Measuring Real Time Decision-Making About UVR Protection
Conditions: Melanoma
Sponsor: Memorial Sloan Kettering Cancer Center

Memorial Sloan Kettering Cancer Center 
IRB Number: 09-137 A(15) 
Approval date: 20-Dec-2017 
Page 1 of 34 
 
 
Measuring Real Time Decision-Making About UVR Protection 
MSKCC NON-THERAPEUTIC/DIAGNOSTIC PROTOCOL 
 
Principal Investigator/Department: 
Jennifer Hay, PhD 
Dept of Psychiatry & Behavioral 
Sciences 
Co-Principal Investigator(s)/Department: 
Yuelin L PhD 
Dept of Psychiatry & Behavioral 
Sciences 
Investigator(s)/Department: 
Mary Brady, MD 
Charlotte Ariyan, MD 
Daniel Coit, MD 
Department of Surgery, GMT 
Department of Surgery, GMT 
Department of Surgery, GMT 
Consenting Professional(s)/Department: 
Jennifer Hay, PhD 
Susan Holland 
Laura Fitzpatrick 
Dept of Psychiatry & Behavioral 
Sciences 
Dept of Psychiatry & Behavioral 
Sciences 
Dept of Psychiatry & Behavioral 
Sciences 
 
Please Note: A Consenting Professional must have completed the mandatory Human Subjects 
Education and Certification Program. 
 
Collaborating Institution(s): 
Jeanne Shoveller, PhD 
University of British Columbia 
Consulting 
Joni Mayer, PhD 
San Diego State University 
Consulting 
Arthur Stone, PhD 
Stony Brook University 
Consulting 
 
Memoria1Sloan-Kettering Cancer Center 
1275 York Avenue 
New York, NY 10021 
 
 
 
 
Table of Contents 
1.0 
PROTOCOL SUMMARY AND/OR SCHEMA .............................................................................. 3 
2.0 
OBJECTIVES AND SCIENTIFIC AIMS ........................................................................................ 4 
3.0 
BACKGROUND AND RATIONALE ............................................................................................... 4 
4.0 
OVERVIEW OF STUDY DESIGN/INTERVENTION ................................................................... 8 

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4.1 
Design ............................................................................................................................................... 8 
4.2 
Intervention ....................................................................................................................................... 8 
5.0 
CRITERIA FOR SUBJECT ELIGIBILITY. ................................................................................. 15 
5.1 
Subject Inclusion Criteria ................................................................................................................ 15 
5.2 
Subject Exclusion Criteria ............................................................................................................... 15 
6.0 
RECRUITMENT PLAN .................................................................................................................. 15 
7.0 
ASSESSMENT/EVALUATION PLAN .......................................................................................... 18 
8.0 
TOXICITIES/SIDE EFFECTS........................................................................................................ 20 
9.0 
PRIMARY OUTCOMES ................................................................................................................. 20 
10.0 
CRITERIA FOR REMOVAL FROM STUDY .............................................................................. 21 
11.0 
BIOSTATISTICS .............................................................................................................................. 21 
12.0 
RESEARCH PARTICIPANT REGISTRATION AND RANDOMIZATION PROCEDURES 
24 
12.1 
Research Participant Registration .................................................................................................... 24 
12.2 
Randomization ................................................................................................................................ 24 
13.0 
DATA MANAGEMENT ISSUES ................................................................................................... 24 
13.1 
Quality Assurance ........................................................................................................................... 25 
13.2 
Data and Safety Monitoring ............................................................................................................ 25 
14.0 
PROTECTION OF HUMAN SUBJECTS ...................................................................................... 27 
14.1 
Privacy ............................................................................................................................................ 27 
14.2 
Serious Adverse Event (SAE) Reporting ........................................................................................ 28 
15.0 
INFORMED CONSENT PROCEDURES ...................................................................................... 28 
16.0 
REFERENCES .................................................................................................................................. 29 
17.0 
APPENDICES ................................................................................................................................... 33 

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1.0 
PROTOCOL SUMMARY AND/OR SCHEMA 
Understanding how people make decisions about ultraviolet radiation (UVR) protection is critical to the 
development of melanoma risk reduction interventions, since UVR exposure is the primary modifiable risk 
factor for melanoma. Strategies available for UVR protection include consistent sun avoidance and shade­ 
seeking, as well as use of sunscreen, clothing, and hats. However, individua Is at high risk for melanoma, 
including first-degree biological relative (siblings, children, or parents) are inconsistent in their UVR 
protection behaviors [22-24]. This behavioral inconsistency is significant for health outcomes since even a 
few episodes of sunburn can greatly increase skin cancer risk. Understanding the decisions that govern 
variations in UVR protection would greatly improve our ability to influence these behaviors. While 
extensive prior research has examined the role of individual differences (such as intentions, beliefs, and 
demographic differences) in average levels of UVR protection, this study will focus on developing a 
measurement strategy to capture within-person variability, or level of consistency, in UVR protection. 
To understand UVR protection decision-making, we will use a mixed qualitative and quantitative approach 
dictated by ethnographic decision tree modeling (EDTM; [l, 2]). This mixed model approach is a well­ 
established approach to elucidating the process of decision-making by identifying factors that groups of 
people use to make real-life decisions that has been used in anthropology, sociology, and psychology for 25 
years. The central goal of EDTM is to uncover and validate the criteria that influence decision making 
about a particular task. EDTM is distinct from other mixed model designs because EDTM addresses 
cognition around decision making in particular, making it highly relevant to our study goals. 
 
Using EDTM guidelines (described in greater detail on page 7), we will develop and establish the validity 
of decision models to explain daily decision-making about sunscreen use, shade-seeking, and UVR 
protective clothing use in melanoma first-degree relatives (FDRs). This study will involve two phases. In 
Phase I, we will conduct qualitative ethnographic interviews with 25 melanoma FDRs and generate a 
decision model for each UVR protection outcome for each rrelanoma FDR and then will construct a 
composite decision-making model incorporating findings across all 25 interviews for each of the three UVR 
protection outcomes (i.e., sunscreen use, shade-seeking, and UVR protective clothing use). Following this, 
in Phase II, we will establish the validity of the models using ecological momentary assessment ofUVR 
protection (over 14 summer days, at 1 pm and 5 pm daily) in 60 different FDRs of 60 different melanoma 
patients. We will report on the level of success of the decision-making models in predicting behavioral 
performance. We will also examine the influence of between- and within-person changes in melanoma 
threat and efficacy, drawn from Witte's Extended Parallel Processing Model [3], as well as satisfaction with 
UVR protection maintenance, drawn from Rothman's theory of health behavior maintenance [4-6] on the 
three major outcomes of the study (i.e., sunscreen use, shade-seeking, and UVR protective clothing use). 
We will recruit equal numbers of women and men, and of those who perceive high and low advantages of 
tanning, to both phases of the study. The study will increase our understanding of the decision-making 
context of behavioral maintenance of UVR protection, and dictate strategies to reduce behavioral 
inconsistency - and increasing maintenance - of UVR protection in those at risk for melanoma and the 
general population. 

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2.0 
OBJECTIVES AND SCIENTIFIC AIMS 
Specific Aim I (Phase I): To generate models explaining decision-making about four UVR protection 
behaviors (sunscreen use, shade-seeking, hat use, use of protective clothing) in melanoma FDRs. 
Specific Aim II (Phase II): To examine theory-driven affective and cognitive predictors of UVR protection 
maintenance (sunscreen use, shade-seeking, hat use, and use of UVR protective clothing) assessed in real 
time. 
3.0 
BACKGROUND AND RATIONALE 
Understanding behavioral patterns in UVR protection is critical to melanoma risk reduction. Melanoma 
accounts for about 70% of skin cancer deaths each year, making it the most fatal form of skin cancer [7]. 
Fortunately, risk factors for melanoma are relatively well-understood, as UVR delivered via sunlight is the 
predominant modifiable cause of melanoma, with approximately 65% to 90% of melanomas caused by 
UVR [8-11]. Accordingly, melanoma prevention recommendations inc Jude daily sun protection strategies 
such as sun avoidance in the middle of the day when UVR exposure is the highest, use of hats and clothing 
to block UVR exposure, and sunscreen use on exposed body parts [7, 12]. These recommendations are 
relevant to the general population, but even more important for those at high risk by virtue of their family 
history, a sun-sensitive phenotype (light skin and eyes, red hair) or other risk factors such as dysplastic 
nevus syndrome (the presence of many moles with irregular borders or coloring; [13]). Over and above 
cumulative UVR exposure, diverse patterns of UVR exposure, variations in the consistency with which 
some people engage in UVR exposure behaviors, lead to different levels of risk, which highlights the need 
to understand protection patterns with detail and nuance. For example, intermittent or recreational sun 
exposure, particularly beach and waterside activities, appear to increase risk much more than occupational 
exposure. Even in the context of regular sun protection a few UVR exposure episodes substantially increase 
risk [14-16]. 
UVR protection is inconsistently practiced among individuals at risk for melanoma. In national studies of 
UVR protection behavior, including the National Health Interview Survey [17] and the Behavioral Risk 
Factor Surveillance System [18], UVR protection is recalled cumulatively over large periods of time such 
as a year, with global indicators of usual behavior (such as "sometimes" or, "most of the time") used to 
indicate different types ofUVR protection. This is also true for intervention studies, where cumulative, 
global self-report strategies are used to indicate intervention outcomes [19]. Direct measures of UVR 
protection have also been used less-widely and include redemption of a sunscreen coupon on the beach 
[20], and direct visual inspection of the skin [19, 21]. Using the predominant, global retrospective 
measurement strategy, inconsistent UVR protection is the norm for individuals with a family history of 
melanoma [22-26]. For instance, Azzarella and colleagues [22] found that 47% of first-degree relatives of 
melanoma patients used sunscreen on their face inconsistently and 71% sought shade inconsistently (e.g., 

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rarely, sometimes, often, more than half the time). Geller and colleagues [23] found that 46% of siblings of 
melanoma patients did not regularly use sunscreen. In a trial to improve early detection and prevention 
behaviors in melanoma siblings that included telephone motivational interviewing and tailored educational 
materials, 30% of siblings in control and treatment groups used sunscreen sporadically or not at all [24]. 
Decision-making has a potentially important role in cancer prevention behaviors, but has not been studied. 
Medical decision-making research has paved the way to an improved understanding about how people 
choose the best course of cancer screening, or cancer treatment [40, 41]. Useful decision aids have been 
developed to facilitate patients' deliberate analysis of the benefits and drawbacks of alternative medical 
courses of action that maximize satisfaction and minimize regret [42]. In contrast, research in decision­ 
making about cancer prevention "is in its infancy" [43]. The emerging paradigm of naturalistic decision­ 
making proposes that health-related decisions made outside the clinic setting, in naturalistic environments, 
necessarily entail evaluation of the ecological context where the decision is made [44]. In the context of 
cancer prevention, naturalistic decision-making may be quite important in the repeated assessment of a 
single behavioral option - such as whether to use sunscreen. 
 
Daily assessment could also enhance understanding of the decision-making context for UVR protection. 
There is a substantial literature examining predictors of UVR protection (including seeking shade, 
sunscreen use, wearing sun protection hats and clothing) in those at increased risk for melanoma, all have 
examined between-subject factors. For example, increased use of UVR protection has been reported among 
women, younger individuals [26], those with higher education [22], and those without a prior recent history 
of tanning [23]. Attitudinal factors related to increased use of protection include higher risk perception for 
melanoma [38], optimism [39], self-efficacy for UVR protection [22, 25], and the perception of fewer 
sunbathing advantages, social norms about UVR protection, and higher benefits and reduced barriers for 
sunscreen use [25]. 
Yet given the inconsistency with which UVR behaviors are performed, there are likely important decision­ 
making factors that vary within-person as well as between-person, that help dictate sociaL environmentaL 
and contextual variation in people's lives. Indeed, UVR protection utilized on family beach vacations may 
be different from what is utilized at soccer games or while walking a dog, and may differ based on the 
temperature, cloud cover, how rushed one feels in the morning, or might be based on the availability of 
clothing or sunscreen at any point in time. Understanding the basis of this variation may be useful in 
targeting interventions to encourage greater maintenance of UVR protection behaviors. 
Ecological momentary assessment diary methods could capture information about daily patterns of UVR 
protection. Diary methods, in which research participants answer questions regarding their behavior or 
attitudes on their own without researcher involvement in real-time fashion, have been used extensively in 
sociological research to provide self-revealing records about day to day particulars of a person's life [27]. 
Qualitative and quantitative diaries are ecologically valid alternatives to global self-report questionnaires, as 
assessment points occur close to the time of the actual experience in the natural environment where it 
occurs. Paper and pencil diary methods have been used to examine UVR protection with general and high­ 
risk populations [28-32], outdoor workers [33], and schoolchildren [34]. Diary methods have been 
validated against direct researcher observation [34] (in which the researcher is present with the participant 
and directly observes participant behavior), biological markers of sunscreen usage and UVR exposure [31], 
and questionnaires [30]. In individuals at high risk for melanoma, Brandburg and colleagues [28, 29] 
showed that diary methods showed less underreporting of sunbathing occasions and sunburns. 

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Over the µtst decade, the use of computerized diaries to collect data in real time has supplanted paper and 
pencil methods as the gold standard for diary methodology. This is due to documented problems with paper 
and pencil methods - including the risk of participants' reporting on their behaviors cumulatively rather 
than in real time, or at the end of the reporting period. Additionally, ecological momentary assessment 
(EMA) minimizes missing data by providing automatic skip-outs and audible prompts, and allows for 
accurate reporting of missing data by reporting time of completion [35] Adherence with these EMA 
methods is quite good, and appear to be highly dependent on training provided to participants (See Section 
4.2 Intervention for the extensive training we provide to participants). In populations such as smokers, 
cancer patients, and pain patients using EMAs from three weeks to three months, adherence with 
"responding to auditory alerts," the most global measure of adherence, is in the range of 88-98% [35, 36]. 
In the current proposaL given our short assessment time frame (14 days), the fact that we are examining an 
asymptomatic, non-clinical population, and the extensive training regarding how to use the interactive voice 
response (IVR) system that we offer, we believe that the study will be quite feasible with relatively low 
levels of nonresponse to audible prompts, and low levels of missing data overall. To achieve the high rates 
of adherence reported in the literature, we will follow the seven recommendations proposed by experts in 
the field of ecological momentary assessment [37]: 1) Integrate compliance concerns throughout the study 
protocol and build in compliance feedback and prompts for participants; 2) adequate training of subjects on 
the IVR; 3) make the IVR user-friendly; 4) program reminders into the IVR; 5) efficient handling within the 
IVR of question branching to administer correct questions in correct order; 6) built-in "livability" features 
to ease incorporation of IVR into their daily lives, and; 7) emphasize participant accountability for the data 
through tracking of adherence. We will evaluate reasons for refusal and patterns of missing data in 
primary statistical analyses. Dr. Arthur Stone, an originator of EMA strategies and expert in 
methodological issues with EMA, has agreed to be a consuhant on our study and will provide input during 
the EMA questionnaire development, implementation of the Phase II study, and data analysis. 
In addition to our use of the IVR data, we will also use audio narrative diaries to explore how first-degree 
relatives of melanoma patients make decisions regarding sun protection on a daily basis. Audio diaries are 
research µtrticipants' verbal narratives about behavior, attitudes, or beliefs (dictated by a study's research 
focus) that are captured when participants speak into a recording device. The sun protection questionnaire 
delivered through the IVR system will include a statement at the end that will instruct participants to 
verbally record their own narrative of their sun protection use for the assessed time-period (i.e., either from 
morning to approximately 12:30 pm, or from approximately 12:30 to approximately 5 pm). Participants will 
be able to speak directly into their phones to record their audio narratives. The voice direction delivered 
through the phone will instruct participants to share in their own words the methods of sun protection they 
used for the assessed time-period and to explain the reasons why they chose to use such methods. 
Ethnographic decision-tree modeling (EDTM) is an ideal method to examine decision-making about UVR 
protection. EDTM is a mixed (qualitative and quantitative) research method specifically designed to 
elucidate the process of decision-making by identifying factors that groups of people use to make real-life 
decisions. For the past 25 years, EDTM has been used by anthropologists and psychologists to model 
decisions such as medical treatment decision-making [45, 46], including needle sharing decisions among 
drug users [47] and the decision to recycle beverage cans [48]. In her comprehensive book on this 
method, Gladwin [2] outlined the theory behind EDTM, that decision-making involves a serial 
consideration of options that maximize outcomes subject to constraints dictated by simplifying rules or 
heuristics in making everyday decisions [49], and reducing the cognitive demand of decisions. 

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In practice, EDTM guides development and validation of a formal decision tree of choice for a specific 
decision task The decision tree is comprised of an ordered set of "if then" decision rules that describe the 
principal considerations people use in making a choice for the decision task 
 
EDTM involves two phases. The goal of the fast phase is to develop a composite decision model for a 
specific decision task This phase involves ethnographic interviews with individuals comprised of open­ 
ended questions to understand the factors that influence their decision-making for that decision task After 
each ethnographic interview the researcher develops a decision tree for that research participant. When all 
interviews have been conducted, the researcher constructs a composite decision model for the decision task 
by grouping decision criteria used by the sample interviewed, and mapping their relationships in 
hierarchical order so that the flow of the 'if then' decision rules are predictive of choices in the sample. 
Reasons for performing the task come first in the hierarchical flow, with constraints for not performing the 
task coming second. Phase two involves model validation of the composite decision models generated in 
phase one. The composite model is tested using a new participant sample using a self-report survey that is 
based on the model; each question in the survey represents a criterion or decision factor. The goal of this 
phase is to quantitatively determine the sensitivity and specificity of the model. 
 
Limitations of EDTM include the lengthy nature of the process and reliance on retrospective memory in 
model development. Strengths of the method involve the opportunity to develop a complex understanding 
of real-life decision making in a group of people, the sequential design that results in a quantitatively 
validated model of the decision-making context in question, and the ability of the model to explain when 
behavior is performed and avoided. EDTM is ideally situated to address applied research problems by 
pinpointing opportunities for intervention in real-world decisions in public health. 
Health behavior theory may improve our understanding of the consistency ofUVR protection. Witte's 
Extended Paralle1 Process Model [3] offers an account of the conditions under which illness threat may lead 
to health protective behavior. In the context of heightened illness threat (severity and susceptibility be liefs) 
and heightened beliefs that they can overcome the threat (self-efficacy and response-efficacy), people will 
act to do so via health protective behavior, or "danger control." In situations where threat is high but people 
don't believe they can manage it, behavioral avoidance, or "fear control" will result as people work to 
reduce their feelings of threat rather than their chances of becoming ill. Beliefs related to threat control 
include self-efficacy, or confidence that one can perform the rehavior, and response-efficacy, or confidence 
that performing the behavior will protect against the health threat. Meta-analytic work examining this 
premise has found that pairing strong threat with high-self efficacy indeed maximizes behavior change [3]. 
In one of the only theories specifically addressing health behavior change maintenance, Rothman [50] has 
proposed and confirmed that satisfaction with the results of behavioral adoption - such as satisfaction with 
the results of smoking cessation or weight loss - determines whether individuals maintain health behavior 
over time [4, 5, 51]. 
We will examine these theory-based predictors - melanoma threat and efficacy, and satisfaction with UVR 
protection behavior - as between-subject and within-subject variables in this study. Accordingly, along 
with the most important decision factors, we will determine whether overall levels of these cognitive 
beliefs, or daily variations in these beliefs, are important in the maintenance of UVR protection over time in 
melanoma FDRs. 
Study Significance. This is a measurement study aimed at understanding the discrete decision-making 
factors that dictate sun protection behavior on a daily basis. Given the clinical significance of even very 
few sunburn events, and the documented higher risk associated with some sun exposure contexts 

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(recreational) over others (occupationa 1), new measurement strategies are needed in order to capture daily 
variation in sun protection, as well as the decision-making factors that dictate them. Accordingly, this new 
measurement strategy will be useful in assessing the impact of future intervention strategies that aim to 
increase the consistency of sun protection in higher and average risk individuals, and to address decision 
making factors that may set the stage for risky sun protection events. 
An understanding of real time decision-making for UVR protection will provide a critical starting point to 
address the inconsistency with which those at high risk for melanoma practice this important cancer 
prevention behavior. Assessment of variations in daily decision-making about UVR protection will 
increase our understanding of the social and environmental context of behavioral maintenance of UVR 
protection, and will advance the development of novel interventions to reduce inconsistency in UVR 
protection in those at high risk for melanoma that can result in risky sunburns and intermittent high-doses of 
UVR. Decision-making models in cancer have been developed to address cancer treatment and screening 
decision-making; in contrast, research in decision-making about cancer prevention "is in its infancy" [43]. 
The study represents a novel first step in examining decision-making in cancer prevention, engaging with 
the complexities of measuring health decision-making in naturalistic settings where most health behaviors 
are performed [44]. The study also contributes to theoretical understandings concerning the processes by 
which health behaviors are maintained, or habituated, over time [50]. 
4.0 
OVERVIEW OF STUDYDESIGN/INTERVENTION 
 
4.1 
Design 
Overview Guided by EDTM, we will first build mode ls of decision-making about UVR protection using 
in-home ethnographic interviews with 25 melanoma FDRs (Phase I). We have chosen to interview 25 
participants based on EDTM recommendations [1, 2]. We will build individual decision models for each 
UVR protection outcome for each melanoma FDR, and subsequently generate and composite decision 
models for the three primary outcomes (i.e., sunscreen use, shade-seeking, and UVR protective clothing 
use) representing the decision-making process and factors across the 25 melanoma FDRs interviewed. In 
Phase II, we will test the validity of each composite mode1. This will be completed using EMA data 
collection with 60 different melanoma FDRs who will report on their sunscreen use, hat use, shade-seeking, 
and use ofUVR protective clothing and decision-making regarding these outcomes via an Interactive Voice 
Response (IVR) system (described below) and audio narrative diaries. We will examine the validity of 
each model and examine the influence of theory-driven affective and cognitive predictors of UVR 
protection maintenance across time. 
Although there are wide variations in sun protection recommendations worldwide, we will fo11ow the 
guide lines provided by the American Cancer Society. Their recommendations include: 1) limit direct sun 
exposure between the hours of 10 am and 4 pm; 2) if shade-seeking is not possible wear sun-protective 
clothing and hats, use sunscreen with an SPF of 15 or higher, and wear sunglasses that block UV rays when 
out in the sun. 
 
4.2 
Intervention 
For each of the samples, we will use a screenmg questionnaire (See Appendix A) to identify melanoma 
FDRs. We will conduct purposive sampling [62] in order to ensure representation of melanoma FDRs with 
diverse approaches to UVR protection. Purposive sampling is a sampling strategy commonly used in 
qualitative research in which research participants are selected to participate based on some characteristic. 

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In Phase I of our study we will screen potential research participants according to whether they meet two 
criteria-participant gender, and their perceived advantages of sunbathing, given the importance of these 
factors in determining UVR behavior [26, 64]. Therefore, we will screen potential Phase I research 
participants according to their perceived advantages of sunbathing [63], to recruit equal numbers of those 
who perceive high versus low advantages of sunbathing. In Phase II we will only engage in purposive 
sampling for the gender criteria to ensure recruiting equal numbers of men and women. For Phase II only, 
we will additionally use the screening questionnaire (See Appendix A) to identify melanoma FDRs who 
report daily (weekday and weekend) outdoor activities due to vacations, retirement, leisure activities or 
work situations for inclusion to the study. 
 
Phase 1 
In-home interview with 25 melanoma FDRs. The in-home interview draws from an ethnographic, 
participant-observation research tradition which prioritizes collection of data in participants' home context 
[65], and has been suggested as the ideal strategy for model building in EDTM [1, 2]. 
 
The term "ethnographic" is an adjective derived from the word "ethnography," which refers both to a 
qualitative research methodological approach (i.e., doing ethnography) and a research product (i.e., 
developing an ethnography, a written account of a culture). Ethnography literally means "a study of a 
people," and this form of qualitative inquiry has served as the bedrock of the field of cultural anthropology 
since its inception. Ethnographic data collection can include a variety of observational techniques, such as 
participant observation (in which a researcher conducts fieldwork, lives among the people h/she is studying, 
and engages in their activities with them), and key informant interviewing (conducting interviews with 
individuals regarded as representative or highly knowledgeable of a culture). The common thread among 
diverse data collection techniques that can be regarded as ethnographic is that they aim to understand the 
broader context grounding individual behavior and beliefs, may be employed in the natural settings where 
such behavior occurs, and use exploratory methods to learn directly from individuals. The interviews that 
we conduct in Phase I of our study are ethnographic in that our interviews are semi-structured, with open­ 
ended questions that allow the interviewer to be responsive to the participant's individual experience; and 
that we conduct the interviews in the home so that we may obtain a better sense of participants' sun 
protection behavioral habits and routines, and may see participants interact directly with their sun protection 
items as they describe their use of such items. 
 
Ms. Shuk will conduct the interviews. The in-home interview will begin by completing the Informed 
Consent process. Following that, the interview discussion will be audio recorded using a digital voice 
recorder. The recordings will be uploaded to our secure network drives through 641 Lexington Ave offices 
or via remote VPN connection the same day when possible, or by the next day if the interviews were 
conducted in the evening. The interview content will be guided by our prior qualitative research with 
melanoma families, state-of-the-art strategies for ethnographic interviewing [65] and EDTM procedures [1, 
2]. We will explore the following topic areas with each participant. (See Appendix B for full in-home 
interview guide): 
• 
Sunscreen use and decision-making during most recent/one other recent sun exposure episode of at 
least 60 minutes or more; 
• 
 Protective clothing use and decision-making during most recent/one other recent sun exposure 
episode of at least 60 minutes or more; 
• 
Seeking shade and decision-making during most recent/one other recent sun exposure episode of at 
least 60 minutes or more; 

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• 
Probes to tmderstand discrepancies in UVR protection behavior across sun exposure episodes; 
• 
House tour to see locations in home where sun protection items are stored 
 
The in-home interview will begin with a discussion of the participant's decision-making about sunscreen 
use and will subsequently consider decision-making about shade-seeking and use of UVR-protective 
clothing. We will frrst ask participants to recall the last time they were out in the sun for a period of 60 
minutes or more during the summer months, whether they used sunscreen of SPF 15 or higher during this 
period of sun exposure, and to talk through the factors that led to their decision to use it or not. If 
participants did use sunscreen during this period of sun exposure, we will ask participants to lead us to the 
location in their home where they store their sunscreen, and if possible, to show us the sunscreen products 
that they used during this period of sun exposure. Having participants see their sunscreen products firsthand 
as they answer questions about their decision-making to use sunscreen may help to jog their memory 
regarding the key factors that influenced their use of sunscreen during the sun exposure episodes under 
examination (if participants are unable to locate the sunscreen items that they used during the sun exposure 
episode, we will still ask them to talk through their decision to use sunscreen and to answer the following 
questions regarding the broader context of their sunscreen use). We will also ask participants to "reenact'' 
how they used sunscreen during the sun exposure episode. As participants describe the story of their 
sunscreen use, we will ask them where on the body they applied sunscreen, whether they reapplied 
sunscreen, the form of sunscreen that they used (e.g., spray, lotion, makeup/moisturizer with SPF) and its 
SPF level. It is likely that participants will share this information regarding their sunscreen use on their own 
without interviewer probing. Following exploration of participant's sunscreen use during their most recent 
period of sun exposure in the summer, we will ask them whether they sought shade or used sun protective 
clothing during the same sun exposure episode, and to describe the factors that led to their use or non-use of 
both sun protection methods. As we carried out with our examination of the participant's sunscreen use (as 
described in the procedure above), if participants did use sun protective clothing or used items to provide 
shade cover (e.g., sun umbrellas), we will ask participants to show us the clothing or shade items they used 
during the sun exposure episode, and to show us how they used the items. As before with our exploration of 
sunscreen use, if participants are unable to locate the clothing or shade items they used during the sun 
exposure episode, we will ask them to describe the reasons that influenced their use of both sun protection 
methods regardless. 
 
Next, we will ask participants to recall a second period of sun exposure of at least 60 minutes or more 
during the summer, but a period where they were in a different location than the first period discussed 
earlier in the interview. We will again ask participants whether they used sunscreen, sought shade, and used 
sun protective clothing during this sun exposure episode and to describe the factors that led to their 
decisions for each behavior. If participants did engage in these sun protection methods and can recall the 
specific items they used, we will ask them whether the items used were different from the items used in the 
first sun exposure episode discussed in the interview. If they used different sun protection items (i.e., 
sunscreen products, sun protective clothing, or sun shade items) in the second sun exposure episode from 
the first sun exposure episode, we will ask participants to show us those items, and demonstrate how they 
used them during the second sun exposure episode. Open-ended probing will be used at "contrast'' points, 
where we will request them to clarify the salient reasons for behavioral performance, followed by 
constraints that could lead to non-performance that may generalize to different behavioral choices across 
locations and situations. If there are inconsistencies in the participant's use of sun 

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protection (i.e., sunscreen use, shade-seeking, use of sun protective clothing) between the two sun exposure 
episodes discussed, we will ask them to explain the reasons that led them to use sun protection in one 
episode but not the other. 
 
We finish the interview with a shadowing procedure, a common participant observation strategy in 
ethnographic research, in which the researcher instructs the research participant to perform a task, and then 
follows or shadows the participant as they perform the task. This procedure will consist of a house tour 
where the interviewer will ask the participant to show her all the locations inside or outside the home where 
s/he stores and applies the items they use for UVR protection, including sunscreen and clothing (e.g., 
bathrooms, closets, purses, bedrooms, garages, cars), and what outdoor areas are used for shade, if any. 
 
The participants will receive $50 in cash for their time and effort on the study. Each in-home interview will 
be transcribed by RA Fisher Ink, an NYC-based transcription vendor, and will be used to generate the 
decision models. If any names are accidentally used in the audio recording, the transcribed version will only 
include the initials. 
 
Generating the decision models. The primary goal of our analysis of the in-home interview data is to 
understand decision-making regarding consistent and inconsistent use of UVR protection in melanoma 
FDRs. In line with EDTM, we will construct three decision models, a tree representing ordered decision 
factors, one for each sun protection outcome. The decision models will present the ordered decision factors 
that dictate use versus nonuse of sunscreen, shade-seeking, and UVR protective clothing (See Figure below 
for an example). Each individual decision tree is a series of statements about the conditions leading to the 
selection of each alternative outcome. After the first interview, Ms. Shuk and Dr. Hay will meet to 
construct three decision tree models (sunscreen use, shade-seeking, UVR protective clothing use) for this 
participant. This will involve 1) sorting data segments into tentative categories; 2) mapping the flow and 
relationship between decision criteria, and 3) labeling and summarizing the content of each category. This 
will be repeated for each of the 25 interviews conducted. Subsequent to the development of the decision 
trees for each participant, the team will convene to form the composite decision models. Elyse Shuk, Drs. 
Hay and Burkhalter and consultants Drs. Mayer and Shoveller by telephone will meet to form the 
composite models for sunscreen use, shade-seeking, and UVR protective clothing use. Responses will be 
grouped to fonn decision criteria and arranged in a hierarchical order, structuring reasons for UVR 

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protection coming first, and the constraints preventing the action addressed next [l]. The ultimate goal is 
to maximize comprehensiveness and inclusiveness of the decision making context for each UVR protection 
behavior, while retaining participant natural language. As we analyze the individual decision trees to create 
composite models, we will consider the effects of gender as a determining factor in sun protection decision­ 
making. We will evaluate whether commonalities exist within sun protection decision-making factors that 
seem particularly influential in shaping sun protection behavior among men and among women in our 
Phase 1 sample. The models will dictate the closed-ended questionnaire used (See Appendix C) in the IVR 
assessment where survey questions represent decision nodes from the mode I-building phase. 
 
Phase 2 
14-day IVR assessment and audio narrative diary. The fmal version of the Phase 2 IVR assessment survey 
has been developed from findings generated from analysis of the in-home interview data obtained in Phase I 
(see Appendix C). We have developed the content of the questionnaire that will be presented through the 
IVR telephone system from the outcome of our decision model development work in Phase 1 of the study. 
IVR is a technology that allows a computer to interact with humans via a phone. In this study, IVR will 
allow us to automate contacting our participants via telephone and allow them to respond to the assessment 
using their telephone keypad. The IVR system will be programmed to ask participants the assessment 
survey via prerecorded audio and direct them on how to answer the survey questions by pressing designated 
buttons on their telephone keypad. 
The IVR and audio diary will be implemented using the MSKCC Web Survey Core Facility. The Core is an 
institutional resource to assist investigators in the creation of secure electronic surveys for use in research. It 
includes programmers to create study-specific surveys, and maintains servers for secure administration and 
storage of data. Core surveys are directly linked to the MSKCC Clinical Trials Research Database (CRDB), 
which is the institution's standard repository for secure storage of µitient study data. The server 
configuration and specifications for the web core are compliant with current standards for data safety and 
privacy and have undergone formal privacy and security review. 
In generating the Phase 2 IVR assessment survey, we have translated each decision criterion identified in 
the four sun protection decision tree composite models generated in Phase 1 into a closed-ended question 
presented in yes/no format, so as to elicit from Phase 2 participants whether each decision criterion 
influenced their sun protection decisions during the assessed time period. For example, in our shade-seeking 
composite model we found that proximity to shade is a key factor dictating use of shade structures during 
outdoor activities. Accordingly, we developed a corresponding question "Was shade conveniently 
available? (yes/no)" and included this question on the IVR assessment survey to test the importance of this 
factor in the use of shade-seeking as a sun protection strategy. We have strived to phrase the closed-ended 
questions with key words and concepts identified in the decision criteria in the composite models [90]. 
During phase 2 recruitment, the study staff will record a series of choices (1s\ 2nd) of the 60 participants 
concerning when, during spring/summer months of2012 and 2013, they will be available for the 14-day 
assessment period and they will be in the continental United States. Eligible participants will be consented 
(in clinic or verbally over the phone) within a week of their 14-day assessment period. Once consented, the 
study staff will administer a short demographic questionnaire, provide training on the participant's data 
collection responsibilities during the 14-day period that includes what to expect, how to respond to the IVR, 
and answer any questions that they may have. 
IVR and audio diary training. Each training session will last approximately 15 minutes and will be done 
over phone by the study staff. The purpose of the training session will be to orient and prepare participants 

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for daily use of the IVR over the duration of the 14 days of ecological momentary assessment sampling 
(See Appendix D). During the training call study staff will review a number of issues with participants, 
including: 1) that participants will receive 2 calls a day, one at approximately 12:30 pm and again at 
approximately 5 pm for each of the 14 days, starting on the 1st day of the agreed upon 14-day period; 2) 
that participants will be able to call the IVR system if they are unable to answer an outbound call from the 
IVR system for any assessment period-i.e., they will be able to call the IVR system by 1:30 pm to 
complete the morning assessment survey, and by 6 pm to complete the afternoon assessment survey; 3) the 
ID number and PIN that they will need to press on their phone keypads in order to complete a survey; 4) 
content of the IVR assessment survey, including a review of each question in the survey; 5) the numbers on 
their phone keypad that they will need to press in order to answer the survey questions; 6) that they should 
answer every question in the survey; 7) that the IVR system will prompt them at the end of each survey to 
record their own narrative describing their use of sun protection and associated decision making during the 
assessed time period; 8) that at the fmal assessment point they will be asked a number of questions to 
evaluate whether IVR prompts influenced their use of sun protection; 9) that study staff will call them a 
couple of times throughout the 2-week assessment to answer any questions they may have and to address 
any technological problems if necessary; and 10) provide the name and phone number of study staff that 
they can call if they have any issues throughout the 2-week assessment. The study staff will complete an 
"IVR Proficiency Checklist" (See Appendix D) with all participants to ensure that they have met all training 
goals, and training procedures will be repeated until proficiency is 100%. 
 
Participants will also be trained in how to record their twice-daily audio narratives of UVR protection and 
decision-making. At the close of the IVR assessment survey, participants will be prompted to share in their 
own words their "story" of their UVR behaviors and related decision-making on that morning or afternoon. 
They will be instructed to not use their names in the recordings. 
Participants will receive the following related technical support: 1) three proactive (i.e., research team 
calling participants) telephone calls to assist usage: 1 training and orientation prior to starting the 14-day 
period; l call a few days after the start of the 14-day period, and fmally l call towards the end of week 
two); 2) a hardcopy of the IVR training script they will receive by telephone from study staff (see Appendix 
D); 3) a hardcopy of the IVR assessment survey so that they will know the content of the assessment (see 
Appendix C); 4) an IVR response card that will contain the participant's 10-digit telephone number for the 
study and 4-digit PIN needed for completing the IVR assessment, and the telephone keypad numbers 
corresponding to the survey responses (see Appendix L); 5) an IVR sticker they can affix to their telephone 
that will contain the telephone numbers of the IVR system and study staff, and 6) a study telephone number 
to request assistance from study staff and/or to report technical problems. 
 
Diary sampling procedure. Study participants will complete twice-daily assessments of their sun protection 
behavior and decision-making during the 14-day assessment period. Participants will be called twice a day 
at approximately 12:30 pm and approximately 5 pm by the IVR system using the primary telephone number 
provided by the participant at consent. They will not be able to influence or select the timing or content of 
assessments, which minimizes potential bias that occurs when participants initiate self-reporting [66]. If the 
IVR gets disconnected or the participant hangs up, the IVR will call them back and begin where it left off. 
If the participant does not answer an outbound call from the IVR system for any assessment period, they 
will have an opportunity to call the IVR system directly at 646-888-0720 to complete the survey 
corresponding to the outbound call that they missed. Specifically, they will be able to call the IVR system 
by 1:30 pm to complete the survey for the morning assessment period, and by 6 pm to complete the survey 
for the afternoon assessment period. 

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At each assessment session, they will be asked to respond to the question series using their telephone 
keypad. At approximately 12:30 pm they will be asked about their UVR protection and decision-making 
for the morning; and at approximately 5 pm, they will be prompted to complete this same assessment for 
the afternoon. At each time period after completing the IVR assessment, they will be prompted through the 
IVR system to record a brief (2-3 minute) description of their UVR protection strategies for that morning or 
afternoon. The IVR will allow a maximum of five minutes for the recording. The questions asking about 
sun protection use and decision making factors will follow a yes/no format to which they will respond using 
their telephone keypad. This format is a heavily-used, easy way to record health behaviors and decision­ 
making factors consistent with EDTM. The IVR assessment survey will also include four closed-ended 
questions to assess: participants' perceived melanoma risk; perceived self-efficacy for following through 
with sun protection; beliefs about the effectiveness of sun protection in preventing melanoma; and level of 
satisfaction with decision to use/not use sun protection. Each assessment should require less than 10 
minutes of the participants' time, keeping participant assessment burden low. Participants will have the 
option of being able to skip or refuse answering any questions they wish. Once the IVR has begun reading a 
question participants can interrupt the recording and move on by inputting their answer via the telephone 
keypad. The time at which participants complete the assessment will be electronically stamped on their 
assessment responses stored on the WEBCORE server. If the participant does not respond to the 1st call for 
each period (i.e., approximately 12:30 pm or approximately 5 pm), then the participant will automatically 
be called back up to 2 times within a one hour period. If the participant does not answer the 1st call for each 
period the system will leave the participant a voice mail message stating that they will be called back again 
shortly. If the participant does not answer the third follow-up call for a given time period the system will 
leave the participant a voice mail message stating that they will be called at the next assessment period. 
This same pattern will occur at the 5 pm assessment. Once the participant answers the call the IVR will not 
call again until the next assessment period. If the call is never answered, this assessment will not be ab le to 
be completed at a later time. However, the i:nrticipant will be able to call the IVR system directly to 
complete the survey if they miss an outbound call for any assessment period. 
 
All IVR data, including the recorded voice narratives, will be stamped with date and time (in Eastern 
Standard Time) to verify compliance with the sampling procedure. To maximize compliance, the study 
team will call participants both once during the first week and second week of the assessment period to 
ascertain whether participants are experiencing any technological difficulties or challenges in completing 
the twice-daily assessments. We have soccessfully used these strategies in the past with lung cancer patients 
[57, 58]. 
Once i:nrticipants have completed their 2 week assessment, study staff will call participants within a week 
to thank them for their participation, and to complete a very brief program satisfaction survey (See 
Appendix N). During this final call staff will arrange to mail participants their $50 money order incentive 
for their time and effort on the study. 
In the unexpected event that the IVR system experiences technical difficulties, our study staff will contact 
participants by phone to complete the assessments or send them paper assessments via mail or email to have 
them complete and mail back to us. The questions are the same as the IVR system. The participants' 
responses will be recorded on paper (see Appendix P). The data will be entered directly into an excel file 
and stored on the secure H file. We will merge it with the export files from the Webcore servers within the 
MSK firewall. 
All study related materials may be emailed or mailed to participants. 

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5.0 
CRITERIA FOR SUBJECT ELIGIBILITY 
5.1 
Subject Inclusion Criteria 
 
• 
 A first-degree biological relative (a child, sibling or parent) as per self report of an MSKCC follow­ 
up surgical patient diagnosed with melanoma as per pathology report or clinician judgment; 
• 
English-fluent; the surveys were designed and validated in English and are not currently available 
in other languages. Translation of questionnaires into other languages would require reestablishing 
the reliability and validity of these measures. Therefore, participants must be able to communicate 
in English to complete the surveys. 
• 
18 years of age or older; 
• 
For Phase I only: FDRs who live within a 50 mile radius of MSKCC to make it feasible for Ms. 
Shuk to be able to arrive at each person's home for the in-home interview without the cost being 
prohibitive; 
• 
 For Phase I only: Can recall a period when s/he was out in the sun for at least one hour on a sunny 
day this past summer 2009. 
• 
 For Phase I only: Can recall a separate period whens/he was out in the sun for at least one hour on 
a sunny day this past summer 2009, buts/he was in a different location from the period referenced 
above. 
• 
 For Phase II only: FDRs who self-report at least 1 consecutive hour in the morning (dawn to 
12:30pm) and 1 consecutive hour in the afternoon (12:30 - 5pm) of daily (weekend and weekday) 
outdoor activities on the screening questionnaire (Appendix A). 
5.2 
Subject Exclusion Criteria 
• 
First-degree relatives of melanoma patients who report never using UVR protection; 
• 
Patients who provide consent for Phase I will not be eligible for Phase II. 
• 
Any first-degree relative of a melanoma patient who already has a first-degree relative who 
consented to the study; 
• 
Unable to provide informed consent. 
 
6.0 
RECRUITMENT PLAN 
For each of the samples (Phase 1=25 FDR µtrticipants; Phase II=60 FDR participants) patients whose FDRs 
may be eligible for this study will be identified by a member of the patient's treatment team, the protocol 
investigator, or research team at Memorial Sloan-Kettering Cancer Center (MSKCC). Using clinic lists 
from the Department of Surgery Gastric/Mixed Tumor Services at MSKCC, study staff or a study 
investigator will do a medical chart review to identify patients who are melanoma patients. Study staff will 
then obtain permission from the attending physician to contact the patient about his or her FDRs' possible 
participation in this study. Once permission is obtained, the study staff will either approach the patient at 
their clinic appointment to provide a brief verbal introduction of the study along with a study brochure 
(Appendix E for Phase 1, Appendix F for Phase 2) to the patient and any accompanying family members or 
mail them a letter (Appendix T) introducing them to the study and letting them know we will contact them 
about the study by phone in a few weeks. 

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If any first-degree relatives are present at the clinic appointment they will be given the consent form in 
addition to the brochure to read over. Once they have read the brochure and consent and are still interested, 
the study staff will administer the screening questionnaire (Appendix A). It will be administered prior to 
obtaining informed consent. The study staff will briefly explain the purpose of the screening questionnaire 
in determining if they are eligible for the study or not. They will make sure the FDR understands that 
completing the form is voluntary but that without completing it they will not be able to participate in the 
study. If an FDR is determined to be ineligible for study participation after administration of the screening 
instrument, s/he will be thanked for his or her time. 
 
We will conduct purposive sampling [62] in order to ensure representation of melanoma FDRs with diverse 
approaches to UVR protection. Purposive sampling is a sampling strategy commonly used in qualitative 
research in which research participants are selected based upon some characteristic [91]. For Phase I of our 
study we will screen potential research participants according to whether they meet two criteria­ 
participant gender, and their perceived advantages of sunbathing, given the importance of these factors in 
determining UVR behavior [26, 64]. Therefore, we will include screening assessment of perceived 
advantages of sunbathing [63] to recruit equal numbers of those who perceive high versus low advantages 
of sunbathing as well as equal numbers of men and women. In Phase II we will only engage in purposive 
sampling for the gender criteria to ensure recruiting equal numbers of men and women. For Phase II, we 
will additionally use the screening questionnaire (Appendix A) to only include melanoma FDRs who report 
daily (weekend and weekday) outdoor activities due to vacations, retirement, leisure activities, or work 
situations. 
If the patient is not accompanied by an FDR at their clinic appointment but approves contact or we are 
contacting the patient by phone from the letter recruitment method, we will collect their identified FDR's 
contact information from the patient. Should a patient refer more than one FDR, we will ask them to 
identify them in order of preference for us to contact, based on their determination of who would most 
likely be eligible and who would most likely be willing to participate. We will then either contact the FDR 
by phone (including leaving a voice message), e-mail or by mailing the FDR a letter (Appendix G Phase I; 
Appendix H Phase II) and consent form. If a letter is mailed to them we will then follow up with a phone 
call to discuss the study, and complete the screening questionnaire by telephone. If the FDR states they did 
not receive a racket or if we have contacted them by phone and not sent a packet, we will offer to email 
them the consent. We will only contact one FDR at a time until they are determined to be ineligible, or 
refuse to consent. Once an FDR agrees to the home interview, we will not attempt to contact any other 
FDRs provided to us by that patient. If permission to contact the FDR is denied by the patient, the FDR 
will become ineligible for the study. We will ask the patient if they would be willing to provide a reason for 
their decision. This information will be obtained solely for the purpose of determining potential sample 
selection biases. 
In the event that we have made several (up to 5) unsuccessful phone call attempts to prospective 
participants, we will mail a letter (Appendix I) to them indicating that they need to contact the study staff if 
they are interested in discussing the study. For FDRs who decline participation, we will ask if they would 
be willing to provide a reason for nonparticipation. This information will be obtained solely for the purpose 
of determining potential sample selection biases. 
For phase I, the consenting professional will consent eligible FDR participants face to face at their home. 
The scheduling for the Phase I in-home interview will be arranged either in the clinic or over the phone by 
the study staff or Ms. Shuk. 

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For Phase II participants, the study staff began screening for eligible participants in the summer of 2011 
with the expectation that the IVR system would be available to use and they could consent in 2011. Due to 
unexpected delays in the development of the IVR, we were not able to consent the potential FDRs whom 
we identified as eligible. We, therefore, asked each person's permission to contact them in the 
spring/summer of 2012 when they could enroll in the study. All 23 persons agreed to be contacted in the 
late spring of 2012 about enrolling in this study. At that time, they will be re-screened for eligibility and if 
interested, consented at that time. We will ask all potential participants to identify a 14-day period when 
they can participate in the study within the summer months of 2012. The participant will be told that they 
should expect to be consented to the study within a week prior to the start of this 14-day period. Depending 
on when period is, the potentia I participants can be consented either face to face in the clinic or verbally 
over the phone. 
As of the end of summer 2012, we still had not completed recruitment and therefore will continue in the 
spring and summer of2013 when we expect to fmish as we only have 30 more FDRs to consent. We are 
going to mail patients in Spring 2013 a letter to introduce the study to them in hopes that this will help 
facilitate the recruitment process (as opposed to only approaching patients in clinic) in order to guarantee 
that we can complete recruitment by the end of summer 2013. 
Throughout the recruitment process of both Phase I and Phase II, we will monitor and evaluate our progress 
toward meeting our recruitment aims of enrolling an equal number of men and women and an equal number 
of individuals who report high and low attitudes toward sunbathing into the study, and we will adjust our 
recruitment strategies accordingly if we are trending toward meeting our recruitment goals in one of these 
categories. For example, if we enroll IO men into Phase I of the study in succession, we will shift toward 
targeting enrollment of women into the study, to ensure that the Phase I study sample will include an equal 
number of men and women. 
All participants will receive $50 in cash or money order for their time and effort on the study (see Appendix 
J Phase 1, Appendix K for Phase 2). There is no cost to study participants. Additionally, all participants will 
receive a packet of information on skin cancer prevention and screening from the NCI website (see 
Appendix M). Once the participant has completed the study, the research staff will ask if they are interested 
in participating in any similar studies. They will also be informed that they may be contacted during or 
shortly after their participation in the study to clarify an answer. 
According to the 2008 Memorial Sloan-Kettering Melanoma Disease Management Team Database, the 
Gastric/Mixed Tumor Service anticipates following approximately 400 post-surgical patients diagnosed 
with melanoma, and 400 additional melanoma patients as new visits. Of these, 85% were diagnosed with 
clinically localized disease. In our pilot recruitment studies with melanoma FDRs, we find that 84% of 
melanoma patients are willing to refer an FDR for behavioral research studies (the remainder refuse or do 
not have eligible FDRs). We anticipate a conservative FDR participation rate of 80% based on prior studies 
evaluating daily diary assessment of UVR protection in a comparable high-risk population [28, 29]. We 
will accept only one family member participant per patient to exclude potential dependency in the data due 
to family membership. Thus for Phase I, we will have a patient pool of 228 that should result in 188 
making a referral of an FDR Of these 188 FDRs, we anticipate 150 available FDRs available to meet our 
target participation of 25 FDRs. For Phase II we expect to have a patient pool of 285 that should result in 
235 making a referral of an FDR. Of these 235 FDRs, we anticipate 188 available FDRs available to meet 
our target participation of 60 FDRs. 

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During the initial contact between the investigator/research staff and the patient and/or FDR, the patient 
and/or FDR may be asked to provide certain health information that is necessary for the recruitment and 
enrollment process. We will use the information provided by the patient, FDR, and/or medical record to 
confirm that the FDR is eligible and to contact the patient and FDR regarding the FDR's study enrollment. 
If the FDR turns out to be ineligible for the research study, the research staff will destroy all information 
collected on the patient and FDR during the initial conversation and medical records, except for any 
information that must be maintained for screening log purposes. 
The recruitment process outlined presents no more than minimal risk to the privacy of the patients and 
FDRs who are screened and minimal PHI will be maintained as part of a screening log. For these reasons, 
we are seeking a (partial) limited waiver of authorization for purposes of (1) reviewing medical records to 
identify patients who are diagnosed with early stage, clinically localized cutaneous melanoma; (2) 
communicating with patients and FDRs regarding possible enrollment of the FDRs; (3) handling of PHI 
contained within these records and provided by patients and/or FDRs; and (4) maintaining information in a 
screening log of patients and FDRs approached. 
7.0 
ASSESSMENT/EVALUATION PLAN 
Screening Questionnaire (Appendix A). This will include information to determine the eligibility of 
potential participants. Accordingly, the form will include information about potential participants' 
relationship to the index patient, gender, home geographical location, level of outdoor activities, use of sun 
protection and a seven-item measure of individuals' beliefs about level of agreement concerning advantages 
of sunbathing (1=strongly disagree to 6=strongly agree). This measure has been used in prior research and 
has good internal (alpha=.95) and test-retest reliability (r=.70, [63]). Participants scoring above the mean 
(4.0) identified in prior research will be designated as perceiving advantages of sunbathing; those scoring 
below the mean will be designated as not perceiving advantages of sunbathing for the purposes of 
stratification assignment. This will take about 5 minutes to complete. 
 
