POW-R Health: Power to Redefine Your Health A Pragmatic Dietary Intervention to Improve Bladder Cancer Survivorship
Phase: PHASE1
Conditions: Stage 0a Bladder Cancer AJCC v8, Stage 0is Bladder Cancer AJCC v8, Stage I Bladder Cancer AJCC v8
Sponsor: Roswell Park Cancer Institute

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PROTOCOL TITLE: 
POW-R Health: Power to Redefine your Health (Internal Title: A Pragmatic Dietary 
Intervention to Improve Bladder Cancer Survivorship) 
PROTOCOL NUMBER:  
I 661820 
PRINCIPAL INVESTIGATOR: 
Karen Yeary, PhD 
Roswell Park Comprehensive Cancer Center 
Elm and Carlton Street 
Buffalo, New York 14263 
716-845-6231 
karen.yeary@roswellpark.org@roswellpark.org 
VERSION NUMBER:  
17 
DATE: 
10/31/2022 
______________________________________________________________________________ 
SPONSOR: Roswell Park Comprehensive Cancer Center 
FUNDING: NIH & NCI  
 
Confidentiality Statement 
Any and all information presented in this document shall be treated as confidential and shall 
remain the exclusive property of the party (ies) mentioned above (Roswell Park Cancer Institute 
Corporation d/b/a Roswell Park Comprehensive Cancer Center). The use of such confidential 
information must be restricted to the recipient for the agreed purpose and must not be disclosed, 
published, or otherwise communicated to any unauthorized persons, for any reason, in any form 
whatsoever without the prior written consent of the party(ies) above. 

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Table of Contents 
1. 
Objectives ............................................................................................................................ 3 
2. 
Background .......................................................................................................................... 4 
3. 
Inclusion and Exclusion Criteria .......................................................................................... 6 
4. 
Local and Study-Wide Number of Subjects ........................................................................ 7 
5. 
Local and Study-Wide Recruitment Methods...................................................................... 8 
6. 
Multi-Site Research ............................................................................................................. 9 
7. 
Study Timelines ................................................................................................................. 10 
8. 
Study Endpoints ................................................................................................................. 10 
9. 
Design ................................................................................................................................ 11 
10. 
Treatment ........................................................................................................................... 12 
11. 
Procedures Involved........................................................................................................... 12 
12. 
Withdrawal of Subjects ...................................................................................................... 16 
13. 
Risks to Subjects ................................................................................................................ 16 
14. 
Potential Benefits to Subjects ............................................................................................ 16 
15. 
Data and Specimen Banking .............................................................................................. 17 
16. 
Measurement of Effect ....................................................................................................... 17 
17. 
Safety Evaluation ............................................................................................................... 17 
18. 
Data Management and Confidentiality .............................................................................. 18 
19. 
Statistical Plan .................................................................................................................... 19 
20. 
Provisions to Monitor the Data to Ensure the Safety of Subjects ...................................... 21 
21. 
Vulnerable Populations ...................................................................................................... 21 
22. 
Community-Based Participatory Research ........................................................................ 21 
23. 
Sharing of Results with Subjects ....................................................................................... 21 
24. 
Setting ................................................................................................................................ 21 
25. 
Provisions to Protect the Privacy Interests of Subjects ...................................................... 23 
26. 
Resources Available........................................................................................................... 23 
27. 
Prior Approvals .................................................................................................................. 24 
28. 
Compensation for Research-Related Injury ....................................................................... 24 
29. 
Economic Burden to Subjects ............................................................................................ 24 
30. 
Consent Process ................................................................................................................. 25 
31. 
Process to Document Consent in Writing .......................................................................... 26 
32. 
Drugs or Devices................................................................................................................ 26 
33. 
References .......................................................................................................................... 27 
34. 
Appendices/ Supplements .................................................................................................. 31 
 

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1. 
OBJECTIVES 
We hypothesize that a behavioral dietary intervention designed to modestly increase cruciferous 
vegetable intake in patients with Non-Muscle Invasive Bladder Cancer (NMIBC) will significantly 
reduce recurrence and progression. Findings from our in vitro, in vivo, and epidemiologic studies1-
10 have shown that dietary isothiocyanates (ITCs) exert potent anti-cancer activities against bladder 
cancer. ITCs are a group of phytochemicals primarily derived from cruciferous vegetables and oral 
consumption of dietary ITCs can be rapidly metabolized, delivered to the bladder, and 
concentrated in the urine—rendering the abnormal bladder epithelium the best target. In our 
retrospective study1, higher consumption of raw cruciferous vegetables was associated with 
reduced bladder cancer-specific and overall mortality.  
We will use the ORBIT Model11 to translate our strong preclinical findings into a novel, dietary 
behavioral intervention to reduce bladder cancer recurrence and progression in diverse patients 
with NMIBC. We will partner with the New York State Cancer Registry (NYSCR) to recruit and 
enroll eligible patients and their clinical care providers in our catchment area, which is 
characterized by a disproportionally high risk of and mortality rate for bladder cancer. The dietary 
intervention will be based on Social Cognitive Theory12 and developed in collaboration with our 
Community Advisory Board consisting of bladder cancer care providers and patients to ensure 
optimal uptake by survivors. To facilitate the rapid translation of research into evidence-based 
practice, implementation support strategies will be identified at the clinic level as an incremental 
step towards integrating the dietary behavioral intervention into current healthcare systems serving 
patients with bladder cancer. The study’s specific aims are:  
Specific Aim 1:  Develop an evidence-based behavioral intervention to increase cruciferous 
vegetable intake, with the goal of attaining desirable urinary ITC levels effective for anti-cancer 
activities. We will work with our Community Advisory Board to adapt materials and methods 
from current evidence-based fruit and vegetable interventions and leverage our findings on ITC 
yield from cruciferous vegetables to develop our dietary intervention, using a systematic process 
consisting of information gathering, discussion groups, and mock intervention delivery. 
Specific Aim 2: Conduct a feasibility pilot of our dietary behavioral intervention through a hybrid 
I implementation randomized controlled design in 80 NMIBC survivors, where the treatment 
group (n=40) will receive an evidence-based telephone intervention to increase cruciferous 
vegetable intake and the control group (n=40) will receive a general fruit and vegetable intake 
intervention based on NCI guidelines. The primary outcomes will be cruciferous vegetable intake 
and urinary ITC levels, and the secondary outcome will be gene expression changes in urinary 
exfoliated epithelial cells as a surrogate for intermediate efficacy. 
Exploratory Aim: Engage the clinical care providers of patients enrolled in our intervention to 
ascertain the barriers and facilitators of intervention implementation within clinical practice 
through conducting 20 semi-structured interviews. The goal is to gain feedback and refine the 
intervention for “real-world’ implementation. 
Primary Objective(s) 
•  Develop an evidence-based behavioral intervention to increase cruciferous vegetable 
intake, with the goal of attaining desirable urinary ITC levels effective for anti-cancer 
activities. We will work with our Community Advisory Board to adapt materials and 
methods from current evidence-based fruit and vegetable interventions and leverage 

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our findings on ITC yield from cruciferous vegetables to develop our dietary 
intervention, using a systematic process consisting of information gathering, discussion 
groups, and mock intervention delivery. 
• Conduct a feasibility pilot of our dietary behavioral intervention through a hybrid I 
implementation randomized controlled design in 80 NMIBC survivors, where the 
treatment group (n=40) will receive an evidence-based telephone intervention to 
increase cruciferous vegetable intake and the control group (n=40) will receive a 
general fruit and vegetable intake intervention based on NCI guidelines. The primary 
outcomes will be cruciferous vegetable intake and urinary ITC levels. 
Secondary Objective(s) 
• The secondary outcome will be to ascertain the level of gene expression changes in 
urinary exfoliated epithelial cells (due to the intervention) as a surrogate for 
intermediate efficacy. 
Exploratory Objective(s) 
• Engage the clinical care providers of patients enrolled in our intervention to ascertain 
the barriers and facilitators of intervention implementation within clinical practice 
through conducting 20 semi-structured interviews. The goal is to gain feedback and 
refine the intervention for “real-world’ implementation. 
2. BACKGROUND 
The problem of bladder cancer.   Bladder cancer is the sixth most common cancer in the US, 
contributing to over 80,000 new cases and 17,000 deaths annually2. The majority of bladder cancer 
(70-80%) is diagnosed at an early stage with cancer confined to the epithelial and lamina propria 
layer of the bladder—also known as non-muscle invasive bladder cancer (NMIBC)4. The standard 
treatment for NMIBC is transurethral resection of bladder tumor, which is a routine clinic 
procedure without hospitalization. However, NMIBC typically recurs (50-80%) with some 
patients experiencing multiple recurrences at similar stages and others (20-30%) progressing to 
muscle-invasive disease, which is associated with cystectomy and poor survival3-5. Depending on 
pathological characteristics, approximately 15% of tumors are defined as high-risk and receive one 
or more doses of intravesical therapeutic agents6, of which Bacillus Calmette–Guerin (BCG) has 
been the gold standard for four decades7. Yet approximately 30% of these patients will be non-
responders to BCG, and high incidence of local side effects are concerns7. For the majority of 
NMIBC patients, no other treatment is available, although they are still at risk of recurrence and 
progression. Current clinical management requires life-long surveillance by cystoscopy for 
NMIBC patients, amounting to bladder cancer being the most expensive cancer to treat per 
patient8-10. An estimated 696,440 people are living with bladder cancer in the US23, the majority 
of which are off treatment and under surveillance. Novel, non-invasive, cost-effective strategies to 
control NMIBC recurrence and progression are urgently needed. 
Dietary isothiocyanates (ITCs) in bladder cancer chemoprevention.  Dietary ITCs are a group 
of phytochemicals primarily derived from cruciferous vegetables (cruciferae) with multi-faceted 
anti-cancer mechanisms. Our group has published 10 peer-reviewed papers11-20 involving in vitro, 
in vivo, and epidemiologic studies demonstrating the important role of dietary ITCs and ITC-rich 
cruciferae in preventing bladder cancer recurrence and progression. The four most common dietary 
ITCs and their primary urinary metabolites potently inhibited the growth of a panel of human 

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bladder cancer cells including NMIBC cells with IC50 values around 10µM averagely15, 17,  which 
is realistically achievable in the urine with a single oral dose of ITC at 10 µmol/kg weight in rats24. 
ITC at 10 µmol/kg (approximately 1 mg/kg) is also readily achievable in humans, with some 
cruciferae yielding as much as 3.4 mg ITC per gram25. Daily oral administration of ITC at the same 
dose level for three weeks significantly inhibits orthotopic bladder cancer growth20. Importantly, 
we demonstrated that dietary ITCs not only inhibit bladder cancer development, but also prevent 
tumor progression into muscle-invasive disease18, 20.  Our group also discovered that orally 
ingested ITCs are rapidly and almost exclusively delivered to the bladder and concentrated in 
urine, showing 2-3 orders of magnitude higher concentration of ITCs and metabolites in the urine 
than in the plasma within 3 hours of dosing18, 20. Storage of the urine in the bladder further enhances 
exposure of malignant cells to ITCs.  Therefore, this unique metabolism and disposition pathway 
makes the bladder the best target for ITCs or ITC-rich cruciferae. In our retrospective study of 239 
bladder cancer patients11, 12, raw cruciferae intake was inversely associated with bladder cancer 
risk, and importantly, associated with a significantly improved disease-specific survival (hazard 
ratio = 0.43, 95% confidence interval = 0.25-0.74).  
Low cruciferae intake in bladder cancer survivors (BCS).  Although the potential beneficial 
effect of dietary ITCs in bladder cancer is compelling, the consumption of the primary dietary 
resource of ITCs—cruciferae—is generally low among BCS. An average of 0.45 serving per day 
was observed in our retrospective study12, similar to the report of the daily consumption of 0.44 
servings in a pilot study of 48 BCS26. Preliminary analysis of food frequency questionnaire (FFQ) 
data from over 1,400 newly diagnosed NMIBC patients from our Be-Well study (R01CA172855)27 
reported that daily intake of cruciferae was about 52.7 gram, or approximately 0.7 servings; while 
urinary ITC level was around 4.4 µM, which is below the averagely 10 µM of ITCs observed to 
stop or kill at least 50% of bladder cancer cells in in vitro models15, 17. Based on our recent findings 
on the diverse range of ITC yield from cruciferae and the various impact of cooking methods on 
the ITC yield28, 29, we believe that at least one serving (~1 cup raw or ½ cup cooked) of cruciferae 
per day, with guidance on the choice of vegetables and cooking conditions, will increase urinary 
ITC levels to the desirable doses needed to exert anti-cancer activities in the bladder.  
Lack of interventions to increase cruciferae intake.  Systematic reviews30-34 and meta-
analyses35 have documented the effectiveness of behavioral dietary interventions to increase 
vegetable intake in adults, including older and male participants, who comprise the majority of 
BCS4. Only one study tested an intervention designed to increase vegetable intake in BCS26. 
Compared to control participants, intervention participants significantly increased their daily 
vegetable intake (2.4 to 3.9 servings) from baseline to 6-months, but not cruciferae intake. The 
intervention also failed to deliver the corresponding increase in urinary ITC concentrations, 
showing comparable ITC levels between intervention and control groups at 6-month follow-up. 
We will use our prior work to maximize ITC exposure in the following ways: 1) ITC yield varies 
as much as 300-fold from raw cruciferae28, thus we will recommend proper vegetables (e.g. 
arugula, cabbage) in our intervention; 2) heavily cooking largely reduces ITC yield, while lightly 
cooking substantially increases ITC yield from cruciferae28. Thus, we will recommend proper 
cooking conditions (e.g. stir-frying, microwaving) in our intervention; 3) peak urinary 
concentration is achieved within 3 hours of dosing and more than 50% of the dose is excreted and 
accumulated in urine within 8 hours of dosing20, 36. Thus, we will recommend consumption at 
dinner time to avoid ITCs being quickly excreted out of body from frequent urination during the 
day. 

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Scientific premise.  Bladder cancer will recur in the majority (50-80%) of NMIBC patients, yet 
current management is close monitoring with additions of intravesical therapies for a small portion 
of patients (15%) only4, 6. Effective interventions are needed to prevent disease recurrence and 
progression and improve cancer-specific survival for NMIBC survivors with minimum side 
effects, participant/provider burden, and cost. Robust preclinical and epidemiological data 
document the promising anti-cancer effects of cruciferae as a source of ITCs against bladder 
cancer. Numerous dietary interventions have effectively increased vegetable intake in diverse 
adults. Yet an effective intervention designed to improve bladder cancer prognosis through 
increasing cruciferae intake has not been developed. We propose to translate our basic science 
research findings in dietary ITCs and bladder cancer into an evidence-based behavioral 
intervention for NMIBC patients with potential for population-level impact. The proposed research 
will accelerate what we currently know into an intervention that could meaningfully impact cancer 
survivorship in a population at high risk of recurrence and progression that are currently under 
surveillance. 
Preliminary Studies.  Dr. Tang’s work has documented the anti-cancer potential of dietary ITCs 
and ITC-rich cruciferae against bladder cancer11-20. Her recent findings on ITC composition data 
in food commonly consumed in the Western diet and the effects of cooking methods on ITC yield 
from cruciferae28 informed the proposed intervention. Dr. Tang co-led the Be-Well study 
(R01CA172855), a prospective cohort of NMIBC survivors27, which provided data to support the 
need of a behavioral dietary intervention to increase cruciferae intake to boost urinary ITC levels. 
Dr. Yeary led The WORD study (2P20MD002329-06), a behavioral weight loss trial of 426 adults 
that included a dietary component to meet intake goals of at least 5-9 servings of fruits and 
vegetables a day38. The intervention significantly increased vegetable intake by 3.44 (1.51, 5.36) 
servings from baseline to 6 months. Components of this intervention will be used in our cruciferae 
intervention for BCS. 
3. INCLUSION AND EXCLUSION CRITERIA 
Inclusion Criteria 
Cancer Patient:  
To be included in this study, participants must meet the following criteria: 
1. Age 18 years old or older (no upper limit). 
2. English speaking. 
3. Diagnosed with stage Tis, Ta, or T1 bladder cancer. 
4. Resides in the Western New York catchment area. 
5. Did not receive a partial or radical cystectomy. 
6. Does not have a prior cancer diagnosis within 12 months of their bladder cancer diagnosis.  
7. Does not have a subsequent more advanced bladder cancer diagnosis. 
8. For Roswell Park Cancer Registry only: Bladder cancer diagnosed 2016-2018, 2019-
current. 
9. Participant must understand the investigational nature of this study and sign an Independent 
Ethics Committee/Institutional Review Board approved written informed consent form 
prior to receiving any study related procedure. 

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Physician: 
To be included in this study, physicians must meet the following criteria: 
1. English speaking. 
2. Physician in a clinic located in the catchment area. 
3. Currently treats bladder cancer patients. 
Refer to Appendix A for the Investigator Study Eligibility Verification Form: Inclusion Criteria. 
Exclusion Criteria 
Cancer Patient: 
Participants Recruitment will be excluded from this study for the following:  
1. Participants who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for 
nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered 
from adverse events due to agents administered more than 4 weeks earlier. 
2. Participants with known brain metastases should be excluded from this clinical trial 
because of their poor prognosis and because they often develop progressive neurologic 
dysfunction that would confound the evaluation of neurologic and other adverse events. 
3. Adults unable to consent.  
4. Adults unable to complete study measures in English. 
5. Individuals who are not yet adults (infants, children, teenagers). 
6. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, 
symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or 
psychiatric illness/social situations that would limit compliance with study requirements. 
7. Unwilling or unable to follow protocol requirements. 
Physician: 
1. Unable to complete the study measures in English. 
Refer to Appendix B for the Investigator Study Eligibility Verification Form: Exclusion Criteria. 
Inclusion of Women and Minorities 
Both men and women and members of all races and ethnic groups are eligible for this study. 
Special Populations 
The following special populations ae excluded from this study: 
• Cognitively impaired adults/adults with impaired decision-making capacity  
• Individuals who are not yet adults (infants, children, teenagers) 
• Pregnant women 
• Prisoners 
4. LOCAL AND STUDY-WIDE NUMBER OF SUBJECTS 
We will recruit 80 bladder cancer patients ≥ 18 years of age.  We will recruit up to 20 physicians 
in the Western New York area. Recruitment for both patients and physicians will take place over 
the span of two years (study duration). 

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5. LOCAL AND STUDY-WIDE RECRUITMENT METHODS 
Patient Recruitment. Using ICD-O-3 codes provided, Dr. Kuliszewski of the NYSCR will lead 
her staff to identify qualifying patients from their database based on the study’s eligibility 
requirements. The NYSCR has identified 199 cases that meet the study’s eligibility criteria in 2018 
and anticipate at least 400 eligible cases in total in 2018 and 2019. A total of 250 eligible patients 
will be contacted to enable researchers to recruit from a pool of at least 100 patients. In prior 
studies, 52.4% to 62.5% of patients contacted by the NYSCR agreed to be contacted by researchers 
for study consent. The NYSCR will send a letter to the physician of record for selected cases 
notifying that the patient was identified for the study, requesting that the NYSCR be notified if the 
patient is unable or ineligible to participate in the study, and requesting information about the 
case’s primary care physician if different from the contacted physician. If no contraindication has 
been received from the physician or if the physician has not responded within 3 weeks, the NYSCR 
will send an informational packet to the patient. The packet will contain: 1) a letter with study 
information; 2) a participant information sheet; and 3) a release of information consent form. After 
two weeks without response, a reminder packet will be sent and followed with up to five phone 
calls. If the NYSCR can’t reach the patient, the patient will be considered a refusal. The NYSCR’s 
materials and procedures will be reviewed by the New York State Department of Health IRB. For 
patients who agree to be contacted about the study, the NYSCR will securely share the patient’s 
name, contact information, and information about their diagnosis with the Roswell study team 
through a secure file transfer. We estimate that from the pool of at least 100 patients who consent 
to be contacted, we will be able to obtain informed consent from at least 80 patients (80%). 
Research staff will contact patients who have agreed to be contacted by phone, whereby they will 
provide a general study overview and conduct a screening interview to confirm eligibility. Staff 
will obtain informed consent to participate in the study by phone; the consent form along with a 
Participant Welcome Letter (Appendix O) will be mailed to participants for record. To assist with 
study retention, we will ask participants for contact information to be used in follow-up. 
Participants will also be given incentives for completing study assessments. The Roswell study 
team will share information with the NYSCR team on the patients who agree to participate in the 
study, as well as any information obtained from study participants that does not match the 
information provided from the NYSCR database (e.g., race, ethnicity). 
Roswell Park Cancer Registry. Due to low enrollment from the NYS Cancer Registry, we will 
also recruit participants from the Roswell Park Cancer Registry that meet the study’s eligibility 
criteria. To avoid overlap with NYS Cancer Registry patients, we will identify potential 
participants by focusing on patients diagnosed within last five years and exclude patients 
diagnosed within 2018-2019 (original parameters for the NYS Cancer Registry recruitment list). 
Study staff will consult with Roswell Park urologist to determine if the patient is unable or 
ineligible to participate in the study. The patients accessioned from the Roswell Park Cancer 
Registry will be contacted by letter (See Appendix T) asking them to participate in the study. Study 
staff will follow-up with potential participants to determine whether they received the letter and if 
they are interested in participating.  
Physician Recruitment. We will ask intervention participants to nominate physicians to 
participate in a short 15-minute semi-structured interview. Research staff will mail an invitation 
letter to nominated physicians that will include an information sheet (Appendix J), opt-in/opt-card 
card, and stamped reply envelope. Within 2-weeks, physicians who do not respond will be 
contacted by phone, fax, or email with no more than 5 attempts. Participating physicians will 

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receive $100. Physicians who verbally consent to participate will be asked to refer other physicians 
to the study. Community Advisory Board (CAB) members will also utilize their networks to 
nominate physicians for staff to contact. We will recruit up to 20 physicians to ensure data 
saturation61. Among clinicians involved in cancer treatment, enrollment rates between 46.3%-92% 
have been reported60, 62, 63, with one study reporting an enrollment rate of 48% among clinicians 
involved in bladder cancer treatment62. Out of the 80 participants enrolled in our intervention, we 
anticipate 40 to nominate their physicians and we expect to receive referrals for 5 additional 
physicians from enrolled physicians and 5 physicians nominated by our CAB. Given an anticipated 
enrollment rate of 48%, we anticipate recruitment of 20 physicians. 
6. MULTI-SITE RESEARCH 
Since this is NIH funded study, Single IRB will be pursued for the NYS DOH (NYS CR) and 
Roswell Park will be serving as the IRB of Record. 

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7. STUDY TIMELINES 
Figure 1 
Study Timeline 
 
Year 1 
Year 2 
Specific Aim 1: Develop a novel dietary intervention for bladder cancer survivors 
Phase 1: 
Information 
gathering 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Phase 2: 
Review 
intervention 
components  
 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Phase 3: 
Mock 
intervention 
delivery to 
CAB 
 
 
 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Phase 4: 
Refine 
intervention 
 
 
 
 
 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Train staff to 
deliver the 
intervention 
 
 
 
 
 
 
 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Specific Aim 2:  Hybrid Type I Feasibility Trial 
NYSCR and 
Roswell Park 
Cancer 
Registry 
recruitment 
(patient agree 
to contact) 
X 
X 
X 
X X 
X 
X 
X X 
X 
X 
X 
X 
X 
X 
 X   X X X X X X X X 
Participant 
recruitment  
X 
X 
X 
X 
X 
X 
X 
X 
X X 
X 
X 
X 
X 
X 
X 
X X X X X X X X 
Participant 
participation* 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X X X X X X X X X 
Data analysis 
and 
dissemination 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X X X 
Exploratory Aim:   Engage providers to ascertain implementation strategies  
Recruit 
providers 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X X X X  
 
 
 
Conduct 
semi-
structured 
interviews 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X X X X  
 
 
Data analysis 
and 
dissemination 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X X X 
*Participant study participation is only for a total of 6 months after enrollment. 

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8. STUDY ENDPOINTS 
Primary Endpoint(s) 
• Urinary ITC levels will be measured using HPLC-based cyclocondensation assay14, 51, 
which measures ITCs and metabolites as low as a few picomoles and has been routinely 
performed in Dr. Tang’s laboratory. The results will be adjusted by urinary creatinine 
level using creatinine assay kits (Caymen, Ann Arbor, MI). Cruciferae intake will be 
assessed using a questionnaire adapted from Thomson et al.52 to capture both intake 
and cooking styles.  
Secondary Endpoint(s) 
• Gene expression will be evaluated via RNA-seq as a surrogate for intermediate 
efficacy, conducted at Roswell Park’s Genomics Shared Resource using NextSeq500 
platform (Illumina Inc.). We have worked with the Genomics core to optimize the 
extraction of RNA samples from urine. With the addition of TRIzol™ right before the 
storage of the cell pellet samples, we were able to extract sufficient amounts of RNA 
and generate high quality RNA-seq data. Dietary intake will be evaluated by three non-
consecutive 24-hour dietary recalls (two weekdays, one weekday) conducted by trained 
staff using the interview-administered Nutrition Data System for Research (NDSR)53. 
• Additional urinary metabolites and potential biomarkers will be explored using 
proteomic and/or metabolomic approaches. 
Exploratory Endpoint(s) 
• Our exploratory endpoint will be identification of barriers, facilitators, and other 
process-related measures relevant to informing the implementation of an evidence-
based cruciferae intervention within clinical practice.  
9. DESIGN 
We will use a Hybrid I implementation randomized-controlled design to simultaneously gather 
outcomes regarding the intervention’s feasibility and process data to facilitate wide-spread 
implementation and dissemination of the intervention into clinical practice if the intervention is 
effective. A total of 80 patients will be recruited on a rolling basis. Forty will be randomized to 
intervention and 40 to control. 

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10. TREATMENT 
The planned evidence-based behavioral intervention using techniques associated with effective 
dietary change in older adults (Table 1): problem solving, plan social support, goal setting, follow-
up prompts, and provide feedback. The 6-month intervention will likely consist of the following, 
although aspects of the intervention may change based on data from the adaptation process: 1) 
Mailed educational materials about the importance of consuming cruciferae, how to maximize 
urinary ITC levels, serving size 
goals, the importance of self-
monitoring, and strategies to 
increase 
intake, 
along 
with 
booklets 
to 
record 
daily 
cruciferae intake; 2) One live 
phone call (~45-60 minutes) 
delivered two weeks after mailing 
materials to verify understanding 
of the educational information 
and help participants complete a 
personalized action plan where 
participants will identify barriers 
and 
facilitators 
(e.g. 
social 
support) to meet identified goals 
(problem 
solving); 
3) 
11 
Interactive 
Voice 
Response 
(IVR) phone messages that will 
begin by asking participants to 
input the servings of cruciferae 
consumed the previous week 
(follow-up prompt). Depending 
on number of servings participants input, they will be routed to one of three paths: a) meeting 
goals, b) not meeting goals but has some progress, c) no progress. Participants on each path will 
receive a tailored phone message (provision of feedback) selected from a library of messages to 
enable participants to meet or maintain their cruciferae goal. A total of 11 IVR calls will be 
delivered weekly for the first three weeks and then bi-weekly for the remainder of the 6-month 
intervention. 
11. PROCEDURES INVOLVED 
Aim 1: Develop an evidence-based behavioral intervention to increase cruciferous vegetable 
intake  
Adaptation. Working with our Community Advisor Board (CAB) consisting of a urologist, clinic 
staff, and BCS, we will refine current evidence-based vegetable interventions to develop a novel 
dietary intervention for BCS. We will use a systematic process consisting of information gathering, 
discussion groups, and mock intervention delivery. Dr. Yeary, who has extensive experience 
adapting evidence-based behavioral interventions for diverse groups, will lead the team through a 
four-stage adaptation process based on the Barrera and Castro framework42 and PEN-3 model for 
cultural adaptation43. We will: 1) identify relevant factors to increase cruciferae intake in BCS; 2) 
Table 1. Intervention Components 
Intervention 
component 
Intervention content/ 
behavior technique 
SCT Construct 
CAB adaptation 
Educational 
Materials 
• Relationships between 
cruciferae, ITC yield, 
and bladder cancer 
• Type of vegetable, 
cooking methods, and 
timing of intake for 
maximum ITC exposure 
• Program goal of 1 
serving of cruciferae per 
day/Goal setting 
• Keeping track of 
servings eaten per day 
• Knowledge 
• Outcome 
expectations 
• Behavioral skills 
• Barriers and 
opportunities 
• Intentions 
 
• Barriers and 
facilitators to 
meeting goals, 
examples from BCS 
day-to-day life, 
strategies to meet 
goals, visuals 
pleasing to BCS  
1 Live 
phone call 
• Review materials 
• Action plan to meet 
program goal/problem 
solving 
• Knowledge 
• Behavioral skills 
• Barriers and 
opportunities 
• Self-efficacy 
• Potential problems 
and subsequent 
solutions for BCS to 
meet goals 
11 
Interactive 
Voice 
Response 
(IVR) phone 
calls  
• Participants enter by 
phone servings of 
cruciferae eaten in prior 
week/follow-up prompt 
• Automated feedback 
based on the extent 
participants met program 
goal/ feedback 
• Barriers and 
opportunities 
• Reinforcement 
• Self-efficacy 
• How to structure the 
cruciferae intake 
form to make it easy 
for BCS to use 
• Construct library of 
IVR feedback 
messages relevant 
to BCS  

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use the PEN-3 model to review each of the intervention’s components (e.g. graphics, terminology, 
saliency of behavioral messages); 3) administer the revised intervention to the CAB for their 
feedback; and 4) refine the intervention based on Step 3. We will also present the program to the 
BCS group meeting at Roswell Park to ensure the intervention is salient to our target population 
by demographic characteristics. The final product will be a 6-month cruciferae intervention for 
BCS grounded in Social Cognitive Theory (SCT).  CAB members will each be compensated $100 
per meeting (up to three meetings), each meeting lasting about 1.5 hours and will be conducted via 
phone or computer. CAB members (bladder cancer survivors) may be asked to complete a 
structured interview over the phone and complete some demographic questions about themselves.  
Structured interviews will last approximately 60 minutes and CAB members will be paid $50 for 
completion of the structured interview. See Appendix K for Study Information Sheet for CAB 
members and Appendix L for CAB Interview Guide) 
Intervention Design. Drawing from the large body of literature on evidence-based behavioral fruit 
and vegetable interventions, the intervention will likely include components used by Wolf et al.44 
and Djuric et al.45 (i.e. educational materials, phone calls, written plans, self-monitoring), who 
significantly increased vegetable intake among participants whose demographic characteristics 
mirror the majority of our target population (i.e. age 65 and older, diverse, male). The following 
evidence-based behavioral techniques associated with effective dietary change in older adults46 
will also be incorporated (Table 1): problem solving, plan social support, goal setting, follow-up 
prompts, and provide feedback. The 6-month intervention will likely consist of the following, 
although aspects of the intervention may change based on data from the adaptation process: 1) 
Mailed educational materials about the importance of consuming cruciferae, how to maximize 
urinary ITC levels, serving size goals, the importance of self-monitoring, and strategies to increase 
intake, along with booklets to record daily cruciferae intake (See Appendix P); 2) One live phone 
call (~45-60 minutes) delivered two weeks after mailing materials to verify understanding of the 
educational information and help participants complete a personalized action plan where 
participants will identify barriers and facilitators (e.g. social support) to meet identified goals 
(problem solving) (See Appendix Q); 3) 11 Interactive Voice Response (IVR) phone messages 
that will begin by asking participants to input the servings of cruciferae consumed the previous 
week (follow-up prompt). Depending on number of servings participants input, they will be routed 
to one of three paths: a) meeting goals, b) not meeting goals but has some progress, c) no progress. 
Participants on each path will receive a tailored phone message (provision of feedback) selected 
from a library of messages to enable participants to meet or maintain their cruciferae goal. A total 
of 11 IVR calls will be delivered weekly for the first three weeks and then bi-weekly for the 
remainder of the 6-month intervention. The CAB will give specific feedback about visual material 
that would be the most appealing to BCS, specific barriers survivors may have to meet study goals, 
examples from survivors’ day-to-day lives to incorporate in the materials, specific phrases and 
language to clearly convey the content, strategies to consume cruciferae with minimum effort, and 
tailored wording or terms that would optimize the participants’ response to IVR feedback. We 
selected phone and mail modalities of intervention delivery because: 1) Phone-based dietary 
interventions are effective35; 2) phone-based interventions are more feasible to implement on a 
wide-scale compared to face-to-face interventions, which take more resources47; 3) IVR would be 
more cost-effective for a clinic to incorporate within its system vs. dedicating staff to provide 
frequent calls. Further, IVR is more feasible and accessible to the target population because BCS 
are typically older (average age at diagnosis is 73 years old); use of text messaging is lower among 
older groups, with less than half reporting email or text messaging for communication48.   

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Control intervention. Participants in the control arm will receive mailed materials about general 
fruit 
and 
vegetable 
intake 
intervention 
based 
on 
published 
NCI 
guidelines. 
(https://cancercontrol.cancer.gov/ocs/). The control intervention will utilize the same delivery 
method (i.e. mailed educational materials, live phone call, IVR calls) and follow the same contact 
schedule as the treatment schedule (See Appendix P and Appendix Q).  We intend to compare our 
tailored cruciferae program with general program on increase of fruit and vegetable intake. We 
anticipate minimal contamination between intervention and control because BCS will be recruited 
throughout our catchment area and our intervention will be delivered individually with each BCS.  
Personnel Training. Dr. Yeary will utilize her extensive experience in training others in the 
delivery of behavioral interventions to train project staff to implement the intervention. A training-
of-trainers model that incorporates didactic education, trainee practice, and written and verbal 
feedback will be used. Training will build knowledge about behavior change promotion, with a 
specific emphasis on delivering the live phone call with fidelity, utilizing participant booklets to 
program the IVR messages, and communicating effectively with participants about health. The 
training will conclude with project staff demonstrating mastery of concepts through mock phone 
sessions and live phone calls, and accurate programming based on booklet data received. Project 
staff will be asked to complete a checklist of topics to monitor intervention fidelity.  
Aim 2: Conduct a feasibility pilot of our evidence-based dietary behavioral intervention  
Study Design. We will use a Hybrid I implementation randomized-controlled design to 
simultaneously gather outcomes regarding the intervention’s feasibility and process data to 
facilitate wide-spread implementation and dissemination of the intervention into clinical practice 
if the intervention is effective. A total of 80 patients will be recruited on a rolling basis. Forty will 
be randomized to intervention and 40 to control.  
Participant Recruitment. Eligibility criteria include: 1) English speaking; 2) diagnosed with 
stage Tis, Ta, or T1 bladder cancer; 3) resides in the Western New York (WNY) catchment area 
(Niagara, Orleans, Genesee, Erie, Wyoming, Chautauqua, Cattaraugus, and Allegany counties); 4) 
did not receive a partial or radical cystectomy; 5) does not have a prior cancer diagnosis within 12 
months of their bladder cancer diagnosis 6) does not have a subsequent more advanced bladder 
cancer diagnosis; and 7) (for Roswell Park Cancer Registry only) diagnosed 2016-2018, 2019-
current.  We chose not to include current cruciferae intake as an eligible criterion because prior 
studies have reported that BCS consumed an average of 0.44-0.45 servings per day12, 26, less than 
half our recommended amount. Using ICD-O-3 codes provided, Dr. Kuliszewski of the NYSCR 
will lead her staff to identify qualifying patients from their database based on the study’s eligibility 
requirements. The NYSCR has identified 199 cases that meet the study’s eligibility criteria in 2018 
and anticipate at least 400 eligible cases in total in 2018 and 2019. A total of 250 eligible patients 
will be contacted to enable researchers to recruit from a pool of at least 100 patients. In prior 
studies, 52.4% to 62.5% of patients contacted by the NYSCR agreed to be contacted by researchers 
for study consent. The NYSCR will send a letter to the physician of record for selected cases 
notifying that the patient was identified for the study, requesting that the NYSCR be notified if the 
patient is unable or ineligible to participate in the study, and requesting information about the 
case’s primary care physician if different from the contacted physician. If no contraindication has 
been received from the physician or if the physician has not responded within 3 weeks, the NYSCR 
will send an informational packet to the patient. The packet will contain: 1) a letter with study 
information; 2) a participant information sheet; and 3) a release of information consent form. After 
two weeks without response, a reminder packet will be sent and followed with up to five phone 

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calls. If the NYSCR can’t reach the patient, the patient will be considered a refusal.  The NYSCR’s 
materials and procedures will be reviewed by the New York State Department of Health IRB. For 
patients who agree to be contacted about the study, the NYSCR will securely share the patient’s 
name, contact information, and information about their diagnosis with the Roswell study team. For 
the Roswell Park Cancer Registry, study staff will consult with Roswell Park urologist to 
determine if the patient is unable or ineligible to participate in the study. The patients accessioned 
from the Roswell Park Cancer Registry will be contacted by letter (See Appendix T) asking them 
to participate in the study. Study staff will follow-up with potential participants to determine 
whether they received the letter and if they are interested in participating. We estimate that from 
the pool of at least 100 patients who consent to be contacted, we will be able to obtain informed 
consent from at least 80 patients (80%). The Roswell study team will share information with the 
NYSCR team on the patients who agree to participate in the study, as well as any information 
obtained from study participants that does not match the information provided from the NYSCR 
database (e.g., race, ethnicity). 
Participant Data and Sample Collection Procedures.  Research staff will contact patients who 
have agreed to be contacted by phone, whereby they will provide a general study overview and 
conduct a screening interview to confirm eligibility. The consent form will be mailed out to 
patients prior to the consenting discussion. We will ask the patient to mail back the consent form 
with the appropriate signatures. We will also provide an additional copy of the consent form for 
their records. We will include a paid postage pre-addressed envelope for the patient to mail back 
the signed consent form to study staff. Baseline Data Collection will be conducted within four 
weeks prior to intervention start. The Data Collector, masked to treatment assignment, will conduct 
telephone surveys with participants and directly enter participants’ responses into pre-programmed 
data collection forms in REDCap49, 50. Surveys will cover sociodemographic variables, faith and 
spirituality beliefs, dietary, and cruciferae intake (Appendix F). Additionally, 24-hour dietary 
recalls will be conducted and instructions (Appendix M) and a reference guide (Appendix N) will 
be mailed out to participants prior to their scheduled recall interview.  Participants will also be 
mailed out track books to help keep track of their fruit and/or vegetable intake during the 
intervention (Appendix R).  Follow-up Assessment (Appendix G1) will be conducted at 6 months 
following the same protocol as the baseline assessment (Appendix F). Participants will receive 
$100 for completing the baseline and 6-month follow-up assessments. In addition, we will ask 
participants’ feedback on the intervention (Appendix G2) as part of the Follow-Up Assessment 
(Appendix G1). The feedback questions (Appendix G2) will be given to those in the cruciferous 
arm only. For cruciferous arm study participants that have completed the 6-month follow-up 
assessment as of the March 21, 2022 Protocol revision, the study participants will be called back 
to complete the feedback questions (Appendix G2).  These study participants will first be sent an 
information sheet (Appendix W) regarding the additional feedback questions before being called. 
When they are called regarding the study feedback questions, they will provide verbal consent 
before proceeding with answering the feedback questions. 
Urine Sample Collection will be conducted at baseline and 6-months. Participants will be 
instructed to collect first-void urine continuously for three days, which will provide a more reliable 
measurement than one-spot urine samples. A specially designed urine collection device consisting 
of a 10-mL container and sponge with a plastic holder will be used, which does not impact urinary 
ITC measurement and has been used in the Be-Well study with documented ease of collection and 
minimal shipment burden. Staff will mail urine collection kits and instructions (Appendix C) to 
participants. Given that recent behaviors may have a large impact on urinary ITC levels, 

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participants will be asked to complete a brief 2-page specimen collection survey (Appendix D) on 
medical and lifestyle status in the past two days. They will then return the survey and urine samples 
to Roswell Park in the provided shipping box with biohazard labels and ice packs via pre-paid 
overnight shipping service. Once received, the urine will be spun down from the sponge, aliquoted, 
and stored at -80⁰C at Dr. Li Tang’s lab (x8247) at Roswell Park. The urine aliquots will be assayed 
at Dr. Tang’s Lab for ITC analysis using HPLC-based cyclocondensation assay.64 This method is 
able to accurately measure as low as a few picomoles of ITCs and their metabolites. Dr. Tang’s 
lab has experience and expertise in running this assay 65 and will process the urine samples and 
perform the measurements. The results will be adjusted by urinary creatinine level, which will also 
be performed in the laboratory, using a commercially available creatinine assay kit (Caymen, Ann 
Arbor, MI). The cell pellets from three urine samples per participant will be combined and 
delivered to Genomics Shared Resources at Roswell Park for RNA-seq analysis in a batch. 
Additional urinary metabolites and potential biomarkers will be explored using proteomic and/or 
metabolomic approaches. All assays will be conducted on the stored urine samples. Neither new 
urine sample collection nor patient contact will occur. 
Exploratory Aim: Engage providers to ascertain specific clinic-level implementation factors 
We will ask intervention participants to nominate physicians to participate in a short 15-minute 
semi-structured interview. Research staff will mail an invitation letter to nominated physicians that 
will include an information sheet (Appendix J), opt-in/opt-card card, and stamped reply envelope. 
Within 2-weeks, physicians who do not respond will be contacted by phone, fax, or email with no 
more than 5 attempts. Participating physicians will receive $100. Physicians who verbally consent 
to participate will be asked to refer other physicians to the study. CAB members will also utilize 
their networks to nominate physicians for staff to contact. 
We will conduct brief 15-minute semi-structured interviews using an interview guide. The guide 
will give physicians a brief overview of our cruciferae intervention. Research staff will then ask 
questions regarding facilitators and barriers of intervention adoption within clinical practice37. 
Staff will ask physicians the needed implementation strategies to sustain the intervention post 
research funding, in addition to intervention modifications to maximize sustained clinic adoption37. 
12. WITHDRAWAL OF SUBJECTS 
Participants can stop their participation at any time.  Participants may refuse to answer any question 
and they may leave the study at any time. 
13. RISKS TO SUBJECTS 
For the survey portion of the study, involvement in this study does not involve any physical risk. 
The possible risks might be feeling uncomfortable answering questions. 
There are no known risks associated with providing a urine sample other than a potential loss of 
confidentiality. 
14. POTENTIAL BENEFITS TO SUBJECTS 
Participants in the intervention and feasibility scale-up pilot may benefit from study participation 
by improving dietary habits and/or reducing bladder cancer recurrence. The information gained 
may also help other bladder cancer patients in the future. Participants will receive $100 for 
completing each assessment—the study will ask participants to complete baseline (see Appendix 

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F) and 6-month follow-up assessments (See Appendix G1). Thus, participants will be able to 
receive up to $200 total in assessments. Participating physicians will receive $100 for the 
interview. 
15. DATA AND SPECIMEN BANKING 
All questionnaire data will be stored in REDCap or in a locked file cabinet. REDCap is a secure 
application supported by Partners Research Computing, Enterprise Research Infrastructure & 
Services (ERIS). ERIS has all the necessary physical and operational securities in place to meet or 
exceed Federal and State security and privacy regulations for data transmission and storage using 
REDCap. Data will only be removed when coded, entered, or audited. The urine samples will be 
processed and stored at Dr. Tang’s laboratory and a dataset will be created to track and record the 
results obtained from laboratory assays on urine samples. The dataset will only contain study IDs 
without any personal identifiable information. The file that contains the link between study ID and 
subject identifiable information will be maintained separately and can only be accessed by Drs. 
Yeary and Tang and will never be released to any laboratory staff. 
16. MEASUREMENT OF EFFECT 
Solid Tumors 
N/A 
Hematologic Tumors 
N/A 
Other Response Parameters 
We will assess the treatment intervention’s effect on the consumption of cruciferae vegetables and 
ITC yield, as specified under the heading, “STUDY ENDPOINTS”. We will also assess changes 
in gene expression via RNA-Seq, so as to identify a panel of genes that respond specifically to 
consumption of cruciferae vegetables as specified in the section of STUDY ENDPOINTS. It is 
well known that isothiocyanates in cruciferae vegetables alter multiple signaling pathways. 
Therefore, the identified panel of genes can be used as biological biomarkers to understand how 
individuals respond to the consumption of cruciferae vegetables, and more importantly, be used as 
biomarkers to monitor the effect of cruciferae vegetables.    
17. SAFETY EVALUATION 
Reporting Unanticipated Problems. 
Unanticipated problem reporting will begin at the time of participant consent. The Reportable New 
Information (RNI) Form will be submitted to the Roswell Park Clinical Research Service (CRS) 
Quality Assurance (QA) Office within 1 business day of becoming aware of the Unanticipated 
Problem. After review, CRS QA Office will submit the RNI to the IRB. 
When becoming aware of new information about an Unanticipated Problem, the updated 
information will be submitted to the CRS QA Office with an updated RNI Form. The site 
Investigator or designated research personnel will report all unanticipated problems to the IRB in 
accordance with their local institutional guidelines. 

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18. DATA MANAGEMENT AND CONFIDENTIALITY 
Individual confidentiality concerning study data and measurements will be ensured through the 
following ways: Participant data will not be identified by name (using only an identification 
number for identification), all data and records in locked storage areas accessible only to project 
staff, and password protected computer data files. Participants will not be personally identified in 
any scientific reports generated by the study. All results will be presented in aggregate form. All 
project staff will undergo training and ongoing continuing education about methods to protect 
confidentiality. All project staff will complete Human Subject Training Requirements. 
We have contracted with an outside company Above Ground Development (AGD) to conduct the 
11 Interactive Voice Response (IVR) phone messages that participants receive as part of the 
intervention.  The study staff will share the following information with AGD that includes 
participant’s name, date of birth and contact phone number. This PHI information will be entered 
into the secure web portal (user interface) and ALL data will be stored with AGD on a secure 
HIPAA Compliant server. 
Safety of subjects. Data safety and monitoring will be overseen by Drs. Yeary and Tang. The 
proposed study is considered extremely low risk. Adverse events will be monitored routinely 
during questionnaire and data collection and participants will be instructed to contact study 
personnel for any issues. Monthly meetings with Dr. Yeary, Dr. Tang, and the Project Coordinator 
(Ms. Harfouche) will also be held to evaluate the status of study subjects. Dr. Qiang Li, a Board 
Certified Bladder Cancer Surgeon, will provide guidance and supervision regarding all the 
reported side effects or potential symptoms possibly related to study participation. Adverse events 
will be labeled as to whether attributed to behavior intervention or not, classified as mild, moderate, 
severe, life threatening, or causing death, and reported to Roswell Park IRB and NIH under 
Institute guidelines. We will track reporting of adverse events in the REDCap study database. All 
clinical trials at Roswell undergo yearly review by an independent Data Safety Monitoring Board.  
Collection of Data and Biospecimens. Project staff will collect questionnaire data from research 
subjects by telephone interview, as dictated by study protocol. Questionnaire data will be directly 
entered into REDCap, a secure web application for building and managing online surveys and 
databases. Only study identification number (Study ID) will be entered when the data are collected. 
All data collected by research assistants are considered part of the subject’s confidential record. 
REDCap is a secure application supported by Partners Research Computing, Enterprise Research 
Infrastructure & Services (ERIS). ERIS has all the necessary physical and operational securities 
in place to meet or exceed Federal and State security and privacy regulations for data transmission 
and storage using REDCap. All data will remain confidential. A file will be separately maintained 
that associates the subject name with that subject’s study ID. This file will remain in a locked file 
cabinet and will not be stored with the actual study data. The urine samples will be collected by 
the participants at home and directly shipped to Roswell Park using prepaid and addressed shipping 
labels. All urine samples will be labeled with assigned study IDs only and no personal information 
will be provided.  
Storage of Collected Data and Biospecimens.  
N/A 
Data Entry Requirement. All data will be coded prior to entry. Any ambiguity in the response to 
a question will be brought to the attention of Ms. Harfouche for clarification. If Ms. Harfouche is 

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unsure how to code the response, the matter will be brought to the attention of Drs. Yeary, Tang, 
and consulted with the statistician (Dr. Yu). Ms. Harfouche will maintain a log, so that future 
occurrences of problems will be handled in the same manner.  
The data entry system will require a login identification and password in order to gain access to 
the data. Where appropriate, validation and range rules will be applied to the actual entry fields. 
Only Dr. Yeary, Dr. Tang, Dr. Yu, and data entry personnel will be able to view the data in its raw 
state. All other authorized personnel will view data via forms and reports in aggregate form created 
by Dr. Yeary, Dr. Tang, and Dr. Yu.  
Access to Cleaned Computer Data. Only Drs. Yeary, Tang, and Yu can give permission for the 
release of aggregated study data. No confidential information will be released without permission.  
19. STATISTICAL PLAN 
Patient. We will use SAS for data analysis and R for RNA-seq data. We will generate descriptive 
statistics and assess group differences at baseline and examine treatment drop-out and missing data 
patterns’ impact on treatment effects. We will calculate summary statistics and compare study 
endpoints and patient baseline characteristics by treatment group using independent sample t-tests 
and Fisher’s exact tests. We will summarize changes between pre- and post-intervention for both 
arms and calculate point estimates and their corresponding 95% confidence intervals. We will 
analyze between-group differences in the change of outcome variables between baseline and post-
intervention using analysis of covariance (ANCOVA). The intervention group will be used as 
factors and the baseline variables used as covariates. Within-group difference between two time-
points will be compared by paired sample t-tests, while between-group differences at each time-
point will be compared by independent sample t-tests or Wilcoxon rank sum tests. RNA-seq data 
will be processed and quality-checked by the Bioinformatics Shared Resource at Roswell Park; 
sample relationships will be explored using sample clustering and principle component analysis. 
We will use DESeq258 to identify significantly differentially expressed (SDE) genes and conduct 
pathway analysis with GSEA59 using rank-based gene list from SDE analysis. All tests will be 
two-sided at the significance level of 0.05. We will use the Benjamini-Hochberg’s method to 
calculate the false discovery rate for gene expression. 
Physician. Interviews will be audio-recorded, transcribed verbatim, checked for accuracy and 
entered into a software program for the management of text data (e.g. NVivo 12). We will code 
transcripts using content analysis. Coding decisions and emergent findings will be discussed until 
an agreement is reached57. 
Sample Size Determination 
Patient: With n=40 for each group, the ANCOVA can achieve 80% power to detect a difference 
of 0.57 within-group standard deviations (SDs) between groups assuming the correlation of post-
intervention and baseline outcome is R2=0.2. Data from the Be-Well study reports a within-group 
SD of 8.9 μM for urinary ITCs and 62 g/day for cruciferae intake; thus, we can detect a difference 
equivalent to 5.1 μM in urinary ITC and 35.3 g/day of cruciferae intake between groups. The 
intervention’s goal is to increase urinary ITC levels from the baseline of 4.4 μM to the desirable 
biological dose of 10 μM and cruciferae intake from the baseline of 52.7 gram (0.7 serving) to at 
least 75 gram (a typical serving size) at 6-month follow up. Given the generally lower cruciferae 
intake observed in other BCS studies (around 0.44-0.45 serving, equivalent to 33-34 gram per 
day)11, 26, the proposed study will have sufficient power to detect our projected differences. 

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Physician: We will recruit up to 20 physicians to ensure data saturation61. Among clinicians 
involved in cancer treatment, enrollment rates between 46.3%-92% have been reported60, 62, 63, 
with one study reporting an enrollment rate of 48% among clinicians involved in bladder cancer 
treatment62. Out of the 80 participants enrolled in our intervention, we anticipate 40 to nominate 
their physicians and expect to receive referrals for 5 additional physicians from enrolled physicians 
and 5 physicians nominated by our CAB. Given an anticipated enrollment rate of 48%, we 
anticipate recruitment of 20 physicians.  
Randomization  
Subjects will be randomized in a 1:1 fashion to the control arm and interventional arm using 
permutated block randomization. We will employ random block sizes of 4 and 2. Randomization 
will be carried out by the Department of Biostatistics and Bioinformatics. 
Demographics and Baseline Characteristics. 
 Descriptive statistics (as appropriate: n, percent, mean, median, min and max) will be used to 
summarize demographic and baseline characteristics. The patient characteristics will also be 
summarized by treatment group. The baseline characteristics between groups will be compared by 
independent sample t-tests and Fisher’s exact tests as appropriate. 
Primary Analysis.  
For primary analysis, the aim is to investigate the between-group differences in the change of 
urinary ITC levels and cruciferae intake between baseline and post-intervention. The comparison 
of change from baseline will be made utilizing analysis of covariance (ANCOVA) and F-tests 
(α=0.05). The intervention group will be used as factors and the baseline variables used as 
covariates. A coefficient for interventional group that is significantly greater than 0 will indicate 
that the intervention increases the ITC levels or cruciferae intake. Within-group difference between 
two time-points will be compared by two-sided paired sample t-tests, while between-group 
difference at each time-point will be compared by two-sided independent sample t-tests (α=0.05). 
Since this is a pilot feasibility study, no adjustment for multiple comparisons will be planned.  
Secondary Analyses.  
The aim of secondary analysis is to investigate the difference in gene expression patterns between 
two groups. Three urine samples per participant will be collected at baseline and month 6, and the 
cell pellets from three urine samples per participants will be combined and subject to RNA-seq. 
RNA-seq data will be processed and quality-checked by Bioinformatics Shared Resource at 
Roswell Park; sample relationships will be explored using sample clustering and principle 
component analysis. We will use DESeq to identify significantly differentially expressed (SDE) 
genes and conduct pathway analysis with GSEA using rank-based gene list from SDE analysis. 
All tests will be two-sided at significance level of 0.05. We will use the Benjamini-Hochberg’s 
method to calculate the false discovery rate (FDR) for gene expression. 
The additional metabolites and biomarkers will be analyzed using the same approach as in primary 
analysis. The univariate distributions of these variables will be examined, and appropriate 
transformations may be applied before analysis. Benjamini-Hochberg’s method to control the 
FDR. 

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Exploratory Analysis.  
Qualitative methodology using content analysis will be used to ascertain physician barriers and 
facilitators to the intervention’s implementation within clinic settings.  
Safety Analysis 
N/A 
Interim Analysis 
None 
20. PROVISIONS TO MONITOR THE DATA TO ENSURE THE SAFETY OF 
SUBJECTS 
N/A 
21. VULNERABLE POPULATIONS 
N/A 
22. COMMUNITY-BASED PARTICIPATORY RESEARCH 
The study does not use a “pure” community-based participatory research approach but does 
include community engagement, which will include engagement of a Community Advisory Board 
to develop the cruciferae intervention. 
23. SHARING OF RESULTS WITH SUBJECTS 
Aggregate study results will be disseminated to the project’s Community Advisory Board, the 
Bladder Cancer Survivorship Group at Roswell Park Comprehensive Cancer Center, the New York 
State Department of Health Cancer Registry, and to participating patients and health care providers 
who consented to be part of the research, written informed consent for participating patients and 
verbal consent for participating health care providers. Study participants will be mailed aggregate 
study results with no personal identifiers. Study results will also be disseminated to academic and 
practice audiences through scientific papers and conferences. 
24. SETTING 
Participant Recruitment. NYSCR will send a letter to the physician of record for selected cases 
notifying him/her that the patient was identified for the study, requesting that NYSCR be notified 
if the patient is unable or ineligible to participate in the study, and requesting information about 
the case’s primary care physician if different from the contacted physician. If no contraindication 
has been received from the physician or if the physician has not responded within 3 weeks, the 
NYSCR will send an informational packet to the patient. The packet will contain: 1) a letter with 
study information; 2) a participant information sheet; and 3) a release of information consent form. 
After two weeks without response, a reminder packet will be sent and followed with up to five 
phone calls. If NYSCR can’t reach the patient, the patient will be considered a refusal. The 
NYSCR’s materials and procedures will be reviewed by the New York State Department of Health 
IRB. For patients who agree to be contacted about the study, the NYSCR will securely share the 
patient’s name, contact information, and information about their diagnosis with the Roswell study 
team.  For the Roswell Park Cancer Registry: study staff will consult with Roswell Park urologist 

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to determine if the patient is unable or ineligible to participate in the study. The patients 
accessioned from the Roswell Park Cancer Registry will be contacted by letter (See Appendix T) 
asking them to participate in the study. Study staff will follow-up with potential participants to 
determine whether they received the letter and if they are interested in participating. We estimate 
that from the pool of at least 100 patients who consent to be contacted, we will be able to obtain 
informed consent from at least 80 patients (80%). Research staff will contact patients who have 
agreed to be contacted by phone, whereby they will provide a general study overview and conduct 
a screening interview to confirm eligibility. The consent form will be mailed out to patients prior 
to the consenting discussion. We will ask the patient to mail back the consent form with the 
appropriate signatures. We will also provide an additional copy of the consent form for their 
records. We will include a paid postage pre-addressed envelope for the patient to mail back the 
signed consent form to study staff. To assist with study retention, we will ask participants for 
contact information to be used in follow-up. The Roswell study team will share information with 
the NYSCR team on the patients who agree to participate in the study, as well as any information 
obtained from study participants that does not match the information provided from the NYSCR 
database (e.g., race, ethnicity). 
The process for contacting the patient, including the number of contact attempts, the letter text 
and/or phone script, the consent form, the data to be collected, and information on any incentives 
for participation will be reviewed by the NYSCR, New York State Department of Health 
(NYSDOH), and the NYSDOH IRB prior to the initiation of any patient/proxy contact. In addition, 
the research team will follow all NYSDOH procedures in conducting their study, including the 
following procedures: 
1. All written materials must include contact information for people who can answer 
questions about the research and participant rights. 
2. Patient consent to participate must be obtained. 
3. If a patient asks to be removed from current or future research studies, this information 
must be sent within two weeks to the NYSCR, so that the patient’s record can be flagged and 
the patient added to a “Do Not Contact” list. 
4. Researchers must immediately report any complaints about the study or the release of 
patient information to the Director of the NYSCR and to the Administrator of the NYSDOH 
IRB. 
If changes are made to any recruitment materials or processes after NYSDOH departmental and 
IRB approval, an IRB amendment must be submitted and approved before the changed materials 
may be used. 
Before receiving case-level Registry data, the Principal Investigator for a research study will be 
required to read and sign a Research Data Use Agreement. This contract describes limitations on 
the use of the data, as well as restrictions on the dissemination of findings, use of personal 
identifiers, and contact with patients identified through data provided by the NYSCR. All staff 
working with confidential data, or with possible access to confidential information from the data, 
are required to have current IRB training certification and to sign a Confidentiality Pledge. The 
Research Data Use Agreement and Confidentiality Pledge documents can be obtaining by emailing 
the NYSCR at nyscr@health.ny.gov.  

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Researchers must agree to maintain the confidentiality of identifiable data received from the 
NYSCR. Identifiable data include any information that would permit, directly or indirectly, the 
identification of any individual. When applying to use the data, researchers should indicate how 
the data will be stored as well as how and when they will dispose of the data after the study is 
completed. In addition, researchers must attest that: 1) no data will be published or released in any 
form where a particular individual or establishment is directly or indirectly identifiable; 2) 
identifiable data obtained from the NYSCR will be used only for the proposed study; 3) identifiable 
information obtained from the NYSCR will not be released to anyone or any institution without 
prior written approval by the NYSDOH; and 4) any publication or report produced using the data 
will acknowledge the source of the data. In the event of a breach of confidentiality, researchers 
must notify the Director of the NYSCR as soon as possible but no later than two business days 
after learning of the breach. 
Physician Recruitment. Research staff will mail an invitation letter to nominated physicians that 
will include an information sheet (Appendix J), opt-in/opt-card card, and stamped reply envelope. 
Within 2-weeks, physicians who do not respond will be contacted by phone, fax, or email with no 
more than 5 attempts. Participating physicians will receive $100. Physicians who verbally consent 
to participate will be asked to refer other physicians to the study. CAB members will also utilize 
their networks to nominate physicians for staff to contact. 
25. PROVISIONS TO PROTECT THE PRIVACY INTERESTS OF SUBJECTS 
Only de-identified data will be accessed and recorded.  Data files will be coded numerically and 
assigned to each participant.  Information gathered from participants will remain anonymous and 
will be referred to only by general category.  There will be no reference by name to any participant 
in any qualitative or quantitative data capture.  No patient identity will be disclosed in the event of 
publication or sharing of data.    
For physicians, the study will not collect any identifiers from the physician. The data collected 
from physician participation would be qualitative only.  Therefore, for the physicians only, we are 
requesting a waiver of HIPPA Authorization. 
The data collected from this study will be organized by a unique identification number assigned to 
the participant so that their identity will be available only to project staff and will remain 
completely confidential. The data manager, study staff, Co-Is and PI of the study will have access 
to the data records.   
All study records will be kept electronically in Roswell Park maintained and secured equipment.  
The electronic data records will be saved and secured on the Roswell Park shared server. Survey 
data will be filed in a locked cabinet located in 311 Carlton House and will not be taken off Roswell 
Park premises. The data will be kept in a locked room where it will remain for approximately five 
years following the completion of the project. 
26. RESOURCES AVAILABLE 
The project will be co-led by Drs. Yeary and Tang, who will serve as multiple PIs on the project. 
Drs. Yeary and Tang will make joint decisions regarding the project. They will collaborate with 
the New York State Department of Health Cancer Registry and the Community Advisory Board 
in making collaborative decisions regarding the project. Communication between the PIs will be 
done in person, through video conferencing (e.g. Zoom, Webex), phone, and email. 

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The project will be coordinated by the Ms. Harfouche (Roswell Park) and all project data will be 
collected by the data collector (Ms. Dauphin). All data will be entered and managed by the database 
manager (Ms. Harfouche). All quantitative data analyses will be done by Dr. Yu. 
Drs. Yeary and Tang will lead the completion of the study’s aims, with Dr. Yeary focused on the 
intervention aspects of the study, and Dr. Tang focused on the biological aspects of the study. Dr. 
Yeary and Dr. Tang will oversee collaboration with the Community Advisory Board (including 
Dr. Qiang Li) in developing the intervention. Dr. Yeary will oversee the intervention’s 
implementation and evaluation. Dr. Yeary will oversee Ms. Harfouche, who will oversee the 
recruiter (Ms. Dauphin), data collector (Ms. Dauphin), and interventionist (Ms. Clark). Dr. Yeary 
will train the interventionist to deliver the intervention. Both Drs. Yeary and Tang will work 
closely with the New York State Department of Health Cancer Registry during the initial stage of 
recruitment. Dr. Tang will oversee the laboratory work and ensure that the biological specimens 
are adequately collected, processed, and analyzed. Non-dietary data analysis will be led by Dr. 
Yeary and Tang, in close collaboration with Dr. Yu. Dietary data analysis will be led by Dr. 
McCann. Specific Aim 3 will be led by Drs. Yeary and Tang, who will oversee staff to recruit 
providers and complete provider telephone interviews.  
The NYSCR employs a staff of over 50 to collect, process, and analyze reports on about 110,000 
diagnosed cases of cancer among New Yorkers each year. The staff includes a 10-member research 
unit, five of whom hold a doctoral degree. Areas of expertise within this unit include cancer 
epidemiology, biostatistics, geographic analysis, and information science. The NYSCR has a 
strong national reputation and provides data to many national and international cancer studies. 
The PIs will work with the New York State Department of Health Cancer Registry and the 
Community Advisory Board to disseminate project results and decide next steps.  
27. PRIOR APPROVALS 
The NYSCR study team will obtain approval of study materials by the NYSDOH Bureau, 
Division, Center, and the NYSDOH IRB. 
28. COMPENSATION FOR RESEARCH-RELATED INJURY 
If the subject believes they have been injured as a direct result of their participation in this research 
study, they will be advised to notify the Roswell Park Patient Advocate at (716) 845-1365 or the 
Dr. Karen Yeary at (716) 845-6231 or Dr. Li Tang at (716) 845-8247. 
Medical diagnosis and treatment for the injury will be offered, and a determination will be made 
regarding appropriate billing for the diagnosis and treatment of the injury. A financial counselor 
(716-845-3161) will be able to provide an explanation of coverage and to answer questions the 
subject may have regarding study related billing. 
The subject is not prevented from seeking to collect compensation for injury related to malpractice, 
fault, or blame on the part of those involved in the research. 
29. ECONOMIC BURDEN TO SUBJECTS 
There are no costs associated with participation in the surveys and/or urine collection. 

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30. CONSENT PROCESS 
Prior to administration of any assessment, participants are informed of the purpose of the study 
and told that their participation is voluntary. Participants are also informed that their responses to 
questions will be kept confidential. If the patient consents verbally, NYSCR or Roswell Park 
Cancer Registry staff will fill out the consent to be contacted form and document that consent to 
be contacted was obtained via phone (Appendix H). If the Registry is unable to contact the patient 
via telephone, and no written response has been received, no other contact will be attempted, and 
the patient will be considered a refusal. At the end of the two registries work, we estimate that 
there will be a pool of at least 100 patients that have consented to be contacted by research staff 
based on response rates from previous studies participated in by the NYSCR. Research staff will 
then contact patients who have agreed to be contacted by phone, whereby they will provide a 
general study overview and conduct a screening interview to confirm eligibility. 
We are requesting a waiver of written consent documentation at the time of initial call, and prior 
to receipt of the signed written consent, for purposes of starting the baseline survey (Appendix F). 
The consent script will be a review of the consent document that is being obtained. The consent 
form will then be mailed out to patients. We will ask the patient to mail back the consent form 
with the appropriate signatures. We will also provide an additional copy of the consent form for 
their records. We will include a paid postage pre-addressed envelope for the patient to mail back 
the signed consent form to study staff.  The consent form will indicate that a participant retains the 
right to withdraw at any time and that their health care will not be affected by their decision to 
participate or refuse to participate in the study. All investigators and project staff will satisfy the 
required IRB training and certification requirements. The IRB training will be completed during 
the early months of the project. For recruitment of health care providers, we will ask intervention 
participants to nominate physicians to participate in short 15-minute semi-structured interviews. 
Intervention participants will provide informed consent before providing their health care 
providers’ contact information. 
For cruciferous arm study participants that have completed the 6-month follow-up assessment as 
of the March 21, 2022 Protocol revision, the study participants will be called back to complete the 
feedback questions (Appendix G2).  Therefore, these study participants will first be sent an 
information sheet (Appendix W) regarding the additional feedback questions before being called. 
When they are called regarding the study feedback questions, they will provide verbal consent 
before proceeding with answering the feedback questions. 
Our Community Advisory Board members will also utilize their networks to nominate physicians 
for the research team to contact. Research staff will mail an invitation letter to nominated 
physicians that will include an information sheet (Appendix K), opt-in/opt-out card (Appendix 
U), and stamped reply envelop. Within 2-weeks, physicians who do not respond will be contacted 
by phone, fax, or email with at most five attempts. Follow-up contact will use the same invitation 
letter originally sent out or a phone script mirroring the information sheet (Appendix J). Physicians 
who decide to participate in the study will provide verbal consent. Physicians who verbally consent 
to participate will also be asked to refer other physicians to the study. We will recruit up to 20 
physicians to ensure data saturation. 
The key elements of the informed consent procedure which will be explained to the participants 
are: 1) the research status of the study- particularly the assessment; 2) the prospect of psychological 
risk and the provisions for it; 3) the lack of guarantee of benefit from participation in the 

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assessment, 4) the confidentiality of subjects responses to all study measures; 5) the voluntary 
nature of the study; 6) the receipt of the money for participating in the assessment, and 7) the 
freedom to withdraw from the study or to refuse to answer specific questions at any time.  
Before the survey is conducted, research study staff members will explain: 1) the nature and 
purpose of the research endeavor, 2) that participation in the research component is completely 
voluntary, and 3) that data collected from participants will be confidential and assessed, evaluated 
and reported as aggregate data, as well as precautions taken in the storage of the data. 
The Roswell Park Standard Operating Procedures (SOP): Informed Consent Process for Research 
(HRP-090) will be followed. 
31. PROCESS TO DOCUMENT CONSENT IN WRITING 
The Roswell Park “SOP: Written Documentation of Consent (HRP-091)” will be followed: 
The Investigator (or IRB specified designee) is responsible for obtaining written consent from each 
patient participant in accordance with GCP guidelines using the approved informed consent form, 
before any study specific procedures (including screening procedures) are performed. The 
informed consent form acknowledges all information that must be given to the participant 
according to applicable GCP guidelines, including the purpose and nature of the study, the 
expected efficacy and possible side effects of the treatment(s), and specifying that refusal to 
participate will not influence further options for therapy. Any additional information that is 
applicable to the study must also be included. Additional national or institutionally mandated 
requirements for informed consent must also be adhered to. The participant should also be made 
aware that by signing the consent form, processing of sensitive clinical trial data and transfer to 
other countries for further processing is allowed. For physician participants, we are requesting a 
waiver of written consent. We would not collect any identifiers from the physician. The data from 
physicians would be qualitative only.  Physicians will provide verbal consent. 
The Investigator or designee shall provide a copy of the signed consent form to the participant and 
the signed original shall be maintained in the Investigator File. A copy of the signed consent form 
must be filed in the participant file. At any stage, the participant may withdraw from the study and 
such a decision will not affect any further treatment options. 
32. DRUGS OR DEVICES 
N/A

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34. APPENDICES/ SUPPLEMENTS 
 
Appendix A 
Investigator Study Eligibility Verification Form Inclusion Criteria 
Appendix B 
Investigator Study Eligibility Verification Form Exclusion Criteria 
Appendix C 
Participant Urine Collection Instructions  
Appendix D 
Participant Urine Questionnaire 
Appendix E 
Participant Interview Phone Script  
Appendix F 
Participant Baseline Bladder Questionnaire  
Appendix G 
Participant Follow-up 
Appendix H 
New York State Cancer Registry Contact Materials and Procedures 
Appendix I 
Physician Interview Guide 
Appendix J 
Physician Research Study Information Sheet for Structured Interviews 
Appendix K 
Community Advisory Board (CAB) Research Study Information Sheet 
Appendix L  Community Advisory Board (CAB) Interview Guide 
Appendix M Participant 24-hour Dietary Recall Instructions 
Appendix N 
Participant Food Amounts Booklet (FAB) 
Appendix O 
Participant Welcome Letter 
Appendix P 
Participant Health Magazines (Intervention and Control) 
Appendix Q 
Live Call Scripts (Intervention and Control) 
Appendix R 
Participant Track Books 
Appendix S 
Participant Thank You Letter 
Appendix T 
Recruitment Letter for Roswell Park Cancer Registry 
Appendix U. Invitation Letter for Physician Interview and Opt-In/Out Card 
Appendix V 
POW-R Sympathy Card 
Appendix W Participant Information Sheet for Cruciferous Arm Feedback Questions (For 
Participants that Completed the 6-Month Follow-up Assessment) 
 
 
 
 

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Appendix A INVESTIGATOR STUDY ELIGIBILITY VERIFICATION FORM 
INCLUSION CRITERIA 
Participant Name: ___________________________ 
Medical Record No: _____________________________ 
Title: POW-R Health: Power to Redefine your Health (Internal Title: A Pragmatic Dietary 
Intervention to Improve Bladder Cancer Survivorship) 
INCLUSION CRITERIA 
Yes 
No 
N/A 
All answers must be “Yes” or “N/A” for participant enrollment. 
Date 
 
 
 
1. Age 18 years old or older (no upper limit) 
 
 
 
 
2. English speaking 
 
 
 
 
3. Diagnosed with stage Tis, Ta, or T1 bladder cancer. 
 
 
 
 
4. Resides in the Western New York catchment area. 
 
 
 
 
5. Did not receive a partial or radical cystectomy. 
 
 
 
 
6. Does not have a prior cancer diagnosis within 12 months of their 
bladder cancer diagnosis. 
 
 
 
 
7. Does not have a subsequent more advanced bladder cancer diagnosis. 
 
 
 
 
8. For Roswell Park Cancer Registry only: Bladder cancer diagnosed 2016-
2018, 2019-current. 
 
 
 
 
9. Participant must understand the investigational nature of this study and 
sign an Independent Ethics Committee/Institutional Review Board 
approved written informed consent form prior to receiving any study 
related procedure. 
 
Investigator Signature: ___________________________________ 
Date: ___________ 
Printed Name of Investigator: __________________________________________________ 
 
 

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Appendix B INVESTIGATOR STUDY ELIGIBILITY VERIFICATION FORM 
EXCLUSION CRITERIA 
Participant Name: ___________________________ 
Medical Record No: _____________________________ 
Title: POW-R Health: Power to Redefine your Health (Internal title: A Pragmatic Dietary 
Intervention to Improve Bladder Cancer Survivorship) 
EXCLUSION CRITERIA 
Yes 
No 
N/A 
All answers must be “No” or “N/A” for participant enrollment. 
Date 
 
 
 
1. Participants who have had chemotherapy or radiotherapy within 
4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the 
study or those who have not recovered from adverse events due to 
agents administered more than 4 weeks earlier. 
 
 
 
 
2. Participants with known brain metastases should be excluded from this 
clinical trial because of their poor prognosis and because they often 
develop progressive neurologic dysfunction that would confound the 
evaluation of neurologic and other adverse events. 
 
 
 
 
3. Adults unable to consent. 
 
 
 
 
4. Adults unable to complete study measures in English. 
 
 
 
 
5. Individuals who are not yet adults (infants, children, teenagers). 
 
 
 
 
6. Uncontrolled intercurrent illness including, but not limited to, ongoing 
or active infection, symptomatic congestive heart failure, unstable 
angina pectoris, cardiac arrhythmia, or psychiatric illness/social 
situations that would limit compliance with study requirements. 
 
 
 
 
7. Unwilling or unable to follow protocol requirements. 
 
Participant meets all entry criteria: 
 
  Yes 
  No 
If “NO”, do not enroll participant in study. 
Investigator Signature: ___________________________________ 
Date: __________ 
Printed Name of Investigator: _________________________________________________ 
 

Roswell Park Protocol No.: I 661820 
 
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Appendix C Participant Urine Collection Instructions  
POW-R Health: Power to Redefine your Health 
Program 
INSTRUCTIONS FOR URINE COLLECTION AND SHIPMENT 
 
Thank you for being a part of this study. This sheet provides instructions for urine 
collection. The first morning urine (the time you typically get up and start daily routine) 
should be collected over three consecutive days (3 days in a row).  
 
Materials in provided urine collection kit: 
 
1. 
Urine collection device (see below picture on the left) 
 
 
3 
2. 
Urine collection hat (see below picture on the right) 
 
 
3 
3. 
Biohazard bag with 2 absorbent pads 
 
 
 
 
1 
4. 
Ice packs* 
 
 
 
 
 
 
 
 
2 
5. 
Styrofoam shipping box with biohazard label and UN3373 label  
1 
6. 
FedEx shipping priority overnight label 
 
 
 
 
1 
7. 
Packing tape strips 
 
 
 
 
 
 
 
2 
8. 
Urine collection questionnaire  
 
 
 
 
 
1 
9. 
Plastic bag for urine collection questionnaire 
 
 
 
1 
 
 
 
 
* First, place the ice packs in your freezer as soon as you get the kit so that they are 
frozen by the time the samples are ready to be shipped. 
 
URINE COLLECTION INSTRUCTIONS 
 
1. Collect the first void urine in the morning. 
 
2. Urine can be collected in two ways: 
 
Using the urine collection device: take out the sponge with holder from the 
container, directly urinate onto the sponge, and then insert sponge back into the 
container.  
 
 
 
 
 
 
OR 
Using the urine collection hat: place the urine collection hat on the toilet and 
urinate into it, then submerge the sponge into the urine, and insert the sponge 

Roswell Park Protocol No.: I 661820 
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back into the container. Throw away the urine collection hat into a trash 
receptacle; do not ship the urine collection hat. 
 
 
 
 
 
3. Write the date and time of the collection using a pen directly onto the label on the 
urine collection device. 
 
4. Store the urine sample in its collection device, including both the sponge and 
container, in your refrigerator. The urine is absorbed into the sponge so it should 
not leak from the device. 
 
5. Repeat the first morning urine collection for two more days in a row (Steps 1-4), 
storing the samples in the refrigerator until ready for shipment. 
 
SCHEDULING A FEDEX PICKUP 
 
After collecting the urine samples for three consecutive days, the samples can be 
shipped to Roswell Park Cancer Institute in Buffalo, NY for processing. 
 
** NOTE: FedEx pickups should be scheduled for Monday through Thursday only, to 
ensure prompt delivery to the POW-R Health staff at Roswell Park Cancer Institute. 
Keep the urine samples and collection devices in the refrigerator until the scheduled 
shipping day. ** 
 
6. Call FedEx (1-800-GO-FEDEX; 1-800-463-3339) to schedule a pickup to ship the 
box to Roswell Park Cancer Institute.  Do not take the package to a FedEx retail 
store for shipment or drop in a FedEx drop box. 
a.) Once you have placed the call to FedEx, say “Schedule a Pickup” 
b.) After the automated system has registered your request, dial 0, 
followed by the # sign to be directly transferred to a FedEx representative 
c.) Let the representative know your samples will be delivered via FedEx 
Express service (priority overnight shipping) 
d.) Provide the address from where you would like your samples to be 
retrieved  
 
NOTE: If the FedEx representative asks for the account number, let them know 
you do not have it. The FedEx charge for your package has been pre-paid, and 
as long as the provided FedEx shipping priority overnight label is on the outside 
of your package, it will be picked up.  
 
If you would prefer a FedEx pickup be scheduled on your behalf, please call the POW-R 
Health Study hotline at 1-716-845-8319. 
 
 
PREPARING THE PACKAGE FOR SHIPMENT 
 
7. Place all three urine samples and collection devices, including the containers and 
sponges, in the biohazard bag with absorbent pads. Seal the biohazard bag 
completely.  
 

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8. Remove the styrofoam lid of the shipping box, and place one pre-frozen ice pack 
on the bottom of the styrofoam shipping box. 
 
9. Place the biohazard bag with the urine samples and collection devices on top of 
the ice pack in the shipping box. 
 
10. Place the second pre-frozen ice pack on top of the biohazard bag, and replace 
the styrofoam lid on the shipping box.   
 
11. Complete the urine collection questionnaire.  Place the questionnaire in the 
provided plastic baggie and put it into the shipping box on top of the closed 
styrofoam container. 
 
 
12. Seal the shipping box with the provided packing tape strips.  As a reminder, the 
urine collection hats should be thrown away and not shipped back to us. 
 
13. Remove the adhesive on the provided FedEx shipping priority overnight label and 
place the label on the top of the sealed shipping box.  
 
 
 
 
 
 
 
 
 
 
 
If you have any questions about collection or shipping, please 
contact: 
Li Tang, Ph.D. 
Roswell Park Comprehensive Cancer Center 
Basic Science Building 708 
Elm and Carlton Streets 
Buffalo, NY 14263 
Tel:  716-845-8247 
 
SHIPPING CHECKLIST 
 
The following items should be included in your shipping box: 
 
 3 urine samples and collection devices in biohazard bag 
 2 frozen ice packs 
 Urine collection questionnaire 
 FedEx label on outside of shipping box 

Roswell Park Protocol No.: I 661820 
 
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Page 37 of 175 
 
Appendix D Participant Urine Questionnaire 
 
POW-R Health: Power to Redefine your Health Program Urine Collection 
Questionnaire 
 
Please complete the following table with the date and time of collection for each urine 
sample: 
 
Urine Sample 
Date of Collection 
Time of Collection 
Sample #1 
 
_____ / ______ / _____ 
Month     Day       Year 
 
 
_____ : _____     AM / PM 
                            Circle one 
Sample #2 
 
_____ / ______ / _____ 
Month     Day       Year 
 
 
_____ : _____     AM / PM 
                            Circle one 
Sample #3 
 
_____ / ______ / _____ 
Month     Day       Year 
 
 
_____ : _____     AM / PM 
                            Circle one 
 
 
The following questions are about your diet and lifestyle on 
the day before your first urine collection 
 
 
On the day before your first urine collection, did you …. (Please mark box for Yes 
or No) 
 
 
1.  Eat Broccoli? 
 
 Yes  →  Please specify the type:  
 Raw  
 Lightly Cooked   
 Thoroughly 
Cooked 
 
 No  
 
 
 

Roswell Park Protocol No.: I 661820 
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2.  Eat Broccoli Sprouts? 
 
 Yes  →  Please specify the type:  
 Raw  
 Lightly Cooked   
 Thoroughly 
Cooked 
 
 No  
 
 
 
3.  Eat Cabbage? 
 
 Yes  →  Please specify the type:  
 Raw  
 Lightly Cooked   
 Thoroughly 
Cooked 
 
 No  
 
 
Continue to Next Page 

Roswell Park Protocol No.: I 661820 
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Page 39 of 175 
 
4.  Eat Carrots? 
 
 Yes  →  Please specify the type:  
 Raw  
 Lightly Cooked   
 Thoroughly 
Cooked 
 
 No  
 
 
 
5. Eat Cauliflower? 
 
 Yes  →  Please specify the type:  
 Raw  
 Lightly Cooked   
 Thoroughly 
Cooked 
 
 No  
 
 
 
6.  Eat Brussels Sprouts? 
 
 Yes  →  Please specify the type:  
 Raw  
 Lightly Cooked   
 Thoroughly 
Cooked 
 
 No  
 
 
 
7.  Eat Corn? 
 
 Yes  →  Please specify the type:  
 Raw  
 Lightly Cooked   
 Thoroughly 
Cooked 
 
 No  
 
 
 
8. Eat Kale, Collard Greens, Mustard Greens, or Turnip Greens? 
 
 Yes  →  Please specify the type:  
 Raw  
 Lightly Cooked   
 Thoroughly 
Cooked 
 
 No  
 
 
 
9.  Eat Peas? 
 
 Yes  →  Please specify the type:  
 Raw  
 Lightly Cooked   
 Thoroughly 
Cooked 
 
 No  
 

Roswell Park Protocol No.: I 661820 
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10. Eat Bok Choy or Chinese cabbage? 
 
 Yes  →  Please specify the type:  
 Raw  
 Lightly Cooked   
 Thoroughly 
Cooked 
 
 No  
 
 
 
11.  Eat Garden or Water Cress? 
 
 Yes  →  Please specify the type:  
 Raw  
 Lightly Cooked   
 Thoroughly 
Cooked 
 
 No  
 
 
 
12.  Eat Radish or Turnip? 
 
 Yes  →  Please specify the type:  
 Raw  
 Lightly Cooked   
 Thoroughly 
Cooked 
 
 No  
 
 
 
13.  Eat Celery? 
 
 Yes  →  Please specify the type:  
 Raw  
 Lightly Cooked   
 Thoroughly 
Cooked 
 
 No  
 
 
 
14. Eat Sauerkraut? 
 
 Yes   
 
 No  
 
 
 
Continue to Next Page 

Roswell Park Protocol No.: I 661820 
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15.  Eat Horseradish, Mustard, or Wasabi? 
 
 Yes   
 
 No  
 
 
 
16.  Take any antibiotic prescription medications (e.g., Cipro®, Septra®, 
penicillins, or other)? 
 
 Yes   
 
 No  
 
 
 
17.  Smoke cigarettes? 
 
 Yes  →  Please specify the total number of cigarettes:  
 
 No  
 
 
 
18.  Consume any alcoholic drink? 
 
 Yes  →  Please specify the total number of drinks:  
 
 No  
 
 
 
 
 
Date this questionnaire was completed   |___|___| / |___|___| / |___|___|___|___| 
 
 
 
 
 
 
     Month 
  Day          Year 
 
 
 
 
Thank you very much for your time! 
 
 

Roswell Park Protocol No.: I 661820 
 
10/31/2022 
 
Page 42 of 175 
 
Appendix E Participant Interview Phone Script  
 
POW-R Health: Power to Redefine your Health Program  
PHONE SCREENING 
Paper Copy 
 
Today’s Date _______________               Time ______________ 
 
Leave the following message on the A/M of potential participants (do not say Roswell Park 
Cancer Institute) 
 
 
Hi, this message is for __________________.  This is ______________ calling from the 
POW-R Health: Power to Redefine your Health Program to follow-up on your call expressing 
interest in our study.  I would like to take a few minutes to explain the study in more detail to 
you.  Please call me back between the hours of 8:30am and 5 pm at ____________. If you cannot 
reach me, please leave a message including your name, telephone number, and a convenient time 
to call. Thank you and I hope to speak to you soon. 
 
Speaking to participants: 
 
“This is __________________ calling from Roswell Park Cancer Institute.  I’m calling to 
follow-up on your call expressing interest in our POW-R Health: Power to Redefine your Health 
Program being conducted here at Roswell Park.  I would like to take a few minutes to explain the 
study in more detail to you.  Is this a good time to do that?” 
 
If NO: When would be the best day and time to call you back? 
 
If YES, or if first contact with respondent: 
 
“We are conducting a study here at Roswell Park Cancer Institute to see if someone’s diet can 
reduce their risk of bladder cancer coming back in those who had bladder cancer. We are 
specifically interested in testing whether a vegetable intervention can improve health in those 
who had bladder cancer.   
 
Your participation will last a total of 6 months (about 24 weeks) and includes the following: 
 
We will ask you to complete two assessments. One before the study begins, and one after 
the study ends. Each assessment will consist of: 
o A 45-60-minute survey over the phone 
o Telling us what you’ve eaten over the past 24-hours. This is called a dietary 
recall. This will be done on 3 randomly selected days. Each time it will take about 
15-20 minutes over the phone.  
o Sending us urine samples through the mail.  
- 
Being part of a 6-month program to improve your diet. The program will consist 
of: 

Roswell Park Protocol No.: I 661820 
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o Receiving educational materials about a healthy diet 
o One 20-minute phone call with a Roswell staff member to talk to you about a 
healthy diet 
o 11 interactive voice response automated phone calls, where you will receive a 
phone call from a machine that will ask you how many vegetables you ate during 
a certain time period.  
 
 
To thank you for your time and participation, you will be given a $40 gift card to Tops Markets 
for completing the phone survey and sending the urine sample; and a $20 gift card from Tops 
Markets for completing each dietary recall. So, for each assessment you will have the 
opportunity to receive a total of $100 in gift cards to Tops Markets. Across both assessments you 
will have the opportunity to receive a total of $200 in gift cards to Tops Markets. 
 
Are you still interested in being a part of the study?  
 
May we get your verbal consent to complete the baseline  
If NO: Thank you for your time.  
 
Demographics 
 
New Applicant Introduction Form  
I want you to know that everything said during this conversation is confidential and will 
only be shared with our research team. I would like to share some information with you 
about our program. POW-R Health: Power to Redefine your Health is a healthy eating 
program that focuses on eating more vegetables to improve health. We are currently 
recruiting adults who live in Western New York. During this call I will gather 
information to determine your eligibility to participate in the program and whether the 
program might work for you. This conversation could take up to 15 minutes. Is that ok?  
 
(circle one)       Yes  
No 
 
If YES, continue. 
 
If NO, read this script: Ok Mr./Mrs._________. When would be a good day and time for 
me to call you back? __________________________________________ 
 
 
Let’s begin with your name and address. 
 
1. First: ____________________ Middle: _____________   Last: ______________________ 
 
2. Are you male or female?      Male            Female 
 

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3. Are you Hispanic or Latino/a or Spanish in origin?  
 Yes  
 
Are you (check all that apply): Mexican, Mexican American, Chicano/a 
 
 
 
 
 
  Puerto Rican 
 
 
 
 
 
  Cuban 
 
 
 
 
 
  Another Hispanic, Latino/a, or Spanish origin 
 No  
 
4. Which one or more of the following would you say is your race?  
 (Check all that apply)  
 White  
 Black or African American  
 American Indian or Alaska Native  
 Asian Indian 
 Native Hawaiian  
 Chinese 
 Filipino 
 Japanese 
 Korean 
 Vietnamese 
 Other Asian 
 Other Pacific Islander 
 
5.  What is your address? 
 
Street: _______________________________________________________ 
 
City:_______________________________ Zip Code: ________________  
 
6.   I would like to get your phone numbers:  
 
             Daytime Phone: (___)_____________ (circle one)  home   
work   
cell  
 
 Evening Phone: (___)_____________ (circle one)  home   
work   
cell  
             Other: _________________________ (circle one) home   
work   
cell  
 
      6a. Do you have an email address?  _________________________________________ 
 
7.  What is your date of birth?: 
 
Month: ______________ Day: ____________ Year: ________ 
 
Note: ________________________________________________________________________ 
 
If individual will turn 18 BEFORE the current round of recruitment closes, age ineligibility 
applies and this script is read: 

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Applicant Turning 18 Soon 
I’m sorry ______ , you are not eligible to participate in the program. The program is 
made for those aged 18 and older.  
 
 
Would you like to continue with the questionnaire?      Yes        No 
 
     If answer is YES, continue to Question 8. 
 
     If answer is NO, thank applicant for his/her interest in the program and End Interview. 
 
 
IF THE INDIVIDUAL PASSES THESE SET OF QUESTIONS CONTINUE TO THE 
NEXT SECTION. 
 
Cancer 
 
8.  Have you been diagnosed with stage Tis, Ta, or T1 bladder cancer? These are early 
stages of bladder cancer where the cancer lesion stays in the superficial layer of the bladder 
wall and does not invade the muscle layer. Sometimes they are called superficial bladder 
cancer or non-muscle invasive bladder cancer.  
 
If YES, continue to Question 9. 
 
If DON’T KNOW, continue to Question 9. 
 
If NO, read this script: 
 
9.  Have you received a partial or radical cystectomy? A cystectomy is surgery where a part 
or the entire bladder is removed.   
 
If NO, continue to Question 10. 
 
If YES, read this script: 
 
10.  Have you had been diagnosed with another cancer (other than bladder cancer) during 
the past 12 months?  
 
I’m sorry, ______ , you are not eligible to participate in the program. The program is 
designed for people who have been diagnosed with stage Tis, Ta, or T1 bladder cancer.  
Thank you for your interest, but we will not be able to enroll you. 
I’m sorry, ______ , you are not eligible to participate in the program. The program is 
designed for people who have NOT received a partial or radical cystectomy. Thank you 
for your interest, but we will not be able to enroll you. 

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If NO, continue to Question 11. 
 
If YES, read this script: 
 
 
11.  Have you had chemotherapy or radiotherapy within the last 2 months?  
 
If NO, continue to Question 12. 
 
If YES, read this script: 
 
Medications/Health 
 
12. Have you been told by a doctor that you have any of the following health conditions? 
(circle one) 
 
a. Ongoing or active infection; 
 
b. Crohn’s disease; 
 
c. Inflammatory Bowel Disease; 
d. Other (specify: symptomatic heart failure, unstable angina pectoris, cardiac 
arrhythmia) 
 
e. Psychiatric or social situations that would affect your participation 
 
 
No – Skip to the Consent Section 
 
Yes – Go to question 12a 
 
 
 
12a. Please tell me more about your limitations? _________________________ 
 
___________________________________________________________________ 
 
12b. Record eligibility based on health condition (circle one): 
 
Ineligible 
 
Questionable- refer to PI 
 
Acceptable to continue 
 
I’m sorry, ______ , you are not eligible to participate in the program. The program is 
designed for people who have NOT been diagnosed with another cancer in the past 12 
months of your being diagnosed with bladder cancer. Thank you for your interest, but 
we will not be able to enroll you. 
I’m sorry, ______ , you are not eligible to participate in the program. The program 
would not be safe for those who have had chemotherapy or radiotherapy within the last 
2 months. Thank you for your interest, but we will not be able to enroll you. 

Roswell Park Protocol No.: I 661820 
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If debilitating or such that the individual would have a hard time completing the program, 
then ineligibility applies and this script should be read: 
 
If questionable and referring to PI, then this script should be read: 
 
 
The interview is STOPPED and the individual will be called back. 
Consent 
Congratulations, Mr./ Ms Applicant.  You are eligible to participate in POW-R Health: 
Power to Redefine your Health Program.  Are you still interested in being a part of study?  
 
If Yes, continue to the consent section. 
 
If No, read this script: 
 
 
 
 
 
I would like to now go over the consent form for the study with you.  
(go over consent form). 
 
I will mail you a copy for you to keep.  
 
Before the program begins, you will need to complete the first assessment. Our team will call 
you to collect general information about your health. Our team will also call you on three 
different days to ask what you’ve eaten in the last 24 hours. So in total, you will receive 4 
separate phone calls from our team to collect this information. We will also mail you a urine 
sample collecting kit for you to mail back to us. After we collect this information, you will 
receive your gifts cards for the first assessment. The POW-R Health: Power to Redefine your 
Health program materials will also be sent to you in the mail and one of our interventionists will 
call you.  
 
If you would like to complete the first assessment now, can we get your verbal consent before we 
proceed? [Ask participant to indicate a Yes or No] Do you have any questions?   
 
[If participant chooses to do the survey at another time, we will review the script at that time]  
Welcome to POW-R Health! Someone will be in touch with you soon. 
For below: Ok Mr./Ms._______, Thank you for your interest in the Program. We 
appreciate your time.  
I’m sorry, ______  you are not eligible to participate in the program. Thank you for 
your interest, but we will not be able to enroll you.  
_____, based on the information you have given me, I can’t tell for sure if you are 
eligible for the program. I need to talk with the Program Coordinator about whether 
you are eligible or not. Someone from our team will call you to see if you are eligible. If 
you are eligible, the remaining screening questions will be asked at that time. 

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Appendix F Participant Baseline Bladder Questionnaire  
 
 
Hi, my name is __________ . I’m calling because you kindly agreed to participate in the POW-R Health: Power 
to Redefine your Health Program. If you recall, part of being in the study is completing a survey—once before 
the study starts, and a final time after the study ends. The survey information will be used to see if our dietary 
intervention worked to improve your health. This phone survey will take about 45-60 minutes to complete. Do 
you have time to take the survey now? 
 
If no: What would be a good day and time for me to call you? (please use Telephone Disposition Sheet) 
 
If yes: Thank you! Please remember that everything you say here will be confidential. Your information won’t 
be identified by name (proceed to questions below). 
 
Let’s start off with some information about you. 
 
 
DEMOGRAPHICS 
 
1. What is your marital status?  
1   Married 
 
2   Living as married 
3   Divorced 
4   Widowed 
5   Separated 
6   Single, never been married 
 
2. What is the highest grade or level of schooling you completed?  
1   Less than 8 years 
2   8-11 years 
3   12 years or completed high school 
4   Post high school training other than college (vocational or technical) 
5   Some college 
6   College graduate 
7   Postgraduate  
 
3. Thinking about members of your family living in this household, what is your combined annual 
income, meaning the total pre-tax income from all sources earned in the past year?  
1   $0- $9,000 
2   $10,000-$14,999 
3   $15,000-$19,999 
4   $20,000-$34,999 
5   $35,000-$49,999  
6   $50,000-$74,999 
7   $75,000-$99,999 
8   $100,000-199,999 
9   $200,000 or more 

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4. What is your occupational status?  
1   Employed  
2   Unemployed 
3   Homemaker  
4   Retired  
5   Disabled   
6   Other (Specify)_____________________ 
 
5. How many people currently live in your home (include yourself)? _______ 
 
6. Do you have any kind of health care coverage, including health insurance, prepaid plans such as 
HMOs or government plans such as Medicare, or Indian Health Service? 
1   Yes (if yes, go to 6a) 
2   No 
 
6a. What is the primary source of your health care coverage?  
    
1. A plan purchased through an employer or union (including plans purchased through another 
person’s employer) 
2. A plan that you or another family member buys on your own 
3. Medicaid (primarily for people over age 65) or other state program 
4. Medicare 
5. TRICARE (formerly CHAMPUS), VA, or Military 
6. Alaska Native, Indian Health Service, Tribal Health Service 
7. Some other source 
 
7. We would like to confirm your current address. Do you still live at ______? Read address from 
database. 
 
1 
 Yes 
0 
 No (please specify current address):  
 
_______________________________________________ 
(Name of street, city, state, zip) update if necessary 
 
 
BLADDER CANCER DIAGNOSIS 
 
The next set of questions is about your bladder cancer diagnosis. 
 
8. We would like to confirm the date of your bladder cancer diagnosis. According to our records, you 
were first diagnosed on _______.  Is that correct? 
1 
 Yes 
0 
 No → 
 
8a. What was the date? _________ 
8 
 Don’t Know 
 
8 
 Don’t Know 
9 
 Refused   
 
9 
 Refused 

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9. Did your doctor use a scope to remove the bladder tumor?  This procedure is called a transurethral 
resection. 
1 
 Yes → 
 
9a.  What was the date? _________ 
0 
 No 
 
 
8 
 Don’t Know 
8 
 Don’t Know 
 
9 
 Refused 
9 
 Refused  
 
10. Have you received any additional treatment for bladder cancer since your diagnosis? 
1 
 Yes 
 
 
0 
 No 
 
 
 
8 
 Don’t Know 
 
 
9 
 Refused   
 
 
 
If No, Don’t Know or Refused, go to Question 14. 
 
 
 
 
11. Did you receive chemotherapy (e.g., mitomycin C, thiotepa, doxorubicin)? 
1 
 Yes 
 
0 
 No  
8 
 Don’t Know  
9 
 Refused  
 
12. Did you receive immunotherapy (e.g., bacillus Calmette-Guerin [BCG], interferon)? 
1 
 Yes 
 
0 
 No  
8 
 Don’t Know  
9 
 Refused  
 
13. Did you receive any other treatment? 
1 
 Yes →  
 
 
13a. Specify:________________ 
 
0 
 No  
8 
 Don’t Know  
9 
 Refused  
 
 

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CURRENT LIFESYLE 
 
The next section is about your current lifestyle. Again, this information is completely confidential.   
 
14.   What is your present height without shoes? 
 
|__|__| ft.  |__|__| inches 
8 
 Don’t Know 
9 
 Refused  
 
15.   How much do you currently weigh? 
|__|__|__| pounds 
8 
 Don’t Know 
9 
 Refused 
 
 
Excell
ent 
Very 
Good 
Good 
Fair 
Poor 
Don’t 
Know 
Refuse
d 
16. In general, would you say your 
health is:  
5 
 
4 
 
3 
 
2 
 
1 
 
8 
 
9 
 
17. In general, would you say your 
quality of life is:  
5 
 
4 
 
3 
 
2 
 
1 
 
8 
 
9 
 
 
18.  What is the primary source of drinking water at your current residence? 
 
1 
 Private Well  
2 
 Community Supply (tap water, water filtered at home) 
3 
 Bottled Water 
4 
 Other (specify):_____________ 
8 
 Don’t Know 
9 
 Refused 
 
19.  Over the past 30 days, how many glasses of water per day do you usually drink? 
 
1 
 Less than 1 glass 
2 
 1-2 glasses 
3 
 3-4 glasses 
4 
 5 or more glasses 
8 
 Don’t Know 
9 
 Refused 
 

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20.  Over the past 30 days, how often did you typically feel the need to empty your bladder during the 
day? 
 
1 
 More frequently than once an hour 
 
 
 
 
2 
 Once an hour 
 
 
 
3 
 Once every 2 hours  
 
4 
 Once every 3-5 hours 
 
 
 
 
5 
 Only once or twice a day 
8 
 Don’t Know  
9 
 Refused 
 
21. Are you currently following any special diet?  
 
1 
 Yes  
0 
 No 
8 
 Don’t Know 
9 
 Refused 
 
If No, Don’t Know or Refused, go to Question 23. 
 
22. What type of special diet (check all that apply):  
 
1 
 Vegetarian (with fish)  
1 
 Vegetarian (no fish)  
1 
 Vegan (no meat, chicken, fish, dairy, or eggs)  
1 
 Macrobiotic  
1 
 Paleo  
1 
 Gluten-free  
1 
 Atkins 
1 
 Low Carb 
1 
 Other (specify)__________________  
1 
 Don’t Know 
1 
 Refused 
 
23  Do you currently smoke? 
 
1 
  Yes, every day 
2 
  Yes, some days →  
23a. On how many of the past 30 days did you smoke a  cigarette?    
 
 
 
 
 
 
|__|__| Days   
8 
 Don’t Know 
 
 
 
 
9 
 Refused  
 

Roswell Park Protocol No.: I 661820 
10/31/2022 
 
Page 53 of 175 
 
24.  On average, how many cigarettes do/did you smoke each day? (Note to interviewer: 1 pack=20 
cigarettes)  
 
|__|__|__| Cigarettes per day  
 
8 
 Don’t Know 
9 
 Refused 
 
25.  Over the last 30 days, how many days per week did you exercise for 20 minutes or more? 
 
 None 
 1-2 days 
 3-4 days 
 5 or more days 
 
 
26.  Compared to other people your age, how would you rate the level of your usual physical activity? (If 
currently ill, think about your activity during the past 30 days before your illness). 
 
 Much more active 
 More active 
 About the same 
 Less active 
 Much less active 
 
DIETARY INTAKE 
 
These next questions are about the fruits and vegetables you ate or drank during the past 30 days. Please think 
about all forms of fruits and vegetables including cooked or raw, fresh, frozen or canned. Please think about all 
meals, snacks, and food consumed at home and away from home.  
 
27.  
During the past month, how many times per week did you drink 100% PURE fruit juices? Do not 
include fruit-flavored drinks with added sugar or fruit juice you made at home and added sugar 
to. Only include 100% juice.  
 
___ ___ times per week 
 
28.  
During the past month, not counting juice, how many times per week did you eat fruit? Count 
fresh, frozen, or canned fruit.  
 
___ ___ times per week 
 
29.  
During the past month, how many times per week did you eat cooked or canned beans, such as 
refried, baked, black, garbanzo beans, beans in soup, soybeans, edamame, tofu or lentils. Do NOT 
include long green beans.  
 
___ ___ times per week 

Roswell Park Protocol No.: I 661820 
10/31/2022 
 
Page 54 of 175 
 
 
 
30.  
During the past month, how many times per week did you eat dark green vegetables for example 
broccoli or dark leafy greens including romaine, chard, collard greens or spinach?  
 
___ ___ times per week 
 
31.  
During the past month, how many times per week did you eat orange-colored vegetables such as 
sweet potatoes, pumpkin, winter squash, or carrots? (write number) 
 
___ ___  
 
32.  
Not counting the vegetables mentioned, about how many times per week did you eat OTHER 
vegetables? Examples of other vegetables include tomatoes, tomato juice or V-8 juice, corn, 
eggplant, peas, lettuce, cabbage, and white potatoes that are not fried such as baked or mashed 
potatoes. (write number) 
 
___ ___ times per week 
 
 
 
These next questions are about other vegetables you ate during the past 30 days. Please think about all meals, 
snacks, and food consumed at home and away from home.  
 
 
(Go through table. Frame questions as, “How often did you eat raw arugula? Never, a few times per year, 
once per month, 2-3 times per month, once a week, twice per week, 3-4 times per week, 5-6 times per week, 
or every day.” If they answer never, go to the next vegetable. If they ate any amount, ask, “About how much 
raw arugula did you eat each time? The medium serving size is one cup of the vegetable, about the size of a 
baseball. Lightly cooked generally includes stir fry, sauté, microwave, short-term, e.g. less than 10 minutes, 
steam or bake, and thoroughly cooked includes stew, biol, or long-term, e.g. more than 10 minutes, steam or 
bake.)  

Roswell Park Protocol No.: I 661820 
10/31/2022 
 
Page 55 of 175 
 
Vegetables 
 
 
 
 
 
Never 
 
A Few 
Times 
Per 
Year  
 
 
Once  
per 
month 
 
 
2-3 
Times 
 per 
month 
 
 
Once  
 per 
week 
 
Twice 
 per 
week 
 
 
3-4 
Times 
per 
week 
 
 
5-6 
Times 
per 
week 
 
 
Every 
day 
How much 
each time? 
 
S 
 
M 
 
L 
 
Arugula 
 
raw 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
lightly cooked 
(e.g. stir fry) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
thoroughly 
cooked (e.g. 
stew) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Broccoli 
 
 
raw 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
lightly cooked 
(e.g. stir fry) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
thoroughly 
cooked (e.g. 
stew) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Broccoli sprout 
 
 
raw 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
lightly cooked 
(e.g. stir fry) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
thoroughly 
cooked (e.g. 
stew) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Broccolini 
 
 
raw 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
lightly cooked 
(e.g. stir fry) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
thoroughly 
cooked (e.g. 
stew) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Corn 
 
 
raw 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
lightly cooked 
(e.g. stir fry) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
thoroughly 
cooked (e.g. 
stew) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Roswell Park Protocol No.: I 661820 
10/31/2022 
 
Page 56 of 175 
 
Green cabbage 
 
 
raw (e.g. 
coleslaw) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
lightly cooked 
(e.g. stir fry) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
thoroughly 
cooked (e.g. 
stew) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Red/ 
Purple cabbage 
 
 
raw 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
lightly cooked 
(e.g. stir fry) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
thoroughly 
cooked (e.g. 
stew) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Sauerkraut 
 
 
raw 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
lightly cooked 
(e.g. stir fry) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
thoroughly 
cooked (e.g. 
stew) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Carrots 
 
 
raw 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
lightly cooked 
(e.g. stir fry) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
thoroughly 
cooked (e.g. 
stew) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Cauliflower 
 
 
raw 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
lightly cooked 
(e.g. stir fry) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
thoroughly 
cooked (e.g. 
stew) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Brussels sprouts 
 
 
raw 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Roswell Park Protocol No.: I 661820 
10/31/2022 
 
Page 57 of 175 
 
lightly cooked 
(e.g. stir fry) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
thoroughly 
cooked (e.g. 
stew) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Kale 
 
 
raw 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
lightly cooked 
(e.g. stir fry) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
thoroughly 
cooked (e.g. 
stew) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Kohlrabi 
 
 
raw 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
lightly cooked 
(e.g. stir fry) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
thoroughly 
cooked (e.g. 
stew) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Collard greens 
 
lightly cooked 
(e.g. stir fry) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
thoroughly 
cooked (e.g. 
stew) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Peas 
 
 
raw 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
lightly cooked 
(e.g. stir fry) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
thoroughly 
cooked (e.g. 
stew) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Mustard greens 
 
 
raw 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
lightly cooked 
(e.g. stir fry) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
thoroughly 
cooked (e.g. 
stew) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Turnip 
 
lightly cooked 
(e.g. stir fry) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
thoroughly 
cooked (e.g. 
stew) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Roswell Park Protocol No.: I 661820 
10/31/2022 
 
Page 58 of 175 
 
Turnip greens 
 
lightly cooked 
(e.g. stir fry) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
thoroughly 
cooked (e.g. 
stew) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Bok/ Pak choy 
 
 
raw 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
lightly cooked 
(e.g. stir fry) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
thoroughly 
cooked (e.g. 
stew) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Chinese cabbage/ 
Napa 
 
 
raw 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
lightly cooked 
(e.g. stir fry) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
thoroughly 
cooked (e.g. 
stew) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Daikon root 
 
 
raw 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
lightly cooked 
(e.g. stir fry) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
thoroughly 
cooked (e.g. 
stew) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Celery 
 
 
raw 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
lightly cooked 
(e.g. stir fry) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
thoroughly 
cooked (e.g. 
stew) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Garden cress 
 
raw 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
lightly cooked 
(e.g. stir fry) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
thoroughly 
cooked (e.g. 
stew) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Water cress 
 
 
raw 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Roswell Park Protocol No.: I 661820 
10/31/2022 
 
Page 59 of 175 
 
 
 
We’re going to finish the survey by asking some final questions about sauces and condiments you ate during the 
past 30 days. Please think about all meals, snacks, and food consumed at home and away from home.  
 
(Go through table. Frame questions as, “How often did you eat mayonnaise? Never, a few times per year, 
once per month, 2-3 times per month, once a week, twice per week, 3-4 times per week, 5-6 times per week, 
or every day.” If they answer never, go to the next food. If they ate any amount, ask, “About how much 
mayonnaise did you eat each time? The size of your thumb from knuckle to tip or less? About two thumbs 
worth? Or more than 2 thumbs worth?” 
 
For horseradish, if they consume any amount, ask, “about how much horseradish did you eat each time? 
Smaller than an egg, about the size of egg, or more than the size of an egg?) 
 
lightly cooked 
(e.g. stir fry) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
thoroughly 
cooked (e.g. 
stew) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Radicchio 
lightly cooked 
(e.g. stir fry) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
thoroughly 
cooked (e.g. 
stew) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Radishes 
 
raw 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
lightly cooked 
(e.g. stir fry) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
thoroughly 
cooked (e.g. 
stew) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Roswell Park Protocol No.: I 661820 
 
10/31/2022 
 
Page 60 of 175 
 
 
 
Belief into Action Scale 
Circle a single number for each question below: 
 
1.  Please circle the highest priority in your life now? (most valued, prized) 
 
 
1. My health and independence 
 
2. My family 
 
3. My friendships 
 
4. Job, career or business 
5. My education 
 
6. Financial security 
7. Relationship with God 
 
8. Ability to travel & see the world 
 
9. Listening to music and partying 
 
10. Freedom to live as I choose 
 
2.  How often do you attend religious services? (circle a number below) 
 
 
 
|--------------|--------------|--------------|--------------|--------------|--------------|--------------|--------------|--------------| 
1 
       2                 3 
          4 
     5 
 
6 
        7  
   8 
           9 
     10  
 
 
SAUCES AND CONDIMENTS 
 
 
 
 
 
Never 
 
 
A Few 
Times 
Per 
Year 
 
 
Once  
per 
month 
 
 
2-3 
Times 
 per 
month 
 
 
Once 
 per 
week 
 
Twic
e 
 per 
week 
 
 
3-4 
Time
s per 
week 
 
 
5-6 
Time
s per 
week 
 
 
Ever
yday 
 
 
 
Medium 
Serving 
 
Serving 
Size 
 
 
 
 
 
 
 
 
 
 
 
 
S 
 
M 
 
L 
Mayonnaise and 
mayonnaise-type spreads 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2 Tbsp. 
 
 
 
 
 
 
 
Horseradish 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
¼ cup 
 
 
 
 
 
 
 
Mustard 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2 Tbsp. 
 
 
 
 
 
 
 
Wasabi 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2 Tbsp. 
 
 
 
 
 
 
Never 
Rarely 
Couple 
times/yr 
Every 
few mos 
About 
once/mo 
Several 
times/mo
Daily 
More than 
once/wk 
Every 
week 
About 
every wk 

Roswell Park Protocol No.: I 661820 
10/31/2022 
 
Page 61 of 175 
 
3.  Other than religious services, how often do you get together with others for religious reasons 
 (prayer, religious discussions, volunteer work, etc.)? 
 
 
 
|--------------|--------------|--------------|--------------|--------------|--------------|--------------|--------------|--------------| 
1 
       2                 3 
          4 
     5 
 
6 
        7  
   8 
           9 
     10  
 
 
 
4.  To what extent (on a 1 to 10 scale) have you decided to place your life under God's direction? 
 
 
 
|--------------|--------------|--------------|--------------|--------------|--------------|--------------|--------------|--------------| 
1 
       2                 3 
          4 
     5 
 
6 
        7  
   8 
           9 
     10  
 
 
5. What percentage of your gross annual income do you give to your religious institution or to other 
religious causes each year? 
 
 
|--------------|--------------|--------------|--------------|--------------|--------------|--------------|--------------|--------------| 
1 
       2                 3 
          4 
     5 
 
6 
        7  
   8 
           9 
     10  
6.  On average, how much time each day (in 24 hrs) do you spend listening to religious music or radio, 
or watching religious TV? 
 
 
|--------------|--------------|--------------|--------------|--------------|--------------|--------------|--------------|--------------| 
1 
       2                 3 
          4 
     5 
 
6 
        7  
   8 
           9 
     10  
 
 
7.  On average, how much time each day do you spend reading religious scriptures, books, or other 
religious literature? 
 
 
|--------------|--------------|--------------|--------------|--------------|--------------|--------------|--------------|--------------| 
1 
       2                 3 
          4 
     5 
 
6 
        7  
   8 
           9 
     10  
 
 
8.  On average, how much time each day do you spend in private prayer or meditation?  
 
 
|--------------|--------------|--------------|--------------|--------------|--------------|--------------|--------------|--------------| 
1 
       2                 3 
          4 
     5 
 
6 
        7  
   8 
           9 
     10  
 
 
 
 
Never 
Rarely 
Couple 
times/yr 
Every 
few mos 
About 
once/mo 
Several 
times/mo
Daily 
More than 
once/wk 
Every 
week 
About 
every wk 
Not at all  
(really haven’t  thought about it) 
To a moderate degree 
Completely, totally 
0% 
Less 
than 1% 
1%–2% 
3%–4% 
5%–6% 
7%–8% 
15% or more 
13%–14% 
11%–12%
9%–10%
0 (never) 
1–5 min 
6–10 min 
11–20 min 
21–30 min
31–60 
min 
5 hrs or 
more 
3–4 hrs 
More than 2 hr, 
less than 3 hr 
More than 1 hr, 
less than 2 hr 
0 (never) 
1–5 min 
6–10 min 
11–20 min 
21–30 min
31–60 
min 
5 hrs or 
more 
3–4 hrs 
More than 2 hr, 
less than 3 hr 
More than 1 hr, 
less than 2 hr 
0 (never) 
1–5 min 
6–10 min 
11–20 min 
21–30 min
31–60 
min 
5 hrs or 
more 
3–4 hrs 
More than 2 hr, 
less than 3 hr 
More than 1 hr, 
less than 2 hr 

Roswell Park Protocol No.: I 661820 
10/31/2022 
 
Page 62 of 175 
 
9. On average, how much time each day do you spend as a volunteer in your religious community or 
to help others for religious reasons? 
 
 
|--------------|--------------|--------------|--------------|--------------|--------------|--------------|--------------|--------------| 
1 
       2                 3 
          4 
     5 
 
6 
        7  
   8 
           9 
     10  
 
 
10. To what extent (on a 1 to 10 scale) have you decided to conform your life to the teachings of your  
 
religious faith? 
 
 
 
|--------------|--------------|--------------|--------------|--------------|--------------|--------------|--------------|--------------| 
1 
       2                 3 
          4 
     5 
 
6 
        7  
   8 
           9 
     10  
 
_______________________________________________ 
 
 
 
 
You have finished the survey! Thank you so much for your time. Do you have any questions? 
 
Again, welcome to POW-R Health Program!
0 (never) 
1–5 min 
6–10 min 
11–20 min 
21–30 min
31–60 
min 
5 hrs or 
more 
3–4 hrs 
More than 2 hr, 
less than 3 hr 
More than 1 hr, 
less than 2 hr 
Not at all  
(really haven’t  thought about it) 
To a moderate degree 
Completely, totally 

Roswell Park Protocol No.: I 661820 
 
10/31/2022 
 
Page 63 of 175 
 
Appendix G Participant Follow-up  
Appendix G1. Participant 6-month Follow-up Questionnaire 
 
Hi, my name is __________ . I’m calling because you kindly agreed to participate in the POW-R 
Health: Power to Redefine your Health Program. If you recall, part of being in the study is 
completing a survey—once before the study starts, and a final time after the study ends. The 
survey information will be used to see if our dietary intervention worked to improve your health. 
This phone survey will take about 45-60 minutes to complete. Do you have time to take the 
survey now? 
 
If no: What would be a good day and time for me to call you? (please use Telephone Disposition 
Sheet) 
 
If yes: Thank you! Please remember that everything you say here will be confidential. Your 
information won’t be identified by name (proceed to questions below). 
 
BLADDER CANCER FOLLOW-UP 
 
Let’s begin the survey with questions about your bladder cancer status.  These questions 
refer to the time period since we last talked with you, which is approximately the past 6 
months. 
 
1. In the last 6 months, have you had a clinical assessment, or cystoscopy, for your 
bladder cancer?  
1 
 Yes  
0 
 No  
 
→ Skip to Question 2 (cystectomy) 
8 
 Don’t Know  
→ Skip to Question 2 (cystectomy) 
9 
 Refused    
→ Skip to Question 2 (cystectomy) 
 
1a. What was the date of your last assessment? 
__________  
 
2. In the last 6 months, have you had a cystectomy (surgery to remove the bladder)? 
1 
 Yes  
0 
 No  
 
→ Skip to Question 3 (recurrence) 
8 
 Don’t Know 
→ Skip to Question 3 (recurrence) 
9 
 Refused  
→ Skip to Question 3 (recurrence) 
 
2a. What was the date of the cystectomy? __________  
 
 

Roswell Park Protocol No.: I 661820 
10/31/2022 
 
Page 64 of 175 
 
3. In the last 6 months, have you had a recurrence of your bladder cancer (i.e., did 
your doctor say that the original cancer came back or that you had a new 
lesion/mass/tumor)?  
1 
 Yes  
0 
 No  
 
→ Skip to Question 10 (other cancer) 
8 
 Don’t Know 
→ Skip to Question 10 (other cancer) 
9 
 Refused  
→ Skip to Question 10 (other cancer) 
 
3.1 How many recurrences have you had? _____ (Number)   
 
[Note to Interviewer: If more than 1 recurrence, record the date of the most recent (last) 
recurrence here.] 
3.1a. What was the date of your recurrence? __________  
 
4. Did your recurrent bladder cancer progress to muscle-invasive disease?  
1 
 Yes  
0 
 No  
8 
 Don’t Know 
9 
 Refused 
 
5. Did your doctor use a scope to remove the recurrent bladder tumor?  This 
procedure is called a transurethral resection.  
1 
 Yes → Specify Date in 5a 
0 
 No 
8 
 Don’t Know 
9 
 Refused  
 
5a.  What was the date of transurethral resection (TURBT)? 
_________  
 
6. Did you receive chemotherapy (e.g., mitomycin C, thiotepa, doxorubicin) for your 
bladder cancer recurrence/progression?  
1 
 Yes 
0 
 No  
8 
 Don’t Know  
9 
 Refused  
 
7. Did you receive immunotherapy (e.g., bacillus Calmette-Guerin [BCG], interferon) 
for your bladder cancer recurrence/progression?  
1 
 Yes 
0 
 No  
8 
 Don’t Know  
9 
 Refused  
 

Roswell Park Protocol No.: I 661820 
10/31/2022 
 
Page 65 of 175 
 
8. Did you receive radiation therapy for your bladder cancer recurrence/progression? 
1 
 Yes 
0 
 No  
8 
 Don’t Know  
9 
 Refused  
 
9. Did you receive any other treatment for your bladder cancer 
recurrence/progression? 
1 
 Yes → Specify treatment in 9a 
0 
 No  
8 
 Don’t Know  
9 
 Refused  
 
9a. Specify other treatment received: 
________________  
 
 
10. In the last 6 months, have you been diagnosed with any other types of cancer since 
your original bladder cancer diagnosis?  
1 
 Yes 
0 
 No  
 
→ Skip to Question 11  
8 
 Don’t Know  
→ Skip to Question 11 
9 
 Refused  
→ Skip to Question 11 
 
10a. When did you receive this diagnosis? 
__________ 
 
10b. What was your diagnosis?     
 
 
 
 
                            
 
11. Overall, how would you rate your satisfaction with your current understanding of 
bladder cancer and its treatment?  
1 
 Excellent 
2 
 Very Good 
3 
 Good 
4 
 Fair 
5 
 Poor 
8 
 Don’t Know  
9 
 Refused  
 
Now that we’ve gone over your bladder cancer status, we’re now going to talk about your current lifestyle.  
 
CURRENT LIFESYLE 
 
12. What is your present height without shoes? 
 
|__|__| ft.  |__|__| inches 
8 
 Don’t Know 
9 
 Refused  

Roswell Park Protocol No.: I 661820 
10/31/2022 
 
Page 66 of 175 
 
 
13.   How much do you currently weigh? 
|__|__|__| pounds 
8 
 Don’t Know 
9 
 Refused 
 
 
Excell
ent 
Very 
Good 
Good 
Fair 
Poor 
Don’t 
Know 
Refuse
d 
14. In general, would you say your 
health is:  
5 
 
4 
 
3 
 
2 
 
1 
 
8 
 
9 
 
15. In general, would you say your 
quality of life is:  
5 
 
4 
 
3 
 
2 
 
1 
 
8 
 
9 
 
 
16.  What is the primary source of drinking water at your current residence? 
 
1 
 Private Well  
2 
 Community Supply (tap water or water filtered at home) 
3 
 Bottled Water 
4 
 Other (specify):_____________ 
8 
 Don’t Know 
9 
 Refused 
 
 
 
17.  Over the past 30 days, how many glasses of water per day do you usually drink? 
 
1 
 Less than 1 glass 
2 
 1-2 glasses 
3 
 3-4 glasses 
4 
 5 or more glasses 
8 
 Don’t Know 
9 
 Refused 
 
18.  Over the past 30 days, how often did you typically feel the need to empty your bladder 
during the day? 
 
1 
 More frequently than once an hour 
 
 
 
 
2 
 Once an hour 
 
 
 
3 
 Once every 2 hours  
 
4 
 Once every 3-5 hours 
 
 
 
 
5 
 Only once or twice a day 
8 
 Don’t Know  
9 
 Refused 
 

Roswell Park Protocol No.: I 661820 
10/31/2022 
 
Page 67 of 175 
 
19. Other than being a part of the POW-R Health Program, are you currently following 
any other special diet?  
 
1 
 Yes  
0 
 No 
8 
 Don’t Know 
9 
 Refused 
 
If No, Don’t Know or Refused, go to Question 21. 
 
20. What type of special diet (check all that apply):  
 
1 
 Vegetarian (with fish)  
2 
 Vegetarian (no fish)  
3 
 Vegan (no meat, chicken, fish, dairy, or eggs)  
4 
 Macrobiotic  
5 
 Paleo  
6 
 Gluten-free  
7 
 Atkins 
10 
 Low Carb 
11 
 Other (specify)__________________  
8 
 Don’t Know 
9 
 Refused 
 
21.  Do you currently smoke? 
 
1 
  Yes, every day 
2 
  Yes, some days →  
21a. On how many of the past 30 days did you smoke a 
 
cigarette?    
 
 
 
 
 
 
|__|__| Days   
8 
 Don’t Know 
 
 
 
 
9 
 Refused  
 
22.  On average, how many cigarettes do/did you smoke each day? (Note to interviewer: 1 
pack=20 cigarettes)  
 
|__|__|__| Cigarettes per day  
 
8 
 Don’t Know 
9 
 Refused 
 
23.  Over the last 30 days, how many days per week did you exercise for 20 minutes or 
more? 
 
0 
 None 
1 
 1-2 days 

Roswell Park Protocol No.: I 661820 
10/31/2022 
 
Page 68 of 175 
 
2 
 3-4 days 
3 
 5 or more days 
 
 
24.  Compared to other people your age, how would you rate the level of your usual 
physical activity? (If currently ill, think about your activity during the years before your illness). 
 
1 
 Much more active 
2 
 More active 
3 
 About the same 
4 
 Less active 
5 
 Much less active 
 
 

Roswell Park Protocol No.: I 661820 
 
10/31/2022 
 
Page 69 of 175 
 
DIETARY INTAKE 
 
These next questions are about the fruits and vegetables you ate or drank during the past 30 
days. Please think about all forms of fruits and vegetables including cooked or raw, fresh, frozen 
or canned. Please think about all meals, snacks, and food consumed at home and away from 
home.  
 
25.  
During the past month, how many times per week did you drink 100% PURE fruit 
juices? Do not include fruit-flavored drinks with added sugar or fruit juice you 
made at home and added sugar to. Only include 100% juice.  
 
___ ___ times per week 
 
26.  
During the past month, not counting juice, how many times per week did you eat 
fruit? Count fresh, frozen, or canned fruit.  
 
___ ___ times per week 
 
27.  
During the past month, how many times per week did you eat cooked or canned 
beans, such as refried, baked, black, garbanzo beans, beans in soup, soybeans, 
edamame, tofu or lentils. Do NOT include long green beans.  
 
___ ___ times per week 
 
 
28.  
During the past month, how many times per week did you eat dark green vegetables 
for example broccoli or dark leafy greens including romaine, chard, collard greens 
or spinach?  
 
___ ___ times per week 
 
29.  
During the past month, how many times per week did you eat orange-colored 
vegetables such as sweet potatoes, pumpkin, winter squash, or carrots? (write 
number) 
 
___ ___  
 
30.  
Not counting the vegetables mentioned, about how many times per week did you eat 
OTHER vegetables? Examples of other vegetables include tomatoes, tomato juice or 
V-8 juice, corn, eggplant, peas, lettuce, cabbage, and white potatoes that are not 
fried such as baked or mashed potatoes. (write number) 
 
___ ___ times per week 
 

Roswell Park Protocol No.: I 661820 
 
10/31/2022 
 
Page 70 of 175 
 
 
These next questions are about other vegetables you ate during the past 30 days. Please think 
about all meals, snacks, and food consumed at home and away from home.  
 
 
(Go through table. Frame questions as, “How often did you eat raw arugula? Never, a few 
times per year, once per month, 2-3 times per month, once a week, twice per week, 3-4 times 
per week, 5-6 times per week, or every day.” If they answer never, go to the next vegetable. 
If they ate any amount, ask, “About how much raw arugula did you eat each time? The 
medium serving size is one cup of the vegetable, about the size of a baseball. Lightly cooked 
generally includes stir fry, sauté, microwave, short-term, e.g. less than 10 minutes, steam or 
bake, and thoroughly cooked includes stew, biol, or long-term, e.g. more than 10 minutes, 
steam or bake.)  

Roswell Park Protocol No.: I 661820 
10/31/2022 
 
Page 71 of 175 
 
Vegetables 
 
 
 
 
 
Never 
 
A 
Few 
Times 
Per 
Year  
 
 
Once  
per 
month 
 
 
2-3 
Times 
 per 
month 
 
 
Once 
 per 
week 
 
Twice 
 per 
week 
 
 
3-4 
Times 
per 
week 
 
 
5-6 
Times 
per 
week 
 
 
Every 
day 
How 
much 
each 
time? 
 
S 
 
M 
 
L 
 
Arugula 
 
raw 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
lightly cooked 
(e.g. stir fry) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
thoroughly 
cooked (e.g. 
stew) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Broccoli 
 
 
raw 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
lightly cooked 
(e.g. stir fry) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
thoroughly 
cooked (e.g. 
stew) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Broccoli sprout 
 
 
raw 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
lightly cooked 
(e.g. stir fry) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
thoroughly 
cooked (e.g. 
stew) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Broccolini 
 
 
raw 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
lightly cooked 
(e.g. stir fry) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
thoroughly 
cooked (e.g. 
stew) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Corn 
 
 
raw 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
lightly cooked 
(e.g. stir fry) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
thoroughly 
cooked (e.g. 
stew) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Roswell Park Protocol No.: I 661820 
10/31/2022 
 
Page 72 of 175 
 
Green cabbage 
 
 
raw (e.g. 
coleslaw) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
lightly cooked 
(e.g. stir fry) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
thoroughly 
cooked (e.g. 
stew) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Red/ 
Purple cabbage 
 
 
raw 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
lightly cooked 
(e.g. stir fry) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
thoroughly 
cooked (e.g. 
stew) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Sauerkraut 
 
 
raw 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
lightly cooked 
(e.g. stir fry) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
thoroughly 
cooked (e.g. 
stew) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Carrots 
 
 
raw 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
lightly cooked 
(e.g. stir fry) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
thoroughly 
cooked (e.g. 
stew) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Cauliflower 
 
 
raw 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
lightly cooked 
(e.g. stir fry) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
thoroughly 
cooked (e.g. 
stew) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Brussels sprouts 
 
 
raw 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Roswell Park Protocol No.: I 661820 
10/31/2022 
 
Page 73 of 175 
 
lightly cooked 
(e.g. stir fry) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
thoroughly 
cooked (e.g. 
stew) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Kale 
 
 
raw 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
lightly cooked 
(e.g. stir fry) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
thoroughly 
cooked (e.g. 
stew) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Kohlrabi 
 
 
raw 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
lightly cooked 
(e.g. stir fry) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
thoroughly 
cooked (e.g. 
stew) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Collard greens 
 
lightly cooked 
(e.g. stir fry) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
thoroughly 
cooked (e.g. 
stew) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Peas 
 
 
raw 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
lightly cooked 
(e.g. stir fry) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
thoroughly 
cooked (e.g. 
stew) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Mustard greens 
 
 
raw 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
lightly cooked 
(e.g. stir fry) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
thoroughly 
cooked (e.g. 
stew) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Turnip 
 
lightly cooked 
(e.g. stir fry) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
thoroughly 
cooked (e.g. 
stew) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Roswell Park Protocol No.: I 661820 
10/31/2022 
 
Page 74 of 175 
 
Turnip greens 
 
lightly cooked 
(e.g. stir fry) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
thoroughly 
cooked (e.g. 
stew) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Bok/ Pak choy 
 
 
raw 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
lightly cooked 
(e.g. stir fry) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
thoroughly 
cooked (e.g. 
stew) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Chinese 
cabbage/ Napa 
 
 
raw 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
lightly cooked 
(e.g. stir fry) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
thoroughly 
cooked (e.g. 
stew) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Daikon root 
 
 
raw 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
lightly cooked 
(e.g. stir fry) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
thoroughly 
cooked (e.g. 
stew) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Celery 
 
 
raw 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
lightly cooked 
(e.g. stir fry) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
thoroughly 
cooked (e.g. 
stew) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Garden cress 
 
raw 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
lightly cooked 
(e.g. stir fry) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
thoroughly 
cooked (e.g. 
stew) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Water cress 
 
 
raw 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Roswell Park Protocol No.: I 661820 
10/31/2022 
 
Page 75 of 175 
 
 
 
 
I am now going to ask some questions about sauces and condiments you ate during the past 30 
days. Please think about all meals, snacks, and food consumed at home and away from home.  
 
(Go through table. Frame questions as, “How often did you eat mayonnaise? Never, a few 
times per year, once per month, 2-3 times per month, once a week, twice per week, 3-4 times 
per week, 5-6 times per week, or every day.” If they answer never, go to the next food. If 
they ate any amount, ask, “About how much mayonnaise did you eat each time? The size of 
your thumb from knuckle to tip or less? About two thumbs worth? Or more than 2 thumbs 
worth?” 
 
For horseradish, if they consume any amount, ask, “about how much horseradish did you eat 
each time? Smaller than an egg, about the size of egg, or more than the size of an egg?) 
lightly cooked 
(e.g. stir fry) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
thoroughly 
cooked (e.g. 
stew) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Radicchio 
lightly cooked 
(e.g. stir fry) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
thoroughly 
cooked (e.g. 
stew) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Radishes 
 
raw 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
lightly cooked 
(e.g. stir fry) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
thoroughly 
cooked (e.g. 
stew) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Roswell Park Protocol No.: I 661820 
 
10/31/2022 
 
Page 76 of 175 
 
 
 
Belief into Action Scale 
 
Circle a single number for each question below: 
 
1.  Please circle the highest priority in your life now? (most valued, prized) 
 
 
1. My health and independence 
 
2. My family 
 
3. My friendships 
 
4. Job, career or business 
5. My education 
 
6. Financial security 
7. Relationship with God 
 
8. Ability to travel & see the world 
 
9. Listening to music and partying 
 
10. Freedom to live as I choose 
 
2.  How often do you attend religious services? (circle a number below) 
 
 
 
|--------------|--------------|--------------|--------------|--------------|--------------|--------------|--------------
|--------------| 
1 
       2                 3 
          4 
     5 
 
6 
        7  
   8 
           
9 
     10  
SAUCES AND CONDIMENTS 
 
 
 
 
 
Never 
 
 
A Few 
Times 
Per 
Year 
 
 
Once  
per 
month 
 
 
2-3 
Times 
 per 
month 
 
 
Once 
 per 
week 
 
Twic
e 
 per 
week 
 
 
3-4 
Time
s per 
week 
 
 
5-6 
Time
s per 
week 
 
 
Ever
yday 
 
 
 
Medium 
Serving 
 
Serving 
Size 
 
 
 
 
 
 
 
 
 
 
 
 
S 
 
M 
 
L 
Mayonnaise and 
mayonnaise-type spreads 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2 Tbsp. 
 
 
 
 
 
 
 
Horseradish 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
¼ cup 
 
 
 
 
 
 
 
Mustard 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2 Tbsp. 
 
 
 
 
 
 
 
Wasabi 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2 Tbsp. 
 
 
 
 
 
 
Never 
Rarely 
Couple 
times/yr 
Every 
few mos 
About 
once/mo 
Several 
times/mo
Daily 
More than 
once/wk 
Every 
week 
About 
every wk 

Roswell Park Protocol No.: I 661820 
 
10/31/2022 
 
Page 77 of 175 
 
 
 
3.  Other than religious services, how often do you get together with others for religious 
reasons 
 (prayer, religious discussions, volunteer work, etc.)? 
 
 
 
|--------------|--------------|--------------|--------------|--------------|--------------|--------------|--------------
|--------------| 
1 
       2                 3 
          4 
     5 
 
6 
        7  
   8 
           
9 
     10  
 
 
 
4.  To what extent (on a 1 to 10 scale) have you decided to place your life under God's 
direction? 
 
 
 
|--------------|--------------|--------------|--------------|--------------|--------------|--------------|--------------
|--------------| 
1 
       2                 3 
          4 
     5 
 
6 
        7  
   8 
           
9 
     10  
 
 
5. What percentage of your gross annual income do you give to your religious institution or 
to other religious causes each year? 
 
 
|--------------|--------------|--------------|--------------|--------------|--------------|--------------|--------------
|--------------| 
1 
       2                 3 
          4 
     5 
 
6 
        7  
   8 
           
9 
     10  
6.  On average, how much time each day (in 24 hrs) do you spend listening to religious 
music or radio, or watching religious TV? 
 
 
|--------------|--------------|--------------|--------------|--------------|--------------|--------------|--------------
|--------------| 
1 
       2                 3 
          4 
     5 
 
6 
        7  
   8 
           
9 
     10  
 
 
 
 
 
 
Never 
Rarely 
Couple 
times/yr 
Every 
few mos 
About 
once/mo 
Several 
times/mo
Daily 
More than 
once/wk 
Every 
week 
About 
every wk 
Not at all  
(really haven’t  thought about it) 
To a moderate degree 
Completely, totally 
0% 
Less 
than 1% 
1%–2% 
3%–4% 
5%–6% 
7%–8% 
15% or 
more 
13%–14% 
11%–12%
9%–10%
0 (never) 
1–5 min 
6–10 min 
11–20 min 
21–30 min
31–60 
min 
5 hrs or 
more 
3–4 hrs 
More than 2 hr, 
less than 3 hr 
More than 1 hr, 
less than 2 hr 

Roswell Park Protocol No.: I 661820 
10/31/2022 
 
Page 78 of 175 
 
7.  On average, how much time each day do you spend reading religious scriptures, books, 
or other religious literature? 
 
 
|--------------|--------------|--------------|--------------|--------------|--------------|--------------|--------------
|--------------| 
1 
       2                 3 
          4 
     5 
 
6 
        7  
   8 
           
9 
     10  
 
 
8.  On average, how much time each day do you spend in private prayer or meditation?  
 
 
|--------------|--------------|--------------|--------------|--------------|--------------|--------------|--------------
|--------------| 
1 
       2                 3 
          4 
     5 
 
6 
        7  
   8 
           
9 
     10  
 
 
9. On average, how much time each day do you spend as a volunteer in your religious 
community or to help others for religious reasons? 
 
 
|--------------|--------------|--------------|--------------|--------------|--------------|--------------|--------------
|--------------| 
1 
       2                 3 
          4 
     5 
 
6 
        7  
   8 
           
9 
     10  
 
 
10. To what extent (on a 1 to 10 scale) have you decided to conform your life to the 
teachings of your  
religious faith? 
 
 
 
|--------------|--------------|--------------|--------------|--------------|--------------|--------------|--------------
|--------------| 
1 
       2                 3 
          4 
     5 
 
6 
        7  
   8 
           
9 
     10  
 
_______________________________________________ 
 
 
 
We’re going to finish the survey by asking your opinion about the dietary program you got.  
 
I’m going to read some statements about the dietary program you got. Please let me know 
whether you completely disagree with the statement, disagree with the statement, neither agree 
nor disagree with the statement, agree with the statement, or completely agree with the 
statement. 
 
0 (never) 
1–5 min 
6–10 min 
11–20 min 
21–30 min
31–60 
min 
5 hrs or 
more 
3–4 hrs 
More than 2 hr, 
less than 3 hr 
More than 1 hr, 
less than 2 hr 
0 (never) 
1–5 min 
6–10 min 
11–20 min 
21–30 min
31–60 
min 
5 hrs or 
more 
3–4 hrs 
More than 2 hr, 
less than 3 hr 
More than 1 hr, 
less than 2 hr 
0 (never) 
1–5 min 
6–10 min 
11–20 min 
21–30 min
31–60 
min 
5 hrs or 
more 
3–4 hrs 
More than 2 hr, 
less than 3 hr 
More than 1 hr, 
less than 2 hr 
Not at all  
(really haven’t  thought about it) 
To a moderate degree 
Completely, totally 

Roswell Park Protocol No.: I 661820 
10/31/2022 
 
Page 79 of 175 
 
 
Completely 
disagree 
Disagree 
Neither 
agree nor 
disagree 
Agree 
Completely 
agree 
1. The diet program I received met my 
approval. 
 
 
 
 
 
2. The diet program I received was 
appealing to me. 
 
 
 
 
 
3. I liked the diet program I received. 
 
 
 
 
 
4. I welcomed the diet program I received. 
 
 
 
 
 
 
 
 
Completely 
disagree 
Disagree 
Neither 
agree nor 
disagree 
Agree 
Completely 
agree 
1. The diet program I received fit into my 
lifestyle. 
 
 
 
 
 
2. The diet program I received was suitable 
to my lifestyle. 
 
 
 
 
 
3. The diet program I received was 
applicable to my lifestyle. 
 
 
 
 
 
4. The diet program I received was a good 
match with my lifestyle. 
 
 
 
 
 
 
Feasibility of Intervention Measure (FIM) 
 
 
Completely 
disagree 
Disagree 
Neither 
agree nor 
disagree 
Agree 
Completely 
agree 
1. The diet program I received was 
implementable in my life. 
 
 
 
 
 
2. The diet program I received was possible 
to do in my life. 
 
 
 
 
 
3. The diet program I received was doable. 
 
 
 
 
 
4. The diet program I received was easy to 
use. 
 
 
 
 
 
 
If you are a part of Group A, there are a few feedback questions we would like to ask you at this 
time, is this okay? 
 
 If you are a part of Group B, you have finished the survey! Thank you so much for your time. 
Do you have any questions? Again, thank you for your participation in POW-R Health!  
 
 
 

Roswell Park Protocol No.: I 661820 
10/31/2022 
 
Page 80 of 175 
 
Appendix G2. POW-R Participant Additional Questions to Follow-Up Questionnaire 
 
These questions will be given to those in the cruciferous arm only. 
 
Thank you so much for being a part of the POW-R study. The program you went through 
consisted of a mailed magazine, a phone call with one of our Roswell staff, and then 11 
automated phone calls.  We would like to ask the feedback questions regarding the study at this 
time. 
1. What did you think about the magazine? 
a. What did you like about it? 
b. What would you change? 
 
2. What did you think about the phone call with the Roswell staff person? 
a. What did you like about it? 
b. What would you change? 
 
3. What did you think of the 11 automated calls? 
a. What did you like about it? 
b. What would you change? 
 
4. What do you think having this program as a phone app?  
 
You have finished the survey! Thank you so much for your time. Do you have any questions? 
Again, thank you for your participation in POW-R Health!  
 
 

Roswell Park Protocol No.: I 661820 
 
10/31/2022 
 
Page 81 of 175 
 
Appendix H New York State Cancer Registry Contact Materials and Procedures 
 
POW-R Health: Power to Redefine your Health Program 
NYS Cancer Registry Patient Contact and Data Handling Procedures 
 
The procedures described in this document are standard procedures the New York State Cancer 
Registry (NYSCR) follows for patient contact studies.  
 
I.  Approval Process 
 
1. Roswell Park Cancer Institute IRB approval  
2. NY State Health Department Administrative approval 
 
II. NYSCR Patient Consenting Process (i.e., physician notification and patient consent to 
release name, contact information, and diagnostic information to Roswell Park Cancer 
Institute) 
 
Using ICD-O-3 codes provided in the study protocol, the NYSCR will conduct a search of its 
database to identify eligible patients who were diagnosed with stage Tis, Ta, or T1 bladder 
cancer in 2018 or later, who resided in one of eight counties of interest at diagnosis (Niagara, 
Orleans, Genesee, Erie, Wyoming, Chautauqua, Cattaraugus, and Allegany), who are 18 years of 
age or older, who did not receive a cystectomy, who did not have a prior cancer diagnosis within 
12 months of their bladder cancer diagnosis, who did not have a subsequent more advanced 
bladder cancer diagnosis, and who have not died or opted out of research studies. This search 
will be repeated if needed until the recruitment goal is reached. The NYSCR will contact 
reporting facilities to obtain the patients’ physician information, if missing in the database.  
 
The NYSCR will send a letter to the physician of record for selected cases notifying him/her that 
the patient was identified for the study, requesting that the NYSCR be notified if the patient is 
deceased, too ill or otherwise unable or ineligible to participate in the study, and requesting 
information about the case’s primary care physician if different from the contacted physician. 
The physician will have three weeks to respond. 
 
If no contraindication is received from the physician or if the physician has not responded within 
three weeks, the NYSCR will send an informational packet to the patient. The packet will 
contain: 1) a letter explaining the study and requesting permission to release their name, contact 
information, and diagnostic information to the study’s principal investigator at Roswell Park 
Cancer Institute; 2) a participant information sheet; and 3) a release of information consent form. 
If the NYSCR has not received any response after two weeks a reminder packet of information 
will be sent. Again, if no response is forthcoming after two more weeks, five telephone calls will 
be attempted by the NYSCR (three during regular business hours, and two during non-business 
hours) to describe the study and receive a response (either consent or refusal). If the patient 
consents verbally, NYSCR staff will fill out the consent form and document that the consent was 
obtained via phone. If the Registry is unable to contact the patient via telephone, and no written 
response has been received, no other contact will be attempted, and the patient will be considered 
a refusal.  
 

Roswell Park Protocol No.: I 661820 
10/31/2022 
 
Page 82 of 175 
 
Upon receipt of the consent form, the patient’s name, contact information, and diagnostic 
information will be provided by the NYSCR to the study’s principal investigator at Roswell Park 
Cancer Institute via Roswell’s secure File Transfer Solution (sFTP). The NYSCR will receive a 
unique user name and password in separate emails to transfer the data via sFTP.  
 
 
III. Roswell Park Patient Contact Procedures 
 
Upon receipt of the patient information from the NYSCR, the Roswell Park research team will 
contact the patient by telephone. All members of the Roswell Park research team will have 
completed Collaborative Institutional Training Initiative (CITI training). If the patient is not 
reached during the first attempt, the research team will make additional attempts using the 
following algorithm: five additional attempts at varying dates and times, for a total of six 
attempts over three weeks. Each attempt will be documented in the call manager portion of the 
Electronic Data Capture system. After all phone attempts are exhausted, a traceable Hard to 
Reach Letter will be mailed to the patient’s address listed in the patient profile. The patient will 
be asked to contact the Roswell Park research team if they are interested in learning more about 
the study.  
 
Upon contact with the patient, the Roswell Park research team member will again explain the 
study, administer the screening interview, and obtain consent for the patient’s participation.  The 
Roswell Park research team will record the patient’s real time responses in the corresponding 
Patient Phone Screening Interview Form in the Electronic Data Capture system. The patient will 
be mailed a consent form for them to keep. For respondents who do not wish to participate, the 
telephone contact will be terminated, and they will be ineligible for the study. Information on 
non-participants will be provided to the NYSCR, as well as any information for any individuals 
who indicate that they do not want to be contacted about any future research studies.  
 
 
IV. Data Handling, Dissemination and Storage Procedures 
 
After receipt of the patient information from the NYSCR, the data will be entered and stored in 
REDCap. REDCap is a secure application supported by Partners Research Computing, 
Enterprise Research Infrastructure & Services (ERIS). ERIS has all the necessary physical and 
operational securities in place to meet or exceed Federal and State security and privacy 
regulations for data transmission and storage using REDCap. The dataset containing patient 
contact information will be separated from the research dataset including survey data and urine 
sample tracking data. The data will only be accessed by key members of the Roswell Park 
research team who are in charging of contacting patients. All the data communications between 
NYSCR and Roswell Park will be transferred via Roswell’s secure File Transfer Solution 
(sFTP). A unique username and password will be used for each data transfer and sent in separate 
emails.  
 
 

Roswell Park Protocol No.: I 661820 
 
10/31/2022 
 
Page 83 of 175 
 
 
 
Exhibit A 
 
 
The following information will be provided to Roswell Park for each bladder cancer case 
identified for possible inclusion in the study: 
 
1. Reporting source 
2. Patient name 
3. Patient address and telephone number 
4. Physician name and contact information 
5. Basic demographic information (race, ethnicity, date of birth, county of residence) 
6. Primary site 
7. Summary stage 
8. Histology 
9. Laterality 
10. Date of diagnosis 
11. Age at diagnosis 
12. First course of treatment 
13. Primary surgical procedure 
14. Chemotherapy 
15. Date of last contact 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Roswell Park Protocol No.: I 661820 
10/31/2022 
 
Page 84 of 175 
 
Materials used by the New York State Cancer Registry for the  
POW-R Health: Power to Redefine your Health Program  
[Letter from NYS Cancer Registry to Physician] 
 
Month, Day, Year 
 
 
{Physician Name} 
{Physician Address} 
{Physician City, State Zip} 
 
Dear Dr. “M.D._LAST NAME”: 
 
We are writing to inform you that the New York State Department of Health’s Cancer 
Registry is collaborating with Roswell Park Comprehensive Cancer Center on a pilot 
study of a dietary intervention with a goal to reduce the risk of recurrence in 
individuals diagnosed with non-muscle invasive bladder cancer. Patients diagnosed 
with non-muscle invasive bladder cancer (including Tis, Ta, and T1 disease) who did 
not receive cystectomy and who live in the counties of Niagara, Orleans, Genesee, 
Erie, Wyoming, Chautauqua, Cattaraugus, and Allegany may be eligible for the study.  
 
Our records show that one of your patients was recently diagnosed with bladder 
cancer and meets the study criteria. The patient’s name and other identifying 
information reported to the Cancer Registry are on the enclosed form. We would like 
to contact your patient to assess their interest in participating in the study.   
 
Patients will be sent an introductory letter describing the study and requesting their 
consent for their name, contact information, and some information about their 
diagnosis to be shared with Roswell Park Comprehensive Cancer Center. Patients 
who consent will be contacted by phone regarding participation in the study. Patient 
participation in the study includes participation in a 6-month phone-based dietary 
intervention that will consist of educational materials mailed to the patient’s home, 
one 20-minute phone call with Roswell Park staff to go over the educational 
materials, and 11 automated telephone calls asking participants to report the number 
of vegetable servings they have consumed in the prior week, followed by tailored 
feedback based on the servings reported. Patients will also be asked to complete two 
assessments, one at the beginning of the study, and one at the end. These 
assessments will include a 45-60-minute phone survey, self-collection of a urine 
sample, and three 24-hour dietary recalls. All information that could identify the 
patient will be kept confidential. Names and other identifying information will not be 
used in any publication about the study. 
 
If you do not object to our contacting your patient, you do not need to do anything 
further. However, there may be some reason why your patient cannot or should not 
be contacted about   

Roswell Park Protocol No.: I 661820 
10/31/2022 
 
Page 85 of 175 
 
participation in this study; therefore, we would like to hear from you within the next 
three weeks if you prefer that we do not contact your patient. 
 
If you prefer that we do not contact your patient please complete the enclosed form 
and fax it to “Attn: bladder cancer study” at (518) 473-6789 or mail it back to us in the 
enclosed self-addressed, stamped envelope. If you have any questions about the 
study or the form, please contact Dr. Maggie Kuliszewski at the New York State 
Cancer Registry at (518) 474-2255. Thank you very much for your assistance. 
 
Sincerely, 
 
 
    
Maria J. Schymura, Ph.D.  
Director, New York State Cancer Registry 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Roswell Park Protocol No.: I 661820 
10/31/2022 
 
Page 86 of 175 
 
New York State Cancer Registry 
POW-R Health: Power to Redefine your Health Program 
 
Patient Information Sheet for Physician 
 
Name of Physician 
Address 
Address 
Address 
Telephone number 
 
If information below is incorrect please provide correct information. 
Patient Name  
 
 
 
 
 
 
 
 
Patient Address 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
Telephone number 
 
 
 
 
Patient DOB______________  Sex________ 
 
Race_____ 
 
Diagnosed with non-muscle invasive Tis, Ta, or T1 bladder cancer?          
Yes _____   
No _____   
If yes, date first diagnosed__________________________________________________ 
 
Any medical contraindications to patient contact for the study?  Yes_____   No_____ 
If yes, please explain_______________________________________________________ 
________________________________________________________________________ 
 
 
 
Physician signature_____________________________________ Date_______________ 
 
Please fax the completed form to “Attn: bladder cancer study” at (518) 473-6789. Or mail the 
form in the enclosed self-addressed, stamped envelope to: 
 
POW-R Health: Power to Redefine your Health Program, New York State Cancer Registry, 
NYS Department of Health, Suite 361, Riverview Center, 150 Broadway, Albany, NY 12204  
 
Thank you for your assistance. 
 
Date sent  
 
 
  

Roswell Park Protocol No.: I 661820 
10/31/2022 
 
Page 87 of 175 
 
[Letter from NYS Cancer Registry to Patient] 
{Patient Name} 
{Patient Street Address} 
{Patient City, State, ZIP} 
 
Dear ________________: 
 
The New York State Department of Health’s Cancer Registry is contacting patients who may 
be eligible for a research study. The study is being done in collaboration with researchers at 
Roswell Park Cancer Institute. The purpose of the study is to learn more about how diet may 
reduce the risk of recurrence in individuals with early-stage bladder cancer. Men and women 
who were recently diagnosed with early-stage bladder cancer and who live in the counties of 
Niagara, Orleans, Genesee, Erie, Wyoming, Chautauqua, Cattaraugus, and Allegany may be 
eligible for the study.  
 
Under New York State Public Health Law, hospitals and doctors must report all cases of 
cancer that they find to the New York State Cancer Registry. This is how we learned about 
your diagnosis. 
 
Please take the time to read the enclosed information about this study. We would like to send 
your name, contact information, and some information about your diagnosis to researchers at 
Roswell Park Cancer Institute, so that they can contact you to see if you are eligible for the 
study and interested in participating. However, we need your consent in order to release your 
name and contact information. Please fill out the enclosed consent form to let us know if we 
can share your information with Roswell Park Cancer Institute.  
  
Please mail the completed consent form back to us in the enclosed self-addressed, stamped 
envelope. If we do not receive the form, someone from our office will call you to make sure 
you received this letter and to discuss the study with you.   
 
If you have any questions about this study, please call Dr. Maggie Kuliszewski at the New 
York State Cancer Registry at (518) 474-2255.  
 
 
 
 
 
 
 
If you have any questions about your rights as a participant in this study or think you have 
been harmed by the study, please contact Mr. Tony Watson, the Administrator of the 
Institutional Review Board at the New York State Department of Health at (518) 474-8539. 
 
We greatly appreciate your help with this study. 
 
 
Sincerely,  
 
 
Dr. Maria Schymura, Director 
New York State Cancer Registry 

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Enclosures 
 
POW-R Health: Power to Redefine your Health Program New York State Department of 
Health Cancer Registry 
 
Participant Information Sheet 
 
 
The New York State Department of Health’s Cancer Registry and Roswell Park Cancer 
Institute are collaborating on a research study of individuals with bladder cancer in New York 
State. The purpose of the study is to better understand how diet may reduce the risk of 
recurrence in men and women diagnosed with early-stage bladder cancer. 
 
Procedure:  A researcher from Roswell Park Cancer Institute will contact you to see if you are 
eligible for the study and would like to participate. If you decide to participate, you will 
receive a 6-month dietary intervention that may improve your health. The intervention will 
include educational materials mailed to your home, a 20-minute phone call with Roswell Park 
staff to go over the educational materials, and 11 automated phone calls that will give you 
feedback on your diet based on how many vegetables you report eating during the past week. 
To see if our dietary intervention improves health, we will also ask you to complete two 
assessments, one at the beginning of the study, and one at the end of the study. The 
assessment will include a 45-60-minute survey, a self-collected urine sample, and three 
dietary recalls. Individuals who are eligible for and participate in the study will receive up to 
$200 in gift cards at a local retail store as a token of appreciation for their participation. 
 
Voluntary Participation: Taking part in this study is up to you. You may stop taking part at 
any time. You may refuse to answer any question. If you decide not to take part, you will not 
lose any benefits that you would normally receive.   
  
Confidentiality:  We will keep all of your answers and health information private, as required 
by law. If you decide to participate in the study, we will assign a code to you and use the code 
instead of your name. Any records that include your name and could link you to the coded 
information will be kept in electronic files accessible only to assigned study staff and will be 
password-protected on the computer. Access will be allowed only to the researchers involved 
in the study who have signed a confidentiality agreement. Your name and other identifying 
information will not appear in any reports of this study. Your address will not be used to send 
any additional promotional information whatsoever.   
 
Benefits:  You may or may not benefit from the study intervention. Information about your 
experience in the study may contribute to our understanding of factors that reduce the risk of 
recurrence of early-stage bladder cancer and may help other people in the future.   
 
Risks:  There are no known risks to being part of this study. Talking about your health and 
your bladder cancer diagnosis may cause you some stress. There is also the potential (but 
unlikely) loss of confidentiality regarding your responses to questions. We have many 
procedures in place to prevent this. Please see the above section on confidentiality.  

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Questions about the Study:   
If you have any questions about this study, please call Dr. Maggie Kuliszewski at the New 
York State Cancer Registry at (518) 474-2255.  
  
 
 
 
 
 
 
 
 
 
If you have any questions about your rights as a participant in this study or think you have 
been harmed by the study, please contact Mr. Tony Watson, the Administrator of the 
Institutional Review Board at the New York State Department of Health at (518) 474-8539. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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[NYS CANCER REGISTRY PATIENT CONSENT FORM]  
 
INFORMED CONSENT FOR FURTHER CONTACT 
POW-R Health: Power to Redefine your Health Program 
 
I understand that by checking the first statement and by signing this form below I am agreeing 
to allow the New York State Cancer Registry to release my name, contact information, and 
some information about my bladder cancer diagnosis to Roswell Park Cancer Institute.   
 
Please check one of the following statements.  Please sign and return in the enclosed 
envelope. 
 
 
1.  
 
 I consent to the release of my name, contact information, and some 
information about my bladder cancer diagnosis to Roswell Park Cancer Institute. I understand 
that a researcher from that organization will contact me to see if I am eligible for the study and 
would like to participate. 
 
 
Name (please print) 
 
 
 
 
 
 
 
 
Signature  
 
 
 
 
 
 
 
Address 
 
 
 
 
 
 
Telephone #  
 
 
 
 
 
 
Date 
 
 
 
 
 
 
 
 
 
 
 
 
 
2.  
 
 I do not consent to the release of my name, contact information, or 
information about my bladder cancer diagnosis to Roswell Park Cancer Institute. I do not 
want anyone from that organization to contact me.  
 
 
(Name of patient pre-printed on the bottom – in case above is illegible) 
 
 
 
 

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STATEMENT TO BE READ REGARDING THE STUDY PURPOSE, PROCEDURES 
INVOLVED, RISKS AND BENEFITS INVOLVED, AND CONFIDENTIALITY 
NYS Cancer Registry Patient Contact – (if mailed response was not obtained) 
 
Hello, my name is                                 .  May I please speak with ______________________)?  
 
I’m from the New York State Department of Health’s Cancer Registry. We’re collaborating with 
Roswell Park Cancer Institute on a research study of individuals with bladder cancer in New 
York State. The purpose of the study is to better understand how diet may reduce the risk of 
recurrence in men and women diagnosed with early-stage bladder cancer. Men and women who 
were recently diagnosed with early-stage bladder cancer and who live in the counties of Niagara, 
Orleans, Genesee, Erie, Wyoming, Chautauqua, Cattaraugus, and Allegany may be eligible for 
the study. Recently, we sent you a letter asking for your consent for us to share your name, 
contact information, and some information about your bladder cancer diagnosis with Roswell 
Park Cancer Institute. Did you receive the letter? 
  
IF “YES”, PROCEED WITH SCRIPT BELOW. 
IF “NO”, ASK IF THEY WOULD LIKE TO CONTINUE OR HAVE YOU SEND ANOTHER 
LETTER.  
IF “ANOTHER LETTER”, VERIFY ADDRESS.  
IF “CONTINUE”, PROCEED WITH SCRIPT BELOW. 
 
As the letter explains, the purpose of the study is to better understand certain factors that may 
reduce the risk of recurrence in men and women diagnosed with early-stage bladder cancer. If 
you consent for us to share your name and contact information with Roswell Park Cancer 
Institute, a researcher will contact you to see if you are eligible for the study and would like to 
participate. If you decide to participate, you will receive a 6-month dietary intervention that may 
improve your health. The intervention will include educational materials mailed to your home, a 
20-minute phone call with Roswell Park staff to go over the educational materials, and 11 
automated phone calls that will give you feedback on your diet based on how many vegetables 
you report eating during the past week. To see if our dietary intervention improves health, we 
will also ask you to complete two assessments, one at the beginning of the study, and one at the 
end of the study. The assessment will include a 45-60-minute survey, a self-collected urine 
sample, and three dietary recalls.  
 
Taking part in this study is up to you. You may stop taking part at any time. You may refuse to 
answer any question. If you decide not to take part, you will not lose any benefits that you would 
normally receive. Individuals who are eligible for and participate in the study will receive up to 
$200 in gift cards at a local retail store as a token of appreciation for their participation. 
 
All of your answers will be kept private as required by law. All records that include your name 
will be kept in locked file cabinets. All records on the computer will be password-protected. 
Access will be allowed only to the researchers involved in the study. Your name and other 
identifying information will not appear in any reports of this study.  
 

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You may or may not benefit from the study intervention. Information about your experience in 
the study may contribute to our understanding of factors that reduce the risk of recurrence of 
early-stage bladder cancer and may help other people in the future. There are no known risks 
from being a part of the study. Talking about your health and your bladder cancer diagnosis may 
cause you some stress. There is also the potential (but unlikely) loss of confidentiality regarding 
your responses to questions. We have many procedures in place to prevent this.  
 
If you have any questions about this study, please call Dr. Maggie Kuliszewski at the New York 
State Cancer Registry at (518) 474-2255. 
  
 
 
 
 
 
 
 
 
If you have any questions about your rights as a participant in this study or think you have been 
harmed by the study, please contact Mr. Tony Watson, the Administrator of the Institutional 
Review Board at the New York State Department of Health at (518) 474-8539. 
 
Do you consent to the release of your information to Roswell Park Cancer Institute?  If so, 
someone from that organization will contact you by phone.   
 
CHECK THE APPROPRIATE RESPONSE BOX ON THE PATIENT CONSENT FORM. 
SIGN AND DATE THE FORM IN THE BLANK SPACE ABOVE THE PATIENT    
SIGNATURE LINE AND ADD “BY TELEPHONE” AFTER THE DATE. 

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Appendix I 
Physician Interview Guide 
 
Physician Semi-Structured Interview 
 
To be administered right after verbal consent.  
Thank you for agreeing to be a part of this study.  
Our dietary intervention consists of giving bladder cancer patients 3 things: 1) educational 
materials by mail, 2) One 20 minute phone call with a trained staff member to go over the 
educational materials, and 3) 11 automated phone calls that ask patients to report the servings of 
vegetables they ate in the previous week, with automated feedback based on the number of 
servings reported.  
If our study shows that this intervention significantly reduces bladder cancer recurrence in 
bladder cancer patients: 
 
1. To what extent would you welcome such an intervention? 
 
Probe: What would make you like this intervention more?    
2. To what extent would you think the intervention would be a good match for your clinic? 
 
Probe: What would make this intervention fit better within your clinic? 
3. To what extent do you think the intervention would be doable in your clinic? 
 
Probe: What would make this intervention easier for your clinic to use?  
 
 
That concludes the interview. Thank you so much for your time. 
 

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Appendix J 
Physician Research Study Information Sheet for Structured Interviews 
 
Please keep a copy of this form for your reference. 
 
I am (fill in name/role), with the Division of Prevention & Population Sciences at Roswell Park 
Comprehensive Cancer Center. I am working with a team at Roswell Park to learn about the 
barriers and facilitators of intervention implementation within clinical practice. The goal is to 
gain feedback and develop the intervention for “real-world’ implementation. 
 
To accomplish this, we would like to conduct a semi-structured interview with a total of 20 
physicians or health care providers within the area in Western New York. This study is funded 
by the National Cancer Institute. 
 
I would like to tell you more about it before you decide whether or not to participate in this one-
time interview study. Please stop me at any time if you have any questions. Your participation is 
completely voluntary; you do not have to participate. 
 
During the interview, I will provide you with a brief overview of our dietary intervention for 
bladder cancer patients. I will then ask questions regarding facilitators and barriers of 
intervention adoption within clinical practice. I will ask your opinion on the needed 
implementation strategies to sustain the intervention, in addition to intervention modifications to 
maximize sustained clinic adoption. The interview should last approximately 15 minutes. I may 
ask your permission to electronically record the discussion so we can capture information 
accurately. If you object to electronically recording the conversation, please let me know now. 
 
This information will be collected anonymously (without linking it to your name or identity, or 
identifying any patients; all data will be aggregated). We will not be using your name on any of 
the forms or any information that is gathered.  
 
Your involvement in this study does not involve any physical risk to you. The possible risks 
include feeling uncomfortable answering questions, embarrassment, or someone identifying you 
as a participant in the project, although this would be rare. You will not receive any direct health 
benefit from participating in this study. 
 
Participants that complete the interview will receive a $100 gift card to a local retail store. 
 
You do not have to take part in this one-time contact research study. If you decide to participate, 
you can stop your participation at any time. You may refuse to answer any questions and you 
may leave at any time.   
 
Results of this study will yield important information on the feasibility of a dietary behavioral 
intervention to improve bladder cancer outcomes among bladder cancer patients. These results 
have the potential to improve the survivorship outcomes of a group at elevated risk of cancer 
recurrence, as well as for teaching, for research, for scientific publications and/or for 
presentations at scientific meetings. You will not be identified in any way. Your participation is 
completely anonymous because I am not collecting your name (or taking photographs of you).  

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If you have any questions, you are free to ask them now. If you have questions or concerns about 
the study at any time, you can call the Roswell Park Office of Research Subject Protection at 
(716) 845-3455.  You may contact me at the telephone number I will provide in a few minutes. 
This study has been reviewed and approved by the Roswell Park Institutional Review Board. 
 
CONTACT INFORMATION: 
 
If you have any questions about this study, you may contact me: 
 
Cassy Dauphin 
Roswell Park Comprehensive Cancer Center 
Elm & Carlton Streets 
Buffalo, NY 14263 
716-845-8319 
 
Or you may contact the Principal Investigator, who is the Director of this study: 
 
Karen Yeary, PhD 
Roswell Park Comprehensive Cancer Center 
Elm & Carlton Streets 
Buffalo, NY 14263 
716-845-1300 Ext 6231 
 
Li Tang, PhD 
Roswell Park Comprehensive Cancer Center 
Elm & Carlton Streets 
Buffalo, NY 14263 
716-845-8247 
 
 
 
 
 
 
 
 

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Appendix K Community Advisory Board (CAB) Research Study Information Sheet 
 
 
Please keep a copy of this form for your reference.  
 
I am (fill in name/role), with the Division of Cancer Prevention and Control at Roswell Park 
Comprehensive Cancer Center. I am working with a team at Roswell Park to adapt materials and 
methods from current evidence-based fruit and vegetable interventions in order to develop a dietary 
intervention for bladder cancer survivors. The goal is to gain feedback and develop the intervention for 
“real-world” implementation. This study is funded by the National Cancer Institute. 
 
I would like to tell you more about it before you decide whether or not to participate. Please stop me at 
any time if you have any questions. Your participation is completely voluntary; you do not have to 
participate. 
 
In this study, you will be asked to attend three meetings (in person or virtual) as a Community Advisory 
Board (CAB) member to help develop a dietary intervention that will be relevant for bladder cancer 
survivors.  You will be asked to review intervention materials and messages and provide feedback for 
improvements. We will also ask you some demographic questions. Each meeting will last approximately 
90 minutes. We may ask your permission to electronically record the discussion so we can capture 
information accurately. If you object to electronically recording the conversation, please let us know. 
 
This information will be collected anonymously (without linking it to your name or identity or identifying 
any patients; all data will be aggregated). We will not be using your name on any of the forms or any 
information that is gathered.  
 
Your involvement in this study does not involve any physical risk to you. The possible risks include feeling 
uncomfortable answering questions, embarrassment, or someone identifying you as a participant in the 
project, although this would be rare. You will not receive any direct health benefit from participating in this 
study. 
 
CAB members will be asked to complete a structured 60 minute interview, will receive $50 for interview, 
compensated  $100 per meeting attended, up to three meetings, and interviews will be conducted over 
the phone. 
 
You do not have to take part in this one-time contact research study. If you decide to participate, you can 
stop your participation at any time. You may refuse to answer any questions and you may leave at any 
time.   
 
Results of this study will yield important information on the feasibility of a dietary behavioral intervention to 
improve bladder cancer outcomes among bladder cancer patients. These results have the potential to 
improve the survivorship outcomes of a group at elevated risk of cancer recurrence, as well as for 
teaching, for research, for scientific publications and/or for presentations at scientific meetings. You will 
not be identified in any way. Your participation is completely anonymous because I am not collecting your 
name (or taking photographs of you).  
 
If you have questions or concerns about the study at any time, you can call the Roswell Park Office of 
Research Subject Protection at (716) 845-3455.  You may contact me at the telephone number I will 
provide in a few minutes. This study has been reviewed and approved by the Roswell Park Institutional 
Review Board. 
 

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CONTACT INFORMATION: 
 
If you have any questions about this study, you may contact me: 
 
Nikia Clark 
Roswell Park Comprehensive Cancer Center 
Elm & Carlton Streets 
Buffalo, NY 14263 
716-845-4888 
 
Or you may contact the Principal Investigators, who are the Directors of this study: 
 
Karen Yeary, PhD 
Roswell Park Comprehensive Cancer Center 
Elm & Carlton Streets 
Buffalo, NY 14263 
716-845-1300 Ext 6231 
 
Li Tang, PhD 
Roswell Park Comprehensive Cancer Center 
Elm & Carlton Streets 
Buffalo, NY 14263 
716-845-8247 

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Appendix L Bladder Community Advisory Board (CAB) Interview Guide 
Thank you for being willing to be a part of helping us make a healthy eating program for bladder 
cancer survivors to improve their health. We’re going to start by asking some questions about 
you.  
1. (Administer demographic survey, page 2) 
 
2. When were you first diagnosed with bladder cancer? 
o What type of treatment did you receive after your bladder cancer diagnosis?  
o How long did the treatment last? 
3. Have you had any recurrence since your initial bladder cancer diagnosis?  
o If yes, when did it happen and what treatment did you receive? 
4. What is the biggest concern you have regarding your bladder cancer diagnosis? 
5. Since your bladder cancer diagnosis, did you change your eating habits?  
o If yes, how did you change your eating habits?  
6. Do you think what you eat can make a difference in terms of bladder cancer prevention or 
recurrence?  
o If yes, how?  
7. Recent research has shown that eating more cruciferous vegetables can reduce the 
chances of bladder cancer coming back in bladder cancer survivors. Cruciferous 
vegetables include broccoli, arugula, brussels sprouts, green or white cabbage, and 
turnips.   
o What do you think about this information? Is this helpful? Have you heard this 
before? 
8. In your day-to-day life, what might make it easier for you to eat more cruciferous 
vegetables?  
o Probes: Help from your family, help from the healthcare system, help from 
friends, any particular information 
9. Who does most of the shopping for food in your family? 
o If self: What affects the kinds or amount of vegetables you buy? 
o If not self: What role do you play in what they shop for?  
10. Who does most of the planning or preparing of meals in your family? 
o If not self: What role do you play in how meals are planned or prepared? 
11. How do other people in your life impact the kinds and amounts of vegetables you eat?  
 
 
 
 
 
 
 
 
 
 

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Demographic Survey 
 
 
• Are you male or female? 
1   Male 
 
2   Female 
 
• Are you Hispanic or Latino/a or Spanish in origin?  
1  Yes  
 
 
Are you:  
 
1  Mexican, Mexican American, Chicano/a 
 
 
(circle all that apply) 2  Puerto Rican 
 
 
 
 
 
3  Cuban 
 
 
 
 
 
4  Another Hispanic, Latino/a, or Spanish origin 
2  No  
 
•  Which one or more of the following would you say is your race? (Circle all that 
apply)  
1  White  
2  Black or African American  
3  American Indian or Alaska Native  
4  Asian 
5  Other (please specify)___________________ 
 
• How old are you? 
 
____________ years 
 
• What is your marital status?  
1   Married 
 
2   Living as married 
3   Divorced 
4   Widowed 
5   Separated 
6   Single, never been married 
 
• What is the highest grade or level of schooling you completed?  
1   Less than 8 years 
2   8-11 years 
3   12 years or completed high school 
4   Post high school training other than college (vocational or technical) 
5   Some college 
6   College graduate 
7   Postgraduate  
 
• What is your occupational status?  
1   Employed  

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2   Unemployed 
3   Homemaker  
4   Retired  
5   Disabled   
6   Other (Specify)_____________________ 
 
• How many people currently live in your home (include yourself)? _______ 
 
• In the past 12 months, have you received food stamps, also called SNAP, the 
Supplemental Nutrition Assistance Program on an EBT card? 
1   Yes  
2   No 
3   Don’t know 
 
• Do you have any kind of health care coverage, including health insurance, prepaid 
plans such as HMOs or government plans such as Medicare, or Indian Health 
Service? 
1   Yes (if yes, go to 11a) 
2   No 
 
11a. What is the primary source of your health care coverage?  
    
35. 
A plan purchased through an employer or union (including plans 
purchased through another person’s employer) 
36. 
A plan that you or another family member buys on your own 
37. 
Medicaid (primarily for people over age 65) or other state program 
38. 
Medicare 
39. 
TRICARE (formerly CHAMPUS), VA, or Military 
40. 
Alaska Native, Indian Health Service, Tribal Health Service 
41. 
Some other source 
 
I’m going to read you several statements that people have made about their food situation. For 
these statements, please tell me whether the statement was often true, sometimes true, or never 
true for (you) in the last 12 months—that is, since last (name of current month). The first 
statement is: 
 
• “The food that I bought just didn’t last, and I didn’t have money to get more.” Was 
that often, sometimes, or never true for you in the last 12 months?  
1  Often true  
2  Sometimes true  
3  Never true  
4  DK or Refused  
 
•  “I couldn’t afford to eat balanced meals.” Was that often, sometimes, or never true 
for you in the last 12 months?  
1  Often true  

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2  Sometimes true  
3  Never true  
4  DK or Refused  
 
 
 
 
 

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Appendix M Participant 24-hour Dietary Recall Instructions 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
What’s a 24-Hour Recall? 
 Scheduling the Calls  
Measuring Tips 
24-Hour Recalls 
 
 
 
24-hour recalls are 
a way of figuring out 
what you usually 
eat and drink.  We 
will 
get 
this 
information through talking to you on the 
telephone, where we will ask you to 
remember what you ate and drank during 
the previous day.   
 
The telephone recalls will occur on 3 
separate days at the start of the study, 
and 3 separate days at the end of the 
study. The days will be selected at 
random so that weekdays (Monday 
through Thursday) and one weekend day 
(Friday through Sunday) is included. This 
will help us figure out your average diet.  
 
 
 
A person from Roswell Park Cancer 
Institute, Buffalo, NY will be calling you to 
do the recalls. They will call you during 
the times you said would work best with 
your schedule when you signed up to be 
a part of the study. At this time, they will 
call and ask you for details of everything 
-- all foods and liquids (including water) -
- that you ate or drank during the past 24 
hours from midnight to midnight of the 
previous day.  
 
The person will ask you the amount you 
actually ate or drank, not how much was 
put into the dish, cup, or bowl. Please use 
the “Food Amounts Booklet” that we 
sent you with this sheet. The following 
tips will also help you estimate how much 
you eat and drink. 
 
 
 
 
 
   
 
Use measuring cups
and spoons to help you
tell the Roswell person
the exact amount you ate
or drank. 
 
Instead of telling the
Roswell person you had breakfast cereal,
give more details like: 1 cup of wheat
flakes with 1/2 cup of lowfat milk, and 1/2
of a large (8-inch) banana. 
 
▪ Measure the volume of dishes, bowls,
cups, and glasses that you use a lot.
This will help you to figure out and
report 
the 
correct 
volume 
of
food/drink each time you use that
container. 
 
▪ For pieces of food that do not fit into a
cup or spoon, describe the size using
the " Food Amounts Booklet". 
 
For example, 1 corn tortilla (6 inches
across), and 1 cube of cheese (2" long x
1" wide x 1/2" high). You can use weight
or dimensions for reporting meat, fish,
poultry, cheese, pizza, and baked goods.
Include thickness, length, and width of
food using a ruler. Indicate if the weight
was obtained before or after cooking. 
 
Be Specific.  When naming the food or
drink that you ate/drank, give the Roswell
person details. For example, if you ate
meat, details such as the part eaten are
important. If you ate chicken, tell the
person whether it was from the thigh or
breast, or if it was white or dark meat. 
 
Brand Names & Labels. Brand names
of prepared foods are very useful for the
Roswell person, as are labels from the
prepared foods you have eaten. 

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Appendix N. Participant Food Amounts Booklet (FAB) 

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Appendix O. Participant Welcome Letter 
 
Dear POW-R Health Participant, 
 
Welcome to the POW-R Health Program! A group of doctors and bladder cancer survivors have made this program 
to help you live a long and healthy life. 
 
This mailing should include:  
• 2 consent forms (1 for you to sign and mail back to us; 1 for you to keep) 
• 1 Gender, Race, and Ethnicity Form (please mail back to us) 
• 1 envelope (to place the signed consent form and the Gender, Race, and Ethnicity Form) 
• 1 Food Amounts Booklet (Keep this for later) 
• 1 Urine collection kit with one pre-paid FedEx urine shipping box 
 
If you did not receive ALL of these things, please call us right away at: 716-845-1300, Ext 7221.  
 
Please complete all of the forms that are white in color and mail them back to us. Place the signed consent 
form and the Gender, Race, and Ethnicity Form in the envelope. Place the envelop in the urine shipping box 
with your urine sample and mail together.  
 
In about a week, someone will call you to ask you what you ate and drank for the past day. These are called dietary 
recalls. You will be asked to do 3 dietary recalls.  
 
After you complete your dietary recalls, and mail in the white forms (signed consent form; the gender, race, and 
ethnicity form) and the urine collection kit, you will receive the program.  
 
Thank you again for being a part of this important study.  If you have any questions, please don’t hesitate to contact 
us at: 716-845-1300, Ext 7221. 
 
Sincerely, 
 
Karen Yeary, PhD 
 
 
Li Tang, PhD 
 
 

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Appendix P. Participant Health Magazine for Intervention and Control Arm 
 
Intervention Magazine

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Control Magazine 

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Appendix Q. Live Call Scripts (Intervention and Control) 
Intervention 
 
Participant ID: ____              Staff Initials: _____________ 
Date: _______  
 
 
Start Time: ______  
 
End Time:     
 
 Treatment      Control    
Materials that should have been sent to participant 
Cover Letter/Welcome Letter 
POW-R Health Magazine 
POW-R Track Book (24 copies) 
Refrigerator Magnet 
PART A: 
Getting participant on the phone, call intro, packet receipt 
Note: Only make three attempts to reach the participant 
 Phone Answered 
 
Hello, this is [staff name] from the POW-R Health program calling for [participant name], she/he is expecting my call. Is 
[participant name] home/available right now? 
Yes 
Hi [participant name] I’m calling to review the POW-R Health program materials with you. It 
should take about 60 minutes; do you have time to complete it right now? 
No 
That’s okay, can we schedule a time that would work 
better for you? Thanks, I will give you a call then. 
                                            Time to call back 
 Leaving Message 
 
1st Attempt 
This is [staff name] from the POW-R Health program calling for [participant name]. I’m calling to 
review the POW-R Health program materials with you, which should take about 60 minutes. I’ll 
try calling you again, but if you would like to call me back and let me know a good time for us to 
chat, I can be reached at 716-697-4615/716-720-2308. Thanks, and I hope I catch up with you 
soon! 
2nd Attempt 
Hello again, this is [staff name] from the POW-R Health program calling for [participant name]. I 
left a message with you on  
[date] and I am calling you back to review the POW-R 
Health program materials with you, which should take about 60 minutes. I’ll try calling you one 
more time, but if you would like to call me back and let me know a good time for us to chat, I can 
be reached at 716-697-4615/716-720-2308. Thanks, and I hope I catch up with you soon! 
3rd Attempt 
Hello again, this is [staff name] from the POW-R Health program calling for [participant name]. I 
left a message with you on  
[date], and I am calling you back to review the POW-R 
Health program materials with you, which should take about 60 minutes. If you would like to call 
me back and let me know a good time for us to chat, I can be reached at 716-697-4615/716-720-
2308. Thanks, and I hope I catch up with you soon! 

