Development, Validation, and Dissemination of an Integrated Risk Prediction Model and Decision Aid to Discern Aggressive Versus Indolent Prostate Cancer
Phase: NA
Conditions: Decision Support Systems, Clinical, Prostate Cancer
Sponsor: University of California, San Francisco

UCSF IRB Protocol #: 14-12951 
Confidential 
Version(#:(FINAL(1.2((
Version(Date:(8/9/2017(
Page(1(of(63(
 
University of California, San Francisco  
 
DEPARTMENT OF DEFENSE US ARMY MEDICAL RESEARCH TRANSFORMATIVE 
IMPACT AWARD 
Clinical Research Protocol 
PIONEERING ADVANCES IN CARE & EDUCATION (PACE) - HDFCC #17553 
  
 
Protocol Number: 
#14-12951 
Version Date: 
 8/9/2017 
Investigational Product: 
N/A 
IND Number: 
N/A 
Development Phase: 
N/A 
Sponsor: 
Jennifer Shankle – Project Contact  
Department of Defense (DoD) U.S. Dept. of the Army  
Military Medical Research and Development 
820 Chandler Street 
Fort Detrick, MD  21702-5014 
Telephone: 301-619-2193 
Web address:  http://cdmrp.army.mil/ 
Funding Organization: 
U.S. Department of Defense U.S. Army Medical Research 
Principal Investigator: 
Name: Peter R. Carroll, MD, MPH  
Telephone: 1-415-353-7098 
Fax: 1-415-476-5366  
E-mail:  Peter.Carroll@ucsf.edu  
 
Medical Monitor: 
N/A 
 
 
Coordinating Center: 
If applicable:  UCSF Department of Urology 
 
Approval: 
 
 
2/3/2017 
Peter R. Carroll, MD, MPH; Chair Dept. of Urology  
 
Date 

UCSF IRB Protocol #: 14-12951 
Confidential 
Version(#:(FINAL(1.2((
Version(Date:(8/9/2017(
Page(2(of(63(
 
This confidential information about an investigational product is provided for the exclusive use of 
investigators of this product and is subject to recall at any time.  The information in this document 
may not be disclosed unless federal or state law or regulations require such disclosure.  Subject to the 
foregoing, this information may be disclosed only to those persons involved in the study who have a 
need to know, with the obligation not to further disseminate this information.   

UCSF IRB Protocol #: 14-12951 
Confidential 
Version(#:(FINAL(1.2((
Version(Date:(8/9/2017(
Page(3(of(63(
 
PROTOCOL AGREEMENT 
I have read the protocol specified below. In my formal capacity as Investigator, my duties 
include ensuring the safety of the study subjects enrolled under my supervision and providing the 
Department of Defense U.S. Army Medical Research with complete and timely information, as 
outlined in the protocol.  It is understood that all information pertaining to the study will be held 
strictly confidential and that this confidentiality requirement applies to all study staff at this site. 
Furthermore, on behalf of the study staff and myself, I agree to maintain the procedures required 
to carry out the study in accordance with accepted GCP principles and to abide by the terms of 
this protocol. 
 
Protocol Number:  #14-12951 
 
Protocol Title:  Pioneering Advances in Care & Education (PACE) - HDFCC 17553  
 
 
Protocol Date:  8/9/2017  
 
 
 
8/9/2017  
Investigator Signature  
 
Date 
 
Peter R. Carroll, MD, MPH; Chair and Professor; Department of Urology 
Site # 
001 
 
Site Name 
University of California San Francisco Dept. of Urology 
Address 
550 16th ST.; 6th Floor 
 
Mailstop #1695 
 
San Francisco, CA 94143-1695 
 
 
Phone Number 
1-415-353-7098 

UCSF IRB Protocol #: 14-12951 
Confidential 
Version(#:(FINAL(1.2((
Version(Date:(8/9/2017(
Page(4(of(63(
 
TABLE OF CONTENTS 
 
1!
BACKGROUND 
13!
1.1!
Overview of Non-Clinical Studies ..................................................................................... 13!
1.2!
Overview of Clinical Studies .............................................................................................. 13!
2!
STUDY RATIONALE 
14!
2.1!
Risk / Benefit Assessment .................................................................................................. 14!
3!
STUDY OBJECTIVES 
15!
3.1!
Primary Objective ............................................................................................................... 15!
3.2!
Secondary Objectives ......................................................................................................... 15!
3.3!
Optional Biospecimen Banking .......................................................................................... 15!
4!
STUDY DESIGN 
15!
4.1!
Study Overview .................................................................................................................. 15!
5!
CRITERIA FOR EVALUATION 
15!
5.1!
Primary Efficacy Endpoint ................................................................................................. 15!
5.2!
Secondary Efficacy Endpoints ........................................................................................... 16!
5.3!
Safety Evaluations .............................................................................................................. 16!
5.4!
Other Evaluations ............................................................................................................... 16!
6!
SUBJECT SELECTION 
17!
6.1!
Study Population ................................................................................................................ 17!
6.2!
Inclusion Criteria ................................................................................................................ 17!
6.3!
Exclusion Criteria ............................................................................................................... 17!
7!
CONCURRENT MEDICATIONS 
17!
7.1!
Allowed Medications and Treatments ................................................................................ 17!
8!
STUDY TREATMENTS 
18!
8.1!
Method of Assigning Subjects to Treatment Groups ......................................................... 18!
8.2!
Blinding .............................................................................................................................. 18!
8.3!
Decision Support Intervention ............................................................................................ 18!
8.4!
Supply of Intervention at the Site ....................................................................................... 19!
8.5!
Measures of Intervention Compliance ................................................................................ 19!
9!
STUDY PROCEDURES AND GUIDELINES 
19!
9.1!
Clinical Screening .............................................................................................................. 19!
9.2!
Outcome Assessments ........................................................................................................ 20!
9.3!
Post-Intervention Clinic Visit ............................................................................................. 20!
9.4!
Observational Cohort Component ...................................................................................... 20!
10! EVALUATIONS BY VISIT 
21!
10.1! Contact 1 Screening and Recruitment ................................................................................ 21!
10.2! Contact 2.1 Obtaining Informed Consent ........................................................................... 21!
10.3! Contact 2.2 Scheduling Intervention (intervention arm only) ............................................ 21!
10.4! Contact 3 DSI Coaching (intervention arm only) ............................................................... 22!
10.5! Contact 4 Immediately Upon Arrival at Clinic for Urologist Consultation Visit .............. 22!

UCSF IRB Protocol #: 14-12951 
Confidential 
Version(#:(FINAL(1.2((
Version(Date:(8/9/2017(
Page(5(of(63(
 
10.6! Contact 5 Immediately After Clinic for Urologist Consultation Visit ............................... 22!
10.7! Contact 6 Post-visit Telephone Contact ............................................................................. 22!
10.8! Contact 7 Before Treatment Begins ................................................................................... 23!
11! ADVERSE EXPERIENCE REPORTING AND DOCUMENTATION 
23!
11.1! Adverse Events ................................................................................................................... 23!
12! DISCONTINUATION AND REPLACEMENT OF SUBJECTS 
23!
12.1! Early Discontinuation of Study .......................................................................................... 23!
12.3! Withdrawal of Subjects from the Study ............................................................................. 23!
12.4! Replacement of Subjects .................................................................................................... 24!
13! PROTOCOL VIOLATIONS 
24!
14! DATA SAFETY MONITORING 
24!
15! STATISTICAL METHODS AND CONSIDERATIONS 
24!
15.1! Data Sets Analyzed ............................................................................................................. 24!
15.2! Demographic and Baseline Characteristics ........................................................................ 24!
15.3! Analysis of Primary Endpoint ............................................................................................ 25!
15.4! Analysis of Secondary Endpoints ....................................................................................... 25!
15.5! Interim Analysis ................................................................................................................. 25!
15.6! Sample Size and Randomization ........................................................................................ 25!
16! DATA COLLECTION, RETENTION AND MONITORING 
26!
16.1! Data Collection Instruments ............................................................................................... 26!
16.2! Data Management Procedures ............................................................................................ 26!
16.3! Data Quality Control and Reporting ................................................................................... 26!
16.4! Archival of Data ................................................................................................................. 26!
16.5! Availability and Retention of Investigational Records ...................................................... 27!
16.6! Monitoring .......................................................................................................................... 27!
16.7! Subject Confidentiality ....................................................................................................... 27!
17! ADMINISTRATIVE, ETHICAL, REGULATORY CONSIDERATIONS 
27!
17.1! Protocol Amendments ........................................................................................................ 27!
17.2! Institutional Review Boards and Independent Ethics Committees .................................... 28!
17.3! Informed Consent Form ..................................................................................................... 28!
17.4! Publications ........................................................................................................................ 29!
17.5! Investigator Responsibilities .............................................................................................. 29!
18! REFERENCES 
30!
19! FIGURES AND TABLES 
33!
19.1! Figure 1. Decision Support Intervention Study Schematic ................................................ 33!
19.2! Table 1. DSI Trial - Schedule of Events ............................................................................. 34!
19.3! Table 2. Summary Table of Patient-reported Outcome Surveys and Time Points ............ 36!
19.4! Table 3. Clinician-reported Outcome Measures and Time Points ..................................... 38!
19.5! Table 4. Interventionist-reported Outcome Measures and Time Points ............................. 38!
20! APPENDICES 
39!
20.1! Appendix A. Coaching Intervention – Internet Access to DSI Tool .................................. 39!

UCSF IRB Protocol #: 14-12951 
Confidential 
Version(#:(FINAL(1.2((
Version(Date:(8/9/2017(
Page(6(of(63(
 
20.2! Appendix B. Coaching Intervention – No Internet Access to DSI Tool  ........................... 51!
 

UCSF IRB Protocol #: 14-12951 
Confidential 
Version(#:(FINAL(1.2((
Version(Date:(8/9/2017(
Page(7(of(63(
 
LIST OF ABBREVIATIONS 
ACS 
American Cancer Society 
AE 
adverse event 
AS 
Active Surveillance 
AUA 
American Urological Association 
 
 
BX 
Biopsy 
 
 
CAPRA 
Cancer of the Prostate Risk Assessment score 
CaPSURE 
Cancer of the Prostate Strategic Urologic Research Endeavor 
CFR 
Code of Federal Regulations 
CP 
Choice Predisposition 
CPS 
Control Preferences Scale 
CRF 
case report form 
CROM 
Clinician-reported outcome measure 
CRC 
Clinical Research Coordinator 
 
 
D&L 
Diet and lifestyle 
DMC 
Data Monitoring Committee 
DNA 
Deoxyribonucleic acid 
DoD-TIA 
Department of Defense Transformative Impact Award 
DSE 
Decision Self-efficacy  
DSI 
Decision Support Intervention 
DSMB 
Data Safety Monitoring Board 
DQI 
Decision Quality Instrument 
 
 
ECOG 
Eastern Cooperative Oncology Group (ECOG) performance status 
EPIC 
Expanded Prostate Index Composite-26 items 
 
 
FDA 
Food and Drug Administration 
FFPE 
Formalin Fixed Paraffin Embedded 
 
 
GCP 
Good Clinical Practice 
 
 
HIPAA 
Health Insurance Portability and Accountability Act of 1996 
 
 
ICF 
informed consent form 
ICH 
International Conference on Harmonisation 

UCSF IRB Protocol #: 14-12951 
Confidential 
Version(#:(FINAL(1.2((
Version(Date:(8/9/2017(
Page(8(of(63(
 
IEC 
Independent Ethics Committee 
IRB 
Institutional Review Board 
 
 
MaxPC 
Memorial Anxiety Scale for Prostate Cancer (MAX-PC) 
MRI 
Magnetic Resonance Imaging 
 
 
PCa 
Prostate Cancer 
PCa SCOPED 
Prostate Cancer SCOPED Form (Situation, Choice, Objectives, 
People, Evaluation, and Decision) 
PI 
Principal Investigator 
PIVOT 
Prostate Intervention Versus Observation Trial  
PSA 
Prostate Specific Antigen 
PROM 
Patient-reported Outcome Measures 
 
 
QL 
Question List – Summary Form 
QOL 
Quality of Life 
 
 
RNA 
Ribonucleic acid 
 
 
SAE 
serious adverse experience 
SSCa 
Service Satisfaction with Cancer Care 
SF-12 
Short Form-12 (4-week recall) 
 
 
TIBI-CaP 
Total Illness Burden Index – Prostate Cancer 
TRUS 
Transrectal Ultrasound 
 
 
US/UG 
Up-staging / Up-grading 

UCSF IRB Protocol #: 14-12951 
Confidential 
Version(#:(FINAL(1.2((
Version(Date:(8/9/2017(
Page(9(of(63(
 
PROTOCOL SYNOPSIS 
TITLE 
DoD-TIA RCT PCa Decision Tool 
SPONSOR 
University of California San Francisco; Dept. of Urology 
FUNDING 
ORGANIZATION 
Department of Defense (DoD) U.S. Dept. of the Army  
Military Medical Research and Development 
NUMBER OF SITES 
4 
RATIONALE 
Current clinical-pathologic descriptions of prostate cancer (e.g. 
grade, stage, PSA) can be used to estimate a patient’s risk of 
harboring more aggressive disease and the risk of recurrence post-
therapy. However, there are limited data on how well patients 
understand this information and how this affects their management 
decisions. Decision support tools have been proposed to help men 
with prostate cancer through their decision process, yet most are not 
tailored to a patient’s unique biology or preferences.11 
Our study evaluates the first decision support intervention that uses 
service learning (student) coaches as a low-cost workforce to 
administer a decision aid with personalized risk estimates based on 
patient tumor features. In a single-arm pilot study at UCSF, we found 
this intervention was feasible and acceptable, and associated with 
increased patient knowledge (IRIS #14-13332). We now propose to 
evaluate this decision support intervention in a multi-site clinical trial.   
 
STUDY DESIGN 
This is a site-randomized, cluster-crossover clinical trial of a decision 
support intervention (DSI) vs. usual care, among men with low 
prognostic risk prostate cancer, to assess differences in informed 
decision making (i.e., knowledge), anxiety, and decision quality and 
self-efficacy. 
PRIMARY 
OBJECTIVE 
To assess the impact of the DSI on knowledge (i.e., informed 
decision-making) regarding risks associated with different 
management strategies for prostate cancer, given one is diagnosed 
with low-risk prostate cancer. 
SECONDARY 
OBJECTIVES 
1). To assess the impact of the DSI on anxiety, decision quality and 
self-efficacy. 2). After the DSI or usual care, to compare choice of 
prostate cancer management / treatment selected.   
NUMBER OF 
SUBJECTS 
160 subjects enrolled, allowing for attrition (12) and non-response 
(12), leaving ~136 fully evaluable subjects. 
SUBJECT 
SELECTION 
CRITERIA 
Inclusion Criteria: A patient diagnosed with prostate cancer who meets the 
following criteria: 
1.( PSA <= 15 ng/ml  

UCSF IRB Protocol #: 14-12951 
Confidential 
Version(#:(FINAL(1.2((
Version(Date:(8/9/2017(
Page(10(of(63(
 
1.( Clinical stage cT1/2,N0,M0 
2.( Biopsy Gleason grade 2-6 OR (or 3+4 AND <=33% cores are 
positive for adenocarcinoma);  
a.( A minimum of 10 diagnostic cores taken by a systematic 
directed approach.  Sampling may be obtained by target 
TRUS or MRI imaging.   
3.( No treatment yet 
a.( No previous radiation or simultaneous use of androgen 
deprivation 
b.( Prior use of 5-alpha reductase inhibitor is allowed if 
they have been stopped for 6 or more months and 
biopsy performed when patient was not taking the 
drug.    
4.( English language proficient and ability to sign an ICF 
5.( Considered candidates for active surveillance at their institution by 
the treating urologist.  
 
Exclusion Criteria: Participants who have received any therapy for 
prostate cancer or who do not read/speak English or whose managing 
urologist does NOT deem them as a candidate for active surveillance.   
TEST PRODUCT, 
DOSE, AND ROUTE 
OF 
ADMINISTRATION 
Participants assigned to the intervention will receive Decision Support 
in the form of a decision aid+health coaching. The decision aid 
(delivered by internet and as a PDF document) provides participants 
with a report on options and outcomes as described in the literature; 
along with more tailored risk information. The tailored risk 
information will include their estimated risk of harboring more 
aggressive prostate cancer based on their clinical/pathologic features 
(i.e., “My Clinical Risk”).  The DSI was developed and piloted at 
UCSF according to the International Patient Decision Aid Standards 
(see http://ipdas.ohri.ca/) (IRS# 14-13332), and incorporates tailored 
risk models developed and validated at UCSF and community sites 
[1]. The tailored models estimate a patient’s risk of having more 
aggressive prostate cancer if, theoretically, one was to remove their 
prostate gland at that time (i.e., undergo surgery as active treatment) 
and have the entire gland reviewed (i.e., risk of up-staging or up-
grading (US/UG)). 
CONTROL 
PRODUCT, DOSE 
AND ROUTE OF 
ADMINISTRATION 
Participants assigned to the control arm will receive usual care, 
including whatever information materials are provided to them by 
their urologist. (We will assess what materials they reviewed by 
surveying patients.)  

UCSF IRB Protocol #: 14-12951 
Confidential 
Version(#:(FINAL(1.2((
Version(Date:(8/9/2017(
Page(11(of(63(
 
DURATION OF 
SUBJECT 
PARTICIPATION 
AND DURATION OF 
STUDY 
Subjects will be in an active study phase for approximately 4-6 weeks, 
depending on their scheduling with their local urologist. Within those 
six weeks, we will approach them about the study; if 
interested/consented, they will be asked to complete baseline surveys 
online (paper will be available if preferred); access the decision aid; 
and talk to the health coach; complete pre-visit surveys; meet with 
their urologist; and complete follow-up surveys. Once the participant 
has met with his urologist and made a management decision, he is 
done with the active intervention phase of the study, and will roll-over 
into an observational cohort component only of the study. In this 
phase, we will ask participants to complete surveys on their prostate 
cancer status and quality of life annually and allow us to access their 
medical chart to abstract data on their health and prostate cancer 
status.   
CONCOMMITANT 
MEDICATIONS 
Allowed: Participants may take any medications unrelated to their 
prostate cancer during the study. After their visit with their local 
urologist when they make a management decision, participants may 
follow any medical regimen for their prostate cancer. 
 
Prohibited: We will not enroll participants who have already 
received treatment for their prostate cancer. 
EFFICACY 
EVALUATIONS 
 
PRIMARY ENDPOINT 
•!
Knowledge regarding the risks and benefits associated with 
different management choices for men with localized/early stage 
prostate cancer. 
SECONDARY 
ENDPOINTS 
•!
Anxiety, decision self-efficacy, health-related quality of life.  
•!
Choice of prostate cancer management / treatment selection. 
OTHER 
EVALUATIONS 
Optional:  In the future, we may consider banking saliva and FFPE 
tumor tissue from already performed biopsies for future research 
studies. Biospecimen donation will be optional. 
SAFETY 
EVALUATIONS 
There are not planned safety evaluations. The active phase of this 
behavioral intervention is brief, ~4-6 weeks. Participants will not be 
receiving any active treatment for their cancer during this phase. The 
main risks may be anxiety or confusion regarding the risks and 
benefits associated with their current diagnosis and decision ahead, 
and risk of loss to privacy by participating in a research study.  
PLANNED INTERIM 
ANALYSES  
As a behavioral intervention trial testing knowledge as the primary 
outcome, there an interim analysis is not planned. 

UCSF IRB Protocol #: 14-12951 
Confidential 
Version(#:(FINAL(1.2((
Version(Date:(8/9/2017(
Page(12(of(63(
 
STATISTICS 
Primary Analysis Plan 
We will use univariate statistical tests (e.g., chi-square, t-test) and 
multivariate regression to assess the difference in the probability of 
the primary outcome between subjects randomized to the intervention 
and control arms for each site.   
Rationale for Number 
of Subjects 
Standard power calculations for chi-square tests to compare two 
proportions along with adjustments for potential correlation of 
responses within sites, missing data and attrition show that tests based 
on a sample of 136 subjects would have power to detect an alternative 
where the probability of the primary response increases from 0.5 in 
the control sites to 0.75 in the intervention sites. We will enroll 160 
subjects to allow for attrition and survey non-response. 
 

UCSF IRB Protocol #: 14-12951 
Confidential 
Version(#:(FINAL(1.2((
Version(Date:(8/9/2017(
Page(13(of(63(
 
1!
BACKGROUND 
A critical public health need exists for improved prognostic tools to distinguish aggressive 
from indolent prostate cancer at diagnosis, and for better support systems to guide patients 
in decision-making regarding management options. Our proposal addresses both needs, and 
is poised to improve management of low-risk prostate cancer in the United States (U.S.) in the 
near term. 
1.1!
Overview of Non-Clinical Studies 
Patients generally are at risk for both under-treatment and over-treatment relative to their 
personal priorities and the best available medical evidence [2-4]. This is certainly true in the case 
of low-risk prostate cancer patients, who are often over-treated with surgery or radiation relative 
to what they say they would have preferred if fully informed about all the options and outcomes, 
including the risks and benefits of active surveillance.  
Decision support interventions tailored to specific clinical crossroads have increased patient self-
efficacy, knowledge, question-asking, and satisfaction; and decreased decisional conflict, regret, 
anxiety, and distress [2, 5-17]. Such informed and involved patients tend to pursue less invasive 
treatment options than they might otherwise settle upon under usual care [18, 19].  
However, in the area of prostate cancer, these decision support interventions have not provided 
personalized risk estimates to patients. The need for personalized risk estimates arises from the 
potential for an initially low-risk prostate cancer to be reclassified over time if it is not treated 
with surgery or radiation. Many patients and physicians avert that risk by erring on the side of 
active treatment (surgery or radiation) rather than active surveillance.  
To reduce the risk of over-treatment, our team has developed individual risk prediction models 
that we have now integrated into our decision support intervention (DSI).  
Decision support interventions must be delivered to patients in an effective and efficient manner. 
Our team has refined a comprehensive DSI, which prompts patients to review risk and other 
educational materials, as well list questions in writing for their physicians [7]. We have also 
refined a service learning workforce to deliver the intervention remotely, by internet and 
telephone, in a way that does not require clinics to modify their practices, and that leverages 
unpaid student interns receiving academic credit as part of their academic training [7].  
Delivering such decision support should increase patient knowledge and question-asking, and 
these proximal outcomes should increase the proportion of men making informed decisions 
regarding their selection of active surveillance, surgery, or radiation for low-risk prostate cancer. 
This study will evaluate whether our intervention is feasible and effective in delivering 
individually tailored decision support to men prior to their first urology visit upon diagnosis with 
low-risk prostate cancer; and whether a higher proportion of men make informed decisions with 
less anxiety or decisional regret.     
1.2!
Overview of Clinical Studies 
Not applicable 

UCSF IRB Protocol #: 14-12951 
Confidential 
Version(#:(FINAL(1.2((
Version(Date:(8/9/2017(
Page(14(of(63(
 
2!
STUDY RATIONALE 
Age-adjusted mortality rates have fallen nearly 40% since the start of the prostate specific antigen 
(PSA) screening era, and are at their lowest level in the past 80 years [20]. Prostate cancer 
remains the second leading cause of cancer mortality among men in the U.S.[20], but a wide array 
of novel diagnostic and therapeutic interventions promise to drive mortality rates down further.  
 
The Prostate Intervention Versus Observation Trial (PIVOT) reported an early survival benefit 
for men diagnosed with high-risk disease (e.g., prostate cancer of high grade, stage, and/or 
PSA) treated with surgery rather than observation—but no benefit for men with low-risk disease 
[21, 22]. Moreover, all treatments entail risk of long-term quality of life (QOL) impacts (e.g. 
erectile dysfunction, incontinence) [23], and many men—often those opting for newer, 
technology-intensive treatments—ultimately express regret regarding their treatment decisions 
and low satisfaction with their clinical or QOL outcomes [24]. 
 
A growing consensus deems current rates of over-treatment of low-risk prostate cancer 
unacceptable, as the morbidity associated with avoidable interventions accounts for much of the 
suffering associated with prostate cancer in the U.S. [25]. One solution is to screen more 
selectively, to reserve treatment for men with aggressive cancer, and to guide those with 
indolent, lower-risk disease to active surveillance (AS)—i.e., careful monitoring with serial 
assessments and curative treatment at any sign of progression [26, 27]. Multiple factors underlie 
over-treatment of low-risk disease; key among them is the concern that a biopsy may not fully 
reflect tumor aggressiveness. The rate of biopsy under-sampling—i.e., a biopsy indicating low-
risk characteristics for a tumor that ultimately proves to be higher grade or stage—is estimated at 
20-30% [28].  
 
Decision support tools have been proposed to help men with prostate cancer through their 
decision process, yet most are not tailored to a patient’s unique biology or preferences [29]. 
Our study evaluates the first decision support intervention that uses service learning (student) 
coaches as a low-cost workforce to administer a decision aid with personalized risk estimates 
based on patient biology. In a single-arm pilot study at UCSF, we found this intervention was 
feasible and acceptable, and associated with increased patient knowledge.     
2.1!
Risk / Benefit Assessment 
This study involves minimal risks not materially greater than those that may be experienced in 
usual care. Men receiving the DSI may not have yet been exposed to the level of detail contained 
in the decision aid. Some men might react negatively to the detail. However, generally decision 
support is not associated with harms such as anxiety or distress, and the coaching session is 
designed to help men absorb the information in the decision aid and write up questions in a 
question list. We cannot be sure that men will benefit directly, however the study will add 
important knowledge to our scientific understanding of how best to educate men about treatment 
options for early-stage prostate cancer. These insights could shape decision support for years to 
come. Therefore, the potential benefits outweigh the risks. 

UCSF IRB Protocol #: 14-12951 
Confidential 
Version(#:(FINAL(1.2((
Version(Date:(8/9/2017(
Page(15(of(63(
 
3!
STUDY OBJECTIVES 
3.1!
Primary Objective  
The primary objective is to increase the rate of informed decision-making among men with early-
stage prostate cancer.  
3.2!
Secondary Objectives 
Secondary objectives relate to assessing the effect of decision support on anxiety, decision self-
efficacy, and decision quality, as measured by validated survey instruments, and management 
choice. 
3.3!
Optional Biospecimen Banking 
In the future, we may also request archival leftover tumor tissue from a participant’s recent 
prostate biopsy and saliva for banking for future research.  If the scientific team were to decide to 
proceed with banking biospecimens we would do so based on tissue studies associated with the 
CaPSURE™ study (IRB # 10-00881) and its related sub-study CaPSURE Tissue (IRB# 13-
12624).     
4!
STUDY DESIGN 
4.1!
Study Overview 
This is a four-site, site-randomized, two-period, cluster-crossover design. 160 subjects are 
planned. Sites will be randomized in pairs to period 1 usual care or intervention. After all sites 
have met accrual goals, the pairs will cross over to intervention or usual care. In usual care, study 
participants will complete surveys and prepare for their visit as they usually would, and receive 
whatever education materials and counseling is normally provided by the sites. We will assess 
the materials and counseling received by surveying the patients about this. In the intervention, 
subjects will be contacted by the coordinating site (UCSF) and offered educational materials that 
include personalized risk estimates, along with coaching to help list questions for their upcoming 
visit with the urologist.    
5!
CRITERIA FOR EVALUATION 
5.1!
Primary Efficacy Endpoint 
The primary endpoint is the proportion of patients who respond accurately to two survey items 
assessing whether they are more likely to die of prostate cancer or other causes (other causes are 
more likely); and whether waiting three months to make a treatment decision will affect their 
survival a lot; somewhat; or a little or not at all (a little or not at all is the correct answer). 
Knowledge of these key facts is an important endpoint because patients often associate the word 
cancer with high mortality risks, and with urgency to act. Patients also often associate more 
invasive treatment with greater benefit.  
In the case of early-stage, low-risk prostate cancer, patients should recognize that early-stage 
prostate cancer patients are more likely to die of other causes than prostate cancer; and that most 
can safely take three months to make decisions. This knowledge opens patients up to 
consideration of active surveillance along with surgery and radiation therapies.  

UCSF IRB Protocol #: 14-12951 
Confidential 
Version(#:(FINAL(1.2((
Version(Date:(8/9/2017(
Page(16(of(63(
 
Our intervention aims to educate patients about their (low) mortality risk and the time available 
for decision-making after their cancer diagnosis before they see their urologist for primary 
treatment counseling. Therefore, we will assess this endpoint just prior to the first urology 
appointment after a biopsy confirms early-stage low-risk cancer, and compare the usual care 
results to the intervention arm. 
 In preliminary studies at an academic medical center with highly educated patients, our 
intervention increased the proportion of patients responding accurately from 69% to 88%. 
Meanwhile, at our community sites, 52% of usual care patients responded accurately. We 
hypothesize that in our randomized controlled trial, we will see over 75% of patients respond 
accurately in the intervention arm, versus 50% in the usual care arm. 
5.2!
Secondary Efficacy Endpoints  
We will assess the impact of our intervention on decision self-efficacy, decision quality, anxiety, 
and satisfaction, based on participant responses to validated surveys. We will also measure 
patient understanding of reclassification risk, based on a custom survey designed for this study. 
(Please see Table 2 for further details on study schedule) 
We will measure decision self-efficacy before and after the intervention (before the medical 
appointment); to assure that the intervention is working as intended. In prior studies we and other 
researchers have shown that similar pre-consultation decision support interventions are 
associated with pre/post increases in decision self-efficacy. In the usual care arm, we will 
measure decision self-efficacy before the medical appointment. 
We will measure decision quality, anxiety, and understanding of reclassification risk before and 
after the medical appointment.  The study will record management or treatment approach 
selected by the participant.   
We will measure satisfaction after the medical appointment. 
5.3!
Safety Evaluations 
There are no anticipated clinical or physical risks associated with participation in this study. The 
primary anticipated risks associated with this study are losses to privacy, or anxiety or 
discomfort associated with the survey questions. Participants will be told that their participation 
is voluntary, and participants will be allowed to skip questions.  The key questions that we want 
participants to answer (or be considered as having missing answers on primary outcomes) are 2 
knowledge questions. In our sample size calculations, we will conservatively plan for around 
10% missing responses (N~15) on our primary outcome, as well as 10% attrition (N~15 subjects) 
from consent to visit.  
5.4!
Other Evaluations 
We will measure covariates that will inform exploratory analyses, including quality of life (SF-
12 [30, 31], EPIC [32], diet and lifestyle (D&L) [33], decision self-efficacy (DSE), control 
preferences scale (CPS) [34], choice disposition (CP) [35], and demographics. 
.   
   

UCSF IRB Protocol #: 14-12951 
Confidential 
Version(#:(FINAL(1.2((
Version(Date:(8/9/2017(
Page(17(of(63(
 
6!
SUBJECT SELECTION 
6.1!
Study Population 
Subjects with a diagnosis of low-risk prostate cancer (PCa) who meet the inclusion and exclusion 
criteria will be eligible for participation in this study.   
6.2!
Inclusion Criteria 
1.( Male ≥18 years of age and newly diagnosed PCa (within 3-months).    
2.( Documentation of a low-risk PCa diagnosis as evidenced by clinical features of the 
following criteria: 
a.( PSA test at diagnosis ≤15 ng/ml  
b.( Localized PCa (cT1/T2,N0,M0) 
c.( Biopsy Gleason grade 2-6 OR (or 3+4 AND <=33% cores are positive for 
adenocarcinoma) 
i.( A minimum of 10 diagnostic cores taken by a systematic directed approach.  
Sampling may be obtained by target TRUS or MRI imaging.   
d.( No treatment yet 
i.( No previous radiation or simultaneous use of androgen deprivation   
ii.( Prior use of 5-alpha reductase inhibitor is allowed if they have been 
stopped for 6 or more months and biopsy performed when patient was not 
taking the drug   
e.( English language proficient and ability to provide ICF 
f.( Managing urologist considers them a candidate for active surveillance  
3.( Written informed consent (and assent when applicable) obtained from subject and ability for 
subject to comply with the requirements of the study, including the ability to read and speak 
English. 
6.3!
Exclusion Criteria  
Participants will be ineligible if they: 1) have pursued any active therapy for prostate cancer 
will be excluded; 2) are unable to read/speak English; or 3) if their managing urologist does 
NOT deem them as a candidate for active surveillance.   
7!
CONCURRENT MEDICATIONS 
All subjects should be maintained on the same medications throughout the entire study period, as 
medically feasible, with no introduction of new chronic therapies. 
7.1!
Allowed Medications and Treatments 
Standard therapy for non-prostate cancer conditions is allowed throughout the study.  After the 
active intervention is completed and primary and secondary outcomes have been assessed 
(shortly after the visit with the managing urologist), the participant may pursue whatever 

UCSF IRB Protocol #: 14-12951 
Confidential 
Version(#:(FINAL(1.2((
Version(Date:(8/9/2017(
Page(18(of(63(
 
treatment he chooses for his prostate cancer.  At this point, the participant will roll-over to an 
observation phase only. 
8!
STUDY TREATMENTS 
8.1!
Method of Assigning Subjects to Treatment Groups 
The trial will use a randomized crossover design using 4 community-based urology sites.  Two 
sites will be randomized to initiate the study in the ‘decision support coaching intervention’ arm 
while the remaining 2 sites will start in the ‘usual care arm’.  Each site will accrue 20 
participants before crossing over to the alternate arm (see Figure 1).  A total of 160 newly 
diagnosed men who are pre-treatment with low risk prostate cancer will be enrolled into the 
study.  If the participating site is unable to meet the recruitment goal of 40 participants per site 
(for a final sample of 160 participants); the investigators may add sites to achieve the final study 
sample size of 160 during the funding period of this grant.   
8.2!
Blinding 
The participating site will be randomized to DSI or usual care at study initiation and will 
crossover once they have met their accrual goal of 20 participants (see Figure 1).  Patients 
recruited at each site will be blinded to the assignment of their site. Patients will be informed 
during recruitment and consent that the study will give surveys to assess patient knowledge and 
related outcomes at four sites, and examine how variations in patient education strategies are 
associated with patient survey responses. The clinic staff and physicians will NOT be blinded to 
the assignment; however, the primary outcome will be determined before the patient conducts 
their decision making consultation with the physician. The statistician will remain blinded to the 
randomization status of the sites during the analysis phase only.  
8.3!
Decision Support Intervention 
Participants randomly assigned to the Intervention will receive access to our decision aid, 
developed following the International Patient Decision Aids Standards with the input of patients, 
family members, physicians, nurses, clinic staff, decision scientists, and clinical researchers [1].  
After reviewing the decision aid, either via a secure website or a PDF file emailed to them 
(whichever is most convenient for them), patients will speak with a trained coach. The coach will 
review the decision aid screen by screen, or page by page, and write down any questions that the 
patient voices about the contents of the decision aid. The coach will then review the decision aid 
help text to address questions that are covered there, and save the remaining questions for the 
attention of the attending urologist at the upcoming visit. Specifically, the coach will save a 
word-processed document with the patient’s questions for the physician, and send that file to the 
site study coordinator, who will print copies for the patient, family, and physician and make 
those copies available to all parties at the time of the clinic visit. Our surveys will also assess 
what other decision or communication aids the patient may have accessed on their own prior to 
the visit. 
Our decision aid incorporates the following estimates: 
-(
Survival and quality of life outcomes from the CaPSURE outcomes database for patients 
who underwent active surveillance, surgery, or radiation. 

UCSF IRB Protocol #: 14-12951 
Confidential 
Version(#:(FINAL(1.2((
Version(Date:(8/9/2017(
Page(19(of(63(
 
-(
Risk of reclassification (“upstaging” or “upgrading”) based on demographic, clinical, and 
pathologic parameters using a model developed at UCSF and tested using UCSF and 
CaPSURE data. 
8.3.1! Formulation of Control Product 
 The participants assigned to the control arm will be treated with usual care, including whatever 
information materials are typically provided to them by clinics (e.g. prostate cancer brochure 
from the American Cancer Society (ACS), American Urological Association (AUA) or their 
local institutions educational materials on diagnosis and treatment options). One of our surveys 
will assess what information materials each patient has seen prior to the visit. 
8.4!
Supply of Intervention at the Site 
After patients are consented and enrolled in the study, intervention site coordinators will assure 
that they complete online or paper surveys, and will notify the coordinating site (UCSF) when 
these are complete. This will trigger the UCSF team to contact the patient by telephone and 
email, to communicate: 
1.( The Uniform Resource Locator (URL) for the decision aid 
2.( A PDF copy of the decision aid 
The coach will also schedule a time for the coaching call, which is to occur before the urology 
visit.  
During the coaching call, the coach will review the decision aid screen by screen or page by 
page; write down questions that the patient has for their doctor; and communicate those 
questions to the doctor via the site coordinator.  
8.5!
Measures of Intervention Compliance 
Our interventionists (the coaches) will report on whether patients partially completed the 
coaching call; or fully completed the coaching call; or whether they never attended the coaching 
call.  
9!
STUDY PROCEDURES AND GUIDELINES 
A Schedule of Events representing the required testing procedures to be performed for the 
duration of the study is diagrammed in Table 1. 
Prior to conducting any study-related activities, written informed consent and the Health 
Insurance Portability and Accountability Act (HIPAA) authorization must be signed and dated 
by the subject.  If appropriate, assent must also be obtained prior to conducting any study-related 
activities. 
This is a site randomized study.  Therefore, each site’s health providers and staff will be aware of 
whether they are delivering the intervention or usual care at a given time. 
9.1!
Clinical Screening 
Participants will be identified for eligibility to participate in this study by the coordinators 
(CRC’s clinical research coordinators) at each site based by screening the medical charts.  CRC’s 

UCSF IRB Protocol #: 14-12951 
Confidential 
Version(#:(FINAL(1.2((
Version(Date:(8/9/2017(
Page(20(of(63(
 
will identify patients who have been recently diagnosed with low-risk prostate cancer, and 
provide a list to their site urologist(s) to ensure these patients are potential candidates for active 
surveillance.  Those meeting eligibility criteria will be contacted by phone by the CRC for 
potential enrollment into this study.   Introduction to the study and obtaining informed consent 
(IC) will use two methodologies: 
 
1.( Phone based recruitment:  If the man expresses interest, the CRC will obtain verbal 
permission to be contacted by the data coordinating center at UCSF.  The CRC will enter 
data into the REDCaP database case report forms (CRF) (specifically, the subject 
identifiers, and eligibility for study).  The UCSF data coordinating center will send the 
paper-mode informed consent form (ICF), HIPAA and the baseline participant surveys to 
the man via traceable FedEx overnight mail.  
2.( In person clinic recruitment:  If the patient is being seen in the clinic, the CRC will 
obtain the signed IC and will forward the original signed copy to the UCSF data 
coordinating center. The CRC will enter data into the REDCaP database CRFs.  
Specifically, the subject identifiers, eligibility for study, study biopsy results form, coach 
contact preferences, and appointment information forms.  The UCSF data coordinating 
center will send the baseline participant surveys to the man via traceable FedEx overnight 
mail.   
 
Those consenting will be asked to complete baseline surveys. Once those steps are complete, 
depending on the site’s random assignment, the participant will either be asked to proceed with 
the Decision Support Intervention or standard informational brochure/s used in clinical care for 
men with newly diagnosed prostate cancer.  The procedures associated with the DSI are 
described in section 8.3.  
9.2!
Outcome Assessments 
Our primary and secondary outcomes will be assessed via surveys, according to the schedule in 
the Table 2.   
9.3!
Post-Intervention Clinic Visit 
Participants will proceed to have their regularly scheduled visit with their urologist to discuss 
their management options.  We will request participants to complete one additional survey after 
this visit as described in the Table 2. 
9.4!
Observational Cohort Component 
After the participant has had his urologist visit where he makes a decision about management, he 
has completed the active intervention component of this trial and will automatically roll-over 
into the CaPSURE™ observational cohort.  He will be mailed surveys approximately annually, 
which may ask about his health and prostate cancer status, health resource utilization, lifestyle 
habits, overall and prostate cancer-specific anxiety and quality of life.  He may choose to 
withdraw or not complete these surveys at any time.  We will also request permission to conduct 
clinical follow-up indefinitely by reviewing this medical chart or obtaining information on his 
health and prostate cancer status from his healthcare provider. 

UCSF IRB Protocol #: 14-12951 
Confidential 
Version(#:(FINAL(1.2((
Version(Date:(8/9/2017(
Page(21(of(63(
 
10! EVALUATIONS BY VISIT 
10.1!
Contact 1 Screening and Recruitment 
Onsite research coordinator will screen for potential eligible participants in their electronic 
medical record (EMR) ~two weeks in advance of the scheduled consultation visit with the 
urologist.  This includes approaching patients who are low-risk and have an upcoming 
appointment at the practice for initial treatment decision consultation with the urologist. This will 
be done by phone by the onsite CRC or in person during a clinic visit.  The onsite CRC will 
discuss explain the study and if the patient agrees to consider participation they will notify UCSF 
data coordinating center to send a baseline study packet by traceable FedEx that includes 
informed consent, HIPAA and T1 surveys (see Table 2.  Summary of Patient-reported Outcome 
Measures (PROMs) and Time Points).    
10.2!
Contact 2.1 Obtaining Informed Consent 
Includes: enrolling them; administering all baseline/pre-intervention surveys (e.g. SF-12, EPIC, 
demographics, brief lifestyle questions (e.g., smoking, physical activity), as well as choice 
predisposition (CP), decision self-efficacy (DSE) and control preferences scale (CPS)) [30, 32, 
34, 35]. Site study coordinator alerts patient they must allow time before and after their visit to 
fill out surveys (on arrival and before leaving the clinic). Note this contact could conceivably be 
by telephone and the surveys could be filled out by Internet. After all surveys are complete, the 
site staff will enter the patient into the UCSF system to trigger a call from a student coach.   
1.(
After obtaining the informed consent in REDCaP the CRC will complete the following 
forms in REDCaP:   
a.( Subject Identifier Form in REDCaP and Registration Form in CaPSURE.  This 
action assigns the subject a unique research ID and assignment to study arm 
(usual care vs, intervention) in REDCaP and CaPSURE secure websites. 
b.( Complete Study Eligibility Form. 
c.( Complete Study Biopsy Form.  Record medical history, including:  PSA at 
diagnosis; tumor stage; prostate volume; biopsy diagnosis date with primary and 
secondary Gleason grade; and ECOG performance score [36]. 
2.(
REDCaP will provide participant with the access to patient reported-surveys and 
demographics data. 
3.(
If the participant opts for the paper-mode, the CRC will provide the participant with a 
paper packet of patient surveys.   
10.3!
Contact 2.2 Scheduling Intervention (intervention arm only) 
Includes: Student coach contacts patient (by email or phone) to send PDF and URL of decision 
aid, and schedule a phone call for 3 days prior to the medical visit (see Appendix A).  
1.( The CRC will complete the following forms in REDCaP:   
a.! Appointment Information Form 
b.( Coach Contact Preferences Form 

UCSF IRB Protocol #: 14-12951 
Confidential 
Version(#:(FINAL(1.2((
Version(Date:(8/9/2017(
Page(22(of(63(
 
10.4!
Contact 3 DSI Coaching (intervention arm only) 
Includes: Student coach calls patient and conducts intervention interview, reviewing each screen 
of the decision aid, typing up patient questions for the doctor, and referring the patient to help 
text about the decision aid content. Student coach then sends question list to site coordinator to 
be printed and given to physician at the time of the appointment.  
 
The student health coach will upload to REDCaP before the visit with the urologist.   
a.( A summary Question List (QL) form includes the following areas of concern 
generated by the participant and coach using the PCa SCOPED model [37]: 
i.( Situation – clarifying facts about my condition 
ii.( Choices (treatment) – Which options are available 
iii.( Objectives – Clarifying my goals and priorities 
iv.( People – Clarifying roles and responsibilities 
v.( Evaluation – Clarifying how my choices affect my objectives 
vi.( Decisions – Clarifying which choice is best and next steps 
b.( Complete and upload the Prostate Cancer SCOPED model form  
10.5!
Contact 4 Immediately Upon Arrival at Clinic for Urologist Consultation Visit 
Includes: Immediately upon arrival, patient should fill out Time 2 surveys – e.g. on tablet or at a 
kiosk or on paper. These will include Decision Quality Instrument [38], Max PC [39, 40], DSE 
[35], Control Preferences Scale [34], Choice Predisposition [35], and Reclassification Risk 
Understanding. Clinic staff or site study coordinator should print question list and give copies to 
the patient/family and attending physician for use during the medical visit.  
 
1.(
Print the QL and PCa SCOPED forms for review by the urologist.   
10.6!
Contact 5 Immediately After Clinic for Urologist Consultation Visit 
Clinic staff or site study coordinator must ensure that patient should fill out Time 2 surveys – e.g. 
on tablet or at a kiosk or on paper:   
1.( These will include Decision Quality Instrument [38], Max PC [39, 40], Choice 
Predisposition [35], and Reclassification Risk Understanding.  
2.( Site coordinator also must ensure that physician fills out MD satisfaction survey.  
The Schedule of Events table explains the procedures and role based responsibilities for the 
onsite CRC and the UCSF data coordinating research staff.   
10.7!
Contact 6 Post-visit Telephone Contact 
At the study team’s discretion, we may call patients to conduct a qualitative debrief of the 
intervention and medical visit. We will do this at the start of each period to ensure that we are 
surfacing qualitatively any unexpected issues with study structure or procedures. We will 
conduct these debrief calls until we are confident that study-related issues have been resolved.  

UCSF IRB Protocol #: 14-12951 
Confidential 
Version(#:(FINAL(1.2((
Version(Date:(8/9/2017(
Page(23(of(63(
 
10.8!
Contact 7 Before Treatment Begins 
The decision support intervention is complete at 10.7 and participant will be rolled into the 
CaPSURE disease specific registry for prospective follow up of management, recurrence status 
and survival status.  
1.( After consultation visit with the treating MD but before treatment is initiated the participant 
will be asked to complete the following surveys: 
a.( Diet and Lifestyle survey [33, 41] 
b.( Total Illness Burden Index – Cancer of the Prostate (TIBI-CaP) [42] 
c.( Service Satisfaction with Cancer Care  (SSCa) [43] 
11! ADVERSE EXPERIENCE REPORTING AND DOCUMENTATION 
11.1!
Adverse Events 
This is a behavioral medicine trial with no clinical investigations.   
12! DISCONTINUATION AND REPLACEMENT OF SUBJECTS 
12.1!
Early Discontinuation of Study 
A subject may be discontinued from study treatment at any time if the subject, the investigator, 
or the Sponsor feels that it is not in the subject’s best interest to continue.  The following is a list 
of possible reasons for study treatment discontinuation:  
•!
Subject withdrawal of consent (or assent) 
•!
Subject is not compliant with study procedures (i.e., does not complete coaching session 
before consultation visit with the treating urologist and therefore no decision aid is 
completed).   
•!
Lost to follow-up 
•!
Sponsor request for early termination of study 
All subjects who discontinue study treatment will be encouraged to complete all remaining 
scheduled visits and procedures. 
All subjects are free to withdraw from participation at any time, for any reason, specified or 
unspecified, and without prejudice. 
Reasonable attempts will be made by the investigator to provide a reason for subject 
withdrawals.  The reason for the subject’s withdrawal from the study will be specified in the 
subject’s source documents. 
12.3!
Withdrawal of Subjects from the Study 
A subject may be withdrawn from the study at any time if the subject, the investigator, or the 
Sponsor feels that it is not in the subject’s best interest to continue.   
All subjects are free to withdraw from participation at any time, for any reason, specified or 
unspecified, and without prejudice. 

UCSF IRB Protocol #: 14-12951 
Confidential 
Version(#:(FINAL(1.2((
Version(Date:(8/9/2017(
Page(24(of(63(
 
Reasonable attempts will be made by the investigator to provide a reason for subject 
withdrawals.  The reason for the subject’s withdrawal from the study will be specified in the 
subject’s source documents.  As noted above, subjects who discontinue study treatment early 
(i.e., they withdraw prior to Contact 5) will not be administered further study surveys. 
Participants who withdraw before Contact 4 will be encouraged to attend their scheduled medical 
visit (see section 10.5).   
12.4!
Replacement of Subjects 
Subjects who withdraw from the study will not be replaced.  We will conduct our analyses on an 
intent-to-treat basis and will rely on multiple methods (including censoring and imputation) to 
examine the sensitivity of our findings to missing data.  
13! PROTOCOL VIOLATIONS 
A protocol violation occurs when the subject, investigator, or Sponsor fails to adhere to 
significant protocol requirements affecting the inclusion, exclusion, subject privacy, and primary 
endpoint criteria.  Protocol violations for this study include, but are not limited to, the following: 
Failure to meet inclusion/exclusion criteria 
Failure to withdraw participant from the intervention arm in a timely fashion when the 
participant requests voluntary withdrawal from the study.   
Failure to comply with Good Clinical Practice (GCP) guidelines will also result in a protocol 
violation. The Sponsor will determine if a protocol violation will result in withdrawal of a 
subject. 
When a protocol violation occurs, it will be discussed with the investigator and a Protocol 
Violation Form detailing the violation will be generated. This form will be signed by a Sponsor 
representative and the Investigator. A copy of the form will be filed in the site’s regulatory 
binder and in the Sponsor’s files. 
14! DATA SAFETY MONITORING 
Not applicable 
15! STATISTICAL METHODS AND CONSIDERATIONS 
Prior to the analysis of the final study data, a Statistical Analysis Plan (SAP) will be written 
describing all analyses that will be performed.  The SAP will contain any modifications to the 
analysis plan described below.   
15.1!
Data Sets Analyzed 
All eligible patients who are enrolled in the study will be included in the analysis. 
15.2!
Demographic and Baseline Characteristics 
We will compare several demographic and baseline characteristics between subjects in the 
intervention and control groups at baseline.  These include age, race, and clinical characteristics 
such as prostate specific antigen.  

UCSF IRB Protocol #: 14-12951 
Confidential 
Version(#:(FINAL(1.2((
Version(Date:(8/9/2017(
Page(25(of(63(
 
15.3!
Analysis of Primary Endpoint 
The primary statistical analysis will compare the probability of correctly responding to the two 
knowledge survey questions between subjects randomized to the intervention and control sites 
using logistic regression.  The primary predictor of the logistic model will be the binary, site-
specific intervention indicator.  We will also include site, time and intervention group by time 
interaction terms.  Since randomization by site may not balance, all relevant sociodemographic 
and clinical characteristics of the subjects may be included in the models; we will also include 
other factors that are not balanced between the groups.  We will assess balance by comparing 
means of continuous characteristics using two sample t-tests and by comparing categorical 
characteristics using chi-square tests. 
15.4!
Analysis of Secondary Endpoints 
The statistical analyses of the secondary endpoints will follow the same regression model 
approach as with the primary endpoint using a regression model appropriate for the outcome 
type.  For example, we will use linear regression to analyze continuous endpoints such as 
MaxPC and polytomous logistic regression for categorical endpoints of decision support 
intervention (DSI) coaching versus usual care.   
15.5!
Interim Analysis 
Not Applicable 
15.6!
Sample Size and Randomization 
We will base sample size calculations on the comparison of the probability of correctly 
responding to the two survey questions between subjects at the intervention versus control sites 
with a design effect correction to accommodate the potential correlation of responses within sites 
[44].  That is, we will inflate the sample sizes resulting from standard sample calculations for the 
comparison of two proportions by the design effect, 1 + (n-1)*rho, where n is the sample size per 
site and rho is the intraclass correlation coefficient of the primary binary response[45].  We are 
interested in detecting an alternative where the probability of the primary response increases 
from 0.5 in the control sites to 0.75 in the intervention sites.  Standard power calculations for chi-
square tests to compare two proportions [45] show that tests based on a total sample size of 116 
would have power 0.8 to detect the alternative of interest.  Since our study design involves 8 
clusters (four sites measured in two time periods), our initial design would include 15 subjects 
measured in each site at each time.  Preliminary data indicate that the intraclass correlation 
coefficient of the primary response is quite low within sites; the estimated intraclass correlation 
coefficient was less than 0.01.  This estimate produces a design effect of 1.14 and we inflate the 
required number of subjects per site and time to 17 for a total sample size of 136. 
Randomization: At baseline, this study will randomize two sites to the intervention and two sites 
to serve as controls.  There are six possible assignments of two intervention and control sites in 
our study and we will generate a uniform (0,1) random number to select one of them. 

UCSF IRB Protocol #: 14-12951 
Confidential 
Version(#:(FINAL(1.2((
Version(Date:(8/9/2017(
Page(26(of(63(
 
16! DATA COLLECTION, RETENTION AND MONITORING 
16.1!
Data Collection Instruments 
The Investigator will prepare and maintain adequate and accurate source documents designed to 
record all observations and other pertinent data for each subject treated with the study drug.   
Study personnel at each site will enter data from source documents corresponding to a subject’s 
visit into the protocol-specific electronic Case Report Form (eCRF) OR paper CRF when the 
information corresponding to that visit is available.  Onsite CRCs will have access to a UCSF 
hosted REDCaP database (see https://redcap.ucsf.edu/index.php ).  The database will be 
partitioned by each site to maintain the confidentiality of site specific participants.   
For eCRFs: If a correction is required for an eCRF, the time and date stamps track the person 
entering or updating eCRF data and creates an electronic audit trail.  Paper-mode CRFs will be 
used only for PROMs which will be entered into the REDCaP database.  For paper CRFs:  If a 
correction is made on a CRF, the study staff member will line through the incorrect data, write in 
the correct data and initial and date the change. 
The Investigator is responsible for all information collected on subjects enrolled in this study.  
All data collected during the course of this study must be reviewed and verified for completeness 
and accuracy by the Investigator.  A copy of the CRF will remain at the Investigator’s site at the 
completion of the study. 
16.2!
Data Management Procedures 
The data will be entered into a validated database.  The Data Management group will be 
responsible for data processing, in accordance with procedural documentation.  Database lock 
will occur once quality assurance procedures have been completed. 
All procedures for the handling and analysis of data will be conducted using good computing 
practices meeting FDA guidelines for the handling and analysis of data for clinical trials. 
16.3!
Data Quality Control and Reporting 
After data have been entered into the study database, a system of computerized data validation 
checks will be implemented and applied to the database on a regular basis. For EDC studies: 
Queries are entered, tracked, and resolved through the EDC system directly.  For paper studies: 
Query reports (Data Clarification Requests) pertaining to data omissions and discrepancies will 
be forwarded to the Investigators and study monitors for resolution.  The study database will be 
updated in accordance with the resolved queries.  All changes to the study database will be 
documented. 
16.4!
Archival of Data 
The database is safeguarded against unauthorized access by established security procedures; 
appropriate backup copies of the database and related software files will be maintained.  
Databases are backed up by the database administrator in conjunction with any updates or 
changes to the database.   
At critical junctures of the protocol (e.g., production of interim reports and final reports), data for 
analysis is locked and cleaned per established procedures. 

UCSF IRB Protocol #: 14-12951 
Confidential 
Version(#:(FINAL(1.2((
Version(Date:(8/9/2017(
Page(27(of(63(
 
All ICF, HIPAA, and/or paper-mode PROMs will be digitally archived and attached to the 
relevant section in the REDCaP database.  
16.5!
Availability and Retention of Investigational Records 
The Investigator must make study data accessible to the monitor, other authorized 
representatives of the Sponsor (or designee), IRB/IEC, and Regulatory Agency (e.g., FDA) 
inspectors upon request.  A file for each subject must be maintained that includes the signed 
Informed Consent, HIPAA Authorization and Assent Form and copies of all source 
documentation related to that subject.  The Investigator must ensure the reliability and 
availability of source documents from which the information on the CRF was derived. 
All study documents (patient files, signed informed consent forms, copies of CRFs, Study File 
Notebook, etc.) must be kept secured for a period of two years following marketing of the 
investigational product or for two years after centers have been notified that the IND has been 
discontinued.  There may be other circumstances for which the Sponsor is required to maintain 
study records and, therefore, the Sponsor should be contacted prior to removing study records for 
any reason. 
16.6!
Monitoring 
Not applicable 
16.7!
Subject Confidentiality 
No raw / identifiable data from the study will be shared with the study sponsor, the Department 
of Defense U.S. Army Medical Research Transformative Impact Award group.   
17! ADMINISTRATIVE, ETHICAL, REGULATORY CONSIDERATIONS  
The study will be conducted according to the Declaration of Helsinki, Protection of Human 
Volunteers (21 CFR 50), Institutional Review Boards (21 CFR 56), and Obligations of Clinical 
Investigators (21 CFR 312). 
To maintain confidentiality, all laboratory specimens, evaluation forms, reports and other records 
will be identified by a coded number and initials only.  All study records will be kept in a locked 
file cabinet and code sheets linking a patient’s name to a patient identification number will be 
stored separately in another locked file cabinet.  Clinical information will not be released without 
written permission of the subject, except as necessary for monitoring by the FDA.  The 
Investigator must also comply with all applicable privacy regulations (e.g., Health Insurance 
Portability and Accountability Act of 1996, EU Data Protection Directive 95/46/EC). 
17.1!
Protocol Amendments 
Protocol amendments cannot be implemented without prior written IRB/IEC approval except as 
necessary to eliminate immediate safety hazards to patients.  A protocol amendment intended to 
eliminate an apparent immediate hazard to patients may be implemented immediately, provided 
the IRBs are notified within five working days. 

UCSF IRB Protocol #: 14-12951 
Confidential 
Version(#:(FINAL(1.2((
Version(Date:(8/9/2017(
Page(28(of(63(
 
17.2!
Institutional Review Boards and Independent Ethics Committees 
The protocol and consent form will be reviewed and approved by the IRB/IEC of each 
participating center prior to study initiation.  Serious adverse experiences regardless of causality 
will be reported to the IRB/IEC in accordance with the standard operating procedures and 
policies of the IRB/IEC, and the Investigator will keep the IRB/IEC informed as to the progress 
of the study.  The Investigator will obtain assurance of IRB/IEC compliance with regulations. 
Any documents that the IRB/IEC may need to fulfill its responsibilities (such as protocol, 
protocol amendments, Investigator’s Brochure, consent forms, information concerning patient 
recruitment, payment or compensation procedures, or other pertinent information) will be 
submitted to the IRB/IEC.  The IRB/IECs written unconditional approval of the study protocol 
and the informed consent form will be in the possession of the Investigator before the study is 
initiated.  The IRB/IECs unconditional approval statement will be transmitted by the Investigator 
to the Sponsor or designee prior to the shipment of study supplies to the site.  This approval must 
refer to the study by exact protocol title and number and should identify the documents reviewed 
and the date of review. 
Protocol and/or informed consent modifications or changes may not be initiated without prior 
written IRB/IEC approval except when necessary to eliminate immediate hazards to the patients 
or when the change(s) involves only logistical or administrative aspects of the study.  Such 
modifications will be submitted to the IRB/IEC and written verification that the modification 
was submitted and subsequently approved should be obtained.   
The IRB/IEC must be informed of revisions to other documents originally submitted for review; 
serious and/or unexpected adverse experiences occurring during the study in accordance with the 
standard operating procedures and policies of the IRB; new information that may affect 
adversely the safety of the patients of the conduct of the study; an annual update and/or request 
for re-approval; and when the study has been completed. 
17.3!
Informed Consent Form  
Informed consent will be obtained in accordance with the Declaration of Helsinki, ICH GCP, US 
Code of Federal Regulations for Protection of Human Subjects (21 CFR 50.25[a,b], CFR 50.27, 
and CFR Part 56, Subpart A), the Health Insurance Portability and Accountability Act (HIPAA, 
if applicable), and local regulations. 
The Investigator will prepare the informed consent form, assent and HIPAA authorization and 
provide the documents to the Sponsor or designee for approval prior to submission to the 
IRB/IEC.  The consent form generated by the Investigator must be acceptable to the Sponsor and 
be approved by the IRB/IEC.  The written consent document will embody the elements of 
informed consent as described in the International Conference on Harmonisation and will also 
comply with local regulations. The Investigator will send an IRB/IEC-approved copy of the 
Informed Consent Form to the Sponsor (or designee) for the study file. 
A properly executed, written, informed consent will be obtained from each subject prior to 
entering the subject into the trial.  Information should be given in both oral and written form and 
subjects (or their legal representatives) must be given ample opportunity to inquire about details 
of the study.  If appropriate and required by the local IRB/IEC, assent from the subject will also 
be obtained.  If a subject is unable to sign the informed consent form (ICF) and the HIPAA 
authorization, a legal representative may sign for the subject.   A copy of the signed consent form 

UCSF IRB Protocol #: 14-12951 
Confidential 
Version(#:(FINAL(1.2((
Version(Date:(8/9/2017(
Page(29(of(63(
 
(and assent) will be given to the subject or legal representative of the subject and the original will 
be maintained with the subject’s records. 
17.4!
Publications  
The preparation and submittal for publication of manuscripts containing the study results shall be 
in accordance with a process determined by mutual written agreement among the study Sponsor 
and participating institutions.  The publication or presentation of any study results shall comply 
with all applicable privacy laws, including, but not limited to, the Health Insurance Portability 
and Accountability Act of 1996.  
17.5!
Investigator Responsibilities 
By signing the Agreement of Investigator form, the Investigator agrees to: 
1.( Conduct the study in accordance with the protocol and only make changes after notifying 
the Sponsor (or designee), except when to protect the safety, rights or welfare of subjects. 
2.( Personally conduct or supervise the study (or investigation). 
3.( Ensure that the requirements relating to obtaining informed consent and IRB review and 
approval meet federal guidelines, as stated in § 21 CFR, parts 50 and 56. 
4.( Report to the Sponsor or designee any AEs that occur in the course of the study, in 
accordance with §21 CFR 312.64. 
5.( Ensure that all associates, colleagues and employees assisting in the conduct of the study are 
informed about their obligations in meeting the above commitments. 
6.( Maintain adequate and accurate records in accordance with §21 CFR 312.62 and to make 
those records available for inspection with the Sponsor (or designee). 
7.( Ensure that an IRB that complies with the requirements of §21 CFR part 56 will be 
responsible for initial and continuing review and approval of the clinical study. 
8.( Promptly report to the IRB and the Sponsor (or designee) all changes in the research activity 
and all unanticipated problems involving risks to subjects or others (to include amendments 
and IND safety reports). 
9.( Seek IRB approval before any changes are made in the research study, except when 
necessary to eliminate hazards to the patients/subjects. 
10.( Comply with all other requirements regarding the obligations of clinical investigators and all 
other pertinent requirements listed in § 21 CFR part 312. 

UCSF IRB Protocol #: 14-12951 
Confidential 
Version(#:(FINAL(1.2((
Version(Date:(8/9/2017(
Page(30(of(63(
 
18! REFERENCES  
1. 
Elwyn, G., et al., Developing a quality criteria framework for patient decision aids: 
online international Delphi consensus process. BMJ, 2006. 333(7565): p. 417. 
2. 
Adler, N.E., A. Page, and National Institute of Medicine (U.S.). Committee on 
Psychosocial Services to Cancer Patients / Families in a Community Setting., Cancer 
care for the whole patient : meeting psychosocial health needs. 2008, Washington, D.C.: 
National Academies Press. xxii, 429 p. 
3. 
Brownlee, S., Overtreated : why too much medicine is making us sicker and poorer. 1st 
U.S. ed. 2007, New York, NY: Bloomsbury. 343 p. 
4. 
Hadler, N.M., Worried sick : a prescription for health in an overtreated America. H. 
Eugene and Lillian Youngs Lehman series. 2008, Chapel Hill: University of North 
Carolina Press. 376 p. 
5. 
Belkora, J., et al., Evaluation of question-listing at the Cancer Support Community. 
Translational Behavioral Medicine, 2013. 3(2): p. 162-171. 
6. 
Belkora, J., et al., Decision support by telephone: Randomized controlled trial in a rural 
community setting. Patient Educ Couns, 2012. 89(1): p. 134-42. 
7. 
Belkora, J., et al., Coaching patients in the use of decision and communication aids: RE-
AIM evaluation of a patient support program. BMC Health Serv Res, 2015. 15(1): p. 
209. 
8. 
Belkora, J.K., et al., Monitoring the implementation of Consultation Planning, Recording, 
and Summarizing in a breast care center. Patient Educ Couns, 2008. 73(3): p. 536-43. 
9. 
Dimoska, A., et al., Can a "prompt list" empower cancer patients to ask relevant 
questions? Cancer, 2008. 113(2): p. 225-37. 
10. 
Hacking, B., et al., Testing the feasibility, acceptability and effectiveness of a 'decision 
navigation' intervention for early stage prostate cancer patients in Scotland - a 
randomised controlled trial. Psychooncology, 2013. 22(5): p. 1017-24. 
11. 
Kinnersley, P., et al., Interventions before consultations for helping patients address their 
information needs. Cochrane Database Syst Rev, 2007(3): p. CD004565. 
12. 
Pitkethly, M., S. MacGillivray, and R. Ryan Recordings or summaries of consultations 
for people with cancer. Cochrane Database of Systematic Reviews, 2008.  DOI: 
10.1002/14651858.CD001539.pub2. 
13. 
Roter, D.L., Patient participation in the patient-provider interaction: the effects of 
patient question asking on the quality of interaction, satisfaction and compliance. Health 
Educ Monogr, 1977. 5(4): p. 281-315. 
14. 
Roter, D.L., Patient question asking in physician-patient interaction. Health Psychol, 
1984. 3(5): p. 395-409. 
15. 
Sepucha, K.R., et al., Consultation planning to help breast cancer patients prepare for 
medical consultations: effect on communication and satisfaction for patients and 
physicians. J Clin Oncol, 2002. 20(11): p. 2695-700. 
16. 
Sepucha, K.R., et al., Building bridges between physicians and patients: results of a pilot 
study examining new tools for collaborative decision making in breast cancer. J Clin 
Oncol, 2000. 18(6): p. 1230-8. 

UCSF IRB Protocol #: 14-12951 
Confidential 
Version(#:(FINAL(1.2((
Version(Date:(8/9/2017(
Page(31(of(63(
 
17. 
Stacey, D., et al., Decision aids for people facing health treatment or screening decisions. 
Cochrane Database Syst Rev, 2011(10): p. CD001431. 
18. 
Griffin, S.J., et al., Effect on health-related outcomes of interventions to alter the 
interaction between patients and practitioners: a systematic review of trials. Ann Fam 
Med, 2004. 2(6): p. 595-608. 
19. 
Harrington, J., L.M. Noble, and S.P. Newman, Improving patients' communication with 
doctors: a systematic review of intervention studies. Patient Educ Couns, 2004. 52(1): p. 
7-16. 
20. 
Siegel, R.L., K.D. Miller, and A. Jemal, Cancer statistics, 2016. CA Cancer J Clin, 2016. 
66(1): p. 7-30. 
21. 
Wilt, T.J., et al., Radical prostatectomy versus observation for localized prostate cancer. 
N Engl J Med, 2012. 367(3): p. 203-13. 
22. 
Wilt, T.J., et al., The Prostate cancer Intervention Versus Observation 
Trial:VA/NCI/AHRQ Cooperative Studies Program #407 (PIVOT): design and baseline 
results of a randomized controlled trial comparing radical prostatectomy to watchful 
waiting for men with clinically localized prostate cancer. Contemp Clin Trials, 2009. 
30(1): p. 81-7. 
23. 
Wilt, T.J., et al., Systematic review: comparative effectiveness and harms of treatments 
for clinically localized prostate cancer. Ann Intern Med, 2008. 148(6): p. 435-48. 
24. 
Schroeck, F.R., et al., Satisfaction and regret after open retropubic or robot-assisted 
laparoscopic radical prostatectomy. Eur Urol, 2008. 54(4): p. 785-93. 
25. 
Ganz, P.A., et al., NIH State-of-the-Science Conference Statement: Role of active 
surveillance in the management of men with localized prostate cancer. NIH Consens 
State Sci Statements, 2011. 28(1): p. 1-27. 
26. 
Carroll, P.R., J.M. Whitson, and M.R. Cooperberg, Serum prostate-specific antigen for 
the early detection of prostate cancer: always, never, or only sometimes? J Clin Oncol, 
2011. 29(4): p. 345-7. 
27. 
Cooperberg, M.R., P.R. Carroll, and L. Klotz, Active surveillance for prostate cancer: 
progress and promise. J Clin Oncol, 2011. 29(27): p. 3669-76. 
28. 
Conti, S.L., et al., Pathological outcomes of candidates for active surveillance of prostate 
cancer. J Urol, 2009. 181(4): p. 1628-33; discussion 1633-4. 
29. 
Lin, G.A., et al., Patient decision aids for prostate cancer treatment: a systematic review 
of the literature. CA Cancer J Clin, 2009. 59(6): p. 379-90. 
30. 
Ware, J., et al., SF-12:  How to Score the SF-12 Physical and Mental Health Summary 
Scales, 1998, QualityMetric, Incorporated: Lincoln, RI. 
31. 
Ware, J., et al., SF-12:  How to Score Version 2 of the SF-12 Physical and Mental Health 
Summary Scales, 2002, QualityMetric, Incorporated: Lincoln, RI. 
32. 
Wei, J.T., et al., 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(6): p. 899-905. 
33. 
Feskanich, D., et al., Reproducibility and validity of food intake measurements from a 
semiquantitative food frequency questionnaire. J Am Diet Assoc, 1993. 93(7): p. 790-6. 

UCSF IRB Protocol #: 14-12951 
Confidential 
Version(#:(FINAL(1.2((
Version(Date:(8/9/2017(
Page(32(of(63(
 
34. 
Degner, L.F., J.A. Sloan, and P. Venkatesh, The Control Preferences Scale. Can J Nurs 
Res, 1997. 29(3): p. 21-43. 
35. 
O'Conner, A.M. User manuel-decision self-efficacy scale. Patient Decision Aids, Ottawa 
Hospital Research Institute (OHIR) 1995  [cited 2015; Available from: 
https://decisionaid.phri.ca/docs/develop/Tools/Decision_SelfEfficacy.pdf. 
36. 
Oken, M.M., et al., Toxicity and response criteria of the Eastern Cooperative Oncology 
Group. Am J Clin Oncol, 1982. 5(6): p. 649-55. 
37. 
Belkora, J. SCOPED. 2016; Website for Jeff Belkora's SCOPED model as a checklist for 
making decisions]. Available from: http://scoped.com/. 
38. 
Sepucha, K.R. Prostate Cancer Decision Quality Index v1.0. Massachusetts General 
Hospital 2013 ]; Available from: 
http://www.massgeneral.org/decisionsciences/research/DQ_Instrument_List.aspx. 
39. 
Roth, A., et al., Assessing anxiety in men with prostate cancer: further data on the 
reliability and validity of the Memorial Anxiety Scale for Prostate Cancer (MAX-PC). 
Psychosomatics, 2006. 47(4): p. 340-7. 
40. 
Roth, A.J., et al., The memorial anxiety scale for prostate cancer: validation of a new 
scale to measure anxiety in men with with prostate cancer. Cancer, 2003. 97(11): p. 
2910-8. 
41. 
Chasan-Taber, S., et al., Reproducibility and validity of a self-administered physical 
activity questionnaire for male health professionals. Epidemiology, 1996. 7(1): p. 81-6. 
42. 
Litwin, M.S., et al., Assessment of prognosis with the total illness burden index for 
prostate cancer: aiding clinicians in treatment choice. Cancer, 2007. 109(9): p. 1777-83. 
43. 
Sanda, M.G., et al., Quality of life and satisfaction with outcome among prostate-cancer 
survivors. N Engl J Med, 2008. 358(12): p. 1250-61. 
44. 
Neuhaus, J.M. and M.R. Segal, Design effects for binary regression models fitted to 
dependent data. Stat Med, 1993. 12(13): p. 1259-68. 
45. 
Cohen, J., Statistical power analysis for the behavioral sciences. 1988, Hillsdale, NJ: L. 
Erlbaum Associates. 
 

UCSF IRB Protocol #: 14-12951 
Confidential 
Version(#:(FINAL(1.2((
Version(Date:(8/9/2017(
Page(33(of(63(
 
19! FIGURES AND TABLES 
19.1!
Figure 1. Decision Support Intervention Study Schematic 
Site
Site
Site
Site
Site%randomization
Intervention%Site%1
Intervention%Site%2
Usual%Care%Site%1
Usual%Care%Site%2
Intervention%Site%3
Intervention%Site%4
Usual%Care%Site%3
Usual%Care%Site%4
Site%coordinator%(SC)%screens%for%study%eligibility%(low@risk)
Patient%schedules%urology%visit%with%site
SC%consents%patient%if%eligible%and%willing
SC%surveys%patient:%SF@12,%EPIC,%Diet/Lifestyle;%Demographics;%
Decision%Self@Efficacy%(DSE);%Control%Preferences%Scale%(CPS);%Choice%Predisposition%(CP)
SC%refers%patient%to%Coach
Coach%contacts%patient:%schedules%call
Coach%emails%patient:%decision%aid%link%and%PDF
Coach%calls%patient:%reviews%DA%and%lists%questions
Coach%emails%SC:%patient%question%list
SC%gives%question%list%printout%to%patient%and%(separately)%to%MD
Patient%arrives%at%clinic
SC#surveys#patient:#DQI*,#MaxPC,#DSE,#CPS,#CP,#Risk#Understanding,#Ed#Materials#
Patient%appointment%with%urologist
Intervention
SC%surveys%patient:%DQI,%MaxPC,%DSE,%CPS,%CP,%Risk%Understanding
Patient%leaves%clinic
Lauren%Stupar%calls%first%3%patients%at%each%site%in%each%period:%qualitative%debrief
SC%surveys%patient%before%treatment%commences%:%TIBI,%Satisfaction
Patient%enters%CAPSURE%cohort
When%site%accrues%20%patients,%crosses%over;%at%40%patients,%study%ends
AT%EACH%SITE
Usual#Care
*DQI#pre@visit#is#the#primary#outcome
 
 

UCSF IRB Protocol #: 14-12951 
Confidential 
Version(#:(FINAL(1.2((
Version(Date:(8/9/2017(
Page(34(of(63(
 
19.2!
Table 1. DSI Trial - Schedule of Events1 
 
Intervention Arm 
 
 
Usual Care Arm 
Screen and Recruit 
1.( Post “Diagnosis Confirmation” phone 
call by the physician or the clinical 
nurse, the onsite CRC will contact the 
patient about their eligibility and 
interest in participating in the decision 
support study. If they obtain verbal 
permission, will send them a packet of 
information with the Informed Consent 
(IC), HIPAA and T1 surveys via 
FedEx 
2.( Onsite CRC enters REDCaP CRFs: 
a.( Subject Identifiers 
b.( Eligibility for Study  
3.( Onsite CRC notifies UCSF data 
coordinating center to send FedEx 
package – this could be done by call or 
e-mail. 
Screen and Recruit 
1.( Post “Diagnosis Confirmation” phone 
call by the physician or the clinical 
nurse, the onsite CRC will contact the 
patient about their eligibility and 
interest in participating in the decision 
support study and obtain verbal 
permission to send them a packet of 
information with the Informed Consent, 
HIPAA and T1 surveys via FedEx 
2.( Onsite CRC enters REDCaP CRFs: 
a.( Subject Identifiers 
b.( Eligibility for Study  
Onsite CRC notifies UCSF data coordinating 
center to send FedEx package – this could be 
done by call or e-mail. 
Enters Decision Support Coaching Study 
T1:  Obtain Informed Consent and HIPAA2 
Enter into REDCaP CRFs:   
1.( Study Biopsy Results 
2.( Appointment Information 
T1:  Obtain Informed Consent and HIPAA – 
Enter into REDCaP 
Enter into REDCaP CRFs:   
1.( Study Biopsy Results 
2.( Appointment Information  
T1:  Administer T1 surveys  - paper or web-
mode option 
Enter into REDCaP CRF: 
T1:  Administer T1 surveys – paper or web-
mode option 
Enter into REDCaP CRF: 
                                               
1 Color grid for distribution of tasks associated with the study timed events: 
Onsite Coordinator task 
UCSF Data coordinating Center task 
 
2 If patient is recruited by phone by the onsite CRC, they will notify UCSF to send the paper ICF and HIPAA.  The 
UCSF Data coordinating center will send paper regulatory documents to patient via FedEx.  Patient signs and 
returns signed regulatory forms to UCSF via FedEx.  UCSF CRC will scan ICF and HIPAA and attaches into 
REDCaP database.  UCSF CRC will push e-mail to the onsite CRC to notify her/him that patient has consented.  
UCSF CRC will insure that both the site and the participant have a paper copy of the signed ICF and HIPAA.  Upon 
receipt of a fully executed signed ICF and HIPAA form, the onsite CRC will enter information about the biopsy and 
the upcoming doctor appointment into REDCaP so the coach can begin the contact and coaching parts of the 
intervention.   

UCSF IRB Protocol #: 14-12951 
Confidential 
Version(#:(FINAL(1.2((
Version(Date:(8/9/2017(
Page(35(of(63(
 
 
Intervention Arm 
 
 
Usual Care Arm 
1.( Consent and HIPAA Forms – UCSF to 
provide copies to site 
1.( Consent and HIPAA Forms – UCSF to 
provide copies to site 
T2:  Onsite CRC completes the following 
REDCaP CRFs:   
1.( Coach Contact Preferences   
This completes the onsite CRC referral to the 
coach 
 
Coach contacts patient and schedules coaching 
call 
 
Coach emails patient:  decision aid (DA) link 
and PDF 
 
Coach calls patient:  reviews DA and lists 
questions 
 
Coach emails CRC:  patient question list 
 
Patient arrives at practice for consult visit with Urologist 
T3:  CRC gives question list printout to patient 
(separately) and to MD 
 
T3:  Patient completes T3 surveys before visit  
T3:  Patient completes T3 surveys before visit 
Patient appointment with Urologist 
T4:  Patient completes T4 surveys  after visit 
T4:  Patient completes T4 surveys  after visit 
Patient leaves practice 
UCSF research staff call first 3 patients at each 
site for qualitative debrief 
UCSF research staff call first 3 patients at each 
site for qualitative debrief 
Before Treatment Commences 
T5:  Patient completes T5 surveys 
T5:  Patient completes T5 surveys 
 
Patient enters CaPSURE™ cohort 
 
 
Patient opts for Participation in the Diet & Lifestyle Sub-study of CaPSURE™ 
 
 
 

UCSF IRB Protocol #: 14-12951 
Confidential 
Version(#:(FINAL(1.2((
Version(Date:(8/9/2017(
Page(36(of(63(
 
19.3!
Table 2. Summary Table of Patient-reported Outcome Surveys and Time Points 
Instruments with Time Frame 
# Items 
Time 
(minutes) 
Consent 
T1 
Intervention 
T2 
Pre-
visit 
T3 
Post-visit 
T4 
Pre-
treatment 
T5 
Short Form 12 (SF-12)  
12 
10 
X 
 
 
 
 
Expanded Prostate Cancer Index Composite (EPIC-26)  
26 
20 
X 
 
 
 
 
Diet and Lifestyle  
10 
10 
X 
 
 
 
X 
Patient Demographics (including weight, height, smoking) 
6 
5 
X 
 
 
 
 
Demographics:  Age at diagnosis (calculated from data 
entry by CRC) 
1 
1 
X 
 
 
 
 
Control Preferences Scale (CPS)  
1 
2 
X 
 
 
 
 
Decision Self-Efficacy (DSE)  
1 
2 
X 
 
X 
 
 
Choice Predisposition (CP) 
2 
3 
X 
 
X 
X 
 
Access to patient education materials 
6 
3 
 
 
X 
 
 
Access to Other Diagnostic Tests and External 
Interventions 
6 
5 
 
 
X 
 
 
Decision Quality Instrument (DQI)  
35 
20 
 
 
X 
X 
 
Risk Reclassification Understanding 
1 
2 
 
 
X 
X 
 
Memorial Anxiety Scale for Prostate Cancer (Max PC)  
4 
5 
 
 
X 
X 
 
Service Satisfaction with Cancer Care  
7 
5 
 
 
 
 
X 
Total Illness Burden Index for Prostate Cancer – TIBI-CaP  
27 
10 
 
 
 
 
X 
Patient Debrief Telephone Interview (Based on the CIT)  
*3 
0-20 
 
 
 
 
X* 
                                               
3 Qualitative Interview Debrief Interview Guide – See IRB application other study documents for interview guide.  Applies only to DSI participant only and not 
to the usual care participant.   

UCSF IRB Protocol #: 14-12951 
Confidential 
Version(#:(FINAL(1.2((
Version(Date:(8/9/2017(
Page(37(of(63(
 
Instruments with Time Frame 
# Items 
Time 
(minutes) 
Consent 
T1 
Intervention 
T2 
Pre-
visit 
T3 
Post-visit 
T4 
Pre-
treatment 
T5 
Total Number of Items and Time to Complete Surveys 
147 
105 
58|25 
 
57|31 
42|20 
40|20-40 

UCSF IRB Protocol #: 14-12951 
Confidential 
Version(#:(FINAL(1.2((
Version(Date:(8/9/2017(
Page(38(of(63(
 
19.4!
Table 3. Clinician-reported Outcome Measures and Time Points 
Instruments with Time Frame for Administration 
# Items 
Time 
(minutes) 
Consent 
T1 
Intervention 
T2 
Pre-
visit 
T3 
Post-
visit 
T4 
Pre-
treatment 
T5 
Physician Satisfaction 
2 
5 
 
 
 
X 
 
 
19.5!
Table 4. Interventionist-reported Outcome Measures and Time Points 
Instruments with Time Frame for Administration4 
# Items 
Time 
(minutes) 
Consent 
T1 
Intervention 
T2 
Pre-
visit 
T3 
Post-
visit 
T4 
Pre-
treatment 
T5 
Coaching Call Degree of Completion (study-specific; added to 
uTRAC) 
2 
2 
 
 
X 
 
 
 
                                               
4 Interventionist items are completed by the health coach.   

UCSF IRB Protocol #: 14-12951 
Confidential 
Version(#:(FINAL(1.2((
Version(Date:(8/9/2017(
Page(39(of(63(
 
20! APPENDICES 
20.1!
Appendix A. Coaching Intervention – Internet Access to DSI Tool  
 

UCSF IRB Protocol #: 14-12951 
Confidential 
Version(#:(FINAL(1.2((
Version(Date:(8/9/2017(
Page(40(of(63(
 
 

UCSF IRB Protocol #: 14-12951 
Confidential 
Version(#:(FINAL(1.2((
Version(Date:(8/9/2017(
Page(41(of(63(
 
 

UCSF IRB Protocol #: 14-12951 
Confidential 
Version(#:(FINAL(1.2((
Version(Date:(8/9/2017(
Page(42(of(63(
 
 
 

UCSF IRB Protocol #: 14-12951 
Confidential 
Version(#:(FINAL(1.2((
Version(Date:(8/9/2017(
Page(43(of(63(
 
 

UCSF IRB Protocol #: 14-12951 
Confidential 
Version(#:(FINAL(1.2((
Version(Date:(8/9/2017(
Page(44(of(63(
 
 

UCSF IRB Protocol #: 14-12951 
Confidential 
Version(#:(FINAL(1.2((
Version(Date:(8/9/2017(
Page(45(of(63(
 
 
 

UCSF IRB Protocol #: 14-12951 
Confidential 
Version(#:(FINAL(1.2((
Version(Date:(8/9/2017(
Page(46(of(63(
 
 
 

UCSF IRB Protocol #: 14-12951 
Confidential 
Version(#:(FINAL(1.2((
Version(Date:(8/9/2017(
Page(47(of(63(
 
 
 

UCSF IRB Protocol #: 14-12951 
Confidential 
Version(#:(FINAL(1.2((
Version(Date:(8/9/2017(
Page(48(of(63(
 
 
 

UCSF IRB Protocol #: 14-12951 
Confidential 
Version(#:(FINAL(1.2((
Version(Date:(8/9/2017(
Page(49(of(63(
 
 
 

UCSF IRB Protocol #: 14-12951 
Confidential 
Version(#:(FINAL(1.2((
Version(Date:(8/9/2017(
Page(50(of(63(
 
 
 

UCSF IRB Protocol #: 14-12951 
Confidential 
Version(#:(FINAL(1.2((
Version(Date:(8/9/2017(
Page(51(of(63(
 
20.2!
Appendix B. Coaching Intervention – No Internet Access to DSI Tool 5 
                                               
5 Appendices as referenced in section 10.3 of this protocol.  These are examples of the Decision Aid that is sent to 
the participant by e-mail.  If the participant does not have Internet access, a paper version is sent to the participant 
via paper-mode mail for them to follow along with during the coaching call, as illustrated in Appendix B.   
 

UCSF IRB Protocol #: 14-12951 
Confidential 
Version(#:(FINAL(1.2((
Version(Date:(8/9/2017(
Page(52(of(63(
 
 
 

UCSF IRB Protocol #: 14-12951 
Confidential 
Version(#:(FINAL(1.2((
Version(Date:(8/9/2017(
Page(53(of(63(
 

UCSF IRB Protocol #: 14-12951 
Confidential 
Version(#:(FINAL(1.2((
Version(Date:(8/9/2017(
Page(54(of(63(
 

UCSF IRB Protocol #: 14-12951 
Confidential 
Version(#:(FINAL(1.2((
Version(Date:(8/9/2017(
Page(55(of(63(
 

UCSF IRB Protocol #: 14-12951 
Confidential 
Version(#:(FINAL(1.2((
Version(Date:(8/9/2017(
Page(56(of(63(
 

UCSF IRB Protocol #: 14-12951 
Confidential 
Version(#:(FINAL(1.2((
Version(Date:(8/9/2017(
Page(57(of(63(
 

UCSF IRB Protocol #: 14-12951 
Confidential 
Version(#:(FINAL(1.2((
Version(Date:(8/9/2017(
Page(58(of(63(
 

UCSF IRB Protocol #: 14-12951 
Confidential 
Version(#:(FINAL(1.2((
Version(Date:(8/9/2017(
Page(59(of(63(
 

UCSF IRB Protocol #: 14-12951 
Confidential 
Version(#:(FINAL(1.2((
Version(Date:(8/9/2017(
Page(60(of(63(
 

UCSF IRB Protocol #: 14-12951 
Confidential 
Version(#:(FINAL(1.2((
Version(Date:(8/9/2017(
Page(61(of(63(
 

UCSF IRB Protocol #: 14-12951 
Confidential 
Version(#:(FINAL(1.2((
Version(Date:(8/9/2017(
Page(62(of(63(
 

UCSF IRB Protocol #: 14-12951 
Confidential 
Version(#:(FINAL(1.2((
Version(Date:(8/9/2017(
Page(63(of(63(