Ethnographic Semi-Structured In-Home Interview -Phase I Only (Appendix B). The in-home interview 
guide will consist of several components. First, we will ask participants to recall the most recent time they 
spent outdoors on a sunny summer day for one hour or more. We will ask participants to describe how they 
made decisions whether to use three methods of sun protection: sunscreen with an SPF of 15 or higher, sun 
protective clothing such as a shirt with sleeves or a hat, and seeking shade or staying under an umbrella. 
Second, we will ask participants to recall another period when they spent time outdoors for at least one hour 
on a sunny summer day; we will ask participants to recall a period when they were in a different outdoor 
environment than the period just discussed. As before, we will ask participants to talk through how they 
made decisions to use the three methods of sun protection under examination (i.e., sunscreen with an SPF of 
15 or higher, sun protective clothing such as a shirt with sleeves or a hat, and seeking shade or staying 
under an umbrella). If inconsistencies are present in the participant's sun protection behavior-using 
sunscreen, sun protective clothing, or seeking shade/staying under an umbrella-across the two sun 
exposure episodes reported, we will ask the participant to compare their use of sun protection across both 
episodes. The goal here will be to understand the reasons that led the participant to make different decisions 
to use sunscreen, and/or sun protective clothing, seek shade/stay under an umbrella across the two periods 
of time spent outdoors. We will ask a few demographic questions as well as ask each person's experience 
with different kinds of electronic equipment. We expect the interview to take about 90 minutes. 
Home Tour - Phase I Only. The final piece of the in-home interview will be a brief house tour, in which we 
will ask participants to show the areas inside or outside their home where they store their sun protection 

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items. As participants present the sun protection items we will ask them if there are any other reasons why 
they may use or not use the item when they spend time outdoors. Seeing the items in front of them may 
prompt participants to remember details regarding the item's use. We expect the tour to take about 15 
minutes. 
Digital Voice Recorder. For Phase I, we will use a digital voice recorder to record the ethnographic in­ 
home interviews. 
 
Demographic Questionnaire (Appendix R). We will ask a few demographic questions once the 
participant has consented as well as ask each person's experience with different kinds of electronic 
equipment. We expect the questionnaire to take less than 5 minutes to complete. 
Interactive Voice Response (NR) Diary Assessment - Phase II Only (Appendix C). The NR diary 
assessment survey will be modeled on the composite decision model for each assessed sun protection 
behavior (sunscreen use, shade seeking, hat use, use of sun protective clothing) that was developed in Phase 
I. For each assessment (at approximately 12:30 and 5 pm daily), participants will receive an IVR call to 
report their sun protection attitudes and behaviors for that morning or afternoon. The IVR assessment 
survey asks participants to report on the following: 1) whether or not they have used each of the following 
sun protection methods: sunscreen, hats, shade-seeking, and protective clothing; 2) the presence or absence 
of 21 decision criteria identified in Phase 1 to influence sun protection decision making; and 3) theory­ 
driven affective and cognitive predictors. 
In addition to answering questions about their sun exposure and protection through the IVR phone keypad, 
at the end of each assessment participants will be asked by the IVR to record an audio narrative diary that 
will capture their own thoughts about their sun protection choices during that assessed time period ( i.e., 
either the morning or afternoon on a given day in the 14-day assessment period). The IVR will direct 
participants with the following instruction after participants complete the assessment at both approximately 
12:30 pm and approximately 5 pm. "Please now speak into your phone to describe in your own words your 
use of sun protection during the time period(s) you have just reported on." After the instruction to record 
the audio narrative, the IVR will inform the participant the time at which they will receive their next call. 
Theory-driven affective and cognitive predictors will include perceived risk for melanoma and efficacy 
(UVR protection self- and response-efficacy) based on Witte's Extended Parallel Process Model [3]. We 
will assess these predictors at each assessment point, twice daily for 14 days. We have elected not to 
include melanoma severity in the assessment given that it is generally not found to be predictive ofUVR 
protective behaviors in melanoma FDRs [22, 25]. To measure perceived risk for melanoma we will use one 
established question that has been used in prior UVR protection studies with melanoma FDRs [22-26]: B) 
perceived absolute likelihood with verbal anchors (1 = no chance, 2 = unlikely, 3 = moderate chance, 4= 
likely, 5 = certain to happen), 
 
Efficacy beliefs [72] will be assessed through two questions assessing the extent to which the participant 
feels capable of UVR protection in general (self-efficacy; 1=''Not at all capable," 2="somewhat incapable," 
"3=somewhat capable," "4="extremely capable") and the extent to which the participant believes that UVR 
protection strategies can prevent melanoma (response-efficacy; l=''Not at all effective," 2= "a little 
effective," 3= "moderately effective," 4= "extremely effective" ). 
 
We will also assess satisfaction with UVR protection consistent with Rothman's theory of health behavior 
maintenance [50] via one question adapted to satisfaction with UVR protection based on Rothman's work 
on satisfaction with smoking cessation [4, 5]. Accordingly, we will ask "How satisfied are you with your 

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decision to engage in sun protection behavior this morning (or) this afternoon?" ( l =''Not at all satisfied," 2 
for "a little satisfied," 3 for "moderately satisfied," 4 for "extremely satisfied.") 
 
Within a week of completing the final IVR assessment on day 14, the study staff will call the participants to 
complete a brief program satisfaction survey consisting of 17 items to address any barriers to using the IVR. 
Additionally, in accordance with prior ecological momentary assessrrent research, the IVR will ask 
participants to self-report the extent to which the IVR prompting acted as a cue-to-action in their two-week 
assessment period of sun protection behavior. It is expected to take about 5 minutes to complete. 
8.0 
TOXICITIES/SIDE EFFECTS 
Individuals may find it stressful to answer questions regarding their sun protection behaviors. The risk 
associated with answering these questions is expected to be minimal. Participants' level of distress will be 
carefully monitored by the research staff and by Dr. Hay. Participants may refuse any part of their 
participation, from answering questions that they find distressing, to refusing the home tour, or recording 
twice-daily audio narrative diaries through the IVR system. If a participant is significantly distressed, Dr. 
Hay or a covering attending will assess the participant and make an appropriate referral for clinical care if 
needed. 
 
 
 
 
9.0 
PRIMARY OUTCOMES 
The following ultraviolet radiation protection (UVR) behaviors will be assessed as primary outcomes: 
 
• 
Continuous sun avoidance and/or shade-seeking behavior 
• 
Sunscreen use 
• 
Use of UVR protective clothing 
• 
Use of hats 
 
Our first aim is to generate models explaining decision-making about three UVR protection behaviors 
(sunscreen use, shade-seeking, use of protective clothing) in melanoma FDRs. We will model daily 
decision-making processes for UVR protection through qualitative and quantitative research strategies. In 
Phase I, we will conduct in-home ethnographic interviews with 25 melanoma FDRs and generate a decision 
making model for each UVR protection behavior for each melanoma FDR, and subsequently construct a 
composite decision-making model for each of the UVR protection outcomes (i.e., sunscreen use, shade­ 
seeking, and UVR protective clothing use) representing prominent decision making factors across all 25 
FDRs interviewed. In Phase II we will establish the validity of the models via examination of daily 
decision-making about UVR protection using ecological momentary assessment via IVR (over 14 days in 
the summer/early fall, at approximately 12:30 pm and 5 pm daily) in 60 different melanoma FDRs from 
Phase I. As outlined in EDTM methodology, we will report on the level of success of the decision-making 
model in predicting uptake of each of the three UVR protection strategies. 
Our second aim is to examine theory-driven affective and cognitive predictors of UVR protection 
maintenance (sunscreen use, shade-seeking, hat use, and use of UVR protective clothing) assessed in real 
time. We will examine the role of melanoma threat and efficacy beliefs in determining UVR protection 
maintenance drawn from Witte's Extended Parallel Processing Model [3], and will examine the role of 
satisfaction in UVR protection maintenance drawn from Rothman' s theory of health behavior maintenance 

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[4-6]. We will examine both between-person and within-person changes in these predictors, as well as 
salient decision-making factors (Identified in Aim I), in predicting maintenance of sunscreen use, shade­ 
seeking, hat use, and use of UVR protective clothing. 
10.0 
CRITERIA FOR REMOVAL FROM STUDY 
Participants will be taken off study protocol under the following circumstances: 1) FDR voluntarily 
withdraws from study; 2) onset of severe cognitive impairment that makes participation in the study 
impossible, such as impaired ability to read or to provide accurate answers to the interviewer; 3) the 
participant expresses significant distress related to completion of the study assessments (the PI or a 
covering attending will refer the patient to clinical services if needed); or 4) if the study doctor believes it is 
in the participant's best interest to do so. 
 
 
11.0 
BIOSTATISTICS 
Overview.  This exploratory study is divided into two phases. Phase I involves in-home interviews of 25 
participants to understand the factors that affect participants' decision-making about UVR protection 
(sunscreen use, shade-seeking, use of protective clothing). Qualitative data analyses will be carried out in 
Phase I to generate an Ethnographic Decision-Tree Modeling (EDTM) tree as described in Section 4.2. For 
example, a participant may be most likely to use sunscreen when it is a sunny day and when he/she is 
outdoors, at the beach, or at an outdoor sporting event. The participant may also state that he/she uses 
sunscreen whenever together with a young child, even though it may not be a sunny day. 
In Phase II, we plan to recruit a sample of 60 melanoma first degree relatives (FDRs) and use IVR 
technology so that they can record their daily sun protection behaviors and decision criteria. The IVR 
system will call participants twice daily at approximately 12:30 pm and 5 pm for a period of 14 days. The 
participant will use their telephone keypad to answer a series of questions on their UVR protection 
behaviors, which will be four dichotomous, self-reported outcomes: sunscreen use, shade-seeking, hat use, 
and protective clothing use). The assessment will also address factors that affect UVR protection 
behaviors. These decision factors are based on the qualitative data we collected in Phase I. For example, 
we will ask participants to report the presence or absence of environmental factors (e.g., weather 
conditions), convenience/situational factors (e.g., availability of sun protection items), and social­ 
interpersonal (e.g., activities engaged in). Data collected through IVR will generally be analyzed by 
Generalized Estimating Equations (GEEs) to explore the decision factors that promote or hinder the 
probability of UVR protection behavior. 
Specific Aim I: To generate models explaining decision-making about three UVR protection behaviors 
(sunscreen use, shade-seeking, use of protective clothing) in melanoma FDRs. 
Aim I will involve the EDTM methodology described in Section 4.2. Audio-recorded narrative data will be 
coded and summarized into an EDTM tree. 
For example, dee ision factors such as convenience, weather, or social support for UVR protection may 
emerge as important factors. Because we are examining behaviors that involve highly comp lex 
interactions, we need to first understand the phenomenon more fully. Pertinent to Aim 1 is the use of 
descriptive statistics to summarize the sizes of the terminal decision nodes. Each node on the EDTM tree 
represents the pathway by which a person makes the decision to use or not to use UVR protection. The size 
of a terminal node in the EDTM tree represents the number of people who follow a specific decision 

