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The goal of this research study is to learn about quality of life, sexual functioning, and symptoms in women who have undergone abdominal radical trachelectomy for cervical cancer.
This is an investigational study.
Up to 100 patients will be enrolled in this study. All will be enrolled at MD Anderson.
Before Surgery:
If you agree to take part in this study, before you have the abdominal radical trachelectomy surgery, the following information will be recorded during one of your regular clinic visits:
During and After Surgery:
During and after surgery, the following information will be gathered from your medical record or you will be asked:
Once a year for up to 5 years, if you return for an annual routine follow up visit, the results of any pap smears you have had will be collected.
Once a year for up to 5 years, you will also be asked the following questions about your health and fertility, either by mail or during a regular clinic visit:
Questionnaires:
You will complete 4-5 questionnaires at each of the following times:
These questionnaires will ask about your physical health, mental and emotional health, pain, vitality, social functioning, general health, quality of life, and sexual functioning. It will take about 15 minutes to complete 5 questionnaires. If you do not receive your follow-up care at MD Anderson, the questionnaires will be mailed to you at the above time-points with a prepaid return envelope. Mailed questionnaires will be returned to the study chair in an envelope marked CONFIDENTIAL with NO RETURN ADDRESS on the return envelope. Your name will not appear on the questionnaires or return envelope. Instead, a code will be used (on the questionnaires only) that will connect the questionnaires with your medical record. Only the study chair or study coordinator will have access to the code document. The document is kept in a locked filing cabinet and/or password protected computer. All responses will be stored in a locked office.
Length of Study:
You will be on study for up to 5 years. If the disease returns, you will be taken off study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Questionnaire | Radical trachelectomy outcomes for cervical cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaires | Behavioral | 5 Questionnaires at differing times before and after surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean scores for the General Health-Related Quality of Life (SF-12) | Completed SF-12 questionnaires at baseline and at each follow-up visit (4-6 weeks, 6 months, 1 year, and annually for 4 more years) | Follow up visits annually |
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Inclusion Criteria:
Exclusion Criteria:
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Women with histologically confirmed, primary adenocarcinoma, squamous cell carcinoma or adenosquamous carcinoma of the uterine cervix.
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| Name | Affiliation | Role |
|---|---|---|
| Michael M. Frumovitz, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |