Study Stopped
Lack of accrual/Slow accrual
Yoga in Improving Quality of Life in Patients With Non-small Cell Lung Cancer Undergoing Treatment
The Effect of Yoga and Exercise on the Quality of Life of Patients With Non-Small Cell Lung Cancer
2 other identifiers
interventional
1
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable nonsmall-cell-lung-cancer
Started Jan 2012
Shorter than P25 for not_applicable nonsmall-cell-lung-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedFirst Submitted
Initial submission to the registry
September 6, 2016
CompletedFirst Posted
Study publicly available on registry
September 9, 2016
CompletedSeptember 9, 2016
September 1, 2016
1.6 years
September 6, 2016
September 6, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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
Study Arms (2)
Arm I (yoga)
EXPERIMENTALPatients 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.
Arm II (emotional support group therapy)
ACTIVE COMPARATORPatients 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.
Interventions
Participate in emotional support group therapy
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.
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.
Eligibility Criteria
You may qualify if:
- Patients with any type of non-small cell lung cancer who are undergoing medical treatment, including surgery, radiation and / or chemotherapy.
You may not qualify if:
- Metastasis to the brain, problems during surgery leading to myocardial infarction or hemorrhage, cerebral infarction or hemorrhage, respiratory failure, non-healing surgical wound.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mary S Shall, PT, PhD
Virginia Commonwealth University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 6, 2016
First Posted
September 9, 2016
Study Start
January 1, 2012
Primary Completion
August 1, 2013
Study Completion
August 1, 2013
Last Updated
September 9, 2016
Record last verified: 2016-09
Data Sharing
- IPD Sharing
- Will not share