Cancer-related Fatigue and Symptom Clusters - Effects of Virtual, Imagined and Real-life Nature-based Therapy in Cancer Survivors - a RCT
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 172
- 试验地点
- 4
- 主要终点
- Fatigue
研究概览
简要总结
This is a randomized, controlled, bicenter trial comparing the effects on symptoms and quality of life in cancer survivors. Three nature-based therapies will be compared with a wait-list group. The therapies are: virtual reality simulated forest, guided imaging and classic forest bathing. Each intervention lasts 30 minutes and takes place once a week for 8 weeks. All interventions involve different stimulus types: visual, olfactory, auditory and tactile.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Patients who have completed treatment for cancer (*with the exception of long-term adjuvant endocrine therapy).
- •Subjective Impairment due to Cancer-Related Fatigue (CrF) . NCCN-recommended questions are used for screening ("How exhausted do you feel on a scale of 0 to 10?" and "How impaired do you feel by this fatigue on a scale of 0 to 10?" (threshold >4 on either scale).
- •At the time of study inclusion, it must be expected that no further antitumor therapy measures will be started within the next 6 months.
- •Patients must be able to refrain from smoking up to 15 minutes before the intervention (smoking within 15 minutes before therapy impairs the participant's ability to perceive the aroma of the phytoncides).
- •Written and valid informed consent from the patient.
排除标准
- •Presence of inadequately controlled major depression in the opinion of the investigator.
- •Asthma (inhaled phytoncides may cause airway irritation, exacerbation of asthma, or bronchoconstriction).
- •Known allergy to pine or citrus fragrance.
- •Medical history of seasickness (virtual reality can cause nausea/vomiting with no improvement after 5-10 minutes).
- •History of seizures (virtual reality may increase susceptibility to seizures due to the changing light in the forest video).
- •Visual and hearing impairments that are not corrected by visual or hearing aids.
- •Unwillingness to store and share personal medical data as part of the protocol.
- •Participation in another clinical trial focusing on behavioural or complementary medicine interventions.
- •Missing or incomplete consent form.
结局指标
主要结局
Fatigue
时间窗: 8 weeks (end of intervention)
The Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) is a validated tool for the reliable measurement of fatigue in patients with cancer and other chronic diseases. The questionnaire has high internal consistency and validity and allows assessment of fatigue and its impact on quality of life and disease progression. 13 items to measure self-reported fatigue and its impact on daily activities and functions. Scores range from 0 to 52, with higher scores indicating less fatigue (better outcome).
Sleep
时间窗: 8 weeks (end of intervention)
The Pittsburgh Sleep Quality Index (PSQI) measures subjective sleep quality. The 19-item questionnaire generates seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medications, and daytime disturbances. The sum of the scores for these seven components gives a global score. Scores range from 0 to 21, with higher scores indicating poorer sleep quality (worse outcome).
Depression
时间窗: 8 weeks (end of intervention)
The Patient Health Questionnaire-9 (PHQ-9) is often used for the initial diagnosis of depression and for monitoring the course of the illness. The PHQ-9 consists of 9 questions that ask about the main and core symptoms of depression over the past two weeks, providing a structured and objective assessment of the severity of depression. Scores range from 0 to 27, with higher scores indicating more severe depression (worse outcome).
Concentration
时间窗: 8 weeks (end of intervention)
The Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) is a 5-point Likert scale measure of chemotherapy-induced cognitive impairment in cancer patients. The questionnaire consists of 24 items covering four different domains: self-perceived cognitive impairment, feedback from others, perceived cognitive ability, and impact on quality of life. The assessment of these cognitive aspects indicates a relationship with objective symptoms and allows for a nuanced assessment of treatment-induced cognitive impairment. Scores range from 0 to 148, with higher scores indicating better perceived cognitive functioning (better outcome).
次要结局
- Fatigue(8 weeks (end of intervention))
- Sleep(8 weeks (end of intervention))
- Depression(8 weeks (end of intervention))
- Concentration(8 weeks (End of intervention))
- Resilience(8 weeks (end of intervention))
- Mindfulness(8 weeks (end of intervention))
- Anxiety(8 weeks (end of intervention))
- Quality of life Questionnaire(8 weeks (end of intervention))
- Sensation of stress(8 weeks (end of intervention))
- Simulator Disease (Virtual reality group only, arm 2)(8 weeks (end of intervention))
- Physical Activity and Sport Questionnaire(8 weeks (end of intervention))
- Safety evaluation(Through 8 weeks of intervention (Weeks 0-8))
- Average daily step count (measured via wearable activity tracker)(Cumulative average daily steps over Weeks 1-8)
- Heart rate variability(8 weeks (end of intervention))
- Natural killer cell activity(8 weeks (end of intervention))
- Serum cytokine concentrations (IL-6, IL-10, TNF-alpha)(Week 4 (Mid-intervention), Week 8 (End of intervention))
研究者
Marcela Winkler, MD
Head of Integrative Medicine
Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)