A Feasibility Study Followed By A Randomized Phase II Study Of Yoga For Radiation Therapy Side Effects In Prostate Cancer
Conditions: Prostate Cancer
Sponsor: Abramson Cancer Center at Penn Medicine

  
CONFIDENTIAL 
This material is the property of the University of Pennsylvania.  Do not disclose or use except as authorized in writing by the study 
sponsor 
CLINICAL RESEARCH PROTOCOL 
 
 
 
 
 
 
 
 
A Feasibility Study Followed by a Randomized Phase II Study of Yoga for Radiation Therapy 
Side Effects in Prostate Cancer. 
 
 
 
 
 
Principal 
investigator: 
Neha Vapiwala, MD 
Department of Radiation Oncology 
Hospital of University of Pennsylvania 
Perelman Center for Advanced Medicine 
3400 Civic Center Blvd. 
Philadelphia, PA 19104 
Telephone: 215-614-0461 
Email: Neha.Vapiwala@uphs.upenn.edu 
 
Sub-
investigators: 
Avital Mazar Ben-Josef, DMD, RYT  
Paul Wileyto, PhD 
John Christodouleas, MD, MPH 
Zelig Tochner, MD 
Justin Bekelman, MD 
Stephen Hahn, MD 
 
Study Product: 
Curtiland Deville, MD 
N/A 
 
Protocol 
Number: 
UPCC# 05813 
IRB# 817490 
 
IND Number: 
N/A  
 
 
 
 

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Initial Version:  02/06/2013 
Amended: 
 03/04/2013 
Amended:  
 03/19/2013 
Amended: 
 05/06/2013 
Amended:  
 05/22/2013 
Amended:  
  08/21/2013 
Amended:  
  05/09/2014  
Amended:  
  09/24/2014 
 

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Table of Contents 
 
STUDY SUMMARY ..................................................................................................................... 1 
1 INTRODUCTION ................................................................................................................... 2 
1.1 BACKGROUND ..................................................................................................................... 2 
2 STUDY OBJECTIVES ........................................................................................................... 4 
3 STUDY DESIGN ..................................................................................................................... 5 
3.1 GENERAL DESIGN ............................................................................................................... 5 
3.2 STUDY MEASURES ............................................................................................................... 5 
3.3 PRIMARY STUDY ENDPOINTS .............................................................................................. 8  
3.3.1     Pilot Study ................................................................................................................... 8   
3.3.2    Randomized phase II study……………………… ………………………………………….9  
3.3.2.1   Primary study endpoints……………………………………………………………...9      
3.3.2.2   Secondary study endpoints………………………………………………...…………9     
4 SUBJECT SELECTION AND WITHDRAWAL ................................................................ 9 
4.1 INCLUSION CRITERIA ........................................................................................................... 9 
4.2 EXCLUSION CRITERIA ....................................................................................................... 10 
4.3 SUBJECT RECRUITMENT AND SCREENING ......................................................................... 10 
4.4 
RANDOMIZATION ............................................................................................................... 11 
4.5 EARLY WITHDRAWAL OF SUBJECTS .................................................................................. 11 
4.5.1 When and How to Withdraw Subjects ....................................................................... 11 
4.5.2 Data Collection and Follow-up for Withdrawn Subjects .......................................... 11 
5 STUDY DRUG ...................................................................................................................... 11 
6 STUDY PROCEDURES ....................................................................................................... 11 
7 STATISTICAL PLAN .......................................................................................................... 12 
7.1 
DESIGN .............................................................................................................................. 12 
7.1.1    Pilot Study..................................................................................................................12 
7.1.2   Randomized Phase II Study........................................................................................13  

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7.1.2.1     Sample Size Determination…………………………………………………13  
7.1.2.2    Statistical Methods…………………………………………………………..13 
7.1.2.3   Subject Populations for Analysis…………………………………………….14  
8 SAFETY AND ADVERSE EVENTS .................................................................................. 14   
    8.1    ASSESSING AND REPORTING OF AE‟S AND SAE‟S ............................................................ 14 
     8.2     INSTITUTIONAL REVIEW BOARD NOTIFICATION BY INVESTIGATOR………………….….15 
 
     8.3     DATA SAFETY MONITORING COMMITTEE NOTIFICATION BY INVESTIGATOR……..……...16 
     8.4    ABRAMSON CANCER CENTER INTERNAL DATA SAFETY AND MONITORING .................... ..16 
9 DATA HANDLING AND RECORD KEEPING ............................................................... 18 
9.1 CONFIDENTIALITY ............................................................................................................. 18 
9.2 SOURCE DOCUMENTS ........................................................................................................ 18 
9.3 CASE REPORT FORMS ........................................................................................................ 19 
9.4 RECORDS RETENTION ........................................................................................................ 19 
10 STUDY MONITORING, AUDITING, AND INSPECTING .......................................... 19 
10.1 STUDY MONITORING PLAN .............................................................................................. 19 
10.2 AUDITING AND INSPECTING ............................................................................................. 20 
11 ETHICAL CONSIDERATIONS ....................................................................................... 20 
12 STUDY FINANCES ............................................................................................................ 21 
12.1 FUNDING SOURCE ............................................................................................................ 21 
12.2 CONFLICT OF INTEREST ................................................................................................... 21 
12.3 SUBJECT STIPENDS OR PAYMENTS ................................................................................... 21 
13 PUBLICATION PLAN ....................................................................................................... 21 
14 REFERENCES .................................................................................................................... 23 
APPENDIX 
 
       YOGA FOR PROSTATE CANCER QUESTIONNAIRE  
 
 

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List of Abbreviations 
 
 
 
CAM – Complementary and Alternative Medicine 
 
ED – Erectile Dysfunction 
 
SD – Sexual Dysfunction 
 
UI – Urinary Incontinence  
 
IIEF - The International Index of Erectile Function Questionnaire. 
 
