Testing Decision Aids to Improve Prostate Cancer Decisions for Minority Men
Phase: PHASE3
Conditions: Stage II Prostate Cancer, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer, Stage III Prostate Cancer, Stage I Prostate Cancer, PSA Level Five to Ten, PSA Level Less Than Five, PSA Level Ten to Fifty
Sponsor: Alliance for Clinical Trials in Oncology

 
Participants:  
NCORP CCDR components of the Alliance (lead), ECOG-ACRIN, NRG, and SWOG NCORP Research Bases 
 
Version Date 11/30/18 
 
Update #06 
ALLIANCE FOR CLINICAL TRIALS IN ONCOLOGY 
ALLIANCE A191402CD 
TESTING DECISION AIDS TO IMPROVE PROSTATE CANCER DECISIONS FOR MINORITY 
MEN 
ClinicalTrials.gov Identifier: NCT03103321 
A limited access study 
 
Study Chair 
Jon C. Tilburt, MD 
Mayo Clinic 
 
 
Community Oncology Co-chair 
Health Disparities Co-Chair 
CCDR Co-chair 
 
 
 
 
 
 
 
 
 
 
 
 
GU Co-chair 
Health Disparities  
CCDR Committee Chair 
 
 
 
 
 
 
 
 
 
GU Committee Chair 
Health Outcomes Committee Co-Chairs 
 
 
 
 
 
 
 
 
Primary Statistician 
Secondary Statistician 
 
 
   
   
 
 
 
Data Manager 
Protocol Coordinator 
 
 
 
  
 
 
 
Limited Access Institutions 
ARM 1: Beaumont NCORP (Michigan), MI005 (ECOG, NRG, SWOG) 
ARM 3: Bronx Veterans Administration NY177 (NRG, SWOG) 
 
Greenville Health System (Greenville, SC), SC045 (NRG, SWOG) 
 
Columbia University, NY024 (NRG, SWOG) 
 
Lewis Cancer and Research Pavilion at St. Joseph's, GA106  
 
Lehigh Valley Hospital-Cedar Crest PA055  (ECOG, NRG, SWOG) 
(ECOG, NRG, SWOG) 
 
Montefiore Medical Center-Einstein, NY313 (ECOG, NRG) 
 
Med. Univ. of South Carolina, SC008 (ECOG, NRG, SWOG) 
 
University of New Mexico, NM004 (ECOG, NRG, SWOG) 
 
Stroger/Cook County Hospital, IL042 (ECOG, NRG) 
 
ARM 2: Aurora Saint Luke's Medical Center WI011 (ECOG, NRG) 
ARM 4: Augusta University Medical Center, GA 020 (ECOG, NRG, SWOG) 
               Kaiser Permanente-Bellflower CA031 (NRG, SWOG) 
 
Georgia NCORP, GA031 (ECOG, NRG, SWOG) 
 
Northwell Health, NY387 (NRG) 
 
Hawaii NCORP, HI010 (NRG, SWOG) 
 
Ochsner Health System New Orleans LA007 (ECOG, NRG) 
 
Kaiser Permanente-Oakland, CA752  (NRG, SWOG) 
 
Virginia Commonwealth University, VA010 (ECOG, NRG) 
 
LSU-Shreveport, LA017 (ECOG, NRG, SWOG) 

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Study Resources 
Expedited Adverse Event Reporting 
 
Medidata Rave iMedidata portal 
 
OPEN (Oncology Patient Enrollment Network) 
 
Biospecimen Management System 
 
 
Protocol Contacts: 
A191402CD Nursing Contact 
 
 
 
 
 
Protocol-related questions may be directed as follows: 
Questions: 
Contact (via email): 
Questions regarding patient eligibility, treatment, 
and dose modification: 
Study Chair, Nursing Contact, Protocol Coordinator, 
and (where applicable) Data Manager 
Questions related to data submission, RAVE or 
patient follow-up: 
Data Manager  
Questions regarding the protocol document and 
model informed consent: 
Protocol Coordinator 
Questions related to IRB review 
Alliance Regulatory Inbox 
 
 
 
 

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CANCER TRIALS SUPPORT UNIT (CTSU) ADDRESS AND CONTACT INFORMATION 
For regulatory requirements: 
For patient enrollments:  
For study data submission: 
Regulatory documentation must 
be submitted to the CTSU via the 
Regulatory Submission Portal. 
 
Regulatory Submission Portal: 
(Sign in at www.ctsu.org and 
select the Regulatory Submission 
sub-tab under the Regulatory 
tab.) 
 
Institutions with patients waiting 
that are unable to use the Portal 
should alert the CTSU Regulatory 
Office immediately at 
 to receive further instruction 
and support. 
 
Contact the CTSU Regulatory 
Help Desk at 
 for 
regulatory assistance. 
 
Please refer to the patient 
enrollment section of the protocol 
for instructions on using the 
Oncology Patient Enrollment 
Network (OPEN), which can be 
accessed at 
 
Contact the CTSU Help Desk 
with any OPEN-related questions 
at
 
 
 
Data collection for this study will 
be done exclusively through 
Medidata Rave.  Please see the data 
submission section of the protocol 
for further instructions. 
The most current version of the study protocol and all supporting documents must be downloaded from 
the protocol-specific Web page of the CTSU Member Web site located at
 Access to the 
CTSU members’ website is managed through the Cancer Therapy and Evaluation Program - Identity and 
Access Management (CTEP-IAM) registration system and requires user log on with CTEP-IAM username 
and password. Permission to view and download this protocol and its supporting documents is restricted and 
is based on person and site roster assignment housed in the CTSU RSS. 
For clinical questions (i.e., patient eligibility or treatment-related) see the Protocol Contacts, Page 2 
For non-clinical questions (i.e., unrelated to patient eligibility, treatment, or clinical data submission) 
contact the CTSU Help Desk by phone or e-mail:  
CTSU General Information Line – 
. All calls and 
correspondence will be triaged to the appropriate CTSU representative. 
The CTSU website is located at 
. 
 
 
 

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TESTING DECISION AIDS TO IMPROVE PROSTATE CANCER DECISIONS FOR MINORITY MEN 
 
 
Eligibility Criteria (see Section 3.2) 
Required Initial Laboratory  
Prostate biopsy within 4 months prior to registration showing  
Values 
newly diagnosed prostate cancer, stage T1-3N0 or X M0 or X (see §3.2.1) 
 
 
In addition, patients must have: 
PSA < 50 ng/mL 
- Gleason score 6-10 
Patients who have had a history of non-cutaneous malignancy in the previous 5 years are not eligible. 
Patients with history of non-melanoma skin cancer are eligible. 
Scheduled prostate cancer consultation to be the first consultation after diagnosis (see §3.2.4) 
Patients may not be concurrently enrolled to another clinical trial for the treatment of cancer. Co-
enrollment to biospecimen studies is allowed. Patients may be enrolled to other clinical trials after 
completing all of the baseline interventions and measures. 
Must be able to read and comprehend English (see §3.2.6) 
Age ≥ 18 years 
 
 
 
Schema 
 
 
Randomized 
by institution 
 
 
 
 
 
 
 
Pre- and During-consultation 
 
 
 
 
R 
 
Decision Aids1,2 
 
 
 
 
E 
 
 
 
Baseline 
Questionnaires 
given after 
Initial Visit 
 
12-Month 
Questionnaires and 
Chart Review 
G 
 
Pre-consultation2 
 
 
I 
 
Decision Aid Only 
 
 
S 
 
 
 
 
T 
 
During-consultation1 
 
 
E 
 
Decision Aid Only 
 
 
R 
 
 
 
 
 
 
Usual Care 
 
 
 
 
 
 
 
 
 
 
 
1 
“Prostate Choice” Decision Aid 
2 
“Knowing Your Options” Decision Aid 
 
Please refer to the full protocol text for a complete description of the eligibility criteria and intervention 
plan. 
 
 
Site personnel will be trained on the delivery of the intervention prior to the enrollment of any patients. This 
will consist of either video training and telephone conferencing or on-site training. 
 
 
 

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Table of Contents 
 
Section 
Page 
1.0 
BACKGROUND ..................................................................................................................................... 7 
1.1 
Significance and rationale .................................................................................................................... 7 
1.2 
Study Goals ........................................................................................................................................ 11 
1.3 
Significance ........................................................................................................................................ 11 
1.4 
Description of Interventions to be tested ............................................................................................ 11 
1.5 
Design and Intervention Plan ............................................................................................................. 13 
2.0 
OBJECTIVES ....................................................................................................................................... 15 
2.1 
Primary objective ............................................................................................................................... 15 
2.2 
Secondary objectives .......................................................................................................................... 15 
3.0 
PATIENT SELECTION ...................................................................................................................... 15 
3.1 
On-Study Guidelines .......................................................................................................................... 15 
3.2 
Eligibility Criteria .............................................................................................................................. 15 
4.0 
PATIENT REGISTRATION .............................................................................................................. 16 
4.1 
CTEP/DCP Registration Procedures .................................................................................................. 16 
4.2 
CTSU Registration Procedures .......................................................................................................... 16 
4.3 
Patient Registration Requirements ..................................................................................................... 18 
4.4 
Patient Registration/Randomization Procedures ................................................................................ 19 
4.5 
Stratification and Treatment Assignments ......................................................................................... 20 
5.0 
STUDY CALENDAR ........................................................................................................................... 21 
6.0 
DATA AND SPECIMEN SUBMISSION ........................................................................................... 22 
6.1 
Data Collection and Submission ........................................................................................................ 22 
7.0 
STUDY IMPLEMENTATION ........................................................................................................... 23 
7.1 
Identification of participating institutions .......................................................................................... 23 
7.2 
Site training ........................................................................................................................................ 23 
7.3 
Site scheduling and clinic space requirements ................................................................................... 23 
8.0 
INTERVENTION ................................................................................................................................. 24 
8.1 
Patient identification, scheduling, and consent .................................................................................. 24 
8.2 
Procedures for intervention on the day of the prostate cancer consult ............................................... 25 
8.3 
12-month follow up ............................................................................................................................ 26 
9.0 
ADVERSE EVENTS ............................................................................................................................ 26 
10.0 
MEASURES .......................................................................................................................................... 26 
10.1 
Prostate Cancer Treatment Questionnaire (knowledge measure)....................................................... 26 
10.2 
Decisional Conflict Scale (DCS) ........................................................................................................ 26 
10.3 
Expanded Prostate Cancer Index Composite Short Form (EPIC-26) ................................................. 27 
10.4 
Decisional Regret Scale ..................................................................................................................... 27 
11.0 
END OF INTERVENTION ................................................................................................................. 27 
11.1 
Duration of Treatment ........................................................................................................................ 27 
11.2 
Managing ineligible patients and registered patients who never receive protocol intervention ......... 27 
11.3 
Extraordinary Medical Circumstances ............................................................................................... 27 

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12.0 
STATISTICAL CONSIDERATIONS ................................................................................................ 28 
12.1 
Study Design ...................................................................................................................................... 28 
12.2 
Statistical Design and Analysis for the Primary Endpoint ................................................................. 28 
12.3 
Sample Size, Accrual Time, and Study Duration ............................................................................... 31 
12.4 
Supplementary Analysis Plans ........................................................................................................... 31 
12.5 
Monitoring ......................................................................................................................................... 32 
12.6 
Reporting ............................................................................................................................................ 32 
12.7 
Inclusion of Women and Minorities ................................................................................................... 33 
13.0 
GENERAL REGULATORY CONSIDERATIONS AND CREDENTIALING ............................. 34 
13.1 
Limited Access requirements ............................................................................................................. 34 
14.0 
REFERENCES ..................................................................................................................................... 35 
15.0 
MODEL INFORMED CONSENT FORM ........................................................................................ 40 
APPENDIX I 
BASELINE QUESTIONNAIRE BOOKLET ................................................................... 46 
APPENDIX II 
FOLLOW-UP (12-MONTH) QUESTIONNAIRE BOOKLET .................................. 49 
 
 
 

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1.0 
BACKGROUND 
1.1 
Significance and rationale 
Prostate cancer (PCa) treatment is a significant public health burden. Approximately 240,000 men 
were diagnosed with PCa and 28,000 died of this malignancy in 2011.1 More than 81% of incident 
cases are localized PCa.2 Clinical guidelines recommend active surveillance for many men with low 
risk prostate cancer, while radiation therapy and surgery are treatment options, for patients with 
intermediate (organ confined and Gleason score of 7) or high-risk disease (non-organ confined and 
Gleason scores 8-10).3,4 
Men face difficult choices in making treatment decisions for prostate cancer that include important 
tradeoffs between functional outcomes and cancer control. Clinical guidelines recommend active 
surveillance, radiation therapy and surgery as acceptable treatment alternatives, especially for 
patients with intermediate disease (organ confined and Gleason score of 7) and radiation therapy and 
surgery for  high-risk disease (non-organ confined and Gleason scores 8-10).3,4 Surgery and radiation 
therapy provide similar mortality reduction but markedly different long-term urinary and sexual 
functional outcomes.5-10 For every 20 patients undergoing radiation therapy or surgery, 6-10 will 
experience erectile dysfunction and 1-5 will have urinary incontinence.8,10 Active surveillance for 
men with low-risk PCa (organ-confined and Gleason score 6), may avoid or delay the risks of adverse 
functional outcomes associated with treatment, but may also promote anxiety. Active surveillance is 
not a recommended option for high risk disease.  
The predominant mode of addressing this excess burden of PCa to date has been through promoting 
screening in minority men; recent guideline changes suggest that this approach is no longer a viable 
option.11 Tailoring treatment decisions for those patients with intermediate and high-risk PCa who 
may benefit most from definitive treatment, while informing patients with low-risk PCa about active 
surveillance and eliciting and respecting the values of all patients, represents a viable alternative 
strategy to reduce this excess burden.  
PCa disproportionately affects African-American (AA) and American Indian/Alaska Native (AI/AN) 
men. Previous studies suggest that AA men have a higher incidence of more aggressive or advanced 
stage PCa and cancer-specific mortality compared to the general population.12-15 Native Americans 
from the Northern and Southern Plains also experience disparities in PCa stage and survival 
comparable to AA men; PCa is also the second leading cause of cancer-related mortality in Native 
American men overall.16,17 AI/AN men from these regions experience greater PCa mortality than 
non-Hispanic whites.17 In Hispanic/Latino men disparities are less clear. In general, although 
national data do not suggest major outcome disparities in this group, local and regional studies, as 
well as patterns of care studies review pockets of disparities particularly related to delays in care or 
different treatment patterns for Hispanic/Latino men.18-23 
Minority men experience disparities in prostate cancer knowledge, care patterns, and suffer from 
more functional outcome morbidity in prostate cancer. Combined, these compound known disease 
burden differences in these populations. Studies have documented lower levels of knowledge about 
PCa among African American men compared with other racial groups.24 Historically, AA men are 
less likely to receive radiation therapy or undergo surgery, and more likely to receive “watchful 
waiting” or active surveillance, despite having a higher incidence of intermediate and high-risk 
PCa.25-31 If rates of definitive therapy for minority patients with high-risk PCa were commensurate 
with the general population, the burden of the disease could arguably be reduced considerably. 
Conversely, minority men who do undergo definitive therapy are more likely to experience more 
treatment regret and greater functional outcome burden.32,33 Although little research has been 
dedicated to treatment variation in Native American men, a recent report suggested that this 
underserved population also has lower rates of definitive treatment following a diagnosis of PCa.16 
These data suggest a precarious dilemma: on the one hand greater use of aggressive therapies could 
save lives, but could at the same time exacerbate existing disparities in functional outcomes 
associated with aggressive therapy. 

