Impact of Disney Movies During Chemotherapy on QOL of Gynecologic Oncology Patients: A Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Change of Fatigue during 6 cycles of chemotherapy
研究概览
简要总结
To evaluate the impact of Disney movies on quality of life (QOL) of gynecologic oncology patients.
25 Patients are watching Disney movies on portable DVD players during chemotherapy, 25 patients are not allowed to watch TV.
EORTC QLQ-C30 and EORTC QLQ-FA12 surveys are given to the patients before and after the six chemotherapies.
Hypothesis: Disney movies can elevate patients QOL.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •planned 6 cycles of chemotherapy with carboplatin/paclitaxel or carboplatin/pegylated liposomal doxorubicin
- •Age >18 years
排除标准
- •inadequate knowledge of the German language
研究组 & 干预措施
Disney
watch Disney movies and fill out EORTC QLQ-C30 (Version 3) and EORTC QLQ-FA12 surveys
干预措施: Disney movie (Other)
Disney
watch Disney movies and fill out EORTC QLQ-C30 (Version 3) and EORTC QLQ-FA12 surveys
干预措施: EORTC QLQ-C30 and EORTC QLQ-FA12 surveys (Other)
Control
fill out EORTC QLQ-C30 (Version 3) and EORTC QLQ-FA12 surveys
干预措施: EORTC QLQ-C30 and EORTC QLQ-FA12 surveys (Other)
结局指标
主要结局
Change of Fatigue during 6 cycles of chemotherapy
时间窗: Measured before and after each chemotherapy (at baseline and on average after 3, 6, 9, 12, 15 weeks after inclusion in patients with carboplatin/paclitaxel or after 4, 8, 12, 16, 20 weeks after inclusion in patients with carboplatin/doxorubicin)
To compare change in Fatigue, as defined by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Fatigue (EORTC QLQ-FA12) during 6 cycles of chemotherapy. The EORTC QLQ-FA12 uses for the questions 1 to 12 a four-point scale. The scale scores from 1 to 4: 1 ("Not at all"), 2 ("A little"), 3 ("Quite a bit") and 4 ("Very much"). Half points are not allowed. The range is 3. For the raw score, less points are considered to have a better outcome. Raw score has to be calculated using the mean value for the questions 1 to 12.
Change of Quality of life during 6 cycles of chemotherapy
时间窗: Measured before and after each chemotherapy (at baseline and on average after 3, 6, 9, 12, 15 weeks after inclusion in patients with carboplatin/paclitaxel or after 4, 8, 12, 16, 20 weeks after inclusion in patients with carboplatin/doxorubicin)
To compare change in Quality of Life, as defined by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30 (Version 3)) during 6 cycles of chemotherapy. The EORTC QLQ-C30 (Version 3) uses for the questions 1 to 28 a 4-point scale. The scale scores from 1 to 4: 1 ("Not at all"), 2 ("A little"), 3 ("Quite a bit") and 4 ("Very much"). Half points are not allowed. The range is 3. For the raw score, less points are considered to have a better outcome. The EORTC QLQ-C30 (Version 3) uses for the questions 29 and 30 a 7-points scale. The scale scores from 1 to 7: 1 ("very poor") to 7 ("excellent"). Half points are not allowed. The range is 6. First of all, raw score has to be calculated with mean values. Afterwards linear transformation is performed to be comparable. More points are considered to have a better outcome.
次要结局
未报告次要终点
研究者
Sophie Pils
MD, Principal Investigator
Medical University of Vienna