IPSS - The International Prostate Symptom Score Sheet  
 
BFI - Brief Fatigue Inventory  
 
FACT-G - Functional Assessment of Cancer Therapy-General 
 
 
 
 

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Study Summary 
Title 
A Feasibility Study Followed by a Randomized Phase 2 Study of 
Yoga for Radiation Therapy Side Effects in Prostate Cancer 
Short Title 
Yoga for Prostate Cancer 
Protocol Number 
UPCC# 05813   
Phase 
Feasibility study followed by a randomized Phase II study 
Methodology 
A single arm pilot followed by a 2-arm study 
Study Duration 
12 months for Feasibility. 36 months for Phase II 
Study Center(s) 
Perelman Center for Advanced Medicine 
Objectives 
The purpose of this study is to ascertain the feasibility of yoga 
interventions as well as the effect of yoga on radiation-related 
fatigue, sexual dysfunction and urinary incontinence in patients 
with non-metastatic prostate cancer. 
Number of Subjects 
63 
Diagnosis and Main 
Inclusion Criteria 
Non-metastatic prostate cancer patients undergoing radiation 
therapy 
Study Product, 
Dose, Route, 
Regimen 
N/A 
Duration of 
administration 
Twice weekly yoga sessions for duration of radiation treatment.  
Reference therapy 
N/A 
Statistical 
Methodology 
The primary hypothesis will be tested using a two-group t-test to 
compare difference scores between Yoga and control groups.  
 

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1 
Introduction 
This document is a protocol for a human research study. This study is to be conducted 
according to US and international standards of Good Clinical Practice (FDA Title 21 part 
312 and International Conference on Harmonization guidelines), applicable government 
regulations and Institutional research policies and procedures.  
1.1 
Background 
It is estimated that 241,740 men will be diagnosed with prostate cancer in 2012. From 
2005-2009 the median age at diagnosis for cancer of the prostate was 67 years of age; 
approximately 9.5% between the ages of 45 and 54, 31.6% between 55 and 64, and 
35.5% between 65 and 74 years old. (1). 
For most cancer patients, the most common side effects of cancer as a disease, and cancer 
treatment are pain, depression and fatigue (2). Cancer –related Fatigue (CRF) is defined 
as “a common, persistent, and subjective sense of tiredness related to cancer or to 
treatment of cancer that interferes with usual functioning (3). CRF differs from everyday 
life fatigue, which is usually temporary and can be relieved by rest or sleep. The impact 
of CRF on a patient‟s ability to function in daily life is considerable and has been found 
to adversely affect patients‟ quality of life even more than pain (4-8).  Fatigue is reported 
in 40 -75% of cancer patients. The prevalence of CRF increased to 60-93% in patients 
receiving radiotherapy (RT) (4-6), and when Visual Analogue Fatigue Scales were used, 
the percentage rose up to 99% (9). 
However too many cancer patients suffering from fatigue receive inadequate treatment 
for their symptoms (2). The National Comprehensive Cancer Network guidelines 
recommend that integrative non-pharmacologic interventions be implemented for 
managing CRF. Various studies demonstrated positive effect from physical activity 
interventions during and after cancer treatment. These studies also showed that exercise 
is safe and well tolerated by patients during various cancer treatments including radiation 
therapy (10-13).  
Specifically, prostate cancer patients report high levels of urinary and sexual adverse 
effects with more than half of the patients reporting poor sexual drive (14). Erectile 

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dysfunction (ED) is defined by the National Institute of Health as “the inability to achieve 
or maintain an erection sufficient for satisfactory sexual performance” (15). ED is 
reported in 21% to 85% of patients (16-19). The etiology of ED after RT is still 
debatable, with studies demonstrating occlusive vascular disease and hemodynamics 
interferences, nerve damage and or damage to the proximal penile structures, such as the 
penile bulb, the neurovascular bundle, and the local vascular structures (16, 18). Urinary 
incontinence (UI) is loss of bladder control. There are several forms of UI. The most 
common type is stress incontinence, which is caused by a loss of outlet resistance at the 
bladder neck. UI occurs when the bladder detrusor muscle contracts involuntarily during 
bladder filling, and is a more common side effect of RT. The prevalence of UI after RT is 
24% and may take years to develop (14, 16). 
The popularity of complementary and alternative medicine (CAM) has been growing 
rapidly in the general population with up to 69% of Americans now using some modality 
of CAM (20). Among cancer patients the prevalence of CAM use has increased two to 
threefold in the last two decades (21-23). Most cancer patients use CAM hoping to boost 
their immune system, relieve pain and control cancer and cancer treatment‟s side effects 
(24). The National Center for Complementary and Alternative Medicine (NCCAM) 
defines CAM as “a group of diverse medical and health care systems, practices and 
products that are not presently considered to be part of conventional medicine” 
(http://nccam.nih.gov/health/whatiscam/). Research on the use of yoga as a modality for 
alleviating prostate cancer patients‟ side effects has been minimal (25). 
“The primary aim of yoga is to restore the mind to simplicity and peace, and free it from 
confusion and distress. This sense of calm comes from the practice of yogic asanas and 
pranayama.” B.S. K. Iyengar.  Yoga rejuvenates the body, restores natural energy, 
decreases pain, reduces stress, as well as increases muscular strength and flexibility. 
Nevertheless, most research done in the past using yoga as a treatment modality used 
women and breast cancer patients as the treatment groups. Participation of men in yoga 
may be a challenge. The first goal of our study is to evaluate the feasibility of using yoga 
as a treatment modality in prostate cancer patients. If successful, we will continue 
seamlessly to a randomized study to determine the effects of yoga on fatigue as measured 
by the Brief Fatigue Inventory (BFI). We will also ascertain the effects of yoga on overall 

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QOL as measured by the Functional Assessment of Cancer Therapy-General (FACT-G) 
instrument, E.D. and U.I by using the IIEF and IPSS questionnaires respectively. The 
long-term goal of our study is to determine the approximate effect of yoga on fatigue and 
QOL to inform a subsequent larger randomized study of yoga compared to a control 
group of patients receiving standard supportive care.  QOL instruments will be 
administered pretreatment, during  treatment, and within a week of the last yoga class or 
by the end of radiation.  
2 
Study Objectives 
1. To determine the feasibility of implementing yoga interventions for men with 
non-metastatic prostate cancer undergoing radiation therapy. 
2. To examine the effect of yoga on cancer and radiation related fatigue, stress levels 
and patients‟ quality of life, in addition to standard of care, during active radiation 
therapy.  
3. To examine the effect of yoga intervention on SD, ED and UI during active 
radiation therapy. 
4. To examine the effect of yoga intervention on caregiver quality of life during 
patient‟s active radiation therapy as measured by the FACT-G 
 

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3 
Study Design 
3.1 
General Design 
1. This study will have 2 phases, and will consist of a preliminary study of 
feasibility, and a two-arm, phase 2 randomized study of efficacy, with a go/ no-go 
decision for phase 2 based on feasibility.  
2. Those enrolled in the feasibility study will be part of the yoga treatment arm at 
analysis time. 
3.2 
Study Measures 
1. Baseline information will be collected prior to start of yoga therapy. (age, 
race/ethnicity, marital/partner status, educational history, income, residence 
location, travel time to facility, method of travel, details regarding co-morbidities, 
disease stage, detail of their current radiotherapy). 
2. The Brief Fatigue Inventory (BFI) questionnaire is a 9 –item scale that will be used 
to rapidly assess fatigue severity. The first three questions rate the severity of the 
patient‟s fatigue at its “worst”, “usual” and “now” levels over the last 24 hours, 
with 0 meaning “no fatigue” and 10 being “fatigue as bad as you can imagine”. Six 
questions assess the amount that fatigue has interfered with different aspects of the 
patient‟s life during the past 24 hours. The interference items include general 
activity, mode, walking ability, normal work (includes both work outside the home 
and housework), relations with others, and enjoyment of life. The interference 
questions are measured on a 0 -10 scale, with 0 being “does not interfere” and 10 
being “completely interferes”. Scores on this scale range from 0-10, with a mean 
score of 4.7 and S.D of 2.8.  The BFI questionnaire will be completed by patients 
at the following time points: 
a. Prior to start of radiotherapy i.e. on the day of consultation or on the day of 
simulation or setup.  
b.  Bi-weekly while receiving radiotherapy 

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i. A treatment week is defined as 5 consecutive days of radiotherapy.  
If a patient misses treatment for any reason his treatment week is 
shifted back one day.   
c. Within a week of the last yoga class or by the end of radiation. 
3.  The FACT-G is a commonly used instrument measuring general QOL reflecting 
symptoms or problems associated with malignancies across 4 scales: physical 
well-being (7 items); social/family well-being (7 items); emotional well-being (6 
items); and functional well-being (7 items).  Patients rate all items using a five-
point rating scale ranging from “not at all” to “very much.”  The measure yields 
information about total QOL, as well as information about the dimensions of 
physical well-being, and disease-specific concerns.  Six additional experimental 
items request information regarding how each dimension affects QOL, using a 
“0” (not at all) to “10” (very much so) rating scale.   FACT-G is a 27 item 
compilation of general questions divided into 4 primary QOL domains: physical 
well-being, social/family well-being, emotional well-being, and functional well-
being.  FACT-G takes about 5 minutes to complete and has been written at the 
6th grade level. FACT-G questionnaire will be completed by patients and their 
caregivers who enroll on study at the following time points: 
a. Prior to start of radiotherapy i.e. on the day of consultation or on the day of 
simulation or setup.  
b. In the 4th week of radiotherapy (when treatment-related symptoms are 
expected to peak) 
i. A treatment week is defined as 5 consecutive days of radiotherapy.  
If a patient misses treatment for any reason his treatment week is 
shifted back one day.   
c. Within a week of the last yoga class or by the end of radiation. 
4. The International Index of Erectile Function Questionnaire (IIEF-5), also referred 
to as the Sexual Health inventory for Men (SHIM) will be used to assess ED and 

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SD. Scores range from 0 to 25. Scores (>20) indicate normal degree of erectile 
function. Scores 10> indicate moderate to severe erectile dysfunction. The IIEF 
will be completed by patients at the following time points: 
a. Prior to start of radiotherapy i.e. on the day of consultation or on the day of 
simulation or setup.  
b. In the 4th week of radiotherapy (when treatment-related symptoms are 
expected to peak) 
i. A treatment week is defined as 5 consecutive days of radiotherapy.  
If a patient misses treatment for any reason his treatment week is 
shifted back one day.   
c. Within a week of the last yoga class or by the end of radiation. 
5. The International Prostate Symptom Score Sheet (IPSS) will be used to determine 
the severity of enlarged prostate conditions and measures UI symptoms. Scores on 
this scale range from 0 to 35, where a score of 8-19 indicate moderately 
symptomatic, and 20-35 – severely symptomatic. The 8th question on this scale is 
on QOL and is assigned a score of 1 to 6, where 6 indicates terrible. The IPSS 
will be completed by patients at the following time points:  
a. Prior to start of radiotherapy i.e. on the day of consultation or on the day of 
simulation or setup.  
b. In the 4th week of radiotherapy (when treatment-related symptoms are 
expected to peak) 
i. A treatment week is defined as 5 consecutive days of radiotherapy.  
If a patient misses treatment for any reason his treatment week is 
shifted back one day.   
c. Within a week of the last yoga class or by the end of radiation. 
6. Yoga interventions will consist of twice-weekly classes, 75 minutes each that will 
be offered by a yoga instructor. The simplified poses to be used in this study will 

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include seated (using a chair), standing, and reclining. Yoga poses can and will be 
modified based on each subjects specific needs and restrictions. Not all yoga 
poses will be performed each session. Each session will begin with breathing and 
centering techniques (taking inventory of the levels of energy, posture, stress, 
emotions, and breath). Yoga poses will consist of the following:  
 Sitting on chair: neck and shoulder series (neck and shoulders side, front 
and back movements, shoulder rolls, and arms movement), table pose with 
opposite arm and leg movement, side bend (seated Parighasana), simple 
chair twist (Bharadvajasana).  
 Standing poses:  mountain pose (Tadasana Samasthithi), warrior II series 
(Virabhadrasana II), half moon (Ardha Chandrasana) variation at the wall, 
front warrior series, forward stretch/ bend variation (Uttanasana).  
 Recline poses will include: inverted lake pose (Viparita Karani), bridge 
pose variation (Setubandha Sarvangasana), recline/ sited bound angle pose 
(Supta Baddhakonasana), camel pose (Ustrasana) at the wall, modified 
shoulder stand (salamba sarvangasana), reclining big toe posture with a belt 
(Supta Padangustasana), and corpse pose (Savasana). 
 
3.3 
Study Endpoints 
3.3.1 Pilot Study 
The primary goal of this pilot is to determine the feasibility of recruiting and retaining 
men into a clinical trial of yoga to improve fatigue and health related quality of life in 
prostate cancer patients undergoing radiation treatment. The endpoint is the number of 
evaluable patients accrued, with a minimum target goal of 15 of the first 75 eligible 
patients approached. 
 
3.3.2 Randomized Phase II Study 
    3.3.2.1 Primary Study Endpoints 

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The primary goal is to determine the effect size of yoga on fatigue. The endpoint 
is the difference in BFI fatigue score between time points during radiation therapy 
and baseline prior to radiation. 
 
