Effect of Qigong Therapy in Patients With Advanced NSCLC and GI Cancer Undergoing Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Change in Depression and Anxiety
研究概览
简要总结
Cancer patients face a number of symptoms related to treatment or disease which may impair quality of life, such as decreased functional capacity, fatigue, nausea an vomiting, distress, depression and unmet psychological needs. Due to this array of symptoms, cancer patients often seek supportive complementary and alternative medicine, which many patients use along with conventional treatments. Qigong, a type traditional chinese medicine, is a mind-body exercise that combines meditation, slow physical movements, and controlled breathing. The investigators hypothesise that Qigong therapy is better in the reduction of anxiety and depression levels and the improvement of quality of life in patients with lung and gastrointestinal (GI) cancer who are eligible for anti-cancer treatment, when compared to standard exercise training.
详细描述
As per summary above
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
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
- •A pathologically (histological or cytological) confirmed clinical diagnosis of non-small cell lung cancer (NSCLC) or GI cancer
- •Stage 3 or 4 disease and eligible for anti-cancer treatment
- •Performance status (PS) of 0 - 2 as determined by the Eastern Cooperative Oncology Group-Performance Status
- •Life expectancy estimated at > 4 months
- •Age 18 years or older
- •Willing and able to provide informed consent
- •Must be approved for participation by the oncology treatment team
- •Able to communicate in French or English
排除标准
- •Contraindication to exercise as determined by the oncology treatment team
- •Severe cardiac or neuro-muscular/skeletal disease
- •Engaging in interventions to address anxiety or depressive symptoms
- •Brain metastases
- •Active psychiatric conditions
- •Pregnant or breast-feeding mothers
结局指标
主要结局
Change in Depression and Anxiety
时间窗: 6 weeks
Depression and anxiety will be measured using the Hospital Anxiety Depression Scale (HADS); The HADS is a 14-item self-rated questionnaire, consisting of two 7-item subscales. It was developed to identify anxiety and depression in non-psychiatric medical outpatients. Each item on the HADS is scored from 0 (no problem) to 3 (maximum distress). The HADS will be administered within 2 weeks of completing each exercise program.
Change in Quality of Life (QoL)
时间窗: 6 weeks
The general version of the Functional Assessment of Cancer Therapy scale (FACT-G) will be used to measure Quality of Life (QoL) after completion of each 6 week exercise program. This questionnaire consists of 4 subscales: Physical well-being (PWB), Social well-being (SWB), Emotional well-being (EWB) and Functional well-being (FWB). A change of 4 points on the total FACT score is regarded as clinically significant.
次要结局
- Program Satisfaction(6 weeks)
- Change in functional capacity(6 weeks)
- Change in cancer Symptoms(6 weeks)
研究者
Thomas Jagoe
Associate Professor of Medicine
McGill University