The Effect of Yoga and Exercise on the Quality of Life of Patients With Non-Small Cell Lung Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 1
- Locations
- 1
- Primary Endpoint
- Change of the score of the Trial Outcome Index (TOI)
Study Overview
Brief Summary
The purpose of this research study is to evaluate the effects of yoga (including breathing exercises) on the quality of life in patients, diagnosed and undergoing standard treatments for non-small cell lung cancer.
Detailed Description
This clinical trial studies yoga in improving quality of life in patients with non-small cell lung cancer undergoing treatment. Yoga may help improve quality of life and pulmonary functional capacity in patients with non-small cell lung cancer.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with any type of non-small cell lung cancer who are undergoing medical treatment, including surgery, radiation and / or chemotherapy.
Exclusion Criteria
- •Metastasis to the brain, problems during surgery leading to myocardial infarction or hemorrhage, cerebral infarction or hemorrhage, respiratory failure, non-healing surgical wound.
Arms & Interventions
Arm I (yoga)
Patients undergo traditional medical treatment, participate in yoga comprising basic postures and breathing exercises 3-4 times per week, and attend yoga class once weekly over 30-60 minutes for 12 weeks.
Intervention: FACT-L (Other)
Arm I (yoga)
Patients undergo traditional medical treatment, participate in yoga comprising basic postures and breathing exercises 3-4 times per week, and attend yoga class once weekly over 30-60 minutes for 12 weeks.
Intervention: Pulmonary function test (Other)
Arm II (emotional support group therapy)
Patients undergo traditional medical treatment and participate in emotional support group therapy with a chaplain to work on mind-body therapies comprising guided imagery and spirituality once weekly for 12 weeks.
Intervention: Support Group Therapy (Behavioral)
Arm I (yoga)
Patients undergo traditional medical treatment, participate in yoga comprising basic postures and breathing exercises 3-4 times per week, and attend yoga class once weekly over 30-60 minutes for 12 weeks.
Intervention: Yoga (Behavioral)
Arm II (emotional support group therapy)
Patients undergo traditional medical treatment and participate in emotional support group therapy with a chaplain to work on mind-body therapies comprising guided imagery and spirituality once weekly for 12 weeks.
Intervention: FACT-L (Other)
Arm II (emotional support group therapy)
Patients undergo traditional medical treatment and participate in emotional support group therapy with a chaplain to work on mind-body therapies comprising guided imagery and spirituality once weekly for 12 weeks.
Intervention: Pulmonary function test (Other)
Outcomes
Primary Outcomes
Change of the score of the Trial Outcome Index (TOI)
Time Frame: Baseline to up to 12 weeks
To measure health related quality of life (HRQOL), the TOI will be used,sum of the scores on the Lung Cancer Subscales (LCS) and the physical well-being and functional well-being subscales of the Functional Assessment of Cancer Therapy - Lung (FACT-L) scale. Frequencies, means and standard deviations of the patient characteristics will be compared between groups at baseline to assess the success of the randomization, and whether any baseline values need to be controlled for in analysis. Differences between groups in the change in outcome scores on the FACT-L, LSC, and TOI will be assessed using analysis of covariance, where covariates will include the stratification variable as well as any variables found to differ between groups at baseline.
Measures of pulmonary function
Time Frame: Baseline to up to 12 weeks
Objective pulmonary function will be measured on a 3 measure spirometer ((FVC), forced expiratory volume in 1 second (FEV1) and peak expiratory flow rate (PEFR)). Since there are 3 measures of pulmonary function, the two groups will be compared using mixed model methods.
Secondary Outcomes
No secondary outcomes reported