3.3.2.2 Secondary Endpoints  
The effect size of yoga on ED, UI and general QOL 
4 
Subject Selection and Withdrawal 
4.1 
Subject Recruitment and Screening 
Patients will be recruited from the Perelman Radiation Oncology Center and will be 
assessed for eligibility before starting treatment. Patients will be pre-screened for barriers 
to participation in physical activity using the standard of care metric „ECOG Performance 
Status‟.  All potentially eligible candidates will then be asked to take the Yoga in Prostate 
Cancer Study Questionnaire (**see appendix***) to assess baseline beliefs, goals and 
interest in study participation and approached with details of the clinical study to assess 
their eligibility and interest in enrollment. This survey would be offered to all prostate 
cancer patients seen in the department of radiation oncology during both the feasibility 
and randomized phases of the trial. The questionnaires from all patients who complete 
one will be analyzed as a separate, smaller part of the overall study to better understand 
barriers and promoters to enrollment. Patients and caregivers will be officially enrolled in 
the study only after eligibility is confirmed, the informed consent process is performed 
and relevant signatures are obtained. 
 

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4.2 
Inclusion Criteria 
Patients 
1. Prostate cancer patients undergoing active radiation therapy (external beam 
radiation with photons and/ or protons). Prior or concurrent androgen deprivation 
therapy is permitted. 
2. Patients of age >18 years, and all races will be included in the study.  
 
3. Patients must have an ECOG Performance Score ≤ 1 
4. All patients must sign an informed consent form approved for this purpose by the 
Institutional Review Board (IRB) of the University of Pennsylvania. 
5. Patients must be English-speaking. 
Caregivers 
 
1.  Subject is age >18 years 
2. Subject is English-speaking 
3. Subject must sign an informed consent form approved for this purpose by the 
Institutional Review Board (IRB) of the University of Pennsylvania. 

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4.3 
Exclusion Criteria 
Patients 
1. 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. 
2. 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)  
3. Patients who currently practice or have recently practiced yoga (taken a yoga 
class on a regular basis in the last 6 months). 
4. Patients who are undergoing chemotherapy for any reason 
 
5. Patients with evidence of metastatic disease  
Caregivers 
 
1. Subjects that are unwilling or unable to provide informed consent 
2. Subjects with medical restrictions that may interfere with or prevent them from 
taking part in the yoga interventions 
3. 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) 
4. Patients who currently practice or have recently practiced yoga (taken a yoga 
class on a regular basis in the last 6 months). 
4.4 
Randomization 
Both patients and caregivers will be randomized (without replacement) by lists created 
using small permuted blocks.   
 

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4.5 
Early Withdrawal of Subjects 
4.5.1 When and How to Withdraw Subjects 
The principal investigator may withdraw subjects if it is felt to be necessary for the health 
and safety of the subject. Additionally subjects may be withdrawn for not following study 
instructions. We expect up to 20% of subjects to drop out from the study due to time 
constraints, use of other CAM, and concurrent illness. 
4.5.2 Data Collection and Follow-up for Withdrawn Subjects 
All efforts will be made to connect with the subjects by mail and/or phone to better 
understand the reasons for the withdrawal and make an assessment for better future 
recruitment, as well as for a better implementation of the yoga interventions. 
5 
Study Drug  
N/A 
6 
Study Procedures 
    Feasibility and Yoga Treatment Arm 
Subjects will participate in two 75 minute sessions per week for the duration of radiation 
treatment with a yoga instructor offered for free by Patient Family Services in the 
Perelman Center of Advanced Medicine. Numerous sessions will be offered each week. 
Each session will begin with breathing and centering techniques (taking inventory of the 
levels of energy, posture, stress level, emotions, and breath). Yoga poses will consist of 
the following and can be modified based on patient needs: Sitting on chair: neck and 
shoulder series (neck and shoulders side, front and back movements, shoulder rolls, and 
arms movement), Table pose with opposite arm and leg movement. Side bent. Simple 
chair twist. Standing poses:  Mountain pose, Warrior II series, Half Moon variation at the 
wall, Front warrior series, forward stretch/ bend variation with a chair. Recline poses will 
include: inverted lake pose (legs up the wall with a blanket for support), bridge pose 
variation, recline/ sited bound angle pose, modified Camel pose at the wall, modified 
Shoulder stand (legs up the wall with block support), reclining big toe posture with a belt, 
and corpse pose (Savasana – final rest). Modifications can and will be made based on 

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each subjects specific needs and physical restrictions. Poses will be added progressively. 
Not all poses will be done each session. Additionally subjects will fill out 4 types of QOL 
forms at various points during the study. The first is to be completed prior to start of 
radiation treatment, bi-weekly during treatment and within a week of the last yoga class 
or by the end of radiation 
 
No Yoga Treatment Arm 
Control patients who are randomized to standard of care will not undergo any yoga 
intervention or participate in any structured yoga program during the study duration. 
They will undergo cancer and side effect treatment per standard of care, and they will be 
asked to complete all study-related questionnaires at the same time points as the patients 
in the yoga treatment arm.   
7 
Statistical Plan 
7.1 
Design 
This is a feasibility study followed by a seamless transition to a randomized phase II 
study.  
7.1.1 Pilot study 
Feasibility (aim 1) will be declared if we successfully accrue 15 evaluable patients of the 
first 75 approached. Patients participating in the feasibility portion of the study will move 
seamlessly into the phase II study. The data from these patients will be included in the 
phase II trial portion of this study. Given the number of prostate cancer patients 
historically treated in the Radiation Oncology department, we anticipate that this rate of 
enrollment would allow completion of the phase II trial within <3 years. 
7.1.2 Randomized phase II trial  
7.1.2.1 Sample size determination  
Our goal is to estimate effect sizes for a larger study. We are setting our recruitment aim 
for phase 2 up to 48 subjects, a 20% increase from our target enrollment in order to 
account for potential subject drop out and arrive at N = 40. Inclusion of subject data from 

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the feasibility portion results in N = 55 up to N = 63 should subject attrition levels prove 
lower than expected. Two groups (35 v 20) give us power to estimate an effect size for 
yoga participation with a 95% confidence interval that is approximately 1.1 standard-
deviations wide (compared to the SD of the raw measure). For the corresponding care-
givers, two groups (20 v 20) give power to estimate a CI that is 1.3 SD wide.  The effect 
will be measured as a time x treatment interaction (difference of difference scores).  From 
our own preliminary data, and from Hwang et al. (2008), we know that the within subject 
correlation for fatigue measures is approximately 0.5, and that the SD for the difference 
score will be similar to that of the raw measure at individual time points.  For the time x 
treatment interaction, we will be able to detect a standardized effect size of d=0.7 (0.8 for 
caregivers) at α=0.05 (one-sided) with 80% power. 
 
