Yoga in Improving Quality of Life in Patients With Non-small Cell Lung Cancer Undergoing Treatment

Non-small Cell Lung Cancer Clinical Trial

Official title:

The Effect of Yoga and Exercise on the Quality of Life of Patients With Non-Small Cell Lung Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02895503
• Other study ID #: MCC-13850
• Secondary ID: NCI-2015-01818
• Status: Terminated
• Phase: N/A
• First received: September 6, 2016
• Last updated: September 6, 2016
• Start date: January 2012
• Est. completion date: August 2013

Study information

• Verified date: September 2016
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer
• Recurrent Non-Small Cell Lung Carcinoma

Intervention

Behavioral:
• Yoga
Participate in yoga
• Support Group Therapy
Participate in emotional support group therapy

Other:
• FACT-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.
• Pulmonary 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.

Locations

Country	Name	City	State
United States	Virginia Commonwealth University/Massey Cancer Center	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of the score of the Trial Outcome Index (TOI)	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.	Baseline to up to 12 weeks	No
Primary	Measures of pulmonary function	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.	Baseline to up to 12 weeks	No