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Health system factors including poor patient-provider communication likely bias PCa treatment 
choices in all men, but particularly in minority men. For instance, minority men generally have 
decreased access to high quality hospitals and urologists for PCa.28,34 If disparities from other 
conditions hold true, minority men may also experience implicit bias and suboptimal communication 
from their healthcare professionals.35 While the socio-economic and cultural factors that contribute 
to disparities may differ for AA and AI/AN men, they all pass through health systems that likely 
share common delivery factors that adversely influence outcomes. The Institute of Medicine and 
other bodies have postulated that poor patient-provider communication likely mediate disparities.36,37 
Accordingly, patient-provider communication is a quality of care mediator of disparities that could 
influence appropriateness of care, i.e. whether some options are excluded, whether they are presented 
in a skewed fashion or in a manner where patient values are not consistently elicited or respected. 
Those with high-risk disease may not learn about all primary therapy options available, while those 
with low-risk disease may not learn about active surveillance. Moreover, if specialists do not share 
the full range of treatment options in the context of side effect information (such as erectile 
dysfunction or urinary incontinence) in the context of their current functional status, patients may 
elect for aggressive therapy without a full understanding of the relative merits of each therapy’s 
cancer fighting benefits along with their immediate and long-term functional outcome implications. 
Little research has addressed whether system interventions to improve patient-provider 
communication in prostate cancer can reduce disparities in patient knowledge and functional 
symptom burden while promoting adequate or enhanced cancer control through treatment patterns 
that are consistent with disease risk. Moreover, precious little data exist on whether interventions 
delivered on various health information technology platforms at key points in the care process can 
mitigate known disparities associated with patient-provider communication particularly in the 
confusing arena of prostate cancer. Thus, improving patient-provider communication related to risk 
disclosure along with elicitation of patient goals and preferences is a promising way to strike the 
right balance among oncologic benefits and treatment-related harms associated with different 
prostate cancer treatments for men facing an initial treatment decision. 
Choice of PCa therapy represents a quintessential “preference-sensitive” treatment decision. 
Preference-sensitive decisions are those with significant uncertainty about net outcome benefit, 
where patient values and preferences are especially important to incorporate into treatment 
decisions.38-40 In the absence of randomized trials suggesting which form of initial active therapy 
most reduces mortality, newly diagnosed patients and their physicians should carefully deliberate 
about the quality of life (QOL) implications and burdens of different primary treatments to reach a 
decision that embodies the principles of shared decision making (SDM). SDM is a model of evidence 
disclosure and values elicitation intended for preference-sensitive decisions and is endorsed by all 
major professional societies.3,4,41,42 
Interventions to improve patient knowledge could plausibly reduce disparities in functional outcomes 
by facilitating mastery of experience and self-efficacy interventions that are most consonant with the 
most important or most distressing functional goals and symptoms. Consistent with the 
Biopsychosocial Model of Prostate Cancer Symptom Management,43 we posit that interventions that 
help facilitate a collaborative, shared treatment decision consonant with the patient’s most important 
goals will reduce known disparities in both knowledge as well as functional outcome burden 
(symptom distress). 
 
 

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Decision aids can improve patient knowledge and patient-provider communication by presenting risk 
information and helping elicit patient preferences. They improve knowledge and reduce treatment 
regret in prostate cancer treatment.44-47 Decision aids can mitigate low literacy effects in disparities 
by decreasing the demands required for patients to make an informed treatment decision. They better 
align the task of decision making with the skills and abilities of patients.48,49 In other clinical 
conditions, decision aids have been successfully used to reduce disparities in self-reported symptoms 
and patient knowledge.50 Moreover, a recent systematic review entitled “Interventions to Improve 
Decision Making and Reduce Racial and Ethnic Disparities in the Management of Prostate Cancer” 
among screening eligible men suggests that educational programs can improve knowledge and 
interventions that proactively include discussion of quality of life can improve quality of life 
outcomes.51 Educational interventions like these seem to have greater effect in men with less than a 
college education, thereby neutralizing disparities associated with education and literacy.52 Thus, 
decision aids are a plausible health system intervention that could be delivered in the specialty care 
context to reduce disparities in knowledge and functional outcomes potentially mediated by poor 
communication, that will work even in patients with low health literacy. Existing prostate cancer 
treatment decision aids have a variety of features summarized below. 
 
 

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Author/ 
Date 
Report 
Minority 
Delivery Mode 
Delivery 
Context 
Pro-
prietary 
Tailor 
Risk 
Comment 
Davison & 
Degner 
1997 
No 
Written Information package + 
consultation with nurse + 
(optional) audiotape of visit vs. 
Written information only 
Inside 
specialty visit 
N/A 
No 
Lower anxiety in the intervention group 
(p <.005) 
Auvinen 
2004 
 
Extensive consultation with 
urologist + patient defined own 
role in decision making vs. 
standard treatment protocol 
Inside 
specialty visit 
 
 
20% fewer men chose surgery in the 
intervention group vs. the control group 
(63% vs. 85%) 
Davison 
2007 
 
Personalized treatment 
information + generic video + 
written information vs. generic 
video + written information 
Patient 
education 
center 
 
 
No group differences 
Holmes-
Rovner 
2005 
 
Internet, audio, booklet 
Focus groups;  
Inside 
specialty visit 
 
 
Trend toward improved knowledge. 
Increase in discussion of surgery with 
physician (p=.02); 72% would take more 
active role in decision. 
Van Tol-
Geerdink 
2008 
 
Written decision aid 
Inside 
specialty visit 
 
 
Improved subjective and objective 
knowledge (p<.001) and accurate risk 
perception (p<.001). Patients took active 
decision-making role (p<.001). Greater 
satisfaction with quality of information 
(p=.002) 
Onel1998 
 
Video decision aid 
Inside 
specialty visit 
 
 
Increase in subjective knowledge; high 
level of participation in decision-
making; high level of satisfaction with 
treatment choice. 
Brink 
2000 
 
Interactive CD-ROM 
Focus groups; 
Outside 
specialty visit 
 
 
Increase in knowledge; increase in self-
efficacy. 
Kim 
2001 
 
Interactive CD-ROM 
Inside 
specialty visit 
 
 
High satisfaction with decision aid 
program 
Davison 
2003 
 
Interactive computer program + 
individualized counseling 
session 
Patient 
education 
center 
 
 
Higher percentage of men assumed more 
active role than originally intended 
(p<.001); lower anxiety (p<.001) and 
depression (p=.018); partners also had 
lower anxiety (p<.001) and depression 
(p=.002). 
Flynn 
2004 
 
Interactive CD-ROM 
Outside 
specialty visit 
 
 
Increased knowledge after decision aid 
(p<.001); decreased distress (p<.05); 
decrease in information needs after 
decision aid. 
Schostak 
2004 
 
Personalized, multidisciplinary 
consultation 
Outside 
specialty visit 
(interdisciplina
ry consulting 
service) 
 
 
92.4% felt completely informed; patients 
had equal rates of surgery (43.4%) and 
radiation therapy (42.5%); 66% found 
consultation helpful. 
Van Tol-
Geerdink 
2006 
 
Written decision aid 
Outside 
specialty visit 
 
 
79% accepted greater involvement in 
decision-making; 75% chose lower 
radiation dose; fear of tumor recurrence 
and survival associated with choosing 
higher dose; fear of side effects 
associated with choosing lower dose 
Isabaert 
2008 
 
Decision aid booklet 
Inside 
specialty visit 
 
 
More active involvement in decision-
making; 46% found decision aid 
reassuring; 38% chose surgery; 48% 
chose radiation therapy; 12 % chose 
watchful waiting; 73% felt decision aid 
helped clarify personal preferences; 88% 
would use again. 
From this literature one can surmise fairly consistent effects of decision aids on knowledge gain and 
involvement of men in decision making. Nevertheless, to our knowledge none have been tested on 

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tablet platforms, while also including minority men in sufficient numbers to make robust subgroup 
analyses, and that are freely available for use after the research is complete. Moreover, most of the 
above trials do not reflect recent evidence about the potential role of “active surveillance” in 
management of prostate cancer. Two decision aids fit that description: Prostate Choice and Knowing 
Your Options. Their features are described below. They each represent a synthesis of the best features 
of previous decision aids for delivery within or prior to the specialty visit, but have not yet been 
tested. 
This study is the first to specifically test decision aids for PCa treatment decisions in a manner that 
deliberately over samples minority men in sufficient numbers to make inferences about their effects 
in these subgroups. Although no research that we are aware of has demonstrated that decision aids 
reduce disparities, we hypothesize that eliciting patient’s baseline QOL information, more 
proactively involving them in shared decision-making process and then tailoring initial treatment 
recommendations to their disease severity and priorities can mitigate the negative excess burdens 
associated with treatment side effects. 
1.2 
Study Goals 
The long-term goal of this research is to reduce the excess burden of prostate cancer and the 
morbidity associated with its treatments. The overall objective is to test feasible, effective tools that 
promote SDM for prostate cancer initial treatment decisions, and which improve those decisions in 
a manner that is risk-concordant and patient-centered for minority men. Our aim is to test the 
comparative effectiveness of two kinds of decision aids – during consultation and pre-consultation – 
alone and in combination to improve patient knowledge, symptom burden, and risk-concordant 
treatment utilization in localized prostate cancer.  
1.3 
Significance 
This study will test the efficacy of decision aids in specialty practices that treat above average 
numbers of African American and Native American men and compare their impact in these 
populations to the general population within the infrastructure of the NCORP CCDR components. 
We hypothesize that decision aids will mitigate disparities related to poor patient-provider 
communication by improving knowledge, reducing burden of functional outcomes, as well as 
aligning treatment patterns with disease risk in these minority populations. This study is innovative 
because it tests newer tools, in newer formats, including within the clinical visit context, and with a 
novel trial design. It tests decision aids delivered within the clinical visit using a tablet format 
alongside a web-based decision aid delivered prior to the clinical visit. This study design represents 
a substantial departure from previous approaches by testing the comparative effectiveness of two 
prostate cancer decision aids in a 2x2 factorial cluster-randomized design within the NCORP CCDR 
components that looks at the individual and additive impact of those tools. This context will enable 
us to deliberately over-sample minority men. Knowing whether decision aids work at all, or which 
modes and contexts of decision aid delivery work best to improve communication are compelling 
health care delivery questions for the care of minority men facing the difficult choice of prostate 
cancer treatment. This study would be the first to bring decision aid research to the healthcare of 
Native American men; and would be only the second trial that we are aware of to test decision aids 
specifically in African American men. When complete, this strategy will produce significant 
generalizable inferences about the best way(s) to improve health service delivery to help address 
prostate cancer disparities. 
1.4 
Description of Interventions to be tested 
Decision aids can be delivered within or prior to specialty visits using a variety of modes, including 
paper, tablet, and computer-based platforms. Decision aids delivered prior to the clinical visit prepare 
patients for decisions by providing information to have a basic understanding of facts discussed in a 
clinical consultation. Members of our team 
 have extensive 

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experience testing decision aids outside of the clinical visit. Most of the decision aid literature tests 
them prior to provider visits; these trials improve knowledge, but do not necessarily improve patient-
provider communication.44,45,53-55  The Mayo Clinic team typically tests decision aids for use with 
the clinical visit. These tools are minimal detail props to promote a better conversation. Several 
clinical trials of decision aids delivered within visits show improvement in patient knowledge 
comparable to tools delivered prior to consultation.56,57 In contrast to tools delivered prior to the visit, 
tools delivered within a visit may promote better patient involvement in decision making. How the 
two forms of decision aid delivery might combine to improve outcomes is also uncertain. Despite 
the promise of decision aids, they are rarely used in specialty practice for prostate cancer and in-visit 
decision aids have never been tested as a tool to mitigate both disparities in knowledge as well as in 
functional outcomes for prostate cancer.  
Whether in-visit and out-of-visit decision aids potentiate each other in enhancing decisional quality 
is an additional important unaddressed question that could inform eventual larger scale health 
services implementation strategies in underserved patient populations with PCa.  
Our in-visit tool, Prostate Choice, is a decision aid for PCa treatment that incorporates the best 
available evidence in a literacy-sensitive, easy to use format for patients and providers delivered on 
a tablet device. Prostate Choice has a modular format that covers the key components critical to a 
high quality treatment decision for localized PCa. It personalizes each patient’s PCa risk severity 
using evidence-based prediction tools,16,17,58-65 and assesses pretreatment QOL using a validated 
instrument and elicits the importance of each dimension (urinary incontinence, erectile function) into 
the treatment decision.66 It also reviews all treatment options for localized PCa, including surgery, 
radiation therapy and active surveillance, as well as estimates of treatment benefit for a reduction in 
PCa-specific mortality.10 Moreover, it elicits patient preferences by enabling assignment of relative 
importance of different dimensions of QOL and disease control; it estimates each patient’s overall 
life expectancy using Medicare life tables67 (a strategy endorsed by clinical guidelines).4,67 Upon 
completion of all modules, Prostate Choice provides a one page detailed summary, which can also 
be printed or emailed, as the foundation for future definitive treatment decisions incorporating 
individually tailored evidence-based risks, QOL and preferences as well as potential QOL 
implications regarding treatment. 
Prostate Choice was developed with patients, physicians, and designers with experience in informed 
decision-making. In 2011 with the assistance of the Prostate Cancer Patient Advocate Core of the 
Mayo Clinic Prostate SPORE, Jon Tilburt, MD, MPH and Simon Kim, MD developed a tablet-based 
“app” to walk patients through the main categories of concern in early prostate cancer treatment. It 
is a touch-based interactive user experience that focuses on categories “Your Diagnosis,” “Your 
Situation,” “Your Priorities,” “Your Treatments,” and culminates in a summary combining all the 
categories. Each of the elements of Prostate Choice can be selected by patient or clinician. It is light 
on text, but shows numbers and elicits values to help facilitate a better conversation. It has been user-
tested and found feasible and acceptable by patients and providers. Moreover, it has been further 
refined to ensure that it is at a Flesch-Kincaid 8th grade reading level. It conforms to basic decision 
aid quality criteria.68 
Prostate Choice is designed to cultivate better conversations about treatment risks and benefits 
contextualized in the unique features of the patient’s disease and life circumstance. It will be used in 
tablet form as part of the clinical conversation in whatever way the patient and physician decide. 
Both will be briefed on its functionality by study personnel prior to the visit. 
Knowing Your Options: a Decision Aid for Clinically Localized Prostate Cancer, is designed for 
pre-visit use. Knowing Your Options: A Decision Aid for Clinically Localized Prostate Cancer, was 
developed 
by 
the 
Agency 
for 
Healthcare 
Quality 
and 
Research 
(http://www.effectivehealthcare.ahrq.gov/ehc/decisionaids/prostate-cancer).69 This non-proprietary 
web-based decision aid also uses the best available evidence and has been designed to be used in the 
out-of-visit/pre-visit setting. Similar to Prostate Choice, Knowing Your Options also allows for 
personalization for PCa severity in risk of cancer-specific mortality. It also queries patients about the 

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QOL issues regarding the different primary treatment options for PCa.69,70 To our knowledge its 
efficacy has not been formally tested. All other decision aids for PCa treatment are proprietary, or 
do not reflect the most recent evidence.  
Knowing Your Options was designed as consumer information for patients searching the internet 
directly. It is one of two currently available tools online that seek to summarize research evidence 
for 
patients. 
Development 
details 
are 
available 
at 
http://www.effectivehealthcare.ahrq.gov/ehc/decisionaids/prostate-cancer/. 
Knowing Your Options was designed to lay out the basic facts of treatment choices for patients prior 
to their appointment with their doctor with more extensive written explanation. In this trial, the 
Knowing Your Options tool will be administered prior to initial consultations with urologists when 
eligible patients are presenting to discuss treatment options in the days leading up to/on the day of 
that consultation.  
1.5 
Design and Intervention Plan 
Study population: Eligible patients from participating NCORP CCDR components will be enrolled. 
Men with self-reported racial/ethnic categories American Indian/Alaska Native, African American, 
Hispanic/Latino as well as all other races using existing 2010 Census definitions will be included. In 
addition to the Alliance NCORP CCDR sites, this study will be open to non-Alliance NCORP CCDR 
institutions interested in participating through the CTSU mechanism. Due to geographic clustering 
of African American and Native American populations, institutions will be selected preferentially if 
they can recruit at least half of their overall cohort from one of these two patient populations. We 
anticipate at least 8 sites preferentially accruing half of their participants as African American and 
another 8 sites who can preferentially recruit half of their participants as Native American. The trial 
will encourage Hispanic/Latino men to participate at all sites. 
Randomization: In order to facilitate decision aid administration, enhance patient compliance, and 
avoid treatment arm contamination; we will perform a cluster randomized four-arm clinical trial.70 
We intend to test both during-consultation, pre-consultation and the combination of both during-
consultation and pre-consultation evidence-based decision aids using a novel 2x2 factorial design in 
two key populations. A 2x2 factorial design breaks the combinations of during-consultation and pre-
consultation decision aids into four treatment arms (cells): A) Prostate Choice in-visit combined with 
Knowing Your Options pre-consultation decision aid; B) Prostate Choice within specialty 
consultations and usual pre-consultation care; C) Usual during-consultation care and Knowing Your 
Options decision aid prior to the consultation; and D) Usual during-consultation care and Usual pre-
consultation care.  
In order to answer our question in a manner that preserves strong internal validity, a randomized 
design is preferred.70,71 This approach allows inferences about effects with less concern about 
baseline imbalances between groups, confounding, or chance. We selected a cluster-randomized 
design to bring the rigor of the randomized design in line with the reality of every day practice. 
Furthermore, a cluster-randomized approach avoids contamination effects in the intervention arms.  
Hence, randomization will be conducted at the participating site level instead of patient level. 
Participating sites will be randomized to one of the four arms. AA-oriented and AI/AN-oriented 
practices will be those capable of oversampling two of the three the minority populations we are 
targeting. Randomization will be designed in such a way that AA-oriented and AI/AN-oriented sites 
are distributed equally to the four arms of the study to prevent, as much as possible, one minority 
population from being recruited exclusively in only one or two of the intervention arms.  
Recruitment: The greatest limitation to accrual feasibility is identifying AI/AN men with newly 
diagnosed, localized prostate cancer. National data suggest that conservatively 125 cases of prostate 
cancer occur annually among self-identified Native American men from the Northern Plains and 
Alaska.17 We can identify 80% of those men (N = ~100), and approach 80% of them to participate 
per year (N = 80). We anticipate conservatively that because our intervention is a non-therapeutic 

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intervention limited to the office visit, 40% of eligible men at participating sites could enroll (n=40 
per year for three years) in the Northern Plains and Alaska combined (this is a conservative estimate- 
most Mayo Clinic decision aid trials accrue 70% of patients approached). We have access to several 
urban sites from which to draw African American and Hispanic/Latino men, making their 
recruitment less difficult. The long term success of this line of research will hinge on decision aids 
being successfully used and their having a positive impact on patient knowledge and risk-concordant 
treatment decision making. Because of less geographic clustering, men of Hispanic/Latino ethnicity 
will be recruited from all study sites with a similar overall accrual target, reserving two slots 
minimum for them during the first year of accrual. 
What if we do not accrue enough minority men? The primary outcome of this study is knowledge. 
Aggressive accrual targets for minority men are feasible, but there is no guarantee that they can be 
achieved. Suppose we only achieve accrual of half of the African American and American 
Indian/Alaska Native sample sizes and resorted to fill the remaining enrollment with men of self-
described White/Asian race. Under this scenario (109 Hispanic/Latino, White, or Asian, 21 African 
American, and 21 American Indian/Alaska Native race) we would only be able to make the most 
preliminary (exploratory) inferences about differential outcomes in those subgroups, but our power 
to test our primary outcome, knowledge, would be preserved. (Part of such an exploratory analysis 
could include looking for White vs. all others differences, but such analyses are conceptually flawed 
and would be of limited utility.) Even under this scenario, this trial would make an important 
contribution to the literature on prostate cancer shared decision making and would represent the most 
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2.0 
OBJECTIVES  
2.1 
Primary objective  
To test the comparative effectiveness of decision aids (DA’s) on patient knowledge. 
2.2 
Secondary objectives 
2.2.1 To test the impact of in-visit DA’s alone compared to usual care on quality of life outcomes and 
treatment utilization. 
2.2.2 To test the impact of out-of-visit DA’s alone compared to usual care on quality of life outcomes 
and treatment utilization. 
2.2.3 To test the impact of combined in-visit and out-of-visit DA’s compared to both usual care and 
individual DAs on quality of life outcomes and treatment utilization. 
2.2.4 To test the comparative effectiveness of DA’s on minority men’s knowledge. 
2.2.5 To compare clinic time required to administer the DA’s across arms. 
3.0 
PATIENT SELECTION 
For questions regarding eligibility criteria, see the Study Resources page. Please note that the Study Chair 
cannot grant waivers to eligibility requirements.  
3.1 
On-Study Guidelines 
This clinical trial can fulfill its objectives only if patients appropriate for this trial are enrolled. All 
relevant medical and other considerations should be taken into account when deciding whether this 
protocol is appropriate for a particular patient.  
Although they will not be considered formal eligibility (exclusion) criteria, physicians should 
recognize that the following may seriously increase the risk to the patient entering this protocol: 
• 
Psychiatric illness which would prevent the patient from giving informed consent. 
3.2 
Eligibility Criteria  
___ 
3.2.1 Documentation of disease: Patients must have prostate biopsy within 4 months prior to 
registration showing newly diagnosed prostate cancer, stage T1-3N0 or XM0 or X. In addition, 
patients must have:  
___ 
• 
Gleason score 6-10 
___ 
3.2.2 PSA < 50 ng/mL 
___ 
3.2.3 Patients who have had a history of non-cutaneous malignancy in the previous 5 years are 
not eligible.  Exception: Patients with history of non-melanoma skin cancer are eligible. 
___ 
3.2.4 Scheduled prostate cancer consultation to be the first consultation after diagnosis (i.e. not 
a second-opinion or a consultation following previous discussions of treatment options). 
___ 
3.2.5 Patients may not be concurrently enrolled to another clinical trial for the treatment of 
cancer. Co-enrollment to biospecimen studies is allowed.  Patients may be enrolled to other 
clinical trials after completing all of the baseline interventions and measures. 
___ 
3.2.6 Patients with impaired decision-making capacity (such as with a diagnosis of dementia or 
memory loss) are not eligible for this study. Since the primary outcome of the study is 
knowledge, including patients determined to have impaired decision-making capacity may 
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___ 
3.2.7 Patients must be able to read and comprehend English. Non-English-speaking patients may 
participate so long as an interpreter (e.g., family member, clinic staff, etc.) is present for consent, 
for the Decision Aid administration, and gathering of baseline and follow-up measures. 
___ 
3.2.8 Age ≥ 18 years 
4.0 
PATIENT REGISTRATION 
4.1 
CTEP/DCP Registration Procedures 
Food and Drug Administration (FDA) regulations and National Cancer Institute (NCI) policy require 
all individuals contributing to NCI-sponsored trials to register and to renew their registration 
annually.  To register, all individuals must obtain a Cancer Therapy Evaluation Program (CTEP) 
Identity and Access Management (IAM) account 
.  In addition, 
persons with a registration type of Investigator (IVR), Non-Physician Investigator (NPIVR), or 
Associate Plus (AP) (i.e., clinical site staff requiring write access to OPEN, Rave, or TRIAD or 
acting as a primary site contact) must complete their annual registration using CTEP’s web-based 
Registration and Credential Repository (RCR) 
  Documentation 
requirements per registration type are outlined in the table below. 
Documentation Required 
IVR 
NPIVR 
AP 
A 
FDA Form 1572 
 
 
 
 
Financial Disclosure Form 
 
 
 
 
NCI Biosketch (education, training, employment, 
license, and certification) 
 
 
 
 
HSP/GCP training 
 
 
 
 
Agent Shipment Form (if applicable) 
 
 
 
 
CV (optional) 
 
 
 
 
 
An active CTEP-IAM user account and appropriate RCR registration is required to access all CTEP 
and CTSU (Cancer Trials Support Unit) websites and applications.  In addition, IVRs and NPIVRs 
must list all clinical practice sites and IRBs covering their practice sites on the FDA Form 1572 in 
RCR to allow the following: 
• 
Added to a site roster 
• 
Assigned the treating, credit, consenting, or drug shipment (IVR only) tasks in OPEN 
• 
Act as the site-protocol PI on the IRB approval     
Additional 
information 
can 
be 
found 
on 
the 
CTEP 
website 
at 
  For questions, please contact the 
RCR Help Desk by email at 
 
4.2 
CTSU Registration Procedures 
This study is supported by the NCI Cancer Trials Support Unit (CTSU). 

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IRB Approval:   
Each investigator or group of investigators at a clinical site must obtain IRB approval for this protocol 
and submit IRB approval and supporting documentation to the CTSU Regulatory Office before they 
can be approved to enroll patients.  Assignment of site registration status in the CTSU Regulatory 
Support System (RSS) uses extensive data to make a determination of whether a site has fulfilled all 
regulatory criteria including but not limited to the following: 
• 
An active Federal Wide Assurance (FWA) number 
• 
An active roster affiliation with the Lead Network or a participating organization 
• 
A valid IRB approval 
• 
Compliance with all protocol specific requirements. 
In addition, the site-protocol Principal Investigator (PI) must meet the following criteria: 
• 
Active registration status 
• 
The IRB number of the site IRB of record listed on their Form FDA 1572 
• 
An active status on a participating roster at the registering site. 
Sites participating on the NCI CIRB initiative that are approved by the CIRB for this study are not 
required to submit IRB approval documentation to the CTSU Regulatory Office. For sites using the 
CIRB, IRB approval information is received from the CIRB and applied to the RSS in an automated 
process. Signatory Institutions must submit a Study Specific Worksheet for Local Context (SSW) to 
the CIRB via IRB Manager to indicate their intent to open the study locally.  The CIRB’s approval 
of the SSW is then communicated to the CTSU Regulatory Office.  In order for the SSW approval 
to be processed, the Signatory Institution must inform the CTSU which CIRB-approved institutions 
aligned with the Signatory Institution are participating in the study. 
4.2.1 Downloading Site Registration Documents  
Site registration forms may be downloaded from the A191402CD protocol page located on the 
CTSU members’ website. Permission to view and download this protocol and its supporting 
documents is restricted and is based on person and site roster assignment housed in the CTSU 
RSS. 
• 
Go to 
 and log in to the members’ area using your CTEP-IAM 
username and password 
• 
Click on the Protocols tab in the upper left of your screen 
• 
Either enter the protocol # in the search field at the top of the protocol tree, or 
• 
Click on the By Lead Organization folder to expand 
• 
Click on the Alliance link to expand, then select trial protocol #A191402CD 
• 
Click on LPO Documents, select the Site Registration documents link, and download and 
complete the forms provided.   
4.2.2 Requirements for A191402CD Site Registration  
• 
IRB approval (For sites not participating via the NCI CIRB; local IRB documentation, an 
IRB-signed CTSU IRB Certification Form, Protocol of Human Subjects Assurance 
Identification/IRB Certification/Declaration of Exemption Form, or combination is 
accepted). 
4.2.3 Submitting Regulatory Requirements  
Submit required forms and documents to the CTSU Regulatory Office via the Regulatory 
Submission Portal, where they will be entered and tracked in the CTSU RSS.  

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Regulatory Submission Portal:
   Regulatory Tab   
Regulatory Submission Portal 
When applicable, original documents should be mailed to: 
 
 
Institutions with patients waiting that are unable to use the Portal should alert the CTSU 
Regulatory Office immediately at
 in order to receive further instruction and 
support. 
4.2.4 Checking Your Site’s Registration Status  
You can verify your site registration status on the members’ section of the CTSU website.   
• 
Go to 
 and log in to the members’ area using your CTEP-IAM 
username and password 
• 
Click on the Regulatory tab  
• 
Click on the Site Registration tab 
• 
Enter your 5-character CTEP Institution Code and click on Go 
Note: The status given only reflects compliance with IRB documentation and institutional 
compliance with protocol-specific requirements outlined by the Lead Network. It does not reflect 
compliance with protocol requirements for individuals participating on the protocol or the 
enrolling investigator’s status with the NCI or their affiliated networks. 
4.2.5 Limited access information 
Institutions that are interested in participating in this study must first contact the Study Chair, 
Jon Tilburt 
to review study requirements and procedures and to identify 
who will be responsible for the study at their respective institution. See Section 13.1. 
4.3 
Patient Registration Requirements 
• 
Informed consent: the patient must be aware of the neoplastic nature of his/her disease and 
willingly consent after being informed of the procedure to be followed, the experimental nature 
of the interventions being tested, alternatives, potential benefits, side-effects, risks, and 
discomforts. Current human subjects protection committee approval of this protocol and a 
consent form is required prior to patient consent and registration. 
• 
Patient completed booklets: Patient questionnaire booklets are to be ordered prior to the 
registration of any patients. Patient completed booklets can be ordered by downloading and 
completing the booklet order form (located under the supplemental documents section of the 
A191402CD website) and faxing the form to Attn: Operational Support Clerk at 
 
Samples of the booklets are found in Appendices I and II, which are to be used for reference and 
IRB submission only. They are not to be used for patient completion. 
 
 

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• 
Institutional randomization: Institutions will be randomized to one of four intervention arms:  
1) During- and pre-consultation decision aids 
2) Pre-consultation decision aid only 
3) During-consultation decision aid only 
4) Usual care 
The Alliance Statistics and Data Center will randomize institutions once an institution is 
interested and eligible to participate. All men enrolled at a site will receive the intervention to 
which the treating institution is randomized. 
Specifically, the lead study statistician will randomly assign the initial participating institutions 
to one of the arms before the study is activated.  The randomization will be stratified by center 
type (i.e. which minority group, if any, the center is “targeting”); so that if for example, there 
were four initial centers which specialized in Native American/Native Alaskan men, each would 
be assigned to one of the four arms by randomly selecting one of the four repeatedly without 
replacement, each time assigning that center to one of the remaining arms.  This will be done 
separately for all center types.  For all of these centers, the lead statistician will obtain CTEP 
Institutional IDs (as well as IDs for affiliates, if any, that may be participating), and will then 
provide the Alliance randomization center with the initial set of CTEP IDs for each treatment 
arm. 
Thus, when a patient enrolls at one of the initial participating institutions, the CTEP ID of the 
center can be checked against the initial randomization list, which will determine which 
treatment that patient gets (and all patients at that center).  In addition, the lead statistician will 
create a random sequence of arm assignments for additional institutions of each type that join 
after the study begins, so that whenever a new center joins the study, an arm will already have 
been determined for that center. 
4.4 
Patient Registration/Randomization Procedures 
Patient enrollment will be facilitated using the Oncology Patient Enrollment Network (OPEN).  
OPEN is a web-based registration system available on a 24/7 basis.  To access OPEN, the site user 
must have an active CTEP-IAM account (check at 
) and a 
'Registrar' role on either the LPO or participating organization roster.  Registrars must hold a 
minimum of an AP registration type.  
All site staff will use OPEN to enroll patients to this study.  It is integrated with the CTSU Enterprise 
System for regulatory and roster data and, upon enrollment, initializes the patient in the Rave 
database. OPEN can be accessed at 
 or from the OPEN tab on the CTSU 
members’ side of the website at 
 To assign an IVR or NPIVR as the treating, 
crediting, consenting, drug shipment (IVR only), or investigator receiving a transfer in OPEN, the 
IVR or NPIVR must list on their Form FDA 1572 in RCR the IRB number used on the site’s IRB 
approval.   
Prior to accessing OPEN, site staff should verify the following: 
• 
All eligibility criteria have been met within the protocol stated timeframes.  
• 
All patients have signed an appropriate consent form and HIPAA authorization form (if 
applicable). 
Note: The OPEN system will provide the site with a printable confirmation of registration and 
treatment information. Please print this confirmation for your records. 
Further instructional information is provided on the OPEN tab of the CTSU members’ side of the 
CTSU website at 
  For any additional questions 
contact the CTSU Help Desk at 
 

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4.5 
Stratification and Treatment Assignments 
While not formal stratification factors, randomization will be set up so that sites will the particular 
capacities to oversample minority populations will be distributed between the arms, as illustrated in 
the diagram below. 
 
 
Grouping Factors/Treatment assignments: 
Arm 1: 
Pre -and During Consultation Decision Aids 
Arm 2: 
Pre-Consultation Decision Aid only 
Arm 3: 
During Consultation Decision Aid only 
Arm 4: 
Usual Care 

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5.0 
STUDY CALENDAR 
Laboratory and clinical parameters during treatment are to be followed using individual institutional 
guidelines and the best clinical judgment of the responsible physician. It is expected that patients on this 
study will be cared for by physicians experienced in the treatment and supportive care of patients on this 
trial.  
Pre-Study Testing Intervals  
• 
To be completed ≤ 28 DAYS before registration: History and physical. 
• 
To be completed ≤ 90 DAYS before registration: PSA 
• 
To be completed ≤ 4 MONTHS before registration: Prostate Biopsy  
 
Prior to 
Registration 
Baseline* 
12 months after 
baseline** 
Test and Observations 
 
 
 
History and Physical 
X 
 
 
Height 
X 
 
 
Weight 
X 
 
 
Prostate biopsy 
X 
 
 
Chart Review  
 
 
X(1) 
Labs and Staging 
 
 
 
PSA 
X 
 
 
QOL Instruments 
 
 
 
Baseline Questionnaire 
 
X(2) 
 
One-year Questionnaire 
 
 
X(3) 
* 
To be administered following the surgical consultation 
** +/- 6 weeks 
1 
At 12 months site staff will review the patient’s chart from the 6-month point to the 12-month time-point, 
collecting treatment information and any pertinent events. 
2 
Includes the Prostate Cancer Treatment Questionnaire and the Decisional Conflict Scale. See Section 10.0 
and Appendix I. 
3 
Includes Expanded Prostate Cancer Index Composite (EPIC-26) and the Decisional Regret Scale. See 
Section 10.0 and Appendix II. To be completed by the patient during a clinic visit. If no clinic visit is 
scheduled +/- 6 weeks from the 12-month time-point, study staff should mail the 12-month questionnaire 
with a self-addressed stamped envelope to the patient for him to complete at home and return by mail (see 
Section 8.3.1). 

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6.0 
DATA AND SPECIMEN SUBMISSION  
6.1 
Data Collection and Submission 
Data collection for this study will be done exclusively through the Medidata Rave clinical data 
management system. Access to the trial in Rave is granted through the iMedidata application to all 
persons with the appropriate roles assigned in Regulatory Support System (RSS). To access Rave 
via iMedidata, the site user must have an active CTEP-IAM account (check at 
 and the appropriate Rave role (Rave CRA, Read-Only, Site 
Investigator) on either the LPO or participating organization roster at the enrolling site. 
Upon initial site registration approval for the study in RSS, all persons with Rave roles assigned on 
the appropriate roster will be sent a study invitation e-mail from iMedidata. To accept the invitation, 
site users must log into the Select Login 
using their CTEP-
IAM user name and password, and click on the “accept” link in the upper right-corner of the 
iMedidata page. Please note, site users will not be able to access the study in Rave until all required 
Medidata and study specific trainings are completed. Trainings will be in the form of electronic 
learnings (eLearnings), and can be accessed by clicking on the link in the upper right pane of the 
iMedidata screen. 
Users who have not previously activated their iMedidata/Rave account at the time of initial site 
registration approval for the study in RSS will also receive a separate invitation from iMedidata to 
activate their account. Account activation instructions are located on the CTSU website, Rave tab 
under the Rave resource materials (Medidata Account Activation and Study Invitation Acceptance). 
Additional information on iMedidata/Rave is available on the CTSU members’ website under the 
Rave tab at
 or by contacting the CTSU Help Desk at 
 or by e-
mail at 
   
A Schedule of Forms is available on the Alliance study webpage, within the Case Report Forms 
section. 
Patient-completed questionnaire booklets for this study are to be ordered prior to the registration of 
any patients (see Section 4.4). Samples of questionnaire booklets are available in Appendices I and 
II for reference and IRB submission only. They are not to be used for patient completion. Booklets 
must be given to patients to complete and patients should be instructed to return the booklets to site 
staff either in person or by mail and site staff will enter patient and caregiver responses into Rave.  
 
 

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7.0 
STUDY IMPLEMENTATION 
7.1 
Identification of participating institutions 
It is expected that a majority of participating institutions will be identified prior to the activation of 
this study. However, recruitment of additional institutions will continue following activation of the 
study. Interested sites should contact the study chair, Dr. Tilburt to discuss the criteria listed in 
Section 13.1. 
7.2 
Site training 
Before enrolling patients, each site randomized to one of three intervention arms must determine 
their desired mode of delivery for the decision aids (either by desktop computer or tablet). Sites that 
opt for tablet delivery of the decision aid will receive a tablet from the investigative team: Either by 
shipment or by hand delivery, depending on whether or not a member of the study team travels to 
the participating institution to provide personnel training. 
Site personnel will be trained on the process of data collection and delivery of the intervention prior 
to the enrollment of any patients. This training will be provided either by video/telephone 
conferencing or by on-site training. consist of either video training and telephone conferencing or 
on-site training. The content of the training will consist of co-developing or adapting site-specific 
standard operating procedures (SOPs) that accommodate local site environments while maintaining 
fidelity to the particular study arm to which sites have been randomized. Training will be provided 
by a member of the study team from Mayo Clinic. 
7.3 
Site scheduling and clinic space requirements 
Scheduling: Sites will need to determine the time needed to complete registration, pre-consultation 
decision aid interaction (for applicable study arms), and post-consultation questionnaire completion. 
Study coordinators will need to schedule patients to be present at the study site for sufficient time to 
complete pre- and post-consultation study items. Alternatively, sites must identify processes for pre- 
and post-consultation study requirements to be completed in very close proximity (1 business or less) 
to the visit. 
Space requirements: Sites will need to identify and reserve an adequately private area near or 
adjacent to the patient waiting area. This space will be used to obtain patient consent for participation, 
obtain HIPAA authorization, and interact with the pre-consultation decision aid (for applicable study 
arms), and completion of the post-visit questionnaire.  
Pre-consultation decision aid requirements: For study arms with the pre-consultation decision aid, 
this adjacent space must contain a computer terminal with internet access, or have wireless access 
provided to the room so that a tablet may be used. 
During-consultation decision aid requirements: For study arms that will use the during-
consultation decision aid, sites will need to ensure that exam rooms are provisioned with wireless 
internet access or contain a computer terminal with internet access. Either of these is needed in order 
for the physician to deliver the during-consultation decision aid. 
Physician notification process: Sites should establish a local process for informing the participant’s 
physician that the participant has completed pre-requisite study registration and intervention (where 
applicable). The physician will then be alerted to follow the during-consultation study procedures 
specific to his/her study site. 
 
 

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8.0 
INTERVENTION 
While it is expected that registration will occur on the same day as the initial surgical consultation, the 
intervention (surgical consult visit) must occur within 14 days following registration. Registration may 
occur after the surgical consult visit and patient completion of the Baseline Questionnaire, but must be 
completed no later than the same day as the consultation. 
Participating sites will be randomized to Pre- plus During-Consultation decision aids, Pre-consultation 
decision aid only, during-consultation only decision aid, or usual care arms. 
Arm A 
Pre- and During Consultation 
Decision Aids1, 2 
Arm B 
Pre-Consultation2  
Decision Aid Only 
Arm C 
During Consultation1 
Decision Aid Only 
Arm D 
Usual Care 
 
1 
“Prostate Choice” 
2 
“Knowing Your Options” 
8.1 
Patient identification, scheduling, and consent 
Sites should implement standard procedures for identifying eligible patients for this study. Patient 
eligibility will be determined locally by a combination of chart review and patient self-report.  
Clinical variables about the patients care germane to eligibility will be ascertained by site staff.  Site 
staff must confirm with the patient that this is not a second opinion, and that this is the first face-to-
face visit with the doctor to discuss treatment options. It is not required that patients know their 
diagnosis before the study is introduced to them. 
Prospective patients who are informed about a new diagnosis of prostate cancer will be scheduled to 
receive a follow-up consultation with a physician to discuss treatment options. The scheduled 
prostate cancer consultation must be the first consultation after diagnosis (i.e. not a second-opinion 
or a consultation following previous discussions of treatment options). Physicians may consider 
referring patients to the study team for recruitment upon receipt of positive PCa biopsy results from 
the lab if the cancer diagnosis has already been disclosed by telephone or email. 
It is critical that the site coordinator identify when this visit is scheduled, and plan to make contact 
(or arrange for the patient’s physician to make contact) with the prospective participant before their 
scheduled consultation and inform them about the study. Participating institutions should implement 
a procedure for alerting the study coordinator when an eligible patient has been scheduled for the 
initial consultation. Institutional study coordinators will document all contact with all potentially 
eligible participants and indicate interest/non interest or “not approached.” 
If the prospective participant expresses interest in the study, the study coordinator should instruct the 
patient to arrive at their consultation appointment early enough (as determined by site-specific 
standard operating procedures) to complete all study-related activities. Patient consent may be 
obtained at any time up to and including the day of the consultation, but must be completed prior to 
any study-related activities. In addition, for sites randomized to the pre-consultation decision aid, 
time should be allowed for sufficient and unhurried patient interaction with the pre-consultation 
decision aid. All participants should also be informed that they will need to remain after the 
appointment to complete a short questionnaire (Baseline Questionnaire, see Appendix I). 

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8.2 
Procedures for intervention on the day of the prostate cancer consult 
8.2.1 Patient arrival 
Following the completion of the consent and registration procedures, the study coordinator will 
greet and engage participant and escort them to a private area preferably near the waiting area. 
8.2.2 Arms A and B only: Patient interaction with the pre-consultation decision aid 
The study coordinator will lead the participant to a designated computer terminal or will provide 
a tablet with which the participant, in collaboration with a partner, if desired, may interact with 
the pre-consultation decision aid. Staff will be available for any technical issues that may arise. 
8.2.3 Physician notification 
The physician or appropriate clinical staff (e.g., physician assistant) will be notified when a 
participant has arrived and, if at an institution randomized to Arm A or B, that the patient has 
spent time with pre-consultation decision aid. The physician will thereby know to follow the 
study protocol. 
8.2.4 Consultation 
Arm A: The physician or appropriate clinical staff (e.g., physician assistant) will incorporate 
the during-consultation decision aid in his/her conversation with the patient about treatment 
choice.  In addition, the physician or appropriate clinical staff will engage the patient regarding 
any questions by the patient about the pre-consultation decision aid. Site staff will record the 
time that the patient spends with the pre-consultation decision aid. 
Arm B: Usual care, and the physician or appropriate clinical staff will engage the patient 
regarding any questions by the patient regarding the pre-consultation decision aid. Site staff will 
record the time that the patient spends with the pre-consultation decision aid. 
Arm C: The physician or appropriate clinical staff will incorporate the during-consultation 
decision aid into his/her conversation with the patient about treatment choice. 
Arm D: Usual care. 
All Arms:  At the end of the consultation, the physician will remind the patient that the study 
coordinator has post-visit (baseline) questionnaires for the patient to complete. The study 
coordinator will also assess the time for the consultation, which will be recorded in a separate 
field on the data collection forms. This will be defined as the time from when the physician 
enters the consultation room to when physician's consultative activities end (i.e., when the 
physician leaves the room OR when the patient is handed off to the CRA to complete post-
consultation forms). 
8.2.5 Baseline Questionnaire 
After consultation with the physician, the study coordinator will escort the patient to a private 
area preferably near to the patient waiting area, and provide the Baseline Questionnaire for the 
patient to complete before leaving. 
 
 

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8.3 
12-month follow up 
Follow up to ascertain the patient’s overall and disease specific quality of life and prostate cancer 
treatment regret will be conducted by site coordinators 12 months (+/- 6 weeks) after the patient’s 
consultation.  
8.3.1 Twelve-month follow-up questionnaire 
If the patient has a scheduled follow-up visit within this window, he should be asked to complete 
the 12-month Follow-up Questionnaire during this visit. If no visit is scheduled, site staff will 
mail the Follow-up Questionnaire with a self-addressed stamped envelope to the patient for him 
to complete at home and return to the clinic by mail. If the questionnaire is not returned by mail 
within 4 days, the study coordinator will call the patient (up to 5 attempts) to remind him to 
complete and mail the questionnaire or he or she will offer the patient the opportunity to 
complete the questionnaire over the phone. 
8.3.2 Twelve-month follow-up chart review 
At this time site staff will also conduct retrospective chart review to ascertain treatment 
utilization and complete the follow-up form. Treatment utilization will be categorized by the 
type of treatment the patient had (surgery vs. radiation vs. active surveillance).  
9.0 
ADVERSE EVENTS 
We do not anticipate any additional adverse events related to participation in this study beyond usual care. 
If patients experience any emotional discomfort when completing the questionnaires, they may choose 
not to complete them and/or speak with the site staff. Patients experiencing any physical or psychological 
complications related to their standard of care treatment should discuss this with their treating physician. 
10.0 
MEASURES 
10.1 
Prostate Cancer Treatment Questionnaire (knowledge measure) 
“The Prostate Cancer Treatment Questionnaire” is a 12-item instrument measuring respondent 
knowledge of key information deemed by clinicians to be critical for patients to successfully 
deliberate about preference of treatment for prostate cancer. 
The questionnaire will be administered once, immediately after the consultation (post-consultation) 
and should take no more than 5-6 minutes to complete.”  
10.2 
Decisional Conflict Scale (DCS) 
The decisional conflict scale was developed and validated by O’Connor72 as an instrument intended 
to “elicit 1) health-care consumers' uncertainty in making a health-related decision; 2) the factors 
contributing to the uncertainty; and 3) health-care consumers' perceived effective decision making”. 
The low literacy version of this questionnaire will be used, and it contains 10 items answered on a 3 
point scale (i.e., “yes,” “unsure,” “no”) and may be adapted to specific health-care decision scenarios. 
Example questions include agreement with the following statements: “Did you know which options 
were available to you?” “Did you know the benefit of each option?” “Did you feel sure about what 
to choose?”.  
The questionnaire will be administered once, immediately after the consultation (post-consultation). 
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10.3 
Expanded Prostate Cancer Index Composite Short Form (EPIC-26) 
The Expanded Prostate Cancer Index Composite66 measures health-related quality of life and returns 
summary scores for urinary, bowel, sexual, and hormonal domains with high test-retest reliability 
and internal consistency.  
The questionnaire will be administered once; 12 months after the patient’s initial consultation. The 
instrument contains 26 items, and will take approximately 10-15 minutes to complete.  
10.4 
Decisional Regret Scale 
The Decisional Regret Scale73 is a short, 5-item scale measuring “distress or remorse after a (health 
care) decision.” The instrument has been validated in other decision aid studies.74 Questions are 
answered on a 5-point agreement scale. 
The questionnaire will be administered once; 12 months after the patient’s initial consultation and 
will take approximately 1-3 minutes to complete. 
11.0 
END OF INTERVENTION 
11.1 
Duration of Treatment 
The study intervention will take place in one day and follow-up assessments will occur at 12 months 
following the intervention. 
11.2 
Managing ineligible patients and registered patients who never receive protocol intervention  
Definition of ineligible patients 
A study participant who is registered to the trial but does not meet all of the eligibility criteria is 
deemed to be ineligible.  
Follow-up for ineligible patients who continue with protocol intervention 
Patients who are deemed ineligible after registering may continue the protocol intervention, provided 
the treating physician, study chair, and executive officer agree there are no safety concerns if the 
patient continues protocol intervention. All tests and data submission are to continue as if the patient 
were eligible. Notification of the local IRB may be necessary per local IRB policies. 
Follow-up for ineligible patients who discontinue protocol intervention 
For patients who are deemed ineligible after registering to the trial, who start the study intervention, 
but then discontinue the intervention, the same data submission requirements are to be followed as 
for those patients who are eligible and who discontinue study participation. 
Follow-up for patients who are registered, but who never start study intervention 
For all study participants who are registered to the trial but who never receive study intervention 
(regardless of eligibility), baseline and off-treatment notice data submission required. See the Data 
Submission Schedule accompanying the All Forms Packet. 
11.3 
Extraordinary Medical Circumstances 
If, at any time the constraints of this protocol are detrimental to the patient's health and/or the patient 
no longer wishes to continue protocol participation, protocol participation shall be discontinued. In 
this event: 
• 
Document the reason(s) for discontinuation of protocol participation on data forms. 
• 
Follow the patient for protocol endpoints as required by the Study Calendar. 

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12.0 
STATISTICAL CONSIDERATIONS 
12.1 
Study Design 
This is a non-treatment study evaluating Decision Aids (DAs) for patients with newly diagnosed 
prostate cancer. For this trial, participating institutions are randomized, according to the racial 
distribution of the patient population, to treat patients to one of 4 treatment arms (see Schema). 
Patients will complete on-line DAs if not randomized to the Usual Care arm.  All patients will 
complete a baseline knowledge questionnaire after the initial clinic visit and at 12-months following 
the surgical consultation. 
12.2 
Statistical Design and Analysis for the Primary Endpoint 
Primary Endpoint: The primary outcome, knowledge, will be assessed by a standardized 
questionnaire (i.e., Prostate Cancer Treatment Questionnaire) administered once, immediately after 
the clinical consultation while the patient is still at the study site. The number correct from this 12-
item measure will be reduced to a percentage of total number correct.  
A different method for measuring our primary outcome, knowledge, proposing instead a pre-post 
approach was considered. However, several factors lead us to favor a one-time post-intervention 
measurement:  1) Our study’s randomized design should control for differences in baseline effects; 
2) a pre-post design could be confounded by learning effects associated with the baseline 
measurement since the baseline and post-intervention measurements would only be 1-2 hours apart. 
Such learning affects could lead to artificial improvements in our control group which could limit 
our ability to see “true” differences attributable to the intervention(s); 3) finally, a one-time 
measurement of knowledge will minimize burden to respondents, particularly during the consenting 
and baseline measurement period where we seek to impede clinical workflows as little as possible. 
12.2.1 Analysis Plan 
Although the randomization unit will be participating site, our inferential unit for statistical 
analysis will be the individual patient. Due to the potential for correlation among patients within 
the same site, a mixed effects regression model (also known as random effects model or multi-
level model) will be utilized to examine the effects of the during-consultation Prostate Choice 
and the pre-consultation Knowing Your Options decision aids. Specifically, this model will 
contain a fixed intercept, a fixed effect for having received Prostate Choice, a fixed effect for 
having received Knowing Your Options, and a random, site-specific intercept to allow patients 
within the same site to be correlated. Baseline patient-level characteristics including race, 
ethnicity, severity of disease and site-level characteristics may be incorporated in this model if 
deemed appropriate. A similar approach will be utilized in the statistical analysis of secondary 
endpoints. Furthermore, descriptive statistics will be reported after incorporating cluster 
information, in particular, the empirical cluster size, and the observed intra-cluster correlation. 
 
 

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12.2.2 Sample Size and Power Considerations 
Sample size and power calculation: We first consider power and sample size under the 
assumption that patients within the same site are uncorrelated.  As this is unlikely to be the case 
in a group randomized trial, we will discuss the adjustment of the sample size estimate to account 
for this correlation between patients in the next subsection. A recent Cochrane review suggests 
that most patients can accurately answer 50% (standard deviation of 12%) of the questions asked 
of them.70 On average, DAs increase that knowledge by 20% to 60% of questions asked being 
answered correctly, but 95% of trials show absolute knowledge increases of 10% or greater. We 
will consider an absolute 8% increase in knowledge as a clinically meaningful effect size for 
either during-consultation Prostate Choice or pre-consultation DA in this clinical trial. Note that 
the four arms of this study make up a 2 X 2 factorial design.  Thus, it is natural to consider 
evaluating the decision aids using a two-way analysis of variance (ANOVA).  In this case, the 
two factors in the ANOVA will be having received during-consultation Prostate Choice (yes or 
no) and having received pre-consultation DA (yes or no).  We will consider simultaneously 
testing (at a significance level of 0.025 for each test) the main effects of the two decision aids as 
our primary analysis.  That is, we will simultaneously test the null hypothesis that the average 
knowledge (i.e. the proportion of correct responses to questions) among those who received the 
pre-consultation DA is equal to that among those who did not (vs. an alternative that these two 
averages are not equal), and the null hypothesis that the average knowledge among those who 
received the during-consultation Prostate Choice is equal to that among those who did not (vs. 
an alternative that these two averages are not equal).  A total sample of 100 patients (25 patients 
per arm) would give us approximately 85% power to detect a difference between those receiving 
pre-consultation DA and those not receiving pre-consultation DA, under the alternative that the 
average knowledge among those receiving pre-consultation DA is 58%, and that the average 
knowledge among those not receiving pre-consultation DA is 50%, using a two-sample t-test 
(with two-sided alternative) with a 2.5% significance level (this is equivalent to the F test for the 
main effects in the ANOVA).  Under a similar alternative, the same can be said for the during-
consultation Prostate Choice decision aid.  Thus, if patients within each site were not correlated 
with each other, our target sample size would be 100 patients. There will be some, but 
insufficient power to detect an interaction between the two decision aids, but such effects are 
rare and not anticipated in this study.  Therefore, we will not test for such an interaction in the 
primary analysis. 
Sample size adjustment due to cluster randomization: As mentioned above, we do not believe 
that subjects within each site will truly be independent of each other.  Thus, the application of 
the standard sample size calculation, as above, may lead to an underpowered study. Since we 
expect 𝑘𝑘=20 sites to participate in this clinical trial, we would need about 𝑚𝑚 = 5 patients to be 
enrolled from each site (on average) to achieve a total enrollment of 100 patients. Assuming the 
intra-site correlation coefficient 𝜌𝜌 will be approximately 0.1 (rather than zero) for all study sites, 
we must inflate the target sample size by a factor71 of 1+(m-1)ρ=1+(5-1)*0.1=1.4 to achieve 
comparable power to that in a patient-level randomized trial.  This comes about as follows (we 
consider the pre-decision DA here, but the same derivation holds for the during-consultation 
Prostate Choice).  Suppose the variance of knowledge (Y) is the same for all patients, and is 
equal to σ2, and that n is our total sample size, with n/2 patients receiving the pre-consultation 
DA and n/2 not receiving the pre-consultation DA.  Assuming no correlation between patients 
within the same site, the variance of the sample mean of knowledge among those receiving pre-
consultation DA (Ῡ1) will be σ2/(n/2), as will that for the sample mean of knowledge among 
those not receiving pre-consultation DA (Ῡ2), and our test statistic would have the form [(Ῡ1 - 
Ῡ2) – (µ1 - µ2)]/[σ2/(n/2) + σ2/(n/2)](1/2) (note that the denominator of this statistic simplifies to 
[4σ2/n](1/2)).  However, this is not a correct assumption in our case.  In particular, suppose that 
we have 20 sites, and within each site, we have m (5) patients, between each of whom the 

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correlation is ρ (0.1) (meaning the covariance between any two patients in the same site is ρσ2).  
In this case, the variances of the sample means are not σ2/(n/2), but rather: 
𝑉𝑉𝑉𝑉𝑉𝑉(𝑌𝑌1) =  𝑉𝑉𝑉𝑉𝑉𝑉(𝑌𝑌2) = 𝑉𝑉𝑉𝑉𝑉𝑉ቌ1
ቀ
𝑛𝑛
2ቁ
 ∑𝑌𝑌𝑖𝑖ቍ
=
1
ቀ
𝑛𝑛
2ቁ
2 ቎ቀ𝑛𝑛
2ቁ𝜎𝜎2 + (2) ቌ
ቀ
𝑛𝑛
2ቁ
𝑚𝑚ቍ൬
𝑚𝑚!
(𝑚𝑚−2)! 2!൰𝜌𝜌𝜎𝜎2቏
= 1
ቀ
𝑛𝑛
2ቁ
 ൤𝜎𝜎2 + ൬1
𝑚𝑚൰𝑚𝑚(𝑚𝑚−1)𝜌𝜌𝜎𝜎2൨
= 1
ቀ
𝑛𝑛
2ቁ
 [𝜎𝜎2 + (𝑚𝑚−1)𝜌𝜌𝜎𝜎2]
= 𝜎𝜎2
ቀ
𝑛𝑛
2ቁ
 [1 + (𝑚𝑚−1)𝜌𝜌].
  
 
Thus, the denominator of our test statistic should actually be [(4σ2/n)(1 + (m – 1)ρ)](1/2) .  
Therefore, if we replace the original sample size (n=100) with n(1 + (m – 1)ρ = 100*1.4 = 140 
in the denominator of our original test statistic, we will have a test statistic which accounts for 
the correlation of 0.1 between subjects within each of the 20 sites.  Hence, we will target an 
effective sample size of 140 patients (approximately 35 patients per arm, 7 patients per site). The 
total sample size may be further inflated by 20% to account for ineligible, cancel and loss to 
follow-up for longer term secondary outcomes and allow increased power to detect racial/ethnic 
differences. Therefore, a total number of 172 patients will be enrolled into this clinical trial.  
These 172 patients, recruited from 20 participating sites (about 9 patients per site) will receive 
the intervention (or control) to which their location is randomized.   
Though we have chosen to power this study based on an absolute meaningful difference of 8%, 
we determined the necessary sample size for a range of meaningful differences.  In each case, 
the target power was approximately 85% (thought it varied slightly, as we only considered sizes 
which were divisible by 20, given the number of expected sites) with joint main effect two-sided 
t-tests with two-sided alternatives at the 2.5% significance level.  These sample sizes are as 
follows (not adjusted for ineligibility, cancel and loss to follow-up): 
Meaningful Difference 
Total sample size without 
correlation within sites 
Total sample size adjusted for 
correlation within sites 
4% 
360 
504 
6% 
180 
252 
8% 
100 
140 
10% 
60 
84 
12% 
40 
56 
12.2.3 Study Operating Characteristics 
Interim Analysis:  An interim analysis will be used to test if intervention arm (either during-
consultation Prostate Choice or Knowing Your Options pre-consultation DA) has produced 
better knowledge than the respective control arm. There will be 5 to 6 interim analyses conducted 
of this type before the final analysis with this plan. The O’Brien-Fleming boundaries75 will be 

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used to determine statistical significance in this interim analysis. If any interim analysis is 
statistically significant, the DSMB may consider stopping the trial early due to demonstrated 
efficacy of the intervention arm. 
Futility Analysis:  This study will also be monitored for early stopping for futility. Repeated 
confidence interval approach76 will be used to test futility. At each interim analysis, a 95% one-
sided confidence interval on the difference of knowledge between the intervention and control 
arm will be computed. If the confidence interval does not cover the target alternative of 0.1 for 
one of these comparisons, the DSMB may consider stopping the trial early for futility. 
12.3 
Sample Size, Accrual Time, and Study Duration 
12.3.1 Patient Population: In order to achieve higher minority accrual (at least 43 AA, and at least 43 
AI/AN, and up to 86 White, and/or Asian), we will impose a restriction of at most 50% White 
and/or Asian participants at each site. Patient accrual will be restricted to AA and AI/AN 
minority once 50% White or Asian patients are enrolled. We are not oversampling Asian men 
(n=4) because there are no known disparities in this population. As patient recruitment is not 
blinded to site in the cluster randomization, we will encourage sites to identify patients prior to 
randomization and conduct recruitment by an individual independent from the one who delivers 
the intervention to reduce bias. We will recruit 172 patients (43 per arm).  
In addition, in order to prevent imbalance between the arms, sites that over-accrue to the study 
may be asked to close the study at their institution. Finally, institutions will be given a 
recruitment goal of at least 2 men who report Hispanic/Latino ethnicity per site, and will be 
required to hold two slots for Hispanic/Latino participants for the first year of the study in hopes 
of accruing a similar number of Hispanic/Latino men. These slots will be released after the first 
year of the study if no Hispanic/Latino participants have been recruited at a given site. 
12.3.2 Accrual Rate and Accrual Duration: Based on an estimated accrual rate of 10 patients per 
month across the 20 participating practices, we expect 1 year to identify and train participating 
practices, approximately 18 months to enroll patients into the clinical trial and another 18 months 
to collect follow-up outcomes and perform data cleaning and statistical analysis. The study 
duration of this clinical trial will be 4 years. 
12.3.3 Primary Endpoint Completion Date for ClinicalTrials.gov Reporting: For purposes of 
ClinicalTrial.gov reporting, the Primary Endpoint Completion Date (PECD) for this study is the 
time the last patient registered has been followed for at least 12 months. 
12.4 
Supplementary Analysis Plans 
12.4.1 Secondary endpoints 
Secondary endpoints will be decisional quality, as measured by the DCS and Decisional Regret; 
clinical time required; patient QOL, which will be measured by questionnaires and converted 
into continuous summary scores using standard algorithms; and utilization, which will be 
categorized by the type of treatment the patient received, as determined by chart review at 12 
months post-diagnosis.  We will also consider the primary outcome of knowledge within only 
minority men (pooled) (defined as non-White or Hispanic White), as well as separately within 
the three racial subgroups. It is worth noting that some patients may receive a follow-up biopsy 
before these secondary endpoints are measured (at 12 months after first consultation), which 
could have a strong impact on their DCS and QOL scores.  Thus, whether or not a patient 
receives a follow-up biopsy before 12 months (and the timing of this biopsy) will be taken into 
account when modeling these endpoints. 
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Decisional quality, average clinical time required, and patient QOL scores will be compared 
across DA types using linear mixed models similar to that used to assess the primary endpoint.  
In particular, this model will include fixed effects for Prostate Choice and Knowing Your 
Options and a random, site-specific intercept to allow for subjects within the same site to be 
correlated.  Utilization will be compared across DA types using a generalized linear mixed 
model, again with fixed effects for having received Prostate Choice and having received 
Knowing Your Options and a random, site-specific intercept. 
As mentioned above, the primary analysis will be re-implemented within only minority men as 
a secondary analysis.  We anticipate enrolling approximately 80% minority men.  It is worth 
nothing that, if this were the primary analysis, this sample would give us approximately 78% 
power to detect an absolute difference of 8% in knowledge for either of the decision aid main 
effects using a two-sample t-test (with two-sided alternative) with a 2.5% significance level (i.e. 
the same analysis/assumptions used to power the primary analysis). 
As an additional secondary objective, we will explore whether the overall effects of interventions 
on patient knowledge, quality of life, and treatment utilization differ by racial/ethnic subgroups. 
Our sample size is driven by the primary outcome of knowledge. Oversampling of minority 
populations of interest will achieve a robust representation of these minority populations in our 
final sample, but we have not designed the trial to have sufficient power to ascertain subtle 
subgroup differences in knowledge and quality of life by race/ethnicity subgroups. These 
secondary analyses will be exploratory, because fully testing the racial/ethnic differences would 
require prohibitively large sample sizes, and the literature does not suggest a strong race-based 
rationale for large differences.  If subtle but potentially important trends in subgroup differences 
are identified in these exploratory analyses, those findings could be used to justify a larger study 
examining a primary hypothesis related to racial/ethnic difference or could influence the design 
of subsequent culturally tailored interventions. At present, the science of decision aids and the 
state of the evidence surrounding racial/ethnic differences in the effect of decision aids would 
not support testing such a hypothesis as a primary endpoint. 
12.5 
Monitoring 
12.5.1 Adverse Event Stopping Rules 
This is a behavioral intervention, questionnaire-based outcome study (i.e., this is not a 
therapeutic study) and as such, no adverse event stopping rule will be developed (see Section 
9.0). 
12.5.2 Accrual Monitoring Stopping Rule 
There is no formal plan to monitor for slow accrual.  Meetings to assess recruitment will be 
conducted monthly.  Regulatory DSMB reports will allow decisions to be made regarding 
stopping. 
12.5.3 Other Monitoring 
Conference calls (or webinars, if visual media is shared) will be arranged and conducted on an 
as-needed basis. These meetings will be led by the study chair, and will include the study 
statistician, protocol coordinator, institutional study coordinators and site investigators or their 
designees to monitor accrual, completeness of data collection, and safety. 
12.6 
Reporting 
This study will be monitored by the Alliance Data and Safety Monitoring Board (DSMB), an NCI-
approved functioning body.  Reports containing efficacy, adverse event, and administrative 
information will be provided to the DSMB every 6 months as per NCI guidelines. Reports from these 
meetings will be made available to the study chair, statistician, and participating institutions. 

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Results Reporting on ClinicalTrials.gov: At study activation, this study will have been registered 
within the “ClincialTrails.gov” website. The Primary and Secondary Endpoints along with other 
required information for this study will be reported on ClinicalTrials.gov.  
12.7 
Inclusion of Women and Minorities 
Because prostate cancer occurs primarily in men above the age of 50, recruitment of participants for 
this study will focus upon men aged 50 years and older. Since women and children are not subject 
to prostate cancer, they will be excluded from this study. 
Racial Categories 
DOMESTIC PLANNED ENROLLMENT REPORT 
Ethnic Categories 
Not Hispanic or Latino 
Hispanic or Latino 
Total 
Female 
Male 
Female 
Male 
American Indian/Alaska Native 
0 
43 
0 
0 
43 
Asian 
0 
5 
0 
0 
5 
Native Hawaiian or Other Pacific 
Islander 
0 
2 
0 
0 
2 
Black or African American 
0 
38 
0 
5 
43 
White  
0 
38 
0 
37 
75 
More Than One Race 
0 
3 
0 
1 
4 
Total 
0 
129 
0 
43 
172 
 
 
 

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13.0 
GENERAL REGULATORY CONSIDERATIONS AND CREDENTIALING 
13.1 
Limited Access requirements 
Institutions that are interested in participating in this study must first contact the Study Chair, Jon 
Tilburt to review study requirements and procedures and to identify who will be responsible for the 
study at the institution. 
Criteria for participation will be based on the following: 
• 
Site must provide consultation to newly diagnosed prostate cancer patients 
• 
Site must have providers willing to use a decision aid in patient consults 
• 
Site must be able to recruit 8-10 patients over 2 years 
• 
2-3 of those recruited each year need to self-identify as being from one of two groups: American 
Indian or Alaska Native (i.e. can be “more than one race” with one of those races being American 
Indian/Alaska Native) OR African American 
• 
Sites that see a lot of Hispanic/Latino patients are encouraged to participate, however the trial 
materials and outcome measures require English speaking capacity or assistance by an 
appropriate translator. 

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14.0 
REFERENCES 
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3. 
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4. 
Mohler JL, Armstrong AJ, Bahnson RR, et al. NCCN clinical practice guidelines in oncology: 
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Miller DC, Sanda MG, Dunn RL, et al. Long-term outcomes among localized prostate cancer 
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6. 
Potosky AL, Legler J, Albertsen PC, et al. Health outcomes after prostatectomy or radiotherapy for 
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2000;92(19):1582-1592. 
7. 
Potosky AL, Reeve BB, Clegg LX, et al. Quality of life following localized prostate cancer treated 
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8. 
Sanda MG, Dunn RL, Michalski J, et al. Quality of life and satisfaction with outcome among prostate-
cancer survivors. N Engl J Med. Mar 20 2008;358(12):1250-1261. 
9. 
Taylor KL, Luta G, Miller AB, et al. Long-term disease-specific functioning among prostate cancer 
survivors and noncancer controls in the prostate, lung, colorectal, and ovarian cancer screening trial. J 
Clin Oncol. Aug 1 2012;30(22):2768-2775. 
10. 
Wilt TJ, MacDonald R, Rutks I, Shamliyan TA, Taylor BC, Kane RL. Systematic review: 
comparative effectiveness and harms of treatments for clinically localized prostate cancer. Ann Intern 
Med. Mar 18 2008;148(6):435-448. 
11. 
Screening for prostate cancer: Current recommendation. 2012; 
http://www.uspreventiveservicestaskforce.org/prostatecancerscreening.htm. Accessed May 20, 2012. 
12. 
Cohen JH, Schoenbach VJ, Kaufman JS, et al. Racial differences in clinical progression among 
Medicare recipients after treatment for localized prostate cancer (United States). Cancer Causes 
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13. 
Godley PA, Schenck AP, Amamoo MA, et al. Racial differences in mortality among Medicare 
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1710. 
14. 
Bach PB, Schrag D, Brawley OW, Galaznik A, Yakren S, Begg CB. Survival of blacks and whites 
after a cancer diagnosis. Jama. Apr 24 2002;287(16):2106-2113. 
15. 
Du XL, Fang S, Coker AL, et al. Racial disparity and socioeconomic status in association with 
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16. 
Espey DK, Wu XC, Swan J, et al. Annual report to the nation on the status of cancer, 1975-2004, 
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Henderson JA, Espey DK, Jim MA, German RR, Shaw KM, Hoffman RM. Prostate cancer incidence 
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18. 
White A, Coker AL, Du XL, Eggleston KS, Williams M. Racial/ethnic disparities in survival among 
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19. 
Winkfield KM, Chen MH, Dosoretz DE, et al. Race and survival following brachytherapy-based 
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20. 
Hosain GM, Sanderson M, Du XL, Chan W, Strom SS. Racial/ethnic differences in treatment 
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22. 
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influence the interval between positive prostate biopsy and radical prostatectomy. Urology. Nov 
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Pollack CE, Bekelman JE, Epstein AJ, Liao K, Wong YN, Armstrong K. Racial disparities in 
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Klabunde CN, Potosky AL, Harlan LC, Kramer BS. Trends and black/white differences in treatment 
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33. 
Hu JC, Kwan L, Krupski TL, et al. Determinants of treatment regret in low-income, uninsured men 
with prostate cancer. Urology. Dec 2008;72(6):1274-1279. 
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Pollack CE, Weissman G, Bekelman J, Liao K, Armstrong K. Physician social networks and variation 
in prostate cancer treatment in three cities. Health Serv Res. Feb 2012;47(1 Pt 2):380-403. 
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Johnson RL, Saha S, Arbelaez JJ, Beach MC, Cooper LA. Racial and ethnic differences in patient 
perceptions of bias and cultural competence in health care. J Gen Intern Med. Feb 2004;19(2):101-
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Cooper LA, Hill MN, Powe NR. Designing and evaluating interventions to eliminate racial and ethnic 
disparities in health care. J Gen Intern Med. Jun 2002;17(6):477-486. 
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38. 
O'Connor AM, Llewellyn-Thomas HA, Flood AB. Modifying unwarranted variations in health care: 
shared decision making using patient decision aids. Health Aff (Millwood). 2004;Suppl 
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39. 
Wennberg JE, Fisher ES, Skinner JS. Geography and the debate over Medicare reform. Health Aff 
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Keirns CC, Goold SD. Patient-centered care and preference-sensitive decision making. Jama. Oct 28 
2009;302(16):1805-1806. 
41. 
Berwick DM. Quality chasm factors. Health Aff (Millwood). Sep-Oct 2002;21(5):301-302; author 
reply 303. 
42. 
Berwick DM. A user's manual for the IOM's 'Quality Chasm' report. Health affairs. May-Jun 
2002;21(3):80-90. 
43. 
Prostate Cancer Patient Education Project (PCFEP): Prostate Cancer Symptom Management in Low-
Literacy Men (Cancer Disparities) Part 1. 2013; http://what-when-how.com/cancer-
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about the treatment of early-stage prostate cancer: a critical review. Ann Intern Med. May 4 
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45. 
Lin GA, Aaronson DS, Knight SJ, Carroll PR, Dudley RA. Patient decision aids for prostate cancer 
treatment: a systematic review of the literature. CA Cancer J Clin. Nov-Dec 2009;59(6):379-390. 
46. 
O'Brien MA, Whelan TJ, Villasis-Keever M, et al. Are cancer-related decision aids effective? A 
systematic review and meta-analysis. J Clin Oncol. Feb 20 2009;27(6):974-985. 
47. 
Wei JT, Uzzo RG. Shared decision-making strategies for early prostate cancer. Semin Urol Oncol. Feb 
2002;20(1):74-78. 
48. 
Paasche-Orlow MK, Wolf MS. Promoting health literacy research to reduce health disparities. J 
Health Commun. 2010;15 Suppl 2:34-41. 
49. 
Ratzan SC, Parker RM. Health literacy - identification and response. J Health Commun. Dec 
2006;11(8):713-715. 
50. 
Weng HH, Kaplan RM, Boscardin WJ, et al. Development of a decision aid to address racial 
disparities in utilization of knee replacement surgery. Arthritis Rheum. May 15 2007;57(4):568-575. 
51. 
Sajid S, Kotwal AA, Dale W. Interventions to improve decision making and reduce racial and ethnic 
disparities in the management of prostate cancer: a systematic review. J Gen Intern Med. Aug 
2012;27(8):1068-1078. 
52. 
Lepore SJ, Helgeson VS, Eton DT, Schulz R. Improving quality of life in men with prostate cancer: a 
randomized controlled trial of group education interventions. Health Psychol. Sep 2003;22(5):443-
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53. 
Holmes-Rovner M, Stableford S, Fagerlin A, et al. Evidence-based patient choice: a prostate cancer 
decision aid in plain language. BMC Med Inform Decis Mak. 2005;5:16. 
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Auvinen A, Hakama M, Ala-Opas M, et al. A randomized trial of choice of treatment in prostate 
cancer: the effect of intervention on the treatment chosen. BJU Int. Jan 2004;93(1):52-56; discussion 
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55. 
Volk RJ, Hawley ST, Kneuper S, et al. Trials of decision aids for prostate cancer screening: a 
systematic review. Am J Prev Med. Nov 2007;33(5):428-434. 
56. 
Hess EP, Knoedler MA, Shah ND, et al. The chest pain choice decision aid: a randomized trial. Circ 
Cardiovasc Qual Outcomes. May 2012;5(3):251-259. 
57. 
Mullan RJ, Montori VM, Shah ND, et al. The diabetes mellitus medication choice decision aid: a 
randomized trial. Arch Intern Med. Sep 28 2009;169(17):1560-1568. 

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58. 
Wong CA, Jim MA, King J, et al. Impact of hysterectomy and bilateral oophorectomy prevalence on 
rates of cervical, uterine, and ovarian cancer among American Indian and Alaska Native women, 
1999-2004. Cancer Causes Control. Dec 2011;22(12):1681-1689. 
59. 
Jim MA, Perdue DG, Richardson LC, et al. Primary liver cancer incidence among American Indians 
and Alaska Natives, US, 1999-2004. Cancer. Sep 1 2008;113(5 Suppl):1244-1255. 
60. 
D'Amico AV, Chen MH. Pretreatment prostate-specific antigen velocity and the risk of death from 
prostate cancer in the individual with low-risk prostate cancer. J Clin Oncol. Aug 1 2009;27(22):3575-
3576. 
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D'Amico AV, Chen MH, Catalona WJ, Sun L, Roehl KA, Moul JW. Prostate cancer-specific mortality 
after radical prostatectomy or external beam radiation therapy in men with 1 or more high-risk factors. 
Cancer. Jul 1 2007;110(1):56-61. 
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D'Amico AV, Cote K, Loffredo M, Renshaw AA, Schultz D. Determinants of prostate cancer-specific 
survival after radiation therapy for patients with clinically localized prostate cancer. J Clin Oncol. Dec 
1 2002;20(23):4567-4573. 
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D'Amico AV, Moul J, Carroll PR, Sun L, Lubeck D, Chen MH. Cancer-specific mortality after 
surgery or radiation for patients with clinically localized prostate cancer managed during the prostate-
specific antigen era. J Clin Oncol. Jun 1 2003;21(11):2163-2172. 
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D'Amico AV, Whittington R, Malkowicz SB, et al. Biochemical outcome after radical prostatectomy 
or external beam radiation therapy for patients with clinically localized prostate carcinoma in the 
prostate specific antigen era. Cancer. Jul 15 2002;95(2):281-286. 
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D'Amico AV, Whittington R, Malkowicz SB, et al. Pretreatment nomogram for prostate-specific 
antigen recurrence after radical prostatectomy or external-beam radiation therapy for clinically 
localized prostate cancer. J Clin Oncol. Jan 1999;17(1):168-172. 
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Wei JT, Dunn RL, Litwin MS, Sandler HM, Sanda MG. Development and validation of the expanded 
prostate cancer index composite (EPIC) for comprehensive assessment of health-related quality of life 
in men with prostate cancer. Urology. Dec 20 2000;56(6):899-905. 
67. 
Social Security Administration: Life Tables.  http://www.ssa.gov/oact/STATS/table4c6.html. 
Accessed March 1, 2012. 
68. 
Elwyn G, O'Connor A, Stacey D, et al. Developing a quality criteria framework for patient decision 
aids: online international Delphi consensus process. BMJ. Aug 26 2006;333(7565):417. 
69. 
Knowing your options: A decision aid for men with localized prostate cancer.  
http://www.effectivehealthcare.ahrq.gov/ehc/decisionaids/prostate-cancer/. Accessed January 1, 2012. 
70. 
Stacey D, Bennett CL, Barry MJ, et al. Decision aids for people facing health treatment or screening 
decisions. Cochrane Database Syst Rev. 2011(10):CD001431. 
71. 
Donner A, Klar N. Design and analysis of cluster randomization trials in health research. London / 
New York, N.Y.: Arnold; Co-published by the Oxford University Press; 2000. 
72. 
Rosenberger WF, Lachin JM. Randomization in clinical trials : theory and practice. New York: 
Wiley; 2002. 
73. 
Beydoun HA, Mohan R, Beydoun MA, Davis J, Lance R, Schellhammer P. Development of a scale to 
assess patient misperceptions about treatment choices for localized prostate cancer. BJU Int 
2010;106:334-41. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2888927/ 
74. 
O'Connor A. Validation of a decisional conflict scale. Med Decis Making 1995;15:25-30. 
http://www.ncbi.nlm.nih.gov/pubmed/7898294 
75. 
Wei JT, Dunn RL, Litwin MS, Sandler HM, Sanda MG. Development and validation of the expanded 
prostate cancer index composite (EPIC) for comprehensive assessment of health-related quality of life 
in men with prostate cancer. Urology 2000;56:899-905. 
http://www.ncbi.nlm.nih.gov/pubmed/11113727 

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76. 
Clark JA, Talcott JA. Symptom indexes to assess outcomes of treatment for early prostate cancer. 
Med Care 2001;39:1118-30. http://www.ncbi.nlm.nih.gov/pubmed/11567174 
77. 
Clark JA, Wray NP, Ashton CM. Living with treatment decisions: regrets and quality of life among 
men treated for metastatic prostate cancer. J Clin Oncol 2001;19:72-80. 
http://www.ncbi.nlm.nih.gov/pubmed/11134197 
 
 
 

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15.0 
MODEL INFORMED CONSENT FORM 
Study Title for Study Participants: 
Testing two decision aids on patient knowledge and communication when 
choosing a course of treatment for prostate cancer 
 
Official Study Title for Internet Search on 
  
Alliance A191402CD: Testing Decision Aids to Improve Prostate Cancer 
Decisions for Minority Men 
 
This research study is conducted by the Alliance for Clinical Trials in Oncology, a national clinical 
research group supported by the National Cancer Institute. The Alliance is made up of cancer 
doctors, health professionals, and laboratory researchers, whose goal is to develop better treatments 
for cancer, to prevent cancer, to reduce side effects from cancer, and to improve the quality of life of 
cancer patients. 
 
What is the usual approach to discussing my treatment options? 
You are being asked to take part in this research study that looks at whether computer tools (also 
called “decision aids”) help prostate cancer patients better understand their treatment options and 
help patients talk about their treatment preferences with their doctors. Usually, patients who must 
make treatment decisions for prostate cancer discuss their options with their doctor. Their doctor 
explains available choices, answers questions, and offers his/her recommendation for the best 
treatment option. Doctor recommendations take into account the patient’s age, health, and health 
goals. 
 
 
What are my other choices if I do not take part in this study? 
If you decide not to take part in this study, you have other choices. For example: 
• 
you may choose to have the usual approach described above 
• 
you may choose to take part in a different study, if one is available 
 
 
Why is this study being done? 
Discussing your options for treatment or observation of your prostate cancer is an important next 
step. The purpose of this study is to test whether the use of a decision aid (a visual aid with 
educational information) can improve patients’ knowledge of their condition and options for 
treatment, and whether using a decision aid can help when talking with their doctor. The effects of 
two different prostate cancer decision aids will be tested in this study. One decision aid is called 
“Prostate Choice” and is used by patients during their visit with their doctor. The other decision aid is 
called “Knowing Your Options” and is used by patients before they visit with their doctor.  
 
There will be about 172 men taking part in this study. 

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What are the study groups? 
A computer will by chance assign your doctor’s office or hospital to one of four groups in the study. 
This is called randomization. This is done by chance because no one knows if one study group is 
better or worse than the others. Neither you nor your doctor can choose the group you will be in. The 
four groups are: 
 
• 
Group 1 will use both decision aids: one just before (“Knowing your Options”), and the other 
during your visit with the urologist (“Prostate Choice”). 
• 
Group 2 will use one decision aid (“Knowing your Options”), just before your visit with the 
urologist. 
• 
Group 3 will use one decision aid (“Prostate Choice”), during your visit with the urologist. 
• 
Group 4 will use neither decision aid, and you will have the usual discussion with the 
urologist described above. 
 
If you are in Group 1 or Group 2, you will be asked to go to the clinic for your visit with the urologist 
early so that you will have time to use the decision aid. 
 
It is unclear whether there is any time difference between doctor visits for the different groups as a 
result of the decision aids. 
 
All Groups: After your visit with the urologist, you will be asked to complete a survey about your 
treatment choice, your knowledge about your disease and treatment choices, and your experience in 
discussing treatment options. This survey should take about 10 to 15 minutes to complete. 
 
All Groups: About 1 year after your visit with the urologist, if you have an appointment with him or 
her, you will be asked to complete another survey to ask you about your prostate cancer treatment 
choice and about the results of that choice. If you do not have an appointment with your urologist at 
this time, research staff from your doctor’s office will mail to you the survey so that you can 
complete it at home. A stamped, addressed envelope will be provided with the survey. This survey 
should take about 15 to 20 minutes to complete. 
 
