Effects of Music or Hypnotherapy on Cancer Patients During Chemotherapy - A Prospective Off-centre Randomized Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 81
- 试验地点
- 6
- 主要终点
- ZSDS = Zung Self-rating Depression Scale
研究概览
简要总结
Chemotherapies often induce side effects. This study examines whether hypnosis, music therapy versus standard therapy influence these side effects.
详细描述
Primary study goals are differences in quality of life, nausea and vomiting episodes, fatigue, depression and change of taste.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
Single blinded. The participant knows which group intervention is being used (music, hypnosis or standard care). This is being told while listening to the Intervention. All care Providers only know which "colour" mp3 player is being used (white, orange or black).
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •no previous chemotherapy
- •compliance of the patient to fill out questionnaires
- •informed consent and signed forms
- •histologic secured breast cancer or ovary cancer (residual tumor after surgery equal or less than 0,5 cm)
- •One of following chemotherapy regime:
- •4x Epirubicin / Cyclophosphamid, 12x paclitaxel oder 6x Carboplatin / Docetaxel / Perjeta/ Herceptin oder 6x Doxorubicin, docetaxel, Cyclophosphamid oder 6 x Carboplatin / paclitaxel + / - Avastin oder 4x Epirubicin / Cyclophosphamid -> 12x paclitaxel /herceptin/ perjeta oder 4x Epirubicin / Cyclophosphamid q21->12xcarboplatin, paclitaxel 4 Epirubicin / Cyclophosphamid q14-> 12 carboplatin, paclitaxel
排除标准
- •does not understand the German language
- •psychosis
- •not able to sign consent form
结局指标
主要结局
ZSDS = Zung Self-rating Depression Scale
时间窗: Every three weeks during chemotherapy and one year after last chemotherapy
Change of questionnaire scores
Patient diary, number of emetic episodes, the intensity of Nausea and QoL evaluation (functional living index-emesis questionnaire)
时间窗: Day 1-5 after chemotherapie and before next chemotherapy
Change of questionnaire scores
Quality of life questionnaire - Core30
时间窗: Every three weeks during chemotherapy and one year after last chemotherapy
Change of questionnaire scores
Fatigue assessment questionnaire (FAQ)
时间窗: Every three weeks during chemotherapy and one year after last chemotherapy
Change of questionnaire scores
Screening Scale for Taste Alteration (TA)
时间窗: Every three weeks during chemotherapy and one year after last chemotherapy
Change of questionnaire scores
次要结局
- Change of heart rate(change of average heart rate after 5 minutes rest, 5 minutes before chemotherapy and 5 minutes into chemotherapy)
研究者
Prof. Dr. Joscha Reinhard
Principal investigator
Dr. Horst Schmidt Klinik GmbH