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If YES: Okay great, I’m glad you got a chance to review the material. Just to make sure that the magazine clearly 
conveyed the information, I will now ask you some questions to go over the main points of the magazine. We will then 
work together to create your personal action plan to eat more power vegetables. Before we begin, please pull out the 
packet we sent. It would really help to have them with you for the later part of the call. Please have a pen handy too 
(Go to PART D). 
 
If NO: That is okay. We can still go over what is in the packet right now. Before we begin, please pull out the packet we 
sent. It would really help to have them with you for the later part of the call Please have a pen handy too. (Go to PART B) 
 
 
I’m going to begin by going over the POW-R Magazine. After I go over the magazine’s contents, we’ll complete your 
personal action plan (page 12). I’ll then go over the POW-R Books and the magnet. So, let’s start with the POW-R 
Magazine. Please have your POW-R Magazine next to you so you can follow along what I’m going to review.  
 
 PART C: MAGAZINE CONTENT 
 Welcome to the POW-R Health Program (page 2) 
• 
Among bladder cancer survivors like you, there is still a 50%-80% chance that the bladder 
cancer could come back within 5 years 
• 
Compared to all types of cancers, bladder cancer has the highest chance of coming back 
• 
If the cancer comes back and is not caught at early stages, there is a risk of losing the 
bladder 
• 
Going to your routine check-ups with doctors is good to catch bladder cancer coming back 
at early stages. But they are not enough.  
• 
Doctors made the POW-R Health Program to make sure you live the longest, healthiest 
life possible  
• 
Certain vegetables that can help stop bladder cancer from coming back. These vegetables 
are called power vegetables 
i Interesting convo points ntr 
• 
Power vegetables help reduce death from bladder cancer by 57%            
  
 
    Confirm Intervention Packet Receipt    
 
We are glad you are a part of the program. We put a program packet in the mail for you about the POW-R Health 
Program. The packet should have included a magazine, booklets, and a magnet.  
 
A1. Did you receive the program packet in the mail? 
 
No 
 
Yes 
If YES: (Go to Question A2) 
 
If NO:  It’s really important that you have your packet before we go over it. Let me make a 
note to send you the packet again. What is your mailing address? I’ll call you again after your 
packet is sent. Thank you for taking the time to talk with me. I’ll talk to you again soon.  
 
END CALL. 
 
 
 
       
Mailing 
Address 
A2. If so, did you have time to review the information in this packet? 
 
          No 
 
Yes 
 PART B: OVERVIEW 

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    What are Power Vegetables? (page 4) 
• 
Power vegetables are cruciferous vegetables 
• 
Examples of power vegetables are Broccoli, Turnip, Cabbage, and Arugula 
• 
When power vegetables are eaten, they break down into active things. One of these active 
things is isothiocyanates (eye-so-thye-oh-sigh-nates) or ITCs.  
• 
ITCs have strong anti-cancer actions against many types of cancer, including bladder cancer. 
• 
Do you have any questions about what I’ve covered so far? 
     Interesting convo points 
 
 
 How are Power Vegetables Good at Fighting Bladder Cancer? (pages 4 and 5) 
• 
(Refer participant to picture in magazine on page 5)  
• 
(Go through Steps 1-4 of the picture)  
• 
There is proof that eating power vegetables can help stop bladder cancer from coming back 
 
 
 How Can You Get the Most Anti-Cancer Power From Power Vegetables 
 
• 
The key to getting the most anti-cancer power from power vegetables is to have enough 
ITCs in the urine and to have the bladder inner surface fully soaked in the isothiocyanates as 
long as it can.  
• 
Choose power vegetables that are high or medium in ITCs (look at page 7 in magazine for 
medium and high ITC power vegetables) 
• 
Eat at least one serving of power vegetables per day. One serving size is 1 cup of power 
vegetables at the time you eat it. So if you eat one cup of arugula raw, that would be 1 cup 
raw. If you eat arugula cooked, that would be 1 cup of cooked arugula. One cup is about the 
size of your fist. 
• 
It is best to eat power vegetables fresh, or raw. They can be lightly cooked too, for no more 
than 10 minutes. If you cook power vegetables too much it will reduce their anti-cancer 
power. Don’t use canned power vegetables.  
• 
Eat power vegetables at dinner time or as a late-night snack before bed. When you eat power 
vegetables, the ITCs from the power vegetables can get in the urine within 1 hour and 
slowly build up in the urine over 8 hours. If you eat power vegetables during the day, you 
could lose a lot of ITCs in your urine from going to the bathroom throughout the day. If you 
eat power vegetables at dinner time or as a late-night snack, your body will be able to build 
up the ITCs in your bladder. Although you may go to the bathroom a few times before you 
go to the bed, a fair amount of the ITCs can still build up in the urine and increase the time 
the bladder is soaked in ITCs.  
 Tips to Eat More Power Vegetables (page 10) 
 
• 
Look at pages 10 and 11 in your magazine for tips on how to eat more power vegetables  

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Just to make sure that the magazine clearly conveyed the information, I am now going to ask you a few questions to 
review some of the main points of the magazine. You may feel like I’m testing you, but the purpose of this is to make 
sure that the magazine communicated the information to you clearly. Are you ready? Let’s go!  
 
Note: For a question to be answered correctly, all parts of the question must be answered correctly. 
 
 
 
 TB1 
What is a power vegetable? 
      Correct: A cruciferous vegetable 
 
CORRECT: Yes, that’s right! A power vegetable is a certain type of vegetable called cruciferous vegetables. 
INCORRECT: Power vegetables are cruciferous vegetables.  
 
 
CORRECT: Yes, that’s right- good job! There are a lot of vegetables that are considered cruciferous vegetables. More 
cruciferous vegetables are listed in your POW-R Health Magazine. 
INCORRECT: Ok, no problem, you missed [state answers that are incorrect and correct]. Your POW-R Health 
Magazine lists some power vegetables on page 7. 
 
 
TB3 
How many power vegetable servings do you need to eat 
each day. 
Correct Answer: 1 serving/day 
 
 
 
 
 
No 
Correct 
Yes 
 
CORRECT: Excellent, you’re right. You only need to eat one power vegetable serving a day to help stop bladder 
cancer from coming back. 
INCORRECT: Okay, no problem, the correct answer is 1 serving or cup a day. You only need to eat one power 
vegetable serving a day to help stop bladder cancer from coming back. 
 
TB2 
Please give me three examples of power vegetables. 
Correct Answer: Anything listed in the POW-R Health magazine. 
 
1)     
 
 
2)     
 
 
3)     
 
 
 
No 
Correct 
Yes 
 Part D: Going over Magazine Components: Teach Back Opportunity #1 
Correct 
No 
Yes 

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CORRECT: Excellent, you’re right. 1 serving of a power vegetable is 1 cup at the time you eat it. 1 cup is about the 
size of your fist.  
INCORRECT: Okay, no problem, the correct answer is 1 serving of a power vegetable is 1 cup at the time you eat 
it. 1 cup is about the size of your fist. 
 
TB5 
QUESTION: What is an isothiocyanate or ITC? 
 
 
                                                                    
         Correct 
No     Yes 
 
Correct Answer: An active compound in power vegetables that has 
strong anti-cancer properties  
 
 
CORRECT: Ok great, you really seem to understand what an isothiocyanate/ITC is. 
INCORRECT: Isothiocyanates/ITCs are an active compound in power vegetables that has strong anti-cancer properties. 
 
CORRECT: Yes, that’s right- good job!  
INCORRECT: It’s best to eat power vegetables fresh or raw. If you want to cook them, it’s best to eat them lightly 
cooked, where you cook them for less than 10 minutes.  
 
 
 
 
TB7 
Why is it important to eat power vegetables at dinner or 
as a late-night snack before bedtime? 
 
Correct Answer: Isothiocyanates from power vegetables go to the urine. 
The isothiocyanates in the urine soak the inside of the bladder; the 
longer the isothiocyanates in the urine are in the bladder, the longer the 
bladder will be exposed to the anti-cancer activities. Many people urinate 
several times throughout the day, and less often at night. If you eat 
power vegetables later at night, there is a greater chance that the 
isothiocyanates from the power vegetables will stay in your bladder 
longer.  
 
                                                                                 Correct 
 
                                                                           No       Yes 
 
 
 
CORRECT: Yes, that’s right- good job!  
INCORRECT: Isothiocyanates/ITCs from power vegetables goes to your urine. The urine then goes to your bladder. 
The isothiocyanates in your urine will work to kill any cancer cells in your bladder. The longer the bladder is exposed to 
the isothiocyanates in your urine, the longer it will be exposed to anti-cancer activities. Many people urinate several 
times a day a less often at night. So, there is a greater chance that the isothiocyanates from the power vegetables will say 
in your bladder longer if you eat power vegetables at night.    
 
  TB4 
What is the amount of 1 serving of a power vegetable?  
Correct Answer: 1 cup at time of eating/consumption 
 
 
 
 
 
No 
Correct 
Yes 
TB6 
What is the best way to prepare power vegetables so they 
give you most isothiocyanates/ITCs? 
Correct Answer: It is best to eat power vegetables fresh or raw. 
You can also lightly cook them too (cook for less than 10 minutes). 
 
                                                                               Correct 
 
                                                                          No      Yes 
 
 

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Scoring Circle all questions that were answered incorrectly. 
 
 
 
 
none  
TB3 
TB6 
TB1  
TB4 
TB7 
TB2  
TB5 
 
 
 
 
# Incorrect 
 
ALL CORRECT: Excellent job! You understand the main points of the POW-R Magazine and you 
got all of those questions correct. Now let’s move on and put together an Action Plan! [Go to Part F] 
ANY INCORRECT: [GO TO PART E] 
 
 
 
Only ask questions that were answered incorrectly in Part D. SKIP if all questions were answered correctly in Part D. 
 
Is this part applicable? 
 
You did a good job remembering information that I just covered. I know there was a lot of information covered. So, 
let’s just briefly recap the ones you missed. 
 
 
 
 
 
TB1.2       What is a power vegetable? 
        Correct: A cruciferous vegetable 
 
CORRECT: Yes, that’s right! A power vegetable is a certain type of vegetable called cruciferous vegetables. 
INCORRECT: Power vegetables are cruciferous vegetables.  
 
CORRECT: Yes, that’s right- good job! There are a lot of vegetables that are power vegetables.  
INCORRECT: Ok, no problem, you missed [state answers that are incorrect and correct]. There is a list of power 
vegetables in your POW-R Magazine on page 7. 
  
TB3.2 
How many power vegetable servings do you need to eat 
each day. 
Correct Answer: 1 serving/day 
 
 
 
 
 
No 
Correct 
Yes 
CORRECT: Excellent, you’re right. You only need to eat one power vegetable serving a day to help stop bladder 
cancer from coming back. 
INCORRECT: Okay, no problem, the correct answer is 1 serving a day. You only need to eat one power vegetable 
serving a day to help stop bladder cancer from coming back. 
TB2.2 
Please give me three examples of power vegetables. 
Correct Answer: Anything listed in the POW-R Health magazine. 
 
1)     
 
 
2)     
 
 
3)     
 
 
 
No 
Correct 
Yes 
 Part E: Going over Magazine Components: Teach Back Opportunity #2 
No 
Yes 
Correct 
No 
Yes 

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CORRECT: Excellent, you’re right. 1 serving of a power vegetable is 1 cup at the time you eat it. 1 cup is about the 
size of your fist.  
INCORRECT: Okay, no problem, the correct answer is 1 serving of a power vegetable is 1 cup at the time you eat 
it. 1 cup is about the size of your fist. 
 
TB5.2 
QUESTION: What is an isothiocyanate/ITC? 
 
 
                                                                
Correct 
       No    Yes 
 
Correct Answer: An active compound in power vegetables that has 
strong anti-cancer properties  
 
 
CORRECT: Ok great, you really seem to understand what an isothiocyanate is. 
INCORRECT: Isothiocyanates/ITCs is an active compound in power vegetables that has strong anti-cancer properties. 
 
TB6.2 
What is the best way to prepare power vegetables so they 
give you most isothiocyanates/ITCs? 
Correct Answer: It is best to eat power vegetables fresh or raw. 
You can also lightly cook them too (cook for less than 10 minutes). 
 
                                                                                  Correct 
                                                                               No    Yes 
 
 
CORRECT: Yes, that’s right- good job!  
 INCORRECT: It’s best to eat power vegetables fresh or raw. If you want to cook them, it’s best to eat them lightly 
cooked, where you cook them for less than 10 minutes.  
 
CORRECT: Yes, that’s right- good job!  
INCORRECT: Isothiocyanates/ITCs from power vegetables goes to your urine. The urine then goes to your bladder. 
The isothiocyanates in your urine will work to kill any cancer cells in your bladder. The longer the bladder is exposed to 
the isothiocyanates in your urine, the longer it will be exposed to anti-cancer activities. Many people urinate several 
times a day a less often at night. So there is a greater chance that the isothiocyanates from the power vegetables will say 
in your bladder longer if you eat power vegetables at night.    
 
 
  TB4.2 What is the amount of 1 serving of a power vegetable?  
Correct Answer: 1 cup at time to eating/consumption 
 
 
 
 
 
No 
Correct 
Yes 
TB7.2 
Why is it important to eat power vegetables at dinner 
or as a late night snack before bedtime? 
 
Correct Answer: Isothiocyanates from power vegetables go to the 
urine. The isothiocyanates in the urine soak the inside of the bladder; 
the longer the isothiocyanates in the urine are in the bladder, the 
longer the bladder will be exposed to the anti-cancer activities. Many 
people urinate several times throughout the day, and less often at 
night. If you eat power vegetables later at night, there is a greater 
chance that the isothiocyanates from the power vegetables will stay 
in your bladder longer.  
 
                                                                                 Correct 
                                                                              No    Yes 
 

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Scoring Circle all questions that were answered incorrectly. 
 
 
 
 
none  
TB3 
TB6 
TB1  
TB4 
TB7 
TB2  
TB5 
 
 
 
# Incorrect 
 
ALL CORRECT: Excellent job! You’re an expert now on the POW-R Health Magazine and you got 
all of those questions correct. Now let’s move on and put together an Action Plan! [Go to Part F]] 
ANY INCORRECT: We’ll go over these questions one more time before we end our call today. [GO TO 
PART F ] 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Now let’s go to the Action plan, which is on page 12 of the POW-R Health Magazine. Please fill out this page with me. 
 
 
 Reasons for joining POW-R Health 
What are the most important reasons you have for 
joining the POW-R Health Program. Write this/these 
down in your action plan. 
Participant reason(s): 
 Power vegetable eating goals 
Let’s set some short- and long-term goals. Let’s 
start with a long-term goal. In 6 months, which is by 
the end of this program, how many power vegetable 
cups do you pledge to eat each day. 
Long term goal 
Now let’s set your short-term goal. For this week, 
how many cups of power vegetables will you try to 
eat this week? 
 
Short-term goal 
 Who can help me 
Who can help you eat more power vegetables? Who 
can support you? 
Support person 
 Power vegetable obstacles and strategies 
Let’s now talk about some obstacles that could 
make it harder for you to complete your plan. What 
are one or two obstacles that could make it harder 
for you to eat your power vegetables every day? 
Obstacle 1 
 
 
Obstacle 2 
 
 
What are some strategies you could use to help 
overcome the obstacles you listed? 
Obstacle 1, Strategies (2-4) 
 
 
 
 
Obstacle 2, Strategies (2-4) 
 
 
 
 
 
 
 Part F: Complete Action Plan with Participant 

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One of the things you received in the packet we mailed to you is a POW-R Book. Please have your POW-R Book ready 
to review. In this book, I am asking that you keep track of how many power vegetables you eat every day, and each 
week. Science shows that keeping track of what you eat is a powerful way to change your habits. Keeping track of how 
many power vegetables you eat will help you eat more power vegetables.  Let’s go over all of the parts of the POW-R 
Book. 
Check box when section is covered 
1. 1 POW-R book for each 
week; 24 sent to you—1 is for 
practice to use now. We are 
asking you to keep track of how 
many power vegetables you eat 
every week for the entire 
program.  
3. 7 days in one POW-R book 
5. Each day you say whether 
you ate at least 1 power 
vegetable cup where you 
prepared it in a POW-R Health 
Preferred way (explain what 
this is) 
7. On the back is 
the phone number 
of the person from 
our team that you 
can call if you 
have any 
questions. 
2. Cover page—write down 
dates of the week you are 
keeping track 
 
4. Each day you write down 
how many cups of power 
vegetables you had at dinner 
or after dinner. Only write 
down those power vegetables 
you ate at dinner or after 
dinner (have them open book) 
6. On the first page, is where 
you will write down the total 
number of power vegetables 
you at dinner or after dinner 
for that week. After our phone 
call, you will receive 
automated messages and will 
be asked to enter the number 
of cups of power vegetables 
you ate for the week.  
8. Any questions? 
Let’s practice using the POW-R Track Book. 
 CORRECT: Yes, that’s right- good job! 
INCORRECT: Ok, so the correct total is X. Let’s try that again to make sure you can use the POW-R Book correctly.   
Feel free to use a calculator if that would make things easier.  
 My plan this week to eat more power vegetables 
Now let’s make a plan to eat more power vegetables 
this week. The next time you or someone else goes 
to the grocery store, which power vegetables will 
you buy with medium to high isothiocyanates (page 
7)? 
Power vegetables to buy 
The next time you eat power vegetables, how will 
you make them? Remember that when you cook the 
power vegetable, to cook it for less than 10 minutes. 
Raw, microwave, sauté/stir-fry, steam 
 Practice using POW-R Track Book 
Take a POW-R Track Book. Can you think back 
this past week of any power vegetables you ate at 
dinner or after dinner? If you did not eat any power 
vegetables, how about any type of vegetable? Let’s 
go through each day.  
Monday                        Tuesday                             Wed 
 
Thursday                     Friday                 Sat            Sunday 
Not let’s add how many cups you ate that week 
Total                                                                        Correct 
                                                                          No                Yes 
 Part G: Go over POW-R Track Book 

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Only ask questions that were answered incorrectly in Part E. SKIP if all questions were answered correctly in 
Part D or E. 
 
Is this Part applicable? 
 
Before we end the call, I just want to re-ask you the questions about the key points from the magazine that you were not 
able to recall last time 
 
 
 
TB1.3   What is a power vegetable? 
Correct: A cruciferous vegetable 
 
CORRECT: Yes, that’s right! A power vegetable is a certain type of vegetable called cruciferous vegetables. 
INCORRECT: Power vegetables are cruciferous vegetables.  
 
 
CORRECT: Yes, that’s right- good job! There are a lot of vegetables that are considered cruciferous vegetables.  
INCORRECT: Ok, no problem, you missed [state answers that are incorrect and correct]. If you look at on page X of 
your POW-R Health Magazine, there is a list of cruciferous vegetables.  
 
TB3.3 
How many power vegetable servings do you need to eat 
each day. 
Correct Answer: 1 serving/day 
 
 
 
 
 
No 
Correct 
Yes 
 
 
CORRECT: Excellent, you’re right. You only need to eat one power vegetable serving a day to help stop bladder        
cancer from coming back. 
INCORRECT: Okay, no problem, the correct answer is 1 serving a day. You only need to eat one power vegetable 
serving a day to help stop bladder cancer from coming back. 
CORRECT: Excellent, you’re right. 1 serving of a power vegetable is 1 cup at the time you eat it. 1 cup is about the 
size of your fist.  
INCORRECT: Okay, no problem, the correct answer is 1 serving of a power vegetable is 1 cup at the time you eat 
it. 1 cup is about the size of your fist. 
TB2.3 
Please give me three examples of power vegetables. 
Correct Answer: Anything listed in the POW-R Health magazine. 
 
1)     
 
 
2)     
 
 
3)     
 
 
 
No 
Correct 
Yes 
 TB4.3 
What is the amount of 1 serving of a power vegetable?  
Correct Answer: 1 cup at time of eating/consumption. 
 
 
 
 
 
No 
Correct 
Yes 
 Part H: Going over magazine components: Teach Back Opportunity #3 
No 
Yes 
Correct 
No 
Yes 

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TB5.3 
QUESTION: What is an isothiocyanate? 
 
 
                                                                 No 
Correct 
  Yes 
 
Correct Answer: An active compound in power vegetables that has 
strong anti-cancer properties  
 
 
CORRECT: Ok great, you really seem to understand what an isothiocyanate is. 
INCORRECT: Isothiocyanates are an active compound in power vegetables that has strong anti-cancer properties. 
TB6.3 
What is the best way to prepare power vegetables so they 
give you most isothiocyanates? 
Correct Answer: It is best to eat power vegetables fresh or raw. 
You can also lightly cook them too (cook for less than 10 minutes). 
 
                                                                       Correct 
 
                                                                    No     Yes 
 
 
 
CORRECT: Yes, that’s right- good job!  
INCORRECT: It’s best to eat power vegetables fresh or raw. If you want to cook them, it’s best to eat them lightly 
cooked, where you cook them for less than 10 minutes.  
 
TB7.2 
Why is it important to eat power vegetables at dinner or 
as a late night snack before bedtime? 
 
Correct Answer: Isothiocyanates from power vegetables go to the 
urine. The isothiocyanates in the urine soak the inside of the bladder; 
the longer the isothiocyanates in the urine are in the bladder, the 
longer the bladder will be exposed to the anti-cancer activities. Many 
people urinate several times throughout the day, and less often at 
night. If you eat power vegetables later at night, there is a greater 
chance that the isothiocyanates from the power vegetables will stay in 
your bladder longer.  
 
                                                       Correct 
 
                                                   No     Yes 
 
 
CORRECT: Yes, that’s right- good job!  
INCORRECT: Isothiocyanates from power vegetables goes to your urine. The urine then goes to your bladder. The 
isothiocyanates in your urine will work to kill any cancer cells in your bladder. The longer the bladder is exposed to the 
isothiocyanates in your urine, the longer it will be exposed to anti-cancer activities. Many people urinate several times a 
day a less often at night. So, there is a greater chance that the isothiocyanates from the power vegetables will say in your 
bladder longer if you eat power vegetables at night.    
 
 
Scoring Circle all questions that were answered incorrectly. 
 
 
 
 
none  
TB3 
TB6 
TB1  
TB4 
TB7 
TB2  
TB5 
 
 
 
 
# Incorrect 
ALL CORRECT: Excellent job! You know all the important parts of the POW-R Health Magazine and 
you got all of those questions correct.  
ANY INCORRECT: You did a good job remembering information from the magazine. I know there was 
a lot of information covered. So, let’s just briefly recap the ones you missed before ending the call. 
 

Roswell Park Protocol No.: I 661820 
 
 
 
 
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 PART I: Closing 
 
 
Thanks for taking the time to complete this call. Next week you will start receiving automated phone calls from our 
POW-R Health Program. The purpose of the calls will be to support you to eat more power vegetables. The calls will be 
tailored personally to you. Each call will ask you how many cups of power vegetables you ate for the week, figure out 
whether you are meeting your action plan goals, and then give you tailored support based on the obstacles and strategies 
you wrote down in your action plan. So, it will really be important for you to complete your POW-R Book every day, 
calculate your total power vegetables eaten at dinner or after dinner at the end of every week, and have that available 
when you receive the phone call.  
The system will call you from this number: 716-333-POWR (7697). You can also call this number if you miss the call. 
This number is on the magnet we mailed to you to remind you that this is not a spam number. Can you please get the 
magnet we sent you out? Please place this magnet in a place that you’ll be able to see it. If you miss a call, you can also 
call this number too to complete your automated phone call. There will be 11 automated phone call and we ask you to 
complete all 11 calls.  
Each call will start by asking you what your date of birth is, so the system will know it is you.  For example, if you 
were born January 3, 1953, you would enter 01-03-1953. The system will call you from this number: 716-333-POWR. 
You can also call this number if you miss the call.  
Can you tell me how you will enter your date of birth? [Confirm that the participant       
can provide their DOB correctly] 
DOB 
Correctly read 
No 
Yes 
Each automated phone call will last about 10-15 minutes. Please stay on the phone until the call is complete, otherwise 
the system will think that you did not complete the call and it will call you again. 
(Go over any magazine content questions they missed: Let’s go over one last time the question(s) you missed) 
What questions do you have for me before we hang up? 
Okay, just remember, if you ever have any questions or concerns, 
you can always get a hold of us by calling one of our team 
members at 716-845-1300, Ext 7221. This number is on the back 
of the Track Book and the last page of the magazine. 
 
 
 
Record questions 
 
Thank you for completing the call!  
 
 
 
 
 
 
 
 
Control 
 

Roswell Park Protocol No.: I 661820 
 
 
 
 
10/31/2022 
 
Page 148 of 175 
 
Participant ID: ____              Staff Initials: _____________ 
Date: _______  
 
 
Start Time: ______  
 
End Time:     
             Treatment      Control    
Materials that should have been sent to participant 
Cover Letter/Welcome Letter 
POW-R Health Magazine 
POW-R Track Book (24 copies) 
Refrigerator Magnet 
PART A: 
Getting participant on the phone, call intro, packet receipt 
Note: Only make three attempts to reach the participant 
 Phone Answered 
 
Hello, this is [staff name] from the POW-R Health program calling for [participant name], she/he is expecting my call. Is 
[participant name] home/available right now? 
Yes 
Hi [participant name] I’m calling to review the POW-R Health program materials with you. It 
should take about 60 minutes; do you have time to complete it right now? 
No 
That’s okay, can we schedule a time that would work 
better for you? Thanks, I will give you a call then. 
                                            Time to call back 
 Leaving Message 
 
1st Attempt 
This is [staff name] from the POW-R Health program calling for [participant name]. I’m calling 
to review the POW-R Health program materials with you, which should take about 1 hour. I’ll 
try calling you again, but if you would like to call me back and let me know a good time for us to 
chat, I can be reached at 716-697-4615/716-720-2308. Thanks, and I hope I catch up with you 
soon! 
2nd Attempt 
Hello again, this is [staff name] from the POW-R Health program calling for [participant name]. 
I left a message with you on  
[date] and I am calling you back to review the POW-R 
Health program materials with you, which should take about 1 hour. I’ll try calling you one more 
time, but if you would like to call me back and let me know a good time for us to chat, I can be 
reached at 716-697-4615/716-720-2308. Thanks, and I hope I catch up with you soon! 
3rd Attempt 
Hello again, this is [staff name] from the POW-R Health program calling for [participant name]. 
I left a message with you on  
[date], and I am calling you back to review the POW-R 
Health program materials with you, which should take about 1 hour. If you would like to call me 
back and let me know a good time for us to chat, I can be reached at 716-697-4615/716-720-
2308. Thanks, and I hope I catch up with you soon! 

Roswell Park Protocol No.: I 661820 
 
10/31/2022 
 
Page 149 of 175 
 
 
    Confirm Intervention Packet Receipt    
 
We are glad you are a part of the program. We put a program packet in the mail for you about the POW-R Health 
Program. The packet should have included a magazine, booklets, and a magnet.  
 
A1. Did you receive the program packet in the mail? 
 
No 
 
Yes 
If YES: (Go to Question A2) 
 
If NO:  It’s really important that you have your packet before we go over it. Let me make a 
note to send you the packet again. What is your mailing address? I’ll call you again after your 
packet is sent. Thank you for taking the time to talk with me. I’ll talk to you again soon.  
 
END CALL. 
 
 
 
       
Mailing 
Address 
A2. If so, did you have time to review the information in this packet? 
 
          No 
 
Yes 
 How can you get the best health benefits from fruits and vegetables? 
• 
Vegetables: Fresh, frozen, and canned vegetables can all be a part of healthy eating.  
o Fresh vegetables are best 
o Canned vegetables can be high in salt, so if you buy canned vegetables make sure 
you look for the ‘no salt’ ones. 
• 
Fruit: Fresh, frozen, and canned fruit can all be a part of healthy eating  
o Fresh fruit is best  
o Canned fruit can be high in sugar and calories, so buy canned fruit in 100% fruit 
juice with no sugar added.  
o Be careful of fruit juices! They’re high in sugar and calories, and you can miss out 
on a lot of other vitamins and minerals that eating fruits will give you.  
• 
Eat 2½ to 3 cups of vegetables and 1½ to 2 cups of fruit each day; or a total of 4-5 cups of 
both fruits and vegetables a day. 1/2 cup is about the size of the front of a closed fist. 1 cup 
is about the size of your entire fist or a baseball.  
 PART B: OVERVIEW 

Roswell Park Protocol No.: I 661820 
 
 
 
 
10/31/2022 
 
Page 150 of 175 
 
 
 I’m going to begin by going over the POW-R Magazine. After I go over the magazine’s contents, 
we’ll complete your personal action plan. I’ll then go over the POW-R Books and the magnet. So 
let’s start with the POW-R Magazine. Please have your POW-R Magazine next to you so you can 
follow along what I’m going to review.  
 How to prepare fruits and vegetables? 
 
