cancer
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
Cervical Cancer Care Questionnaires
New cervical cancer patients through stage IVB presenting to the LBJ Gyn-Onc Clinic.
Intervention: Behavioral: Questionnaire
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
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July 2016   (final data collection date for primary outcome measure)

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. Is there an age limit? No

Female
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No
Contact: Lois M. Ramondetta, MD 713-745-5238
United States
 
NCT00519272
2006-0530
No
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
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Principal Investigator: Lois M. Ramondetta, MD M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP