Quality of Life and Cost Utility Analysis in the Treatment of Recurrent, Platinum-Resistant Ovarian Cancer
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Mean Score for the FACT-O instrument
研究概览
简要总结
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.
详细描述
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:
- Questionnaire 1 (The Short Form 12) asks about your physical and emotional health, any pain, social functioning, and general health. This information will help researchers keep track of how you feel and how well you are able to do your usual activities.
- Questionnaire 2 (The Functional Assessment of Cancer Therapy) asks about the symptoms of cancer and how these symptoms may affect your physical, social, and emotional well-being.
- Questionnaire 3 (Medical Outcomes Study) asks about your sexual functioning. Researchers believe this information is important in understanding how health problems affect people's lives.
- Questionnaire 4 (The Functional Assessment of Cancer Therapy/Neurotoxicity questionnaire) asks whether or not you have had any numbness and/or tingling in your hands and/or feet. This numbness/tingling can occur as a side effect of some chemotherapy drugs that are commonly given to patients with ovarian cancer.
- Questionnaire 5 (The Memorial Symptom Assessment Scale) asks about the symptoms of ovarian cancer and the side effects of ovarian cancer treatment.
In addition, you will also be asked to complete the following questionnaires for each cycle of chemotherapy:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with recurrent, platinum-resistant epithelial ovarian cancer who are beginning any second-line treatment
- •Patients must be English-speaking
- •Patients must be able to read and write English
- •Patients receiving all chemotherapy at MD Anderson Cancer Center
排除标准
- •Patients with non-epithelial ovarian cancers including sex-cord stromal tumors, germ cell tumors, low-grade tumors, and metastatic disease to the ovary
- •Patients who are receiving protocol therapy
- •Patients who have had a prior diagnosis of invasive cancer at other sites (excluding basal cell carcinoma of the skin)
- •Patients who are receiving radiation therapy as a treatment modality
结局指标
主要结局
Mean Score for the FACT-O instrument
时间窗: First 2 days of chemotherapy cycles
Participants will complete questionnaires 1 - 5 at baseline and Day 1 of each of their chemotherapy cycles.
次要结局
未报告次要终点