Effect of Qigong Therapy in Patients With Advanced NSCLC and GI Cancer Undergoing Chemotherapy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- McGill University
- Enrollment
- 52
- Locations
- 1
- Primary Endpoint
- Change in Depression and Anxiety
Study Overview
Brief Summary
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
As per summary above
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Standard Exercise
See methods below - standard strength and endurance training
Intervention: Standard Exercise (Behavioral)
Standard Exercise
See methods below - standard strength and endurance training
Intervention: Qigong Exercise (Behavioral)
Qigong exercise
See methods below - medical QiGong therapy session
Intervention: Standard Exercise (Behavioral)
Qigong exercise
See methods below - medical QiGong therapy session
Intervention: Qigong Exercise (Behavioral)
Outcomes
Primary Outcomes
Change in Depression and Anxiety
Time Frame: 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)
Time Frame: 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.
Secondary Outcomes
- Program Satisfaction(6 weeks)
- Change in functional capacity(6 weeks)
- Change in cancer Symptoms(6 weeks)
Investigators
Thomas Jagoe
Associate Professor of Medicine
McGill University