A Feasibility Study Followed By A Randomized Phase II Study Of Yoga For Radiation Therapy Side Effects In Prostate Cancer

Study Overview
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Brief Summary
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This study will ascertain the feasibility and effect of Eischens yoga interventions on radiation related fatigue, sexual dysfunction and urinary incontinence in stage I /II prostate cancer patients undergoing radiotherapy with photons and/or protons without prostatectomy. Subjects must be smoke free and have not taken regular yoga classes 6 months prior to enrollment. Subjects will participate in twice weekly yoga sessions for 8 weeks and complete 4 quality of life forms 5 times during study.

Detailed Description
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The feasibility study refers to the ability to recruit patients willing to participate in the Eischens yoga interventional arm. Those who are recruited during the feasibility study are seemlessly move to the Phase II study, and for this reason the feasibility study and Eischens yoga interventional arms are reported simply as the Eischens yoga interventional arm.

Official Title
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A Feasibility Study Followed By A Randomized Phase II Study Of Yoga For Radiation Therapy Side Effects In Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Radiation: Radiotherapy
* Other: Eischens Yoga


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients Prostate cancer patients undergoing active radiation therapy (external beam radiation with photons and/ or protons). Prior or concurrent androgen deprivation therapy is permitted. Patients of age >18 years, and all races will be included in the study. Patients must have an ECOG Performance Score ≤ 1 All patients must sign an informed consent form Caregivers Subject is age >18 years Subject is English-speaking Subject must sign an informed consent form Exclusion Criteria Patients Patients with medical restrictions that may interfere with or prevent them from taking part in the yoga interventions per their physician orders as evaluated by ECOG Performance Status score. Active, regular cigarette smokers, such that smoking may interfere with relaxation and breathing modalities of the yoga interventions. (Smokers that have been smoke-free for 6 months may be included) Patients who currently practice or have recently practiced yoga (taken a yoga class on a regular basis in the last 6 months). Patients who are undergoing chemotherapy for any reason Patients with evidence of metastatic disease Caregivers Subjects that are unwilling or unable to provide informed consent Subjects with medical restrictions that may interfere with or prevent them from taking part in the yoga interventions Active, regular cigarette smokers, such that smoking may interfere with relaxation and breathing modalities of the yoga interventions. (Smokers that have been smoke-free for 6 months may be included) Patients who currently practice or have recently practiced yoga (taken a yoga class on a regular basis in the last 6 months).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Feasibility Phase: Eischens Yoga Group<br> | Radiation: Radiotherapy<br> <br> Other: Eischens Yoga<br> <br> |
| Phase II: Eischens Yoga Group<br> | Radiation: Radiotherapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brief Fatigue Inventory Score | A 9 item 11 point Likert-scale that rapidly assesses fatigue severity 0 - 90 range with greater numbers indicating greater levels of fatigue | 8 weeks | 
| Functional Assessment of Cancer Therapy: Physical Well-Being Score | 7 item 5 point Likert-scale questionnaire. 0 - 35 range with larger number implies better physical well-being | 8 weeks | 
| Functional Assessment of Cancer Therapy: Social Well-Being Score | 7 item 5 point Likert-scale questionnaire. 0 - 35 range with larger number implies better social well-being | 8 weeks | 
| Functional Assessment of Cancer Therapy: Emotional Well-Being Score | 6 item 5 point Likert-scale questionnaire. 0 - 30 range with larger number implies better emotional well-being | 8 weeks | 
| Functional Assessment of Cancer Therapy: Functional Well-Being | 7 item 5 point Likert-scale questionnaire. 0 - 35 range with larger number implies better functional well-being | 8 weeks | 
| International Index of Erectile Function Score | 5 item and 5 point Likert-scale The scores range from 0 to 25, with scores >21 indicating normal erectile function and scores <12 indicating moderate to severe ED | 8 weeks | 
| International Prostate Symptom Score | 8 item 6 point Likert-scale Scores on this scale range from 0 to 35, with a score of 8 to 19 indicating moderate urinary symptoms and 20 to 35 severe urinary symptoms | 8 weeks |