7.1.2.2 Statistical Methods 
This randomized study is a two-arm longitudinal controlled trial of yoga as a means of 
reducing fatigue over the course of radiation therapy for prostate cancer, with measures 
taken prior to treatment, during treatment, and in follow-up. The analysis will include the 
initial subjects from the feasibility study as an addition to the treatment arm, and we will 
control for any differences between the feasibility group and the randomized treatment 
arm using indicators.  The primary measure, and most secondary measures, are Likert-
style summary scores on a 0-10 scale and will be treated as Gaussian.  The exception is 
retention, which is a binomial count of those remaining enrolled to the end.   
 
Prior to performing analyses, standard data cleaning procedures will be applied (e.g., 
checking for outliers and data entry errors, creating summary scores for analysis, and 
checking that analysis assumptions are met).  The assumptions underlying the statistical 
methods will be examined through the use of standard tests of normality, and graphical 
displays (27).  All analyses will be conducted using Stata software (Stata Corporation, 
College Station, TX).   
 

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We will calculate descriptive statistics for all variables in the study.  For outcome 
variables, we will summarize by treatment group (Yoga versus control) and by time 
point.  We will also estimate correlations within subject for each of the study measures 
taken at different times.   
 
The primary outcome for the randomized, phase II study will be the difference score of 
BFI fatigue while undergoing radiation therapy minus BFI fatigue prior to radiation.  The 
primary hypothesis will be tested using a two-group t-test to compare difference scores 
between Yoga and control groups.  This will be a one-sided test with type-1 error at 
a=0.05.  Similar analysis will be conducted using BFI fatigue at follow-up versus pre-
radiation, and for all of the FACT-G fatigue measures. We will test the difference using a 
one-sided z-test. The FACT-G analysis will be repeated for caregivers (Aim 4). 
 
Effect sizes will be reported for all outcome measures as standardized differences.  The 
effect size will reflect the time x treatment interaction, and the standard deviations will be 
adjusted for within-subject correlation to aid in designing a larger study. 
 
7.1.2.3 Subject Population(s) for Analysis 
Statistically evaluable subjects are those who have attended at least 50% of the available 
yoga sessions offered on the days they receive radiation treatment. 
 
 
Subject attends treatment 
Subject misses treatment (inclement 
weather or machine downtime) 
Yoga offered 
Counts towards evaluability 
Counts towards evaluability 
Yoga session not 
offered 
Doesn‟t count for or against 
evaluability  
Doesn‟t count for or against 
evaluability  
 
- 
All caregivers will follow the same evaluability guidelines as the radiation 
therapy population.  If their associated subject undergoes treatment, the caregiver 
is also considered to have undergone “treatment”. 

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3 Evaluable Sections 
 50 – 70% attendance rate 
 71 – 80% attendance rate 
 > 80% attendance rate 
 
8 
Safety and Adverse Events 
8.1 
Assessing and Reporting of AE/ SAE’s 
Although we do not anticipate any adverse and serious adverse events occurring from 
participation in this trial, should any AE‟s or Serious Adverse Events (SAE) occur and are 
determined by the PI to be related they will be reported to the IRB and Data Safety and 
Monitoring Committee (DSMC) in accordance with the specific procedures of each entity. 
Should any SAE‟s or AE‟s occur they will be assessed using NCI Common Terminology 
Criteria for Adverse Events Version 4.0 (CTCAE 4.0)  
 
8.2     Institutional Review Board (IRB) Notification by Investigator 
All events meeting the Penn IRB Standard Operative Procedure for Unanticipated Events 
posing risks to subjects or others will be reported to the IRB as follows: 
 
Unanticipated problems are:  
(1) Unforeseen; and (2) indicate that participants are at increased risk of harm.  The IRB 
requires investigators to submit reports of the following problems within 10 working days 
with one exception: an Adverse Event (regardless of whether the event is serious or non-
serious, on-site or off-site) that occurs any time during or after the research study, which 
in the opinion of the Principal Investigator is both unexpected and related to research 
procedures. 
 
Note:  An event is “unexpected” when its specificity and severity are not accurately 
reflected in the protocol-related documents, such as the IRB-approved research protocol, 

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any applicable investigator brochure, and the current IRB-approved informed consent 
document, and (b) other relevant sources of information, such as product labeling and 
package inserts; an event is “related to the research procedures” if the event is deemed 
probably or definitely related. 
 
The one exception for prompt reporting within 10 days applies to death of a research 
participant.  If the adverse event involved death as unforeseen and indicates participants 
or others are at increased risk of harm, a submitted report will be required within three 
working days. 
 
All non-serious adverse events will be reported to the Principal Investigator via the 
toxicity care report forms.  Further reporting details can be found in the accompanying 
manual of operating procedures.  
 
8.3 
Data and Safety Monitoring Committee (DSMC) Notification by Investigator 
Any expected, unrelated event that is a Grade 3 or higher should be reported to the 
DSMC within 10 days.  All unexpected deaths or deaths related to the study agent or 
device need to be reported to the DSMC within 24 hours.  All other AEs should be 
reported within 30 days of knowledge. Any SAEs, regardless of site, are to be reported to 
the Principal Investigator within 24 hours via telephone or email.    
 
8.4 
Abramson Cancer Center’s Internal Data and Safety Monitoring 
Data and Safety Monitoring Committee 
The Abramson Cancer Center DSMC is charged with the responsibility of reviewing all 
SAEs, deviations, and Medical/Safety Monitoring reports for all cancer-based protocols 
conducted at the University of Pennsylvania.  The DSMC reviews these document and 
data on a monthly basis and makes recommendation necessary to ensure subject safety 
and study integrity.  The Department of Compliance and Monitoring (DOCM) will 

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monitor and audit the progress and conduct of all cancer-based studies in accordance with 
their National Cancer Institute-approved Institutional Data and Safety Monitoring Plan.   
 