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pathway. For example, we may fmd that many people do not use sunscreen if they do not find it before 
they leave home. In this hypothetical example, the decision factor of convenience trumps all other decision 
factors. We may therefore infer from the sizes of the nodes the importance of the corresponding decision 
pathways and specific decision splits. The most important advantage is that we will be better able to 
distinguish the factors that contribute to sunscreen nonuse from sunscreen use in order to separate the 
barriers from the facilitating decision factors. 
Specific Aim II: To examine theory-driven affective and cognitive predictors of UVR protection 
maintenance (sunscreen use, shade-seeking, hat use, and use of UVR protective clothing) assessed in real 
time. 
The general statistical paradigm for this Aim will be Generalized Estimating Equations (GEE) [83, 84] 
because of the repeated sampling of UVR protection behaviors and their predictors. Over a period of 14 
days, each participant will generate a maximum of 28 assessrrents. Each assessment will yield 4 
dichotomous outcome endpoints (sunscreen use, shade seeking, hat use and protective clothing). 
Additionally, each assessment will probe the decision factors, e.g., on environmental factors, 
convenience/situational factors, cognitive and social-interpersonal factors. For each outcome endpoint, we 
will fit a series of GEE models with a logit link. For example, we may fit the probability of stmscreen use 
as a function of weather (e.g., a dichotomous yes/no indicator of a sunny day). We will calculate the 95% 
confidence interval of the weather indicator on sunscreen use. The procedure will be repeated for other 
decision factors. We will use data visualization and graphs to summarize the 95% confidence intervals 
across decision factors, in the same exploratory procedures as outlined previously in O'Connor et al (2008). 
Our exploratory GEEs approach is the most widely- used approach in the literature of intensive real-time 
data capture (aka Ecological Momentary Assessments, see Stone, 2009). Generally, these GEE models 
allow us to examme the extent to which each decision factor is associated with the health behaviors of 
interest. The repeated assessments will be clustered within persons. The working correlation structure will 
generally be fitted with an auto-regressive mode1because of the intensive daily assessments. The fmal 
number of covariates cannot be determined precisely at this time. However, care will be taken to minimize 
the number of confidence intervals to reduce concerns of multiple confidence intervals and to make the data 
more interpretable. 
Power considerations. 
 
We estimated the statistical power of a GEE model on sunscreen use. The GEE model has a single 
covariate (e.g., a weather indicator).  An extensive literature search did not find prior data on UVR 
protection behaviors. However, we believe that an odds ratio of 1.55 is plausible and is not overly 
optimistic. A hypothetical example helps explain this 1.55 difference. Suppose on a given day, 30 people 
report that it is sunny and the other 30 report that it is not sunny. Then an odds ratio of 1.55 means that we 
will be able to detect a difference between 70% (21 / 30) and 60% (18 / 30) sunscreen use across the two 
groups. Our power calculation showed that a sample size of 60 would be adequate in detecting this 70% vs. 
60% difference. 
Our actual statistical power estimation was based on a more sophisticated Monte Carlo simulation approach 
[86] as we consider study attrition and missed assessments. Formulaic solutions for GEE power 
calculations were deemed inadequate for the current study because they do not apply (e.g., the present study 
involves no randomization to study arms [87, 88]). Our Monte Carlo simulation showed that, with a sample 
size of 60 melanoma FDRs, accounting for clustering effect, respondent attrition and missed assessrrents, 

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we will have 78% power to detect a 1.55 OR in a GEE predictor at a two-sided Type-I error rate of 0.01 
(0.01 Type-I error to provide some control over multiple GEE models). 
To account for correlated longitudinal sunscreen use data nested within study participants, we assumed in 
the power calculation an ARI correlation pattern with a 0.50 co-occurrence probability between two 
consecutive days of sunscreen use. This 0.50 co-occurrence probability was based on the expected co­ 
occurrences if, at any given day, 21 of 30 respondents use sunscreen. We can use a simple 2x2 table to 
demonstrate that, with the fixed marginals at 21 on either day, the expected sunscreen use on both days is 
15 persons (a joint probability of 0.50 = 15/30, below). 
Day 2 
 
Use sunscreen (n=21) 
No use (n=9) 
 
 
Day 1 
Use sunscreen (n=21) 
No use (n=9) 
 
This 0.50 co-occurrence rate retween consecutive days of 0.70 sunscreen use translates into a tetrachoric 
correlation coefficient of 0.082 (by the commonprob2sigma() function in the R package bindata). We thus 
used a rounded 0.10 tetrachoric correlation between two consecutive days in our simulation of an ARI 
correlation matrix. 
The simulations incorporated the following considerations of missing data. For rate of attrition, we 
assumed that 5% of the respondents will stop responding to the EMA assessments by the end of week 1, 
and 5% of the remaining respondents will be lost by the end of week Jwo. Thus, we assumed that we will 
retain 90% of the recruited respondents by the end of study period. Additionally, for any single assessment, 
there is a 30% probability that the assessment will be missing at random. We considered these missing data 
patterns because our prior LUCY data showed overall missing data patterns similar to these assumptions, so 
they are likely quite conservative given that LUCY subjects were quite ill. 
Missing Data Analysis. Although we shall endeavor to obtain final evaluation data even for participants 
who discontinue the use of the hand-held device, we cannot rely on this and will use statistical methods 
appropriate when missing data may be informative. Data "missingness" may shed light on study features 
that affect feasibility. From our prior LUCY study we were able to attain a 89% completion rate for a 14- 
day period. This encouraging assessment completion rate notwithstanding, we will ascertain whether or not 
the number of completed IVR assessrrents differed between the sampling strata [78]. A significant 
difference will be evidence for missing not at random. For example, women may complete more 
assessments than rren do over the 14-day assessment period. If missingness is not at random, we will 
consider imputing the missing data using several missing data imputation techniques [79-81]. These 
techniques are appropriate for different data types, including continuous, dichotomous, and count data. 
Additionally, one recently published data imputation technique by Demirtas and Bedeker is especially 
suitable for dichotomous and/or ordered longitudinal missing data [82]. We will also consider the use of 
Pattern-Mixture Model to control for non-ignorable missing patterns. Pattern-Mixture Model assumes that 
participants can be grouped into a small number of implicit cohorts with different patterns of missing data. 
One such implicit cohort may include participants who miss only a handful of assessments. Conceivably, 
there may be a cohort of participants who miss a few consecutive days of assessments. Pattern-Mixture 
Model can statistically adjust for participants' missing data pattern in order to account for missing not at 
15 
(21*21)/30 
6 
6 
3 

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random. The method models the typical trajectories ofresponses within each of these cohorts and 
combines results across cohorts to make overall comparisons between groups of individual participants. 
Thus, Pattern-Mixture Model corrects the potential statistical bias due to missing not at random, and may 
help identify subgroups that show the lowest response rate to the EMA. There is a SAS macro for Pattern­ 
Mixture mode ling. 
 
 
12.0 
RESEARCH PARTICIPANT REGISTRATION AND RANDOMIZATION PROCEDURES 
12.1 
Research Participant Registration 
Confirm eligibility as defmed in the section entitled Criteria for Patient/Subject Eligibility. 
 
Obtain informed consent, by following procedures defined in section entitled Informed Consent 
Procedures. 
During the registration process registering individuals will be required to complete a protocol 
specific Eligibility Checklist. 
All participants must be registered through the Protocol Participant Registration (PPR) Office at 
Memorial Sloan-Kettering Cancer Center. PPR is available Monday through Friday from 8:30am- 
5:30pm at 646-735-8000. Registrations must be submitted via the PPR Electronic Registration 
System(http://pprQ. The completed signature page of the written consent/RA or verbal script/RA, 
a completed Eligibility Checklist and other relevant documents must be uploaded via the PPR 
Electronic Registration System 
 
12.2 
Randomization 
Not applicable. 
 
13.0 
DATA MANAGEMENT ISSUES 
Feasibility 
According to the 2008 Memorial Sloan-Kettering Melanoma Disease Management Team Database, the 
Gastric/Mixed Tumor Service anticipates following approximately 400 post-surgical patients diagnosed 
with melanoma, and 400 additional melanoma patients as new visits. Of these, 85% were diagnosed with 
clinically localized disease. In our pilot recruitment studies with melanoma FDRs, we fmd that 84% of 
melanoma patients are willing to refer an FDR for behavioral research studies (the remainder refuse or do 
not have eligible FDRs). We anticipate a conservative FDR µtrticipation rate of 80% based on prior studies 
evaluating daily diary assessment of UVR protection in a comparable high-risk population [28, 29]. We 
will accept only one family member participant per family to exclude potential dependency in the data due 
to family membership. Thus for Phase I, we expect to have a patient pool of 228 that should result in 188 
making a referral of an FDR Of these 188 FDRs, we anticipate 150 available FDRs available to meet our 
target participation of 25 FDRs. For Phase II we expect to have a patient pool of 285 that should result in 
235 making a referral of an FDR. Of these 235 FDRs, we anticipate 188 available FDRs available to meet 
our target participation of 60 FDRs. 
 
Data Management 

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Confidentiality of each participant's information will be protected with utmost care. Participants will be 
assigned an identification number that will be used for all study records. Participants will be identifiable 
solely by code number. The list of matching subject names and code numbers will be maintained in a 
locked file cabinet in a separate location in the Department of Psychiatry and Behavioral Sciences office at 
641 Lexington Avenue, 7th Floor, New York, NY 10022. Completed research charts will be maintained in a 
locked file cabinet in a secured, locked office at the MSKCC Department of Psychiatry Research Offices. 
The data collected for this study will be entered into a secure database. Data management and statistical 
analysis will be done on a secured PC, licensed by the Department of Psychiatry and Behavioral Sciences. 
Data entry and analysis will occur in the MSKCC Deµirtment of Psychiatry and Behavioral Sciences office 
at 641 Lexington Avenue, 7th Floor, New York, NY 10022. 
 
Once the participant completes an assessment using IVR, the data is stored on the MSKCC We bCore 
server. The data is stored using an ID number, not name. The data can be retrieved by accessing a web­ 
based system with a login name and password (web address is http://webcore.mskcc.org). Each 
participant's data will be converted into an Excel file for ease of data checking and quality control A 
master file will contain all subject data and will be converted into a format amenable to data analyses. In the 
event that the NR system fails and we need to collect the data by phoning the participants, the data will 
entered manually into this same system regardless of whether we collect it by paper and pen first or enter 
directly into this web-based system. If we collect the data by paper and pen first, we will then enter it into 
this system and file the paper assessment in a locked file cabinet. Participants' audio narrative files will be 
stored on the MSKCC WebCore server as well. Web Core staff will upload the audio files to MSKCC's file 
transferring program for study staff to download and review. 
 
13.1 
Quality Assurance 
Weekly registration reports will be generated to monitor participant accruals and completeness of 
registration data. Routine data quality reports will be generated to assess missing data and 
inconsistencies. Accrual rates and the extent and accuracy of evaluations and follow-up will be 
monitored periodically throughout the study period and potential problems will be brought to the 
attention of the study team for discussion and action. 
Random-sample data quality and protocol compliance audits will be conducted by the study team, 
at a minimum of two times per year, more frequently if indicated. 
 
