Use of Palliative Performance and Symptom Distress Scales in Older Patients With Advanced Ovarian Cancer
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Changes in scale score after surgery and/or chemotherapy
研究概览
简要总结
RATIONALE: Measuring changes in performance status and symptoms distress in patients with cancer may help doctors predict how patients will respond to treatment, and may help the study of cancer in the future.
PURPOSE: This clinical trial is studying changes in performance status and symptoms distress in older patients with advanced ovarian epithelial cancer undergoing surgery and/or chemotherapy.
详细描述
OBJECTIVES:
Primary
- To evaluate the changes in performance status and symptom distress in older patients with presumed or advanced ovarian cancer undergoing surgery and/or chemotherapy.
Secondary
- To explore the association between these changes with chemotherapy drug change, dose reduction, or dose delay due to toxicity in these patients.
- To explore the association between these changes with the development of surgical complications in these patients.
- To observe the response in the Geriatric Assessment (GA) and report the individual item scores.
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
- 65 Years 至 —（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Clinical findings highly suggestive of advanced ovarian epithelial cancer undergoing surgery for definitive diagnosis and staging
- •≥ 65 years of age
排除标准
- •Prior diagnosis of ovarian cancer
- •Inability to read and speak English
- •Inability to comply with study requirements
结局指标
主要结局
Changes in scale score after surgery and/or chemotherapy
时间窗: baseline, post surgery (at the first post-operative clinic visit), 14-21 days post chemotherapy (post cycle 3 and post cycle 6), and at the first follow-up visit
Results will be described by scoring outcome from a professional assessment of performance status as measured by PPSv2, and from a SDS survey which asks about the perceived level of symptom distress the patient is experiencing.PPSv2 is arrayed on a scaled from 10 (bedbound) to 100 (full ambulation) at 10 points increment. A 13-item scale of SDS is used to indicate the degree of distress for a given symptom on a 5 point Likert Scale, ranging from 1 (least amount of distress) to 5 (extreme distress)
次要结局
未报告次要终点