 Tips to Eat More Fruits and Vegetables 
 
o Tips on how to eat more fruits and vegetables are on pages 6-7 of your 
POW-R Health Magazine. 
o You can eat a lot of fruits and vegetables raw. You can also cook them in many different 
ways too 
 PART C: MAGAZINE CONTENT 
 Welcome to the POW-R Health Program (page 2) 
• 
Living a healthy lifestyle is important for bladder cancer survivors 
• 
Eating fruits and vegetables is an important part of health 
• 
Doctors made the POW-R Health Program to make sure you live the longest, healthiest 
life possible  
 
Interesting convo points 
   What are fruits and vegetables? 
     
• 
Fruit and vegetables are plants that have lots of minerals, vitamins, and other healthy things 
that are good for the human body.  
• 
Common fruits and vegetables are listed in the POW-R magazine on page 3. 
 
 
 
 

Roswell Park Protocol No.: I 661820 
 
 
 
 
10/31/2022 
 
Page 151 of 175 
 
 If YES: Okay great, I’m glad you got a chance to review the material. Just to make sure that the 
magazine clearly conveyed the information, I will now ask you some questions to go over the 
main points of the magazine. We will then work together to create your personal action plan to 
eat more power vegetables. Before we begin, please pull out the packet we sent. It would really 
help to have them with you for the later part of the call. Please have a pen handy too (Go to 
PART D). 
 
If NO: That is okay. We can still go over what is in the packet right now. Before we begin, please pull 
out the packet we sent. It would really help to have them with you for the later part of the call Please 
have a pen handy too. (Go to PART B) 
 
 
 
 
 
Just to make sure that the magazine clearly conveyed the information, I am now going to ask you a 
few questions to review some of the main points of the magazine. You may feel like I’m testing 
you, but the purpose of this is to make sure that the magazine communicated the information to 
you clearly. Are you ready? Let’s go!  
Note: For a question to be answered correctly, all parts of the question must be answered correctly. 
 
CTB1 How are fruits and vegetables good for you? 
      Correct: 1) have lots 
of vitamins that 2) 
reduces the risk of 
getting some 
cancers, high blood 
pressure 
(hypertension), heart 
disease, and 
diabetes, 3) fiber in 
fruits and vegetables 
can also help you 
have a healthy weight 
   
  How are fruits and vegetables good for you? (page 4) 
• Research has shown that eating fruits and vegetables can help you live longer. Eating fruits 
and vegetables reduces the risk of getting some cancers, high blood pressure (hypertension), 
heart disease, and diabetes.  
• Fruits and vegetables have all of these great health benefits because they have a lot of 
vitamins C and A, electrolytes, and antioxidants. Vitamin C protects cells and molecules 
from damage that causes many diseases, including cancer.  
• Fruits and vegetables are also a great source of fiber. The fiber in fruits and vegetables lowers 
cholesterol, which reduces heart disease risk. The fiber in fruits and vegetables can also help 
control the body’s blood sugar, which reduces risk of diabetes. Fruits and vegetables can also 
help you have a healthy weight by giving you lots of fiber and water, which can fill you up 
without giving too many calories.  
      
 Part D: Going over Magazine Components: Teach Back 
Correct 
No 
Yes 

Roswell Park Protocol No.: I 661820 
 
 
 
 
10/31/2022 
 
Page 152 of 175 
 
CORRECT: Yes, that’s right!  
INCORRECT: Let’s go to page X in the POW-R Health magazine. On this page, there is a 
description of fruits and vegetables are good for you. Fruits and vegetables are good for you 
because they 1) have lots of vitamins that 2) reduces the risk of getting some cancers, high blood 
pressure (hypertension), heart disease, and diabetes, 3) fiber in fruits and vegetables can also 
help you have a healthy weight. 
 
 
CORRECT: Yes, that’s right- good job!  
INCORRECT: If you look at on page X of your POW-R Health Magazine, there is the 
recommendation on how many cups of fruit to each day for best health. For best health, you need 
to eat 1 ½ to 2 cups of fruit a day. 1 cup of fruit is about the size of your fist. 
CTB3 
How cups of vegetables do you need to eat each 
day? 
Correct Answer: 2 ½ to 3 cups/day 
 
 
No 
Correct 
Yes 
CORRECT: Excellent, you’re right.  
INCORRECT: If you look at on page X of your POW-R Health Magazine, there is the 
recommendation on how many cups of vegetables to each day for best health. For best health, 
you need to eat 2 ½ to 3 cups of vegetables a day. 1 cup of vegetables is about the size of your 
fist. 
CORRECT: Excellent, you’re right. 1 cup of vegetables or fruit is about the size of your 
fist.  
INCORRECT: If you look at on page X of your POW-R Health Magazine, there are pictures of 
what 1 cup looks like. The size of your fist is about 1 cup. 
CORRECT: Ok great, you’re right. 
CTB2 
How many cups of fruit do you need to eat each 
day? 
Correct Answer: 1 ½ to 2 cups/day 
 
No 
Correct 
Yes 
  CTB4 
What does 1 cup of fruit or vegetable look like?  
Correct Answer: 1 cup is about the size of your fist. 
 
 
No 
Correct 
Yes 
 CTB5 
Fresh, frozen, and canned fruits can all be a part of 
healthy eating. Can you please tell me what you 
need to watch out for when you buy canned fruit? 
        No  
Correct 
Yes 
Correct Answer: Added sugars in canned fruit (buy no 
added sugar, 100% fruit juice kind) 

Roswell Park Protocol No.: I 661820 
 
 
 
 
10/31/2022 
 
Page 153 of 175 
 
INCORRECT: If you look at on page X of your POW-R Health Magazine, there is describes 
what types of fruit are best to eat. Fresh, frozen, and canned fruits can all be a part of healthy 
eating. When it comes to canned fruits, you just need to watch out for too much sugar. Buy the 
no added sugar type.  
CORRECT: Ok great, you’re right. 
INCORRECT: If you look at on page X of your POW-R Health Magazine, there is describes 
what types of vegetables are best to eat. Fresh, frozen, and canned vegetables can all be a part of 
healthy eating. When it comes to canned vegetables, you just need to watch out for too much salt. 
Buy the no salt added.  
CTB7 
Can fruit juices be a part of a healthy diet? 
Correct Answer: It’s best to choose fruits you can eat instead 
of drink. Many fruit juices are high in sugar and calories and 
don’t have a lot of minerals that fruit has when you eat them 
instead.  
   Correct 
 
    No             Yes 
 
 
CORRECT: Yes, that’s right- good job!  
 
INCORRECT: If you look at on page X of your POW-R Health Magazine, there it talks about fruit 
juices. It’s best to choose fruits you can eat instead of drink. Many fruit juices are high in sugar and 
calories and don’t have a lot of minerals that fruit has when you eat them instead.  
 
 
Scoring Circle all questions that were answered incorrectly. 
 
 
 
none  
TB3 
TB6 
TB1  
TB4 
TB7 
TB2  
TB5 
 
 
 
 
# Incorrect 
ALL CORRECT: Excellent job! You really read through the POW-R Health Magazine and you got all of 
those questions correct. Now let’s move on and put together an Action Plan! [Go to Part F] 
ANY INCORRECT: [GO TO PART E] 
CTB6 
Fresh, frozen, and canned vegetables can all be a 
part of healthy eating. Can you please tell me what 
you need to watch out for when you buy canned 
vegetables 
          No 
Correct 
Yes 
Correct Answer: Too much salt in canned vegetables 
(buy no salt added kind) 

Roswell Park Protocol No.: I 661820 
 
 
 
 
10/31/2022 
 
Page 154 of 175 
 
 
 
 
Only ask questions that were answered incorrectly in Part D. SKIP if all questions were answered correctly in Part D. 
 
Is this part applicable? 
 
You did a good job remembering information that I just covered. I know there was a lot of 
information covered. So, let’s just briefly recap the ones you missed. 
 
CTB1.2     How are fruits and vegetables good for you? 
      Correct: 1) have lots 
of vitamins that 2) 
reduces the risk of 
getting some 
cancers, high blood 
pressure 
(hypertension), heart 
disease, and 
diabetes, 3) fiber in 
fruits and vegetables 
can also help you 
have a healthy weight 
    
   CORRECT: Yes, that’s right!  
INCORRECT: Let’s go to page X in the POW-R Health magazine. On this page, there is a 
description of fruits and vegetables are good for you. Fruits and vegetables are good for you 
because they 1) have lots of vitamins that 2) reduces the risk of getting some cancers, high blood 
pressure (hypertension), heart disease, and diabetes, 3) fiber in fruits and vegetables can also 
help you have a healthy weight. 
 
 
CORRECT: Yes, that’s right- good job!  
INCORRECT: If you look at on page X of your POW-R Health Magazine, there is the 
recommendation on how many cups of fruit to each day for best health. For best health, you need 
to eat 1 ½ to 2 cups of fruit a day. 1 cup of fruit is about the size of your fist. 
CTB3.2 
How cups of vegetables do you need to eat each day? 
Correct Answer: 2 ½ to 3 cups/day 
 
 
No 
Correct 
Yes 
CORRECT: Excellent, you’re right.  
INCORRECT: If you look at on page X of your POW-R Health Magazine, there is the 
recommendation on how many cups of vegetables to each day for best health. For best health, 
you need to eat 2 ½ to 3 cups of vegetables a day. 1 cup of vegetables is about the size of your 
fist. 
CTB2.2 How many cups of fruit do you need to eat each day? 
Correct Answer: 1 ½ to 2 cups/day 
 
No 
Correct 
Yes 
 Part E: Going over Magazine Components: Teach Back Opportunity 
No 
Yes 
Correct 
No 
Yes 

Roswell Park Protocol No.: I 661820 
 
 
 
 
10/31/2022 
 
Page 155 of 175 
 
CORRECT: Excellent, you’re right. 1 cup of vegetables or fruit is about the size of your 
fist.  
INCORRECT: If you look at on page X of your POW-R Health Magazine, there are pictures of 
what 1 cup looks like. The size of your fist is about 1 cup. 
CORRECT: Ok great, you’re right. 
INCORRECT: If you look at on page X of your POW-R Health Magazine, there is describes 
what types of fruit are best to eat. Fresh, frozen, and canned fruits can all be a part of healthy 
eating. When it comes to canned fruits, you just need to watch out for too much sugar. Buy the 
no added sugar type.  
CORRECT: Ok great, you’re right. 
INCORRECT: If you look at on page X of your POW-R Health Magazine, there is describes 
what types of vegetables are best to eat. Fresh, frozen, and canned vegetables can all be a part of 
healthy eating. When it comes to canned vegetables, you just need to watch out for too much salt. 
Buy the no salt added.  
 
CTB7.2 Can fruit juices be a part of a healthy diet? 
Correct Answer: It’s best to choose fruits you can eat instead 
of drink. Many fruit juices are high in sugar and calories and 
don’t have a lot of minerals that fruit has when you eat them 
instead.  
   Correct 
 
    No             Yes 
 
 
CORRECT: Yes, that’s right- good job!  
 
  CTB4.2 What does 1 cup of fruit or vegetable look like?  
Correct Answer: 1 cup is about the size of your 
fist. 
 
 
No 
Correct 
Yes 
 CTB5.2 
Fresh, frozen, and canned fruits can all be a part 
of healthy eating. Can you please tell me what 
you need to watch out for when you buy canned 
fruit? 
         No 
Correct 
Yes 
Correct Answer: Added sugars in canned fruit (buy 
no added sugar, 100% fruit juice kind) 
CTB6.2 Fresh, frozen, and canned vegetables can all be a 
part of healthy eating. Can you please tell me 
what you need to watch out for when you buy 
canned vegetables 
         No 
Correct 
Yes 
Correct Answer: Too much salt in canned vegetables 
(buy no salt added kind) 

Roswell Park Protocol No.: I 661820 
 
 
 
 
10/31/2022 
 
Page 156 of 175 
 
INCORRECT: If you look at on page X of your POW-R Health Magazine, there it talks about fruit 
juices. It’s best to choose fruits you can eat instead of drink. Many fruit juices are high in sugar and 
calories and don’t have a lot of minerals that fruit has when you eat them instead.  
 
 
Scorin
g 
Circle all questions that were answered incorrectly. 
 
 
 
non
e  
TB3 
TB6 
TB1  
TB4 
TB7 
TB2  
TB5 
 
 
 
 
# Incorrect 
ALL CORRECT: Excellent job! You really read through the POW-R Health Magazine and you got all 
of those questions correct. Now let’s move on and put together an Action Plan! [Go to Part F] 
ANY INCORRECT: We’ll go over these questions one more time before we end our call today. [GO TO 
PART F ] 
 
 
 
Now let’s go to the Action plan, which is on page 9 of the POW-R Health Magazine. Write your answers 
down in the plan. 
 
 
 Reasons for joining the POW-R Health Program 
What are the most important reasons you have 
for joining the POW-R Health Program? Write 
this/these down in your action plan. 
Participant reason(s): 
 Power vegetable eating goals 
Let’s set some short- and long-term goals. Let’s 
start with a long-term goal. In 6 months, which is 
by the end of this program, how many cups of 
fruit and vegetables do you pledge to eat each 
day. 
Long term goal 
Now let’s set your short-term goal. For this 
week, how many cups of fruit and vegetables 
will you try to eat this week? 
 
Short-term goal 
 Who can help me 
Who can help you eat more fruit and vegetables? 
Who can support you? 
Support person 
 Part F: Complete Action Plan with Participant 

Roswell Park Protocol No.: I 661820 
 
 
 
 
10/31/2022 
 
Page 157 of 175 
 
 
 
One of the things you received in the packet we mailed to you is a POW-R Book. Please 
have your POW-R Book ready to review. In this book, I am asking that you keep track of 
how many fruit and vegetables you eat every day, and each week. Science shows that 
keeping track of what you eat is a powerful way to change your habits. Keeping track of 
how many fruit and vegetables you eat will help you eat more fruit and vegetables.  Let’s go 
over all of the parts of the POW-R Book. 
 
Check box when section is covered 
1. 1 POW-R book for each 
week; 24 sent to you—1 
is for practice to use now; 
we are asking you to 
complete a track book 
each week for the entire 
program 
3. 7 days in 
one POW-R 
book 
5. Each day write down how many cups of 
fruit you had that day. (have them go through 
pages of book) 
7. On the 
back is the 
phone 
number of 
the person 
from our 
team that 
you can call 
 Fruit and vegetable obstacles and strategies 
Let’s now talk about some obstacles that could 
make it harder for you to complete your plan. 
What are one or two obstacles that could make 
it harder for you to eat more fruit and 
vegetables every day? 
Obstacle 1 
 
 
Obstacle 2 
 
 
What are some strategies you could use to help 
overcome the obstacles you listed? 
Obstacle 1, Strategies (2-4) 
 
 
 
 
Obstacle 2, Strategies (2-4) 
 
 
 
 
 
 
 My plan this week to eat more fruit and vegetables 
Now let’s make a plan to eat more fruit and 
vegetables this week. The next time you or 
someone else goes to the grocery store, which 
fruit and vegetables will you buy? 
Fruit and vegetables to buy 
 Part G: Go over POW-R Track Book 

Roswell Park Protocol No.: I 661820 
 
 
 
 
10/31/2022 
 
Page 158 of 175 
 
if you have 
any 
questions. 
2. Cover page—write down 
dates of the week you are 
keeping track 
 
4. Each day 
write down 
how many 
cups of 
vegetables 
you had that 
day. (have 
them open up 
book) 
6. On the front page, is where you will write 
down: 1) the total cups of fruit, 2) total cups 
of vegetables, and 3) total number of fruits 
AND vegetables you ate that week. Place a 
check-mark by whether you ate at least 1.5 
cups of fruit that week (yes/no). Same with 
vegetables. After our phone call, you will 
receive automated messages and will be 
asked to enter the total number of cups of 
fruit AND vegetables you ate for the week 
(refer them to last line). It will also ask you 
whether you ate at least 1.5 cups of fruit, and 
2.5 cups of vegetables and you will use the 
information here to tell them ‘yes’ or ‘no’ 
8. Any 
questions? 
 
Let’s practice using the POW-R Track Book. 
 
CORRECT: Yes, that’s right- good job! 
INCORRECT: Ok, so the correct total is X. Let’s try that again to make sure you can use the 
POW-R Book correctly.  Feel free to use a calculator if that would make things easier.  
 
 
Only ask questions that were answered incorrectly in Part E. SKIP if all questions were 
answered correctly in Part D or E. 
 
Is this Part applicable? 
 
Before we end the call, I just want to re-ask you the questions about the key points from the 
magazine that you were not able to recall last time 
 
CTB1.3     How are fruits and vegetables good for you? 
      Correct: 1) have lots 
of vitamins that 2) 
reduces the risk of 
getting some 
cancers, high blood 
pressure 
(hypertension), heart 
disease, and 
 Practice using POW-R Track Book 
Take a POW-R Track Book. Can you think back 
this past week of any fruit you ate? Let’s go 
through each day.  
Monday                        Tuesday                             Wed 
 
Thursday                     Friday                 Sat            Sunday 
Now let’s add how many cups you ate that week 
Total                                                                        Correct 
                                                                          No                Yes 
 Part H: Going over magazine components: Teach Back Opportunity #3 
No 
Yes 
Correct 
No 
Yes 

Roswell Park Protocol No.: I 661820 
 
 
 
 
10/31/2022 
 
Page 159 of 175 
 
diabetes, 3) fiber in 
fruits and vegetables 
can also help you 
have a healthy weight 
   
CORRECT: Yes, that’s right!  
INCORRECT: Let’s go to page X in the POW-R Health magazine. On this page, there is a 
description of fruits and vegetables are good for you. Fruits and vegetables are good for you 
because they 1) have lots of vitamins that 2) reduces the risk of getting some cancers, high blood 
pressure (hypertension), heart disease, and diabetes, 3) fiber in fruits and vegetables can also 
help you have a healthy weight. 
 
 
CORRECT: Yes, that’s right- good job!  
INCORRECT: If you look at on page X of your POW-R Health Magazine, there is the 
recommendation on how many cups of fruit to each day for best health. For best health, you need 
to eat 1 ½ to 2 cups of fruit a day. 1 cup of fruit is about the size of your fist. 
 
CTB3.3 
How cups of vegetables do you need to eat each day? 
Correct Answer: 2 ½ to 3 cups/day 
 
 
No 
Correct 
Yes 
CORRECT: Excellent, you’re right.  
INCORRECT: If you look at on page X of your POW-R Health Magazine, there is the 
recommendation on how many cups of vegetables to each day for best health. For best health, 
you need to eat 2 ½ to 3 cups of vegetables a day. 1 cup of vegetables is about the size of your 
fist. 
CORRECT: Excellent, you’re right. 1 cup of vegetables or fruit is about the size of your 
fist.  
INCORRECT: If you look at on page X of your POW-R Health Magazine, there are pictures of 
what 1 cup looks like. The size of your fist is about 1 cup. 
CTB2.3 How many cups of fruit do you need to eat each day? 
Correct Answer: 1 ½ to 2 cups/day 
 
No 
Correct 
Yes 
  CTB4.3 
What does 1 cup of fruit or vegetable look like?  
Correct Answer: 1 cup is about the size of your 
fist. 
 
 
No 
Correct 
Yes 

Roswell Park Protocol No.: I 661820 
 
 
 
 
10/31/2022 
 
Page 160 of 175 
 
CORRECT: Ok great, you’re right. 
INCORRECT: If you look at on page X of your POW-R Health Magazine, there is describes 
what types of fruit are best to eat. Fresh, frozen, and canned fruits can all be a part of healthy 
eating. When it comes to canned fruits, you just need to watch out for too much sugar. Buy the 
no added sugar type.  
CORRECT: Ok great, you’re right. 
INCORRECT: If you look at on page X of your POW-R Health Magazine, there is describes 
what types of vegetables are best to eat. Fresh, frozen, and canned vegetables can all be a part of 
healthy eating. When it comes to canned vegetables, you just need to watch out for too much salt. 
Buy the no salt added.  
 
CTB7.3 Can fruit juices be a part of a healthy diet? 
Correct Answer: It’s best to choose fruits you can eat instead 
of drink. Many fruit juices are high in sugar and calories and 
don’t have a lot of minerals that fruit has when you eat them 
instead.  
                        Correct 
 
                           No             Yes 
 
 
CORRECT: Yes, that’s right- good job!  
 
INCORRECT: If you look at on page X of your POW-R Health Magazine, there it talks about fruit 
juices. It’s best to choose fruits you can eat instead of drink. Many fruit juices are high in sugar and 
calories and don’t have a lot of minerals that fruit has when you eat them instead.  
 
 
Scoring Circle all questions that were answered incorrectly. 
 
 
 
none  
TB3 
TB6 
TB1  
TB4 
TB7 
TB2  
TB5 
 
 
 
 
# Incorrect 
 CTB5.3 
Fresh, frozen, and canned fruits can all be a part 
of healthy eating. Can you please tell me what 
you need to watch out for when you buy canned 
fruit? 
          No  
Correct 
Yes 
Correct Answer: Added sugars in canned fruit (buy no 
added sugar, 100% fruit juice kind) 
CTB6.3 
Fresh, frozen, and canned vegetables can all be a 
part of healthy eating. Can you please tell me what 
you need to watch out for when you buy canned 
vegetables 
          No  
Correct 
Yes 
Correct Answer: Too much salt in canned vegetables 
(buy no salt added kind) 

Roswell Park Protocol No.: I 661820 
 
 
 
 
10/31/2022 
 
Page 161 of 175 
 
ALL CORRECT: Excellent job! You know all the important parts of the POW-R Health Magazine and 
you got all of those questions correct.  
ANY INCORRECT: You did a good job remembering information from the magazine. I know there 
was a lot of information covered. So, let’s just briefly recap the ones you missed before ending the call. 
 
 
 PART I: Closing 
 
 
Thanks for taking the time to complete this call. Next week you will start receiving automated phone calls from 
our POW-R Health Program. The purpose of the calls will be to support you to eat more fruit and vegetables. 
The calls will be tailored personally to you. Each call will ask you how many fruit and vegetables you ate for 
the week, figure out whether you are meeting your action plan goals, and then give you tailored support based 
on the obstacles and strategies you wrote down in your action plan. So, it will really be important for you to 
complete your POW-R Book every day, calculate your total cups of fruit and vegetables eaten at the end of 
every week, and have that available when you receive the phone call.  
The system will call you from this number: 716-333-POWR (7697). You can also call this number if you miss 
the call. This number is on the magnet we mailed to you to remind you that this is not a spam number. Can you 
please get the magnet we sent you out? Please place this magnet in a place that you’ll be able to see it. If you 
miss a call, you can also call this number too to complete your automated phone call. There will be 11 automated 
phone call and we ask you to complete all 11 calls.  
Each call will start by asking you what your date of birth is, so the system will know it is you. For example, if 
you were born January 3, 1953, you would enter 01-03-1953. The system will call you from this number: 716-
333-POWR. You can also call this number if you miss the call. 
Can you tell me how you will enter your date of birth? [Confirm that the 
participant can provide their DOB correctly] 
DOB 
Correctly read 
No 
Yes 
Each automated phone call will last about 10-15 minutes. Please stay on the phone until the call is complete, 
otherwise the system will think that you did not complete the call and it will call you again. 
(Go over any magazine content questions they missed: Let’s go over one last time the question(s) you missed) 
What questions do you have for me before we hang up? 
Okay, just remember, if you ever have any questions or 
concerns, you can always get ahold of us by calling one of 
our team members at 716-845-1300, Ext 7221. This number 
is on the back of the Track Book and the last page of the 
magazine. 
 
Record questions 
 
Thank you for completing the call!  

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Appendix R. Participant Track Books 
 
Intervention 
 

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Control 
 

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Appendix S. Participant Thank You Letter 
 
[DATE] 
[FIRST AND LAST NAME OF PARTICIPANT] 
[STREET ADDRESS] 
[CITY, STATE   ZIP CODE] 
 
Dear [FIRST NAME OF PARTICIPANT], 
 
I am writing to thank you personally for completing the [baseline/follow-up] assessment of the 
POW-R Health Program.  To show our appreciation for your time and effort, we have enclosed 
Tops gift card for $X.  In 6 months, we will ask you to complete these surveys again and if you 
do, you will earn another $X. 
   
On behalf of the POW-R Health team, thank you so much for supporting our research!  Please 
don’t hesitate to contact us at: 716-845-1300, Ext 7221. 
 
Sincerely, 
 
 
Karen Yeary, PhD  
 
 
Li Tang, PhD 
Principal Investigator  
 
 
Principal Investigator 
 
 

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Appendix T. Recruitment Letter for Roswell Park Cancer Registry 
 
Date 
 
Dear Participant, 
 
We recently received funding from the National Institutes of Health to learn more about how diet 
may reduce the risk of recurrence in individuals with early-stage bladder cancer. Men and 
women who were recently diagnosed with early-stage bladder cancer and who live in the 
counties of Niagara, Orleans, Genesee, Erie, Wyoming, Chautauqua, Cattaraugus, and Allegany 
may be eligible for the study.  
 
We are asking you to take part in this study because you have been diagnosed and treated for 
bladder cancer. The goal of this study is to make a healthy eating program to improve cancer 
outcomes. The purpose of this study is to compare two types of healthy eating programs. This 
study will allow the researchers to know whether different types of healthy eating programs can 
improve the bladder cancer outcomes of the patients. The intervention that you will receive as 
part of this study will be given to you at no cost.  
 
If you agree to take part in this research study, you will receive a $100 gift card for completion 
of the baseline surveys and you will receive another $100 gift card for completion of the 6-month 
survey.   
 
This study has been reviewed and approved by the Roswell Park Institutional Review Board to 
assure that the study plans will not put any participants at risk. Your involvement in this study 
does not involve any physical risk to you. The possible risks might be feeling uncomfortable 
answering questions, embarrassment, or someone identifying you as a participant in the group, 
although this would be rare. You will not receive any direct health benefit from participating in 
this study. 
 
Someone from our office will call you to make sure you received this letter and to discuss the 
study with you.  If you have any questions, please call us at 716-845-XXXX. We hope that you 
will be able to help us by completing the survey.  
 
We hope to hear from you soon! 
 

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Appendix U. Invitation Letter for Physician Interview and Opt-In/Out Card 
 
 
Date 
 
Dear Dr. X, 
 
Your patient or colleague recently participated in the POW-R Health research study, a National 
Cancer Institute (NCI)-funded study that is testing different dietary strategies to lower the risk of 
bladder cancer recurrence. We are excited about this study because it may produce a dietary 
intervention that helps reduce the risk of bladder cancer recurrence and improve bladder cancer 
survivorship.  To be noted, the funded study is a behavior intervention program that has no 
relevance to clinical treatment regardless of whether clinical care is provided.  
 
We are contacting you because either your patient or colleague nominated you to be a part of this 
study. To be part of the study, all we need is to conduct a 15-minute phone interview with you to 
gain a physician’s insight on how our dietary intervention—if proven to be successful—could be 
incorporated into routine care. Physicians who participate will receive a $100 gift card from a 
local store as a small token of our appreciation.   
 
If you can participate in a 15-minute phone interview, please let us know by filling out the card 
included in this mailing. If you do not want to participate, please let us know on the card so we 
do not contact you in the future.  
 
For more detailed information about the study, please review the included information sheet.  
 
Thanks so much for our consideration. We hope to hear from you soon. 
 
 
Sincerely, 
 
 
 
 
Karen Yeary, PhD 
 
 
 
 
 
Li Tang, PhD 
Professor 
 
 
 
 
 
 
Associate Professor  
Cancer Prevention and Control  
 
 
 
Cancer Prevention and Control 
Roswell Park Comprehensive Cancer Center  
Roswell Park Comprehensive Cancer Center 
 
 
 

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 Yes, I’m interested in participating in the phone interview. Please call 
me at:______________ during the following days and times: 
_____________________________________________________ 
 No, I’m not interested in participating. Please do not contact me again 
about this study.  
 
 

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Appendix V. POW-R Sympathy Card 
      
 
Study Number and title: I 661820; POW-R Health: Power to Redefine your Health (Internal 
Title: A Pragmatic Dietary Intervention to Improve Bladder Cancer Survivorship) 
 
Dear […],  
 
We wanted to write to extend our deepest sympathy for the loss of your 
[partner/wife/husband/loved one], [Participant’s name].  
 
No one should ever have to experience such pain and loss - we are sorry that you are.  
 
Please know that we are thinking of you and your loved ones. We send our heartfelt condolences 
and strength your way.  
 
Sincerely,  
[Names of research staff]  
The POW-R Study Research Team  
Roswell Park Comprehensive Cancer Center 
 
 
 
 

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Appendix W. Participant Information Sheet for Cruciferous Arm Feedback Questions (For 
Participants that Completed the 6-Month Follow-up Assessment) 
 
 
 
 
[DATE] 
 
 
Dear POW-R Health Participant,  
 
Thank you for participating in the POW-R Health Program! Your participation will 
make a difference in understanding how to improve the health of bladder cancer 
survivors like you. To make the program better, a Roswell Park team member will 
call you to ask a few questions about what you liked and didn’t like about the 
program. The phone call will take about 10-15 minutes.  
 
Your participation is voluntary. All responses will remain confidential and 
anonymous and will be shared with only the Roswell Park POW-R Health Program 
team. If you don’t want to talk with us, please tell us when we call you. 
 
We believe that your valuable feedback will help make the POW-R Health 
program better, so it can be more useful to more bladder cancer survivors like you. 
Please be on the lookout for a phone call from our POW-R Health team. If you 
have any questions regarding the upcoming phone call please don’t hesitate to 
contact us at: 716-845-1300, Ext 4236. 
 
 
 
Sincerely, 
                    
 
Karen Yeary, PhD  
 
Li Tang, PhD 
Principal Investigator  
 
Principal Investigator