Effects of an Integrative Day-care Clinic Program for Breast Cancer Patients During Chemotherapy: an Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- Hospital Anxiety and Depression Scale (HADS)
研究概览
简要总结
The aim of the study was to evaluate a new integrative day-care clinic concept for breast cancer patients receiving chemotherapy. This is an explorative pilot study. Therefore, all outcomes are analyzed exploratively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •curative malignancy (breast cancer of TNM (T: primary tumor, N: regional nodes, M: metastasis) staging I-III)
- •receiving chemotherapy
- •at least 18 years old
- •written informed consent
- •willing and physically/mentally able to participate in a six hours day care clinic program eleven times during chemotherapy.
排除标准
- •insufficient knowledge of the German language
- •physical or mental disabilities resulting in ineligibility for participation in the program or filling out the questionnaires.
研究组 & 干预措施
Integrative mind-body-medicine group program
The 66 hour program encompasses mindfulness training, yoga, moderate exercise, nutrition, naturopathic self-help strategies, cognitive restructuring and acupuncture for the management of side effects caused by chemotherapy.
干预措施: Integrative mind-body-medicine group program (Behavioral)
结局指标
主要结局
Hospital Anxiety and Depression Scale (HADS)
时间窗: up to 26 weeks (depending on chemotherapy regime)
It measures the 2 dimensions anxiety and depression. Scores range from 0 to 21 with higher values indicate higher distress. Values of \>8 indicate potential subclinical anxiety or depressive disorders
Brief Fatigue Inventory (BFI)
时间窗: up to 26 weeks (depending on chemotherapy regime)
BFI has been validated as a short and comprehensive instrument to assess severity of fatigue (three questions) and fatigue-related impairment (six questions) in cancer patients with a 9-item, 11-point rating scale. Higher scores on the BFI correspond to greater severity of fatigue / impairment through fatigue over the past 24 hours.
Satisfaction with the program
时间窗: up to 26 weeks (depending on chemotherapy regime)
Satisfaction was assessed at T1 by 5 questions regarding fulfilled expectations about the program contents, relevance for coping with cancer, social support of the group setting, transferring into everyday life, and recommendation of the program. Each question could be scored from 1=totally agree to 6=totally disagree.
European Organization for Research and Treatment of Cancer (EORTC) QoL questionnaire (QLQ-C30)
时间窗: up to 26 weeks (depending on chemotherapy regime)
Besides the global quality of life subscale, this instrument assesses five functional domains of quality of life: physical, role, emotional, cognitive, and social function. Symptom scales further assess fatigue, pain, nausea and vomiting, dyspnea, insomnia, loss of appetite, constipation, diarrhea, and financial difficulties. Scores of all subscales range from 0 to 100, while a higher score represents a better level of functioning or a worse amount of symptoms.
Patients and numbers of adverse events
时间窗: up to 26 weeks (depending on chemotherapy regime)
All adverse events that occurred during the study period were recorded by the study physician during each day care clinic visit, regardless of their potential relation to the study intervention. After the intervention, patients were also asked to report adverse events not previously mentioned.
Perceived Stress Scale (PSS)
时间窗: up to 26 weeks (depending on chemotherapy regime)
Perceived stress was assessed by the 10-item version of the PSS, rated for the past month on a 5-point rating scale. For the summed items (range from 0 to 40) a higher total score indicates greater stress.
次要结局
未报告次要终点
研究者
Dr. med. Petra Voiss
Study physician
Universität Duisburg-Essen