Quality of Life Improvement of Breast Cancer Patients During Chemotherapy With Structured Psychological Interventions
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Average Summary Score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
研究概览
简要总结
This study is a randomized controlled trial, taking place at the University Hospital Basel (CH). It aims at the alleviation of breast cancer patients' life quality during chemotherapy.
The intervention group will participate in 10 sessions of structured hypnotherapy during the course of chemotherapy in addition to the standard of care. The control group will have access to the standard of care without any additional treatment. The main goal of the study is to investigate whether quality of life is higher among patients in the intervention group. Additionally, it will be analyzed if the interventions have a positive effect on chemotherapy side effects, symptoms of anxiety and depression and the immune system. Finally, the relative dose intensity (RDI) as well as treatment schedule adherence will be assessed.
There are no risks to be expected from the intervention itself. In the case of positive findings, the standard of psycho-oncological care can be updated by integrating structured hypnotherapeutic interventions into the treatment of patients with breast cancer.
详细描述
Background:
Breast cancer patients who undergo chemotherapy are likely to experience lower life quality, side effects like nausea and vomiting and symptoms of anxiety or depression. At the same time their immune system is down regulated by a stress reaction following cancer diagnosis and also by the chemotherapy itself. Decrease of several immune factors is associated with lower survival expectancy.
Hypnotherapy uses methods like relaxation, symptom-control techniques, imagination and working with inner resources. They can be used to bring positive change for patients both mentally as well as physically. Self-hypnosis techniques are used to bring back a feeling of self-efficacy which is impaired in most cancer patients who report to lose control over their body.
Emerging evidence shows the effectiveness of hypnotherapy in reducing side-effects of medical treatments and improve mental health and quality of life of cancer patients. It was shown that hypnotherapy has a positive effect on several immune factors. But up to now it is not clear if there is also a positive effect on the immune system during chemotherapy.
During Chemotherapy it is important that patients adhere as much as possible to the treatment schedule and to the optimal dosage. Due to chemotherapy side-effects or other reasons it happens regularly that treatment needs be delayed or dosage reduced which in turn lowers the efficiency of the chemotherapy.
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
- •Minimum Age 18 years
- •Primary breast cancer
- •Receiving neo-adjuvant or adjuvant chemotherapy
排除标准
- •Verbal or cognitive deficits that are not compatible with outpatient psychotherapy
- •Not consenting patients and vulnerable persons
- •Psychological disorders that prevent patients from participating in the study (e.g. psychotic disorder)
- •acute suicidality
研究组 & 干预措施
Standard of Care
The control group will receive the standard of psycho-oncological care.
Standard of Care + Structured Hypnotherapy
The intervention group will receive the standard of psycho-oncological care plus 10 hypnotherapeutic sessions every two weeks.
干预措施: Structured Hypnotherapy (Behavioral)
结局指标
主要结局
Average Summary Score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
时间窗: 6 times within 18 weeks + baseline at day 1
The outcome measure will be the average of all 6 time points on the EORTC QLQ-C30 summary score. The summary score ranges from 0 to 100 with higher scores representing a better quality of life. In the statistical analysis this average summary score will be corrected for values of the summary score at T0.
次要结局
- Summary Score of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)(7 times within 18 weeks)
- Hamilton Anxiety and Depression Scale - German Version (HADS-D)(7 times within 18 weeks)
- Interleukin-6(3 times within 18 weeks)
- Immune Factors(3 times within 18 weeks)
- Tumor Marker CA 15-3(3 times within 18 weeks)
- Relative Dose Intensity (RDI)(18 weeks)
- Side Effects of Chemotherapy(7 times within 18 weeks)
- Schedule Modification: Delayed Cycles(18 weeks)
- Schedule modification: Delayed Days(18 weeks)
研究者
Christian Schwegler
Scientific Collaborator
University Hospital, Basel, Switzerland