Protocol Exceptions/ Deviations 
Occasionally, the investigator may need to deviate from the approved protocol.  
Deviations are categorized as reportable and non-reportable.  Reportable deviations may 
be urgent or not.  Urgent deviations may occur on the spot as necessary to protect the 
safety of a study subject and do not allow enough time for reporting in advance.  
However, they must be reported as soon as possible.  
All exceptions/ deviations from the study protocol will be handled as follows: 
 
An exception is a one time, intentional action or process that departs from the IRB and 
CTSRMC approved study protocol, intended for one occurrence. If the action disrupts the 
study progress, such that the study design or outcome (endpoints) may be compromised, 
or the action compromises the safety and welfare of study subjects, advance documented 
IRB and DSMC approval is required 
 
A deviation is a one time, unintentional action or process that departs from the IRB and 
DSMC approved study protocol, involving one incident and identified retrospectively, 
after the event occurred. If the impact on the protocol disrupts the study design, may 
affect the outcome (endpoints) or compromises the safety and welfare of the subjects, the 
deviation must be reported to the DSMC within 5 business days and the IRB within 10 
business days. 
 
 Non-Reportable - During the course of a study, there may be times 
when deviations are outside of the control of the investigator (i.e. a 
subject not showing up for a study visit, laboratory errors, subject 
confusion, etc.).  These types of deviations are not reportable (unless 
they occur at a level that impacts any of the reportable categories), but 
they must be documented in a timely manner to show the impact of the 
deviation and corrective/follow-up actions that are being taken.  

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Documentation can be in clinic/progress notes or in notes/memos to 
file.  Notes/memos should be signed and dated. 
 
 Reporting Deviations/Exceptions - Reports to the IRB and DSMC 
will be done via the DSMC website at www.ctsrmc.org.  Reportable 
deviations must also be sent to the study MM (if applicable). Please 
reference above section.   
 
9 
Data Handling and Record Keeping 
9.1 
Confidentiality 
Information about study subjects will be kept confidential and managed according to the 
requirements of the Health Insurance Portability and Accountability Act of 1996 
(HIPAA).  Those regulations require a signed subject authorization informing the subject 
of the following:  
 What protected health information (PHI) will be collected from subjects in this 
study 
 Who will have access to that information and why 
 Who will use or disclose that information 
 The rights of a research subject to revoke their authorization for use of their PHI.  
 
In the event that a subject revokes authorization to collect or use PHI, the investigator, by 
regulation, retains the ability to use all information collected prior to the revocation of 
subject authorization.  For subjects that have revoked authorization to collect or use PHI, 
attempts will be made to obtain permission to collect at least vital status (i.e. that the 
subject is alive) at the end of their scheduled study period. 
9.2 
Source Documents 
Source data is all information, original records of clinical findings, observations, or other 
activities in a clinical trial necessary for the reconstruction and evaluation of the trial.  
Source data are contained in source documents.  Examples of these original documents 

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and data records include: hospital records, clinical and office charts, laboratory notes, 
memoranda, subjects‟ diaries or evaluation checklists, pharmacy dispensing records, 
recorded data from automated instruments, copies or transcriptions certified after 
verification as being accurate and complete, microfiches, photographic negatives, 
microfilm or magnetic media, x-rays, subject files, and records kept at the pharmacy, at 
the laboratories, and at medico-technical departments involved in the clinical trial. 
9.3 
Case Report Forms 
Electronic case report forms will be developed and completed in Velos in lieu of paper 
case report forms with the exception of Eligibility and AE/SAE forms which will be 
printed out to be signed by the PI.  
 
9.4 
Records Retention 
HIPAA Retention Period (45 CFR164.530(j): 
Protected Health Information (PHI) Research Requests (HIPAA1-008): Records 
documenting research requests, privacy board review or privacy officer expedited review, 
background material, and acceptance or denial of request. Retain 15 years after research 
completed. 
 
Protected Health Information Disclosure Records (HIPAA1-009): Documenting the 
release of PHI, including both authorized and unauthorized releases. Should include 
the date of release, to whom the information was released, and the circumstances of the 
release. Retain 15 years after research completed. 
 
Maintenance of HIPAA records is independent of the regulations for clinical study 
records.  All records of PHI research requests and any type of release will maintained for 
15 years after the research is fully terminated. 
 

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10 Study Monitoring, Auditing, and Inspecting 
10.1 Study Monitoring Plan 
The study PI is responsible for ensuring the ongoing quality and integrity of the research 
study.  In addition, this study will be monitored or audited in accordance with Abramson 
Cancer Center‟s NCI approved Institutional Data and Safety Monitoring Plan.  
 
10.2   Auditing and Inspecting 
The investigator will permit study-related monitoring, audits, and inspections by the IRB, 
government regulatory bodies, and University compliance and quality assurance groups 
of all study related documents (e.g. source documents, regulatory documents, data 
collection instruments, study data etc.).  The investigator will ensure the capability for 
inspections of applicable study-related facilities (e.g. pharmacy, diagnostic laboratory, 
etc.). 
 
Participation as an investigator in this study implies acceptance of potential inspection by 
government regulatory authorities and applicable University compliance and quality 
assurance offices. 
 
11 Ethical Considerations 
This study is to be conducted according to US and international standards of Good 
Clinical Practice (FDA Title 21 part 312 and International Conference on Harmonization 
guidelines), applicable government regulations and Institutional research policies and 
procedures. 
 
This protocol and any amendments will be submitted to a properly constituted 
Institutional Review Board (IRB), in agreement with local legal prescriptions, for formal 
approval of the study conduct.  The decision of IRB concerning the conduct of the study 
will be made in writing to the investigator and a copy of this decision will be maintained 
in the study specific Regulatory Binder which contains “Essential Study Documents”.  In 
addition, NCI requires all cancer based studies to have an independent scientific review.  

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This protocol must be reviewed and fully approved by the Clinical Trials Scientific 
Review and Monitoring Committee (CTSRMC) prior to enrolling any subjects. 
Documentation of CTSRMC approval must also be maintained in the study specific 
Regulatory Binder. 
 
All subjects for this study will be provided a consent form describing this study and 
providing sufficient information for subjects to make an informed decision about their 
participation in this study.  This consent form will be submitted with the protocol for 
review and approval by the IRB and CTSRMC for the study.  The formal consent of a 
subject, using the IRB-approved consent form, must be obtained before that subject is 
submitted to any study procedure.  This consent form must be signed and dated by the 
subject or legally acceptable surrogate, and the investigator-designated research 
professional obtaining the consent. 
12 Study Finances 
12.1 Funding Source 
This study is being funded by the Department of Radiation Oncology at the University of  
Pennsylvania. 
12.2 Conflict of Interest 
Any investigator who has a conflict of interest with this study (patent ownership, 
royalties, or financial gain greater than the minimum allowable by their institution, etc.) 
must have the conflict reviewed by a properly constituted Conflict of Interest Committee 
with a Committee-sanctioned conflict management plan that has been reviewed and 
approved by the study sponsor prior to participation in this study.  All University of 
Pennsylvania investigators will follow the applicable University conflict of interest 
policies. 
12.3 Subject Stipends or Payments 
The University of Pennsylvania does not intend to provide payment for subject 
participation in this research study.   

