Non-small Cell Lung Cancer, Recurrent Non-Small Cell Lung Carcinoma
Conditions
Keywords
Stage IA Non-Small Cell Lung Carcinoma, Stage IB Non-Small Cell Lung Carcinoma, Stage IIA Non-Small Cell Lung Carcinoma, Stage IIB Non-Small Cell Lung Carcinoma, Stage IIIA Non-Small Cell Lung Cancer, Stage IIIB Non-Small Cell Lung Cancer, Stage IV Non-Small Cell Lung Cancer
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.
Interventions
BEHAVIORALYoga
Participate in yoga
BEHAVIORALSupport Group Therapy
Participate in emotional support group therapy
OTHERFACT-L
This is a 44-item self-report instrument which measures multidimensional HRQOL. There are 5 sections dealing with physical, family, emotional, and functional well-being and their relationship with the doctor. There are nine questions in a sixth subscale that are specific to lung cancer (LSC), including shortness of breath, cough, etc. The TOI is the sum of the scores on the LCS and the physical well-being and functional well-being subscales of the FACT-L scale. The FACT-L has been shown to be reliable and valid and sensitive. (Cella, Bonomi, Lloyd, DS, Kaplan, & Bonomi, 1995). The instrument has been used with patients with lung cancer in the Massey Cancer Center.
OTHERPulmonary function test
The pulmonary function test includes forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1) and peak expiratory flow rate (PEFR). Use of a digital spirometer provides an objective and reliable measure of the patient's vital capacity.
Sponsors
Virginia Commonwealth University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of the score of the Trial Outcome Index (TOI) | 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 | 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. |
Countries
United States
Outcome results
None listed