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The goal of this research study is to learn about the quality of life and sexual functioning of women with platinum-resistant ovarian cancer as they receive other treatments for the disease.
Researchers will study the costs for chemotherapy treatments, other medical expenses, and treatment-related expenses that are not medical. Researchers will also review any symptoms these patients may experience related to the cancer or treatment.
In addition, researchers want to learn if and how these patients' caregivers feel the status of these patients' health may have affected the caregivers' productivity at work and at home.
Study Participation:
If you agree to take part in this study, medical and demographic information will be collected from your medical record and/or by asking you in person when you come to the clinic for your routine visits. This information includes your date of birth, medical history, occupation, marital status, race, household income, and number of children and/or other dependents (if any).
On Day 1 of your study participation, you will be interviewed by a research staff member. In this interview, you will be asked about your health and any symptoms related to the cancer and/or cancer treatment. You will also be asked for the best way of contacting you. This interview should take about 30 minutes to complete. After the interview, you will complete a set of 5 questionnaires. In total, the questionnaires should take about 15 minutes to complete. You will repeat these same 5 questionnaires on Day 1 of each of your chemotherapy cycles. The questionnaires include the following:
In addition, you will also be asked to complete the following questionnaires for each cycle of chemotherapy:
You can bring the completed Questionnaires 6-9 with you when you return for your next follow-up visit, email, fax or mail them back to the clinic before your next visit. If necessary, you may complete them over the phone instead. In total, Questionnaires 6-9 should take about 7 minutes to complete each time.
Questionnaire Content:
Your responses on these questionnaires will not be shared with the doctor who is treating you for cancer. If you feel you need a doctor's opinion about anything that is asked about in these questionnaires (such as cancer symptoms or mental or emotional difficulties), please contact your doctor.
If your questionnaire responses show that you may be having emotional difficulties or depression, you will be provided with names of mental health providers in case you would like to receive a mental health screening.
Caregivers' Participation:
Your caregiver will also be asked to complete Questionnaire 6 for each cycle of chemotherapy you receive. Specifically, the caregiver will answer questions about how he or she feels your health status may have affected his or her productivity at work and at home.
Your questionnaires will be used for research purposes only, and your responses will not be shared with the caregiver. Likewise, the caregiver's responses will not be shared with you. You will receive separate return envelopes for mailing back your questionnaires separately from the caregiver's.
Length of Study Participation:
This is a long-term study, and you will remain "on study" for as long as you and the caregiver agree to keep filling out the questionnaires. If you stop receiving treatment for the cancer, your and the caregiver's participation in this study will be over.
This is an investigational study. You will receive stamped, self-addressed envelopes for mailing the questionnaires back to the clinic.
Up to 43 patients and 43 caregivers will take part in this study. All will be enrolled at M. D. Anderson.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Questionnaire | Longitudinal measure of QOL, sexual functioning and symptoms in women with recurrent, platinum-resistant ovarian cancer receiving multiple second-line treatment regimens |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaire | Behavioral | Questionnaires 1 - 5 will be completed on Day 1 of study as a Baseline. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Score for the FACT-O instrument | Participants will complete questionnaires 1 - 5 at baseline and Day 1 of each of their chemotherapy cycles. | First 2 days of chemotherapy cycles |
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Inclusion Criteria:
Exclusion Criteria:
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Female study participants that were diagnosed with Ovarian Cancer that are now "Platinum-Resistant."
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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 |
|---|---|---|---|---|---|---|
| UT MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| The University of Texas M.D.Anderson Cancer Center | View source |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D000077216 | Carcinoma, Ovarian Epithelial |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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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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| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |