Effect of Qigong Therapy in Patients With Advanced Lung and Gastrointestinal Cancer Undergoing Chemotherapy

Study Overview
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Brief Summary
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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.

Detailed Description
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As per summary above

Official Title
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Effect of Qigong Therapy in Patients With Advanced NSCLC and GI Cancer Undergoing Chemotherapy

Conditions
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Carcinoma, Non-Small-Cell Lung, Cancer of the Gastrointestinal Tract

Intervention / Treatment
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* Behavioral: Standard Exercise
* Behavioral: Qigong Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Exercise<br>See methods below - standard strength and endurance training | Behavioral: Standard Exercise<br>* The standard exercise therapy program will include 12 treatments of approximately 45 minutes duration, twice a week for a period of six weeks by the same instructor and at the same location as for Qigong therapy. This exercise program is supervised and consists of cardio-vascular and resistance training exercises. Participants are asked to refrain from practicing Qigong during this 6 week period.<br>Behavioral: Qigong Exercise<br>* Qigong therapy will be led by a trained Qigong instructor and will occur for 45 minutes sessions, twice a week for a period of six weeks. Qigong is a self-directed walking exercise program that involves arm movements that are coordinated with slight movements of the waist, while in a state of deep relaxation or meditation. Patients will be asked to refrain from independent resistance or cardiovascular training during this 6 week period.<br>|
| Experimental: Qigong exercise<br>See methods below - medical QiGong therapy session | Behavioral: Standard Exercise<br>* The standard exercise therapy program will include 12 treatments of approximately 45 minutes duration, twice a week for a period of six weeks by the same instructor and at the same location as for Qigong therapy. This exercise program is supervised and consists of cardio-vascular and resistance training exercises. Participants are asked to refrain from practicing Qigong during this 6 week period.<br>Behavioral: Qigong Exercise<br>* Qigong therapy will be led by a trained Qigong instructor and will occur for 45 minutes sessions, twice a week for a period of six weeks. Qigong is a self-directed walking exercise program that involves arm movements that are coordinated with slight movements of the waist, while in a state of deep relaxation or meditation. Patients will be asked to refrain from independent resistance or cardiovascular training during this 6 week period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Depression and Anxiety | 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. | 6 weeks | 
| Change in Quality of Life (QoL) | 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. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in functional capacity | Functional capcity will be measured using the Simmonds Functional Assessment (SFA) within 2 weeks of finishing each 6-week exercise program. This tool consists of eight items: putting on a sock, tying a belt, putting coins in a cup, reaching forward, repeated reach up (3 times), repeated sit to stand (2 times), speed walk for 50 feet, and walking for 6 minutes. Patient satisfaction will be measured by asking all participants to answer a two item questionnaire with a 10-point visual analog scale response option. | 6 weeks | 
| Change in cancer Symptoms | Symptoms commonly reported by lung and GI cancer patients will be measured using the Edmonton Symptom Assessment Scale (ESAS). The ESAS is a 12-item patient rated symptom questionnaire scored using a 10-point visual analogue scale. The ESAS will be administered within 2 weeks of completing each 6-week exercise program. | 6 weeks | 
| Program Satisfaction | Patient satisfaction will be measured by asking all participants to answer a two-item questionnaire after they have completed each 6-week exercise program. | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Qigong, Complementary Medicine, Exercise, Traditional Chinese Medicine, Meditation, Standard Exercise, Chemotherapy, Advanced cancer, Quality of Life, Functional Assessment of Cancer Therapy, Hospital Anxiety and Depression Scale, Anxiety, Depression, Cancer Nutrition-Rehabilitation Program, Edmonton Symptom Assessment Scale, Simmonds Functional Assessment