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13 Publication Plan 
Neither the complete nor any part of the results of the study carried out under this 
protocol, nor any of the information provided by the sponsor for the purposes of 
performing the study, will be published or passed on to any third party without the 
consent of the study sponsor.  Any investigator involved with this study is obligated to 
provide the sponsor with complete test results and all data derived from the study. 
 

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14 References 
1. The National Cancer Institute. Surveillance Epidemiology and End Results. SEER 
State Fact Sheet: Prostate., 2011 National Institutes of Health State-of-the-Science 
Panel. 
2.  National Institutes of Health State-of-the-Science Conference Statement: 
Symptom Management in Cancer: Pain, Depression, and Fatigue, J. of National 
Cancer Institute, Vol. 95. No.15, 2003 
3. V. Mock, A. Atkinson, A. Barsevick et al. National Comprehensive Cancer 
Network. NCNN Practice Guidelines for Cancer – Related Fatigue. Oncology, 14, 
pp 15-18, 2000. 
4. M. Hofman, J.L. Ryan, C.D. Figueroa-Moseley, P. Jean-Pierre and G.R. Morrow. 
Cancer related Fatigue: The Scale of the Problem, The Oncologist, 12 (suppl1) 
pp. 4-10, 2007 
5. D.H. Henry, H. N. Viswanathan, E.P. Elkin, S. Traina, S. Wade, and D. Cella. 
Symptoms and Treatment Burden Associated with Cancer Treatment: Results 
from a Cross-Sectional National Survey in the U.S. Support Care Cancer. 16, 
pp.791-801, 2008 
6. S. Roberto, L. Abriani, P. Beccaglia, E. Terzoli, and S. Amadori. Cancer related 
Fatigue. Evolving Concepts in Evaluation and Treatment. Cancer, vol. 98, no. 9, 
pp 1786-1801, 2003 
7. M.J Poulson. The Art of Oncology: when the Tumor is not the Target. Not Just 
Tired. J. of Clinical Oncology, vol. 19, n0. 2, 4180-81, 2001 
8. J. Thomas, C. Beinhorn, D. Norton, M. Richardson, S.S Sumler and M Frankel. 
Managing Radiation Therapy Side Effects with Complementary Medicine. J. of 
the Society for Integrative Oncology, vol. 8, no.2, pp 65-80, 2010. 

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9. P. Servaes, C. Verhagen, and G. Bleijenberg. Fatigue in Cancer Patients During 
and After Treatment: Prevalence, Correlates and Interventions. European J. of 
Cancer. 38, pp27-43, 2002. 
10. K.M. Mustian, G. R. Morrow, J. K. Carroll, C.D. Figuero-Moseley, P. Jean-
Pierre, 
and 
G.C. 
Williams. 
Integrative 
Nonpharmacologic 
Behavioral 
Interventions for the Management of Cancer-Related Fatigue. The Oncologist, 12, 
pp52-67, 2007. 
11. F. Cramp and J. Daniel. Exercise for the Management of Cancer – Related fatigue 
in Adults. The Cochrane Collaboration, issue 11, pp 1-38, 2010.   
12. R. Knols, N. K. Aaronson, D. Uebelhart, J. Fransen and G. Aufdemkampe. 
Physical Exercise in Cancer Patients During and After Medical Treatment: A 
Systematic Review of Randomized and Controlled Clinical Trials. J. of Clinical 
Oncology, vol. 23, no. 16, pp 3830-3842, 2005. 
13. C. Ingram and C. Visovsky. Exercise Intervention to Modify Physiologic Risk 
Factors in Cancer Survivors. Seminar in Oncology Nursing. Vol. 23, no.4, pp 
275-284, 2007. 
14. A. E. Kyrdalen, A.A Dahl, E. Hernes, M.C. Smastuen, and S.D. Fossa. A National 
Study of Adverse Effects and Global Quality of Life Among Candidate for 
Curative Treatment for Prostate Cancer. BJU International, pp. 1-10, 2012 
15.  NIH Consensus Development Panel on Impotence : Impotence . JAMA 270, pp 
83-90, 1993 
16. M. Mirza, T.L. Griebling, and M. W. Kazer. Erectile Dysfunction and Urinary 
Incontinence After Prostate Cancer Treatment. Seminars in Oncology Nursing, 
vol. 27, no. 4, pp. 278-89, 2011. 
17. A.L. Burnett et al. Erectile Function Outcome Reporting After Clinically 
Localized Prostate Cancer Treatment. The J. of Urology. Vol. 178, pp. 597-601, 
2007. 

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18. M.W. Brown, J.P.  Brooks, P.S. Albert, and M.M. Poggi. An Analysis of Erectile 
Function after Intensity Modulated Radiation Therapy for Localized Prostate 
Carcinoma. Prostate Cancer and Prostatic Diseases. Vol. 10, pp. 189-93, 2007.  
19. W. Wagner, T. Bolling, C. Hambruegge, J. Hartlapp, and M.G. Krukemeyer. 
Patients‟ Satisfaction with Different Modalities of Prostate Cancer Therapy – a 
Retrospective survey Among 634 Patients. Anticancer Res. vol. 31, no. 11, pp. 
3903-8, 2011. 
20. M.A. Richardson, T. Sanders, J. L. Palmer, A. Greisinger, and E. Singletary. 
Complementary/ Alternative Medicine Use in a Comprehensive Cancer Center 
and the Implications for Oncology. J. of Clinical Oncology. Vol. 18, no. 13, pp. 
2505-14, 2000. 
21. J. Thomas, C. Beinhorn, D. Norton, M. Richardson, S.S Sumler and M Frankel. 
Managing Radiation Therapy Side Effects with Complementary Medicine. J. of 
the Society for Integrative Oncology, vol. 8, no.2, pp 65-80, 2010. 
22. J. S. Yates, K. M. Mustian, G.R. Morrow, L.K Colman et al. Prevalence of 
Complementary and Alternative Medicine use in Cancer Patients During 
Treatment. Support Care Cancer, 13, pp 806-811, 2005. 
23. A.B Swarup, W. Barrett, and A.R. Jazieh. The Use of Complementary and 
Alternative Medicine by Cancer Patients Undergoing Radiation Therapy. Am. J. 
of Clinical Oncology. vol. 29, no. 5, pp. 468-73, 2006. 
24. P.J. Mansky, and D.B. Wallerstedt. Complementary Medicine in Palliative Care 
and Cancer Symptoms Management. The Cancer J. vol. 12, no. 5, pp. 425-31, 
2006. 
25. L.E. Carlson, M. Speca, P. Faris, and K.D Patel. One Year Pre-Post Intervention 
Follow –Up of Psychological, Immune, Endocrine and Blood Pressure Outcome 
of Mindfulness- Based Stress Reduction (MBSR) in Breast Cancer and Prostate 
Cancer Outpatients. Brain Behav. Immun. Vol.21, no. 8, pp. 1038-49, 2007.  
26. J.H. Hwang et al. Effects of Supervised Exercise Therapy in Patients 
Receiving Radiotherapy for Brest Cancer. Yonsei Med. J. voi. 49, No. 3, pp 
443-450, 2008 
27. B.G. Tabachnick, and L.S. Fidell. Using Multivariate Statistics. 4th Edition. 2001 

