M. D. Anderson Symptom Inventory - Ovarian Cancer: Development and Validation in Patients With Ovarian Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 158
- 试验地点
- 2
- 主要终点
- Validate ovarian-cancer module of MDASI-Ovarian Cancer to measure severity of multiple symptoms + impact of these symptoms on daily functioning in patients with ovarian cancers.
研究概览
简要总结
Objectives:
The objective of this study is to delineate and measure the symptom burden experienced by patients with ovarian cancer.
The Primary Aim is to develop and validate an ovarian-cancer module of the M. D. Anderson Symptom Inventory (MDASI-Ovarian Cancer) to measure the severity of multiple symptoms and the impact of these symptoms on daily functioning in patients with ovarian cancers.
The Secondary Aims are:
To develop a detailed description of symptom severity and interference with daily activities experienced by patients with ovarian cancer; To assess the impact of symptom severity on standard functioning and quality of life (QOL) measures, including Eastern Cooperative Oncology Group Performance Status (ECOG PS), Functional Assessment of Cancer Therapy-Ovary (FACT-O), and a single-item QOL scale, in patients with ovarian cancer; To define the qualitative symptom burden of patients with ovarian cancer receiving various treatments.
详细描述
PART 1:
Interview:
If you agree to take part in this study, you will be interviewed about what it is like to have ovarian cancer and any symptoms that you may have experienced. This will be a 1-on-1 interview with the study doctor or a member of the study staff. It will take place during 1 of your regularly scheduled, standard of care clinic visit and should take about 30 minutes to complete.
The interview will be digitally recorded. The electronic recording of the interview will be given a code number and stored on a password-protected computer at M. D. Anderson. No identifying information will be directly linked to your interview recording. Only the researcher in charge of the computer will have access to the code numbers and be able to link the interview recording to you.
Questionnaires:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients 18 years of age or older.
- •Able to speak and read English.
- •Having a diagnosis of high grade invasive epithelial ovarian cancer, peritoneal cancer or fallopian tube cancer confirmed by pathological analysis.
- •Being followed at M D Anderson Cancer Center and Lyndon B. Johnson General Hospital (LBJ Hospital).
- •Has consented to participate.
- •Has not received any current cancer treatment or prior chemotherapy in the last 30 days (phase 2 subset of 40 patients only)
排除标准
- •Having a medical condition or impaired performance status that would preclude participation in the study.
结局指标
主要结局
Validate ovarian-cancer module of MDASI-Ovarian Cancer to measure severity of multiple symptoms + impact of these symptoms on daily functioning in patients with ovarian cancers.
时间窗: Baseline to 2 years (Patient participation done after completing Interview and Surveys during single clinic visit)
次要结局
- Patient Rated Symptom Severity and Interference with Function (Survey Response)(Baseline to 2 years)