Barriers to Care for Patients With Cervical Cancer or Precancerous Lesions

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00519272
First received: August 20, 2007
Last updated: May 30, 2014
Last verified: May 2014
  Purpose

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.

Condition Intervention
Cervical Cancer
Behavioral: Questionnaire

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Prospective Study Examining the Barriers to Care for Harris County Cervical Cancer Patients or Patients With Precancerous Lesions (CIS)

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 200
Study Start Date: July 2006
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

Detailed Description:

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.

  Eligibility

Genders 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. Is there an age limit? No

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00519272     History of Changes
Other Study ID Numbers: 2006-0530
Study First Received: August 20, 2007
Last Updated: May 30, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 20, 2014