Barriers to Care for Patients With Cervical Cancer or Precancerous Lesions
| Tracking Information | |||||
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| First Received Date ICMJE | August 20, 2007 | ||||
| Last Updated Date | February 11, 2013 | ||||
| Start Date ICMJE | July 2006 | ||||
| Estimated Primary Completion Date | July 2014 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00519272 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Barriers to Care for Patients With Cervical Cancer or Precancerous Lesions | ||||
| Official Title ICMJE | A Prospective Study Examining the Barriers to Care for Harris County Cervical Cancer Patients or Patients With Precancerous Lesions (CIS) | ||||
| Brief Summary | Objectives:
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| 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. |
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| Condition ICMJE | Cervical Cancer | ||||
| Intervention ICMJE | 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 |
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| Study Group/Cohort (s) | Cervical Cancer Care Questionnaires
Intervention: Behavioral: Questionnaire |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 150 | ||||
| Completion Date | Not Provided | ||||
| Estimated Primary Completion Date | July 2014 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | 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 |
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| Gender | Female | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00519272 | ||||
| Other Study ID Numbers ICMJE | 2006-0530 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | M.D. Anderson Cancer Center | ||||
| Study Sponsor ICMJE | M.D. Anderson Cancer Center | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | M.D. Anderson Cancer Center | ||||
| Verification Date | February 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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