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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01374100 |
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Date of registration:
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13/04/2011 |
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Primary sponsor: |
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Public title:
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Effect of Qigong Therapy in Patients With Advanced Lung and Gastrointestinal Cancer Undergoing Chemotherapy
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Scientific title:
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Effect of Qigong Therapy in Patients With Advanced NSCLC and GI Cancer Undergoing Chemotherapy |
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Date of first enrolment:
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February 2009 |
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Target sample size:
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52 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01374100 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care
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Countries of recruitment
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Canada
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Contacts
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Name:
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Thomas Jagoe, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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McGill, Cancer Nutrition Rehabilitation Program |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. A pathologically (histological or cytological) confirmed clinical diagnosis of
non-small cell lung cancer (NSCLC) or GI cancer
2. Stage 3 or 4 disease and eligible for anti-cancer treatment
3. Performance status (PS) of 0 - 2 as determined by the Eastern Cooperative Oncology
Group-Performance Status
4. Life expectancy estimated at > 4 months
5. Age 18 years or older
6. Willing and able to provide informed consent
7. Must be approved for participation by the oncology treatment team
8. Able to communicate in French or English
Exclusion Criteria:
1. Contraindication to exercise as determined by the oncology treatment team
2. Severe cardiac or neuro-muscular/skeletal disease
3. Engaging in interventions to address anxiety or depressive symptoms
4. Brain metastases
5. Active psychiatric conditions
6. Pregnant or breast-feeding mothers
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cancer of the Gastrointestinal Tract
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Carcinoma, Non-Small-Cell Lung
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Intervention(s)
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Behavioral: Qigong Exercise
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Behavioral: Standard Exercise
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Primary Outcome(s)
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Change in Depression and Anxiety
[Time Frame: 6 weeks]
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Change in Quality of Life (QoL)
[Time Frame: 6 weeks]
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Secondary Outcome(s)
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Change in cancer Symptoms
[Time Frame: 6 weeks]
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Change in functional capacity
[Time Frame: 6 weeks]
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Program Satisfaction
[Time Frame: 6 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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