Integrative, Resource-oriented Short Term Dance Movement Therapy for Radio-oncological Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Primary objective
研究概览
简要总结
Dance-RT-01 investigates the feasibility and effects of Integrative, resource-oriented short term Dance Movement Therapy (DMT) in radio-oncological patients shortly after radiotherapy (RT). The study assesses clinical outcomes, including reduction of fatigue, improvement of quality of life (QoL), functional capacity and body composition. Immunophenotyping and laboratory blood analyses ensure objectively measurable results. Eligible patients participate in short term DMT, that is combined with psychotherapeutic elements. The trial aims to evaluate DMT's potential as a complementary therapy method in cancer care to support recovery and provide a comprehensive understanding of the therapy's effects.
详细描述
The study is designed as investigator-initiated, prospective, non-randomized feasibility trial and includes radio-oncological patients (ECOG 0-2) who recently completed RT. The primary endpoint is to decide upon the feasibility, as well as identification of specific immunological changes in peripheral blood that contribute to the success of DMT (longitudinal analysis). The benefit for patients is seen in a resource activation after RT and improvement of well-being. Secondary endpoints include functional capacity, measured by maximum grip strength, body composition, assessed through bioelectrical impedance analysis (BIA), assessment of QoL, pain and reduction of fatigue using validated and standardized questionnaires for patient reported outcomes with comparable results. In addition, immunophenotyping is performed. Further laboratory analyses include inflammatory markers, hormone levels, and nutritional biomarkers. These data are analyzed to evaluate correlation of immunological changes with clinical outcomes.
Participants complete five weekly DMT sessions (90 minutes each). Each session integrates structured movement exercises, music, and psychotherapeutic elements, that can be tailored depending on each individual patient. The therapy is carried out by a certified therapeutic dance instructor with expertise in radio-oncology.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Male and female oncological patients
- •Age at least 18 years. No upper age limit
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- •Written informed consent for participation in the study
- •Prior RT received shortly before study inclusion (therapy completed)
- •Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including
排除标准
- •Inability to speak and understand German
- •Serious concurrent neurologic or psychiatric disorders: dementia, uncontrolled seizures, psychosis, schizophrenia, neurosis, autism that would interfere with cooperation with the requirements of the trial
- •Familial, sociological, or geographical condition that would preclude study compliance (these conditions should be discussed with the patient before registration in the study)
- •Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the study team
- •Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
- •Is pregnant or breastfeeding, or expecting to conceive
研究组 & 干预措施
DMT arm
All patients receive a dance movement therapy intervention once a week for 90 minutes over a period of five weeks, which is combined with psychotherapeutic content. The therapy is carried out by one specially trained DMT therapist with experience in radiooncology.
The structure of the sessions is designed in such a way that there is a 15-minute starting phase with a mindfulness exercise and opening flash, followed by a 50-minute active phase in which special topic are carried out:
Therapy sessions and topics:
- Introduction. Get to know. Encounter.
- Body awareness and dealing with one's own limits.
- Social relationships. Proud. Becoming aware of your own resources.
- "Cage of emotions". Release.
- Conclusion. Reflection and transfer to everyday life. Farewell.
干预措施: Dance Movement Therapy (DMT) (Behavioral)
结局指标
主要结局
Primary objective
时间窗: in the week 1 (baseline) in the week 3, in the week 5 (end of study)
Questionnaire-based (EQ-5D-5L) measurement of well-being containts two main parts: 1) descriptive part in 5 dimentions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each dimensions have 5 possible answers: no problems, slight problems, moderate problems, severe problems, extreme problems. This is used to define so-called EQ-5D Health States. A total of 3125 different health states can be recorded. Depending on the level, each dimension is assigned a number, resulting in a 5-digit number combination. This 5-digit number can be converted into a score (EQ-5D-5L Index) using a special algorithm that is not publicly available and represents the patient's state of health. An index value of 1 represents the best possible state of health, whil 2) Visual Analogue Scale (VAS) a vertical scale on which the participants indicate their self-related state of health, with 0 representing "The worst health you can imagine" and 100 "The best health you can imagine".
次要结局
- Assessment of muscle strength using the Jamar hand dynamometer(weekly: in the week 1 (baseline) 2, 3, 4 and 5 (end of study))
- Assessment of Body Mass Index(weekly: in the week 1 (baseline) 2, 3, 4 and 5 (end of study))
- Assessment of percentage proportion in the patient´s body of fat and skeletal muscle using Bioelectrical Impedance Analysis (BIA)(weekly: in the week 1 (baseline) 2, 3, 4 and 5 (end of study))
- Assessment of Resting Metabolism (RM) using Bioelectrical Impedance Analysis (BIA)(weekly: in the week 1 (baseline) 2, 3, 4 and 5 (end of study))
- Assessment of laboratory parameters and comparison with standard values(in the week 1 (baseline) in the week 3, in the week 5 (end of study))
- Immunophenotyping-longitudinal immunological measurements using flow cytometry(in the week 1 (baseline) in the week 3, in the week 5 (end of study))
- Assessment of the side effects of oncological therapy using NCI CTCEA 5.0(in the week 1 (baseline) in the week 3, in the week 5 (end of study))