In addition, after one year, research staff from your doctor’s office will review your medical records 
to see what kinds of treatments you may have received for your prostate cancer (for example, 
surgery, or radiation therapy, or “watchful waiting”). 
 
 
 

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Another way to find out what will happen to you during the study is to read the chart below. Start 
reading at the left side and read across to the right, following the lines and arrows. 
 
Group 1 
Pre- and during visit Decision Aids 
 
 
 
followed by survey 
 
 
 
 
 
12-Month 
Telephone Survey  
Group 2 
Pre-visit Decision Aid only 
 
 
followed by survey 
 
 
 
 
Group 3 
During visit Decision Aid only 
 
 
followed by survey 
 
 
 
 
Group 4 
Usual Care 
 
 
 
followed by survey 
 
 
 
 
How long will I be in this study? 
You will participate in the study on the day of your visit with the urologist and then participate in the 
survey call 12 months after the visit.  
 
 
What extra tests and procedures will I have if I take part in this study? 
Most of the exams, tests, and procedures you will have are part of the usual approach for your cancer. 
However, you may need to have a history and physical to find out if you can be in the study if you 
haven’t had one done recently. 
 
 
What possible risks can I expect from taking part in this study? 
If you choose to take part in this study, there is a risk that: 
• 
You may lose time at work or home and spend more time in the hospital or doctor’s office 
than usual. 
• 
You may be asked sensitive or private questions which you normally do not discuss. You do 
not have to answer any question that you do not want to during the surveys.   
 
 
What possible benefits can I expect from taking part in this study? 
It is not possible to know at this time if a decision aid for prostate cancer treatment decisions will 
increase your knowledge of treatment options and help you talk with your urologist about your 
treatment preferences. It is also not known if a decision aid used before your doctor visit or during 
your doctor visit is more helpful. This study will help researchers learn how to better help people in 
the future who must make difficult treatment decisions. 
 
 

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Can I stop taking part in this study? 
Yes. You can decide to stop at any time. If you decide to stop for any reason, it is important to let the 
study doctor know as soon as possible so you can stop safely. If you stop, you can decide whether or 
not to let the study doctor continue to provide your medical information to the organization running 
the study. 
 
The study doctor will tell you about new information or changes in the study that may affect your 
health or your willingness to continue in the study. 
 
The study doctor may take you out of the study: 
• 
If your health changes and the study is no longer in your best interest 
• 
If new information becomes available 
• 
If you do not follow the study rules 
• 
If the study is stopped by the sponsor or IRB 
 
 
What are my rights in this study? 
Taking part in this study is your choice. No matter what decision you make, and even if your 
decision changes, there will be no penalty to you. You will not lose medical care or any legal rights. 
 
For questions about your rights while in this study, call the ________________________ (insert 
name of center) Institutional Review Board at __________________ (insert telephone number). 
(Note to Local Investigator: Contact information for patient representatives or other individuals at a 
local institution who are not on the IRB or research team but take calls regarding clinical trial 
questions can also be listed here.) 
 
 
What are the costs of taking part in this study? 
There are no costs to you for taking part in this study. You will not be paid for taking part in this 
study. 
 
 
What happens if I am injured or hurt because I took part in this study? 
If you are injured or hurt as a result of taking part in this study and need medical treatment, please 
tell your study doctor. The study sponsors will not offer to pay for medical treatment for injury. Your 
insurance company may not be willing to pay for study-related injury. If you have no insurance, you 
would be responsible for any costs. 
 
If you feel this injury was a result of medical error, you keep all your legal rights to receive payment 
for this even though you are in a study. 
 
Who will see my medical information? 
Your privacy is very important to us and the researchers will make every effort to protect it. Your 
information may be given out if required by law. For example, certain states require doctors to report 

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to health boards if they find a disease like tuberculosis. However, the researchers will do their best to 
make sure that any information that is released will not identify you. Some of your health 
information from this study will be kept in the Alliance central database for research. Your name or 
contact information will not be put in the database. 
 
There are organizations that may inspect your records. These organizations are required to make sure 
your information is kept private, unless required by law to provide information. Some of these 
organizations are: 
 
• 
The Alliance for Clinical Trials in Oncology 
• 
The Institutional Review Board, IRB, is a group of people who review the research with the 
goal of protecting the people who take part in the study. 
• 
The National Cancer Institute in the U.S. 
 
The Alliance has received a Certificate of Confidentiality from the federal government, which will 
help us to protect your privacy. The Certificate protects against the involuntary release of information 
about you collected during the course of the study. The researchers involved in this project may not 
be forced to identify you in any legal proceedings (criminal, civil, administrative, or legislative) at 
the federal, state or local level. However, some information may be required by the Federal Food, 
Drug, and Cosmetic Act, the U.S. Department of Health and Human Services, or for purposes of 
program review or audit. Also, you may choose to voluntarily disclose the protected information 
under certain circumstances. For example, if you or your guardian requests the release of information 
about you in writing (through, for example, a written request to release medical records to an 
insurance company), the Certificate does not protect against that voluntary disclosure. 
 
Where can I get more information? 
You may visit the NCI Web site at 
for more information about studies or general 
information about cancer. You may also call the NCI Cancer Information Service to get the same 
information at: 
 
 
A description of this clinical trial will be available on
, as required by 
U.S. Law. This Web site will not include information that can identify you. At most, the Web site 
will include a summary of the results. You can search this Web site at any time. 
 
 
Who can answer my questions about this study? 
You can talk to the study doctor about any questions or concerns you have about this study or to 
report side effects or injuries. Contact the study doctor __________________ (insert name of study 
doctor[s]) at __________________ (insert telephone number). 
 
 
Contact for Possible Future Research Studies: 
 
The researchers may decide to conduct further research in the future on decision aids for prostate 
cancer. They may want to contact you to learn more about your quality of life following prostate 

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cancer treatment and your long-term satisfaction with your treatment decision. They may also want 
to learn your opinions in the future about decision aids for prostate cancer 
 
I agree that my study doctor, or their representative, may contact me or my physician to see if I wish 
to participate in other research in the future. 
 
 
YES 
 
NO 
 
 
My Signature Agreeing to Take Part in the Study 
I have read this consent form or had it read to me. I have discussed it with the study doctor and my 
questions have been answered. I will be given a signed copy of this form. I agree to take part in the 
study. 
 
Participant’s signature________________________________ 
 
Date of signature_____________________________________ 
 
 

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APPENDIX I 
BASELINE QUESTIONNAIRE BOOKLET 
 
 

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Prostate Cancer Treatment Questionnaire 
 
Please check the TRUE or FALSE box for each statement based on your knowledge of prostate cancer 
treatments. If you are not completely sure, mark ‘Unsure’.   
 
True 
False 
Unsure 
 
1. 
Most prostate cancer spreads quickly to other parts of the body 
1
 
2
 
3
 
2. 
Other illnesses can make treating prostate cancer more difficult 
1
 
2
 
3
 
3. 
Some treatments are better than others at stopping prostate cancer 
1
 
2
 
3
 
4. 
Radiation therapy from a machine for prostate cancer requires weeks of 
daily treatments 
1
 
2
 
3
 
5. 
Radiation seed therapy for prostate cancer requires weeks of daily 
treatments 
1
 
2
 
3
 
6. 
Radiation for prostate cancer can cause rectal pain 
1
 
2
 
3
 
7. 
Surgery for prostate cancer can cause urine leakage 
1
 
2
 
3
 
8. 
For most men, radiation therapy for prostate cancer has no effect on 
urinary control 
1
 
2
 
3
 
9. 
Both surgery and radiation can decrease sexual function 
1
 
2
 
3
 
10  Low-risk prostate cancer can be safely monitored 
1
 
2
 
3
 
11. After prostate cancer surgery, a man will go home with a catheter 
1
 
2
 
3
 
12. Hot flashes is a side-effect of hormone treatment 
1
 
2
 
3
 
Investigator developed. 
 
 
 

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Decisional Conflict Scale 
 
My difficulty in making this choice 
 
A. 
Which treatment option do you prefer? Please check one. 
 
 Surgery 
 Radiation (includes Brachytherapy, IMRT, proton beam) 
 Active Surveillance (also called watchful waiting) 
 Unsure 
 
B.  Considering the option you preferred, please answer 
the following questions: 
Yes 
Unsure 
No 
1. Do you know which options are available to you? ........  
 
 
 
2. Do you know the benefits of each option? .....................  
 
 
 
3. Do you know the risks and side effects of each option?  
4. Are you clear about which benefits matter most to you? 
 
 
 
5. Are you clear about which risks and side effects matter 
most to you? ...................................................................  
 
 
 
6. Do you have enough support from others to make a 
choice? ...........................................................................  
7. Are you choosing without pressure from others? ...........  
 
 
 
8. Do you have enough advice to make a choice? .............  
9. Are you clear about the best choice for you? .................  
 
 
 
10. Do you feel sure about what to choose? .........................  
 
 
 
Decisional Conflict Scale © AM O’Connor, 1993, revised 2005 
 
 
 
 

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APPENDIX II 
FOLLOW-UP (12-MONTH) QUESTIONNAIRE BOOKLET 
 
 

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Expanded Prostate Cancer Index Composite—Short Form (EPIC-26) 
 
 
This questionnaire is designed to measure Quality of Life issues in patients with Prostate cancer. To 
help us get the most accurate measurement, it is important that you answer all questions honestly 
and completely. 
 
 
1. 
Over the past 4 weeks, how often have you leaked urine? 
 
 More than once a day 
 About once a day 
 More than once a week 
 About once a week 
 Rarely or never 
 
2. 
Which of the following best describes your urinary control during the last 4 weeks? 
 
 No urinary control whatsoever 
 Frequent dribbling 
 Occasional dribbling 
 Total control 
 
3. 
How many pads or adult diapers per day did you usually use to control leakage during the last 4 
weeks? 
 
 None 
 1 pad per day 
 2 pads per day 
 3 or more pads per day 
 
 
 

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4. 
How big a problem, if any, has each 
of the following been for you during the last 
4 weeks? 
No Problem 
Very 
Small 
Problem 
Small 
Problem 
Moderate 
Problem Big Problem 
a. Dripping or leaking urine 
 
 
 
 
 
 
b. Pain or burning on urination  
 
 
 
 
 
c. Bleeding with urination 
 
 
 
 
 
 
d. Weak urine stream or incomplete 
emptying 
 
 
 
 
 
 
e. Need to urinate frequently during the day
 
 
 
 
 
 
 
 
5. 
Overall, how big a problem has your urinary function been for you during the last 4 weeks? 
 
 No problem 
 Very small problem 
 Small problem 
 Moderate problem 
 Big problem 
 
 

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6. How big a problem, if any, has each of 
the following been for you? 
No Problem 
Very 
Small 
Problem 
Small 
Problem 
Moderate 
Problem Big Problem 
a. Urgency to have a bowel movement  
 
 
 
 
 
b. Increased frequency of bowel 
movements  
 
 
 
 
 
c. Losing control of your stools  
 
 
 
 
 
d. Bloody stools 
 
 
 
 
 
 
e. Abdominal/ Pelvic/ Rectal pain 
 
 
 
 
 
 
 
7. 
Overall, how big a problem have your bowel habits been for you during the last 4 weeks? 
 
 No problem 
 Very small problem 
 Small problem 
 Moderate problem 
 Big problem 
 
8. How would you rate each of the 
following during the last 4 weeks? 
Very  
poor to none 
Poor 
Fair 
Good 
Very  
Good 
a. Your ability to have an erection? 
 
 
 
 
 
 
b. Your ability to reach orgasm (climax)?
 
 
 
 
 
 
 
 
9. 
How would you describe the usual QUALITY of your erections during the last 4 weeks? 
 
 None at all 
 Not firm enough for any sexual activity 
 Firm enough for masturbation and foreplay only 
 Firm enough for intercourse 
 
10. 
How would you describe the FREQUENCY of your erections during the last 4 weeks? 
 

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 I NEVER had an erection when I wanted one 
 I had an erection LESS THAN HALF the time I wanted one 
 I had an erection ABOUT HALF the time I wanted one 
 I had an erection MORE THAN HALF the time I wanted one 
 I had an erection WHENEVER I wanted one 
 
11. 
Overall, how would you rate your ability to function sexually during the last 4 weeks? 
 
 Very poor 
 Poor 
 Fair 
 Good 
 Very good 
 
12. 
Overall, how big a problem has your sexual function or lack of sexual function been for you during 
the last 4 weeks? 
 
 No problem 
 Very small problem 
 Small problem 
 Moderate problem 
 Big problem 
 
13. How big a problem during the last 4 
weeks, if any, has each of the following 
been for you? 
No Problem 
Very 
Small 
Problem 
Small 
Problem 
Moderate 
Problem Big Problem 
a. Hot flashes  
 
 
 
 
 
b. Breast tenderness / enlargement 
 
 
 
 
 
 
c. Feeling depressed 
 
 
 
 
 
 
d. Lack of energy 
 
 
 
 
 
 
e. Change in body weight 
 
 
 
 
 
 
EPIC-SF 6.2002 © 2002. The University of Michigan. 
 
 

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Decisional Regret Scale 
 
Please think about the decision you made about how to treat your prostate cancer after talking to your doctor. 
Please show how you feel about these statements by circling a number from 1 (strongly agree) to 5 (strongly 
disagree). 
 
Strongly 
Agree 
Agree 
Neither 
Agree nor 
Disagree Disagree 
Strongly 
Disagree 
1. 
It was the right decision  
1 
2 
3 
4 
5 
2. 
I regret the choice that was made  
1 
2 
3 
4 
5 
3. 
I would go for the same choice if I had to do 
it over again 
 
1 
2 
3 
4 
5 
4. 
The choice did me a lot of harm  
1 
2 
3 
4 
5 
5. 
The decision was a wise one 
 
1 
2 
3 
4 
5 
Decision Regret Scale © AM O’Connor, 1996 University of Ottawa