Comprehensive Yoga Program (SKY) as Adjunct Therapy for Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
This randomized pilot trial studies the effect of comprehensive yoga program (SKY) in reducing stress, pain, and fatigue, and improving psychological well-being in patients with prostate cancer. SKY is one of the most widely used breathing techniques derived from yoga. SKY Yoga may improve quality of life in patients with prostate cancer.

Detailed Description
-----------------
PRIMARY OBJECTIVES: I. Determine any change in pain, fatigue and psychological well-being as a result of SKY in prostate cancer (PCa) patients. II. Assess changes in some physiological parameters in response to SKY in the same subjects, compare these with those from Part 1, and assess whether these translate into clinical effects. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I (Control Group): Patients undergo collection of blood, saliva, and hair samples after signing consent (pre-test 1), within 6-8 weeks after pre-test 1 (post-test 1), and within 2-4 months after post-test 1 (post-test 2). Patients may receive yoga instruction for 1 week after post-test 2. ARM II (Yoga Group): Patients receive yoga instruction over approximately 3 hours daily for 5 days of week 1 and over 2 hours once a week of weeks 2-13. Patients also undergo collection of blood, saliva, and hair samples within 2 months prior to starting yoga instruction, within weeks 2-3, and within weeks 14-15.

Official Title
-----------------
A Comprehensive Yoga Program (SKY) as an Adjunct Therapy for Prostate Cancer - A Randomized Pilot Study

Conditions
-----------------
Prostate Carcinoma

Intervention / Treatment
-----------------
* Other: Yoga


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Having finished radiotherapy at least two months ago Ability to speak and read English and give informed consent Have an interest in being part of a study to evaluate yoga-derived exercises and eager to practice some kind of relaxation exercise daily for 3 months Exclusion Criteria: Have a diagnosis of psychiatric illness or other major illness in addition to PCa, such as other cancers, uncontrolled hypertension, lung disease, liver disease or heart disease

Ages Eligible for Study
-----------------
Minimum Age: 45 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Arm I (Control group)<br>Patients may receive yoga instruction for 1 week after post-test 2. | |
| Experimental: Arm II (Yoga group)<br>Patients receive yoga instruction over approximately 3 hours daily for 5 days of week 1 and over 2 hours once a week of weeks 2-13. | Other: Yoga<br>* Receive yoga instruction<br>* Other names: Yoga Therapy;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the anxiety and depression, as defined in Hospital Anxiety and Depression Scale (HADS) | HADS is a 14-item self-rating scale that measures anxiety and depression. HADS will be compared before and after intervention. | 15 weeks after study start | 
| Change in global health-status/QOL scale symptoms as defined in the EORTC Quality-of-life Questionnaire (EORTC QLQ-C30) | European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire (EORTC QLQ-C30) is a cancer-specific 30-item questionnaire incorporating 5-functioning scales, a global health-status/QOL scale and symptoms assessment. | 15 weeks after study start | 
| Change in psychological well-being as defined in the Life Orientation Test-Revised (LOT-R) | LOT-R is a 10-item self-report scale that measures the expectations about positive outcome in general. | 15 weeks after study start | 
| Change in fatigue as defined in 36-item short-form health survey (SF-36) vitality scale | SF-36 is a reliable and valid measure of energy/fatigue in the past month. | 15 weeks after study start | 
| Change in pain based on brief pain inventory - short form | Pain will be assessed with the brief pain inventory - short form (BPI-SF) questionnaire. | 15 weeks after study start | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in antioxidant status: superoxide dismutase | Change in the enzyme indicative of antioxidant status, superoxide dismutase, will be assessed. | 15 weeks after study start | 
| Change in antioxidant status: glutathione peroxidase | Change in the enzyme indicative of antioxidant status, glutathione peroxidase, will be assessed. | 15 weeks after study start | 
| Change in serum 8-isoprostane | Serum 8-isoprostane level will also be measured as an indicator of oxidative stress. | 15 weeks after study start | 
| Change in saliva cortisol | Change in saliva cortisol will be compared before and after the intervention to assess the psychophysiological stress. | 15 weeks after study start | 
| Change in hair cortisol | Change in hair cortisol will be assessed as a measure of psychophysiological stress using a 1-inch strand of hair taken from the back of the head. | 15 weeks after study start |