A Comprehensive Yoga Program (SKY) as an Adjunct Therapy for Prostate Cancer - A Randomized Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Emory University
- Enrollment
- 45
- Locations
- 2
- Primary Endpoint
- Change in global health-status/QOL scale symptoms as defined in the EORTC Quality-of-life Questionnaire (EORTC QLQ-C30)
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 45 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Arm I (Control group)
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.
Intervention: Yoga (Other)
Outcomes
Primary Outcomes
Change in global health-status/QOL scale symptoms as defined in the EORTC Quality-of-life Questionnaire (EORTC QLQ-C30)
Time Frame: 15 weeks after study start
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.
Change in fatigue as defined in 36-item short-form health survey (SF-36) vitality scale
Time Frame: 15 weeks after study start
SF-36 is a reliable and valid measure of energy/fatigue in the past month.
Change in psychological well-being as defined in the Life Orientation Test-Revised (LOT-R)
Time Frame: 15 weeks after study start
LOT-R is a 10-item self-report scale that measures the expectations about positive outcome in general.
Change in the anxiety and depression, as defined in Hospital Anxiety and Depression Scale (HADS)
Time Frame: 15 weeks after study start
HADS is a 14-item self-rating scale that measures anxiety and depression. HADS will be compared before and after intervention.
Change in pain based on brief pain inventory - short form
Time Frame: 15 weeks after study start
Pain will be assessed with the brief pain inventory - short form (BPI-SF) questionnaire.
Secondary Outcomes
- Change in saliva cortisol(15 weeks after study start)
- Change in serum 8-isoprostane(15 weeks after study start)
- Change in antioxidant status: superoxide dismutase(15 weeks after study start)
- Change in antioxidant status: glutathione peroxidase(15 weeks after study start)
- Change in hair cortisol(15 weeks after study start)
Investigators
Omer Kucuk
Principal Investigator
Emory University