Barriers to Care for Patients With Cervical Cancer or Precancerous Lesions
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Purpose
Objectives:
- To identify issues preventing access to early cervical cancer detection and treatment among Harris County cervical cancer patients.
- To examine correlations between responses on religiosity surveys, locus of control (LOC), education, economics, literacy assessment, and stage of disease at presentation for treatment.
- To examine possible changes in responses to surveys after treatment is concluded.
- To use this information to design intervention to improve the health status and health outcomes of this patient population.
- 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.
- 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) |
- 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: | 150 |
| Study Start Date: | July 2006 |
| Estimated Primary Completion Date: | July 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Cervical Cancer Care Questionnaires |
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 |
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.
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| Contact: Lois M. Ramondetta, MD | 713-745-5238 |
| United States, Texas | |
| Lyndon B. Johnson General Hospital | Recruiting |
| Houston, Texas, United States, 77030 | |
| 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: | February 11, 2013 |
| 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 May 23, 2013