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Appendix A 
 
Study ID:  
                          
 
Date:   
 
 
Yoga for Prostate Cancer  
Study Questionnaire 
 
You have been invited to participate in a research study because you are 
a prostate cancer patient here at the Perelman Center for Advanced Medicine, 
and your oncologist has recommended radiation therapy for your treatment. The 
purpose of this questionnaire is to better understand patients’ interest in and 
barriers to participating in therapeutic yoga during their radiation therapy for 
prostate cancer. This is an anonymous questionnaire, so please do not put your 
name anywhere on this document. Participation is voluntary, meaning you may 
choose to participate or not. Choosing not to participate will not negatively affect 
the services and benefits to which you are otherwise entitled.  There are no risks 
or benefits to completing this questionnaire. All information collected will be 
stored securely by the research team. You do not have to answer any question 
you do not want to answer, and you can stop the questionnaire at any time. If you 
choose to participate, completion and return of this questionnaire indicates your 
understanding and consent to the above conditions.  
 
 
Yoga is a 5000 year-old spiritual tradition from India, and one of the most 
popular and commonly practiced mind-body therapies in the United States 
today. The following questions ask for your opinion about the use of yoga for 
cancer-related side effects.   
 
Please do your best to answer each question.  If a question is not clear, please 
let our study coordinator or Dr. Neha Vapiwala know.  Thanks again for your 
time and interest! 
 
 
1. Did you practice yoga before your cancer diagnosis? 
 
 
 
 
2. Have you practiced yoga since your cancer diagnosis?   
 
 
 
 
 
 Yes 
 No 
 Yes 
 
 No 
 

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3. According to you, what does yoga involve? (Please check all that apply) 
 
 
 
 
 
 
 
 
 
 
 
4. How interested are you in practicing yoga regularly?  
 
 
 
 
 
 
5. What prevents or would prevent you from practicing yoga regularly? 
 
 
I find it difficult to practice yoga because… 
Not at all 
agree 
A little 
agree 
Moderately 
agree 
Mostly 
agree 
Complete
agree 
 
I do not have interest in or knowledge of 
yoga 
 
 
 
 
 
I cannot afford it 
 
 
 
 
 
I am not flexible enough 
 
 
 
 
 
I cannot bend or twist due to health 
reasons 
 
 
 
 
 
My religious beliefs do not permit me 
 
 
 
 
 
My job is very demanding 
 
 
 
 
 
I have a lot of responsibilities at home 
 
 
 
 
 
Not at all interested 
 
A little interested 
 
Moderately interested 
 
Mostly interested 
 
Completely interested 
 
 Physical postures and stretching 
 Breathing techniques 
 Meditation and spiritual healing 
 Exercise  
 I have no knowledge of yoga 
 
 
 
 
 
 

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There are no yoga classes where I live 
 
 
 
 
 
Nobody in my family/friends practice 
yoga 
 
 
 
 
 
My oncologist never recommended it to 
me 
 
 
 
 
 
I had a bad experience in the past 
 
 
 
 
 
 
 
6. We are interested in performing a yoga study on improving cancer- and treatment-related 
side effects, specifically urinary and erectile dysfunction amongst prostate cancer patients. 
What is your level of interest in participating in this type of yoga study? 
 
 
 
 
7. Although most patients agree that clinical studies are important for improving medical 
knowledge and patient care, many do not participate in clinical studies. How much do you 
agree with the following statements related to participating in a yoga study? 
 
 
 
 
I find it difficult to participate in a yoga study 
because…. 
Do not 
agree at 
all 
Agree a  
little  
Moderately 
agree 
Mostly 
agree 
Complet
agree
 
I don’t want to be part of an experiment 
 
 
 
 
 
I don’t want to be in the ‘placebo’ (no 
yoga) group 
 
 
 
 
 
My job is very demanding 
 
 
 
 
 
I have a lot of responsibilities at home 
 
 
 
 
 
Not at all interested 
 
A little interested 
 
Moderately interested 
 
Mostly interested 
 
Completely interested 
 
 
 
 
 
 

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I don’t trust medical researchers 
 
 
 
 
 
I don’t want to share my private health 
information 
 
 
 
 
 
I cannot bend or twist due to health 
reasons 
 
 
 
 
 
I am not flexible enough 
 
 
 
 
 
My religious beliefs do not permit me 
 
 
 
 
 
I am not interested 
 
 
 
 
 
My physician or loved ones may not 
support my participation 
 
 
 
 
 
 
            
 8. Each man with prostate cancer may have his own different hopes and expectations for 
how a yoga study could impact him. For each statement below, please pick the closest 
answer by checking the box:  
 
If I participate in a yoga study, I hope and 
expect that… 
Do 
not 
agree at all 
Agree a  
little  
Moderately 
agree 
Mostly 
agree 
Completely
agree 
 
My urinary and/or sexual side effects 
from my cancer and treatment would 
improve a lot 
 
 
 
 
 
 
I would be better able to cope with my 
side effects, even if they don’t improve 
 
 
 
 
 
 
My energy level would increase 
 
 
 
 
 
 
 
 
 
 
 
My anxiety about my diagnosis  
 
and treatment would decrease  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Thank you very much for your time and thought in answering our questionnaire! 
 
Sincerely, 
The Yoga in Prostate Cancer Research Study Team