In Phase I the in-home ethnographic interviews will be recorded using a digital voice recorder, with 
the permission of the participant. These digital audio files will be brought back to the Psychiatry 
and Behavioral Sciences offices and uploaded to our secure network drive the same day. In the 
event that they cannot be brought back same day (i.e. interview took place in the evening) the audio 
file will be uploaded to the secure network drive via VPN. Once the files have been safely uploaded 
to the secure network drive the file will be deleted from the recorder. The participant's name or any 
other personally identifying information will not be used in reports or publications of this study. 
13.2 
Data and Safety Monitoring 
The Data and Safety Monitoring (DSM) Plans at Memorial Sloan-Kettering Cancer Center were 
approved by the National Cancer Institute in September 2001. The plans address the new policies 
set forth by the NCI in the document entitled "Policy of the National Cancer Institute for Data and 
Safety Monitoring of Clinical Trials" which can be found at: 
http://www.cancer.gov/clink:altrials/conducting/dsm-guidelines/pagel. The DSM Plans at MSKCC 

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were established and are monitored by the Office of Clinical Research. The MSKCC Data and 
Safety Monitoring Plans can be found on the MSKCC Intranet at: 
http://smskpsps9/deptlocr/OCR%20Website%20Documents/Clinical%20Research%20Quality%20 
Assurance%20(CRQA)/MSKC<Y/o20Data%20and%20Safety%20Monitoring%20Planpdf 
 
There are several different mechanisms by which clinical trials are monitored for data, safety and 
quality. There are institutional processes in place for quality assurance (e.g., protocol monitoring, 
compliance and data verification audits, therapeutic response, and staff education on clinical 
research QA) and departmental procedures for quality control, plus there are two institutional 
committees that are responsible for monitoring the activities of our clinical trials programs. The 
committees: Data and Safety Monitoring Committee (DSMC) for Phase I and II clinical trials, and 
the Data and Safety Monitoring Board (DSMB) for Phase III clinical trials, report to the Center's 
Research Council and Institutional Review Board. 
 
During the protocol development and review process, each protocol will be assessed for its level of 
risk and degree of monitoring required. Every type of protocol (e.g., NIH sponsored, in-house 
sponsored, industrial sponsored, NCI cooperative group, etc.) will be addressed and the monitoring 
procedures will be established at the time of protocol activation. 
 
13.3 Regulatory Documentation 
 
Participating site that are consulting and/or conducting specimen or data analysis should submit this 
protocol to their IRB according to local guidelines. Copies of any site IRB correspondence should 
be forwarded to MSKCC. 
 
13.4 Audio Recordings 
 
For Phase I, Ms. Shuk will be responsible for carefully handling all digital audio recorders and 
digital recordings (e.g. no cassette tapes) to ensure that all confidentiality procedures and HIPAA 
regulations are followed. All digital voice recorders will be stored in a locked file cabinet. When a 
research interview takes place, the interviewer turns on the recorder at the start of the interview. 
The interview will take place after introductions. The interviewer will avoid discussion of all 
protected health information on digital voice recordings. 
 
When the interview is fmished, the interviewer turns off the recorder. The digital recorder should 
then be brought back to 641 Lexington Ave and uploaded to the shared H: drive in a restricted­ 
access file. In the event that the interview takes places in the evening the digital audio file will be 
uploaded to the shared H: drive in a restricted-access file using VPN. Each digital audio recording 
is assigned and stored by a study ID, not name. Immediately after upload, the interview is deleted 
from the digital audio recorder. 
 
For Phase II participants, we will instruct and emphasize to the participant not to include their name 
in the recorded audio diaries when we train the participants regarding use of the IVR before the 
assessment period commences. We will also instruct Phase 2 participants not to reveal the names of 
any other individuals in their audio diaries, but instead refer to other individuals by either "friend," 
"family member," or by some other role description as appropriate. The study staff will remind 
Phase 2 participants on both of these points during follow-up phone calls during the assessment 
period. 

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In-home interview digital audio recordings will be transcribed by the professional transcription 
service R. A. Fisher Ink. All files will be transmitted electronically to the transcription service 
through MSK's secure File Transfer System. Complete transcripts are transmitted electronically 
from the transcription service to the study staff via a JRSSword protected file transfer protocol (ftp). 
When the transcripts are received, the study staff downloads them to the departmental shared H: 
drive in a restricted-access folder. The transcription service does not share local drives over the 
internet, and all files are removed upon completion. A Business Associate Agreement (BAA) 
detailing these procedures will be signed by both the Principal Investigator for this study and the 
professional transcription service and stored in the research files. It will be specified to the 
transcriber that if any names are identified on the digital audio file that it should be transcribed as 
initials. 
 
14.0 
PROTECTION OF IRJMAN SUBJECTS 
There are two main risks for participants in this study: 1) individuals may find it stressful to answer 
questions regarding their sun protection behaviors; and 2) breaches of confidentiality. Minimal risk of 
psychological distress is posed by study questions that ask participants to identify their current behaviors 
regarding sun protection. Reactions of participants in Phase 1 of the study will be observed during the in­ 
home interview. The PI or a covering attending will follow up with participants who show signs of 
significant distress. Although participants may indirectly benefit from greater understanding of decision­ 
making in relation to sun protection behaviors, there is no guarantee of benefit to participants based on 
study participation. There are no fmancial costs to FDRs for JRrticipating in this study. Participants in Phase 
I and participants in Phase II will each receive $50 in cash or money order for their time and effort on the 
study. 
Participants will be informed that information collected during their participation in this study is considered 
confidential. To ensure confidentiality of data, all records will be identified by the participant's 
identification number, not by name, and will be stored in a locked secure area. All participants are provided 
a phone number in the informed consent that they can use if they are interested in receiving the overall 
results of the study. 
A list matching participants' names and code numbers will be maintained separately and kept in a locked 
secure area in the Department of Psychiatry and Behavioral Sciences at 641 Lexington Avenue. Only the 
PT, Co-PT, and MSKCC research staff will have access to the records. Electronic data sheets and records 
will be maintained on MSKCC servers, with password protected log-on and secure back-ups per MSKCC 
IS SOP. Computer files will only be available to those granted permission to use the approved access code. 
All necessary precautions will be taken to ensure that there is no breach of confidentiality. 
Participation in this study is entirely voluntary. All participants will be required to provide written or verbal 
informed consent that adheres to MSKCC guidelines. FDRs may decide not to participate in this study or 
to withdraw their consent to participate at any time during this study. 
14.1 
Privacy 
 
MSKCC's Privacy Office may allow the use and disclosure of protected health information 
pursuant to a completed and signed Research Authorization form. The use and disclosure of 
protected health information will be limited to the individuals described in the Research 

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Authorization form. A Research Authorization form must be completed by the Principal 
Investigator and approved by the IRB and Privacy Board (IRB/PB). 
14.2 
Serious Adverse Event (SAE) Reporting 
Only SAEs related to the protocol intervention will be reported to the IRB. Any SAE must be 
reported to the IRB/PB as soon as possible but no later than 5 calendar days. The IRB/PB requires a 
Clinical Research Database (CRDB) SAE report be submitted electronically to the SAE Office at 
sae@mskcc.org containing the following information: 
Fields populated from CRDB: 
 
• 
 Subject's name (generate the report with only initials if it will be sent outside of 
MSKCC) 
• 
Disease/histology (if applicable) 
• 
Protocol number and title 
Data needing to be entered: 
• 
The date the adverse event occurred 
• 
The adverse event 
• 
Relationship of the adverse event to the treatment (drug, device, or intervention) 
• 
If the AE was expected 
• 
The severity of the AE 
• 
The intervention 
• 
Detailed text that includes the following 
o 
A explanation of how the AE was handled 
o 
A description of the subject's condition 
o 
Indication if the subject remains on the study 
o 
If an amendment will need to be made to the protocol and/or consent form. 
The Pl's signature and the date it was signed are required on the completed report. 
 
15.0 
INFORMED CONSENT PROCEDURES 
All potential participants will be informed as to their rights as volunteers in a research study. For both 
Phase I and II, if an FDR is not present with the patient in clinic, the study staff will collect contact 
information from the patient about their FDR to be able to contact their FDR. The study staff will then mail 
the FDR a study brochure and informed consent and then contact them to discuss the study and determine 
their interest in participating. For Phase I, the consenting will be done at their home, however, for Phase II 
it will be done within a week of their 14-day assessment period begim1ing. Depending on when this period 
is, participants can be consented either in clinic or verbally over the phone. If the FDR is present in the 
clinic with the patient, the study staff will determine their eligibility and, for phase I, arrange to have Ms. 
Shuk come to their house where the consenting will take place. The study staff will obtain 2 copies of the 
informed consent, one for the participant and one for the research record. The study staff or Ms. Shuk will 
arrange for a convenient time for the in-home interview and home tour for phase 1. 
 
Before protocol-specified procedures are carried out, consenting professionals will explain full details of the 
protocol and study procedures as well as the risks involved to participants prior to their inclusion in the 

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study. Participants will also be informed that they are free to withdraw from the study at any time. All 
participants must sign an !RB/PB-approved consent form indicating their consent to participate. This 
consent form meets the requirements of the Code of Federal Regulations and the Institutional Review 
Board/Privacy Board of this Center. The consent form will include the following: 
1. The nature and objectives, potential risks and benefits of the intended study. 
2. The length of study and the likely follow-up required. 
3. Altematives to the proposed study. (This will include available standard and investigational 
therapies. In addition, patients will be offered an option of supportive care for therapeutic 
studies.) 
4. The name of the investigator(s) responsible for the protocol. 
5. The right of the participant to accept or refuse study interventions/interactions and to withdraw 
from participation at any time. 
Before any protocol-specific procedures can be carried out, the consenting professional will fully explain 
the aspects of µttient privacy concerning research specific infonnation. In addition to signing the IRB 
Informed Consent, all patients must agree to the Research Authorization component of the informed 
consent form. 
Each participant and consenting professional will sign the consent form. The participant must receive a 
copy of the signed informed consent form. 
16.0 
REFERENCES 
1. 
Beck, K.A., Ethnographic Decision Tree Modeling: A Research Method for Counseling 
Psychology. Journal of Counseling Psychology, 2005. 52(2): p. 243-249. 
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17.0 
APPENDICES 
APPENDIX A: 
PARTICIPANT SCREENING FORM 
APPENDIX B: 
 ETHNOGRAPHIC SEMI-STRUCTURED IN-HOME INTERVIEW GUIDE 
APPENDIX C: 
IVR DIARY ASSESSMENT 
APPENDIX D: 
IVR TRAINING TELEPHONE SCRIPT/MANUAL 
APPENDIX E: 
 STUDY BROCHURE: PHASE I 
APPENDIX F: 
 STUDY BROCHURE: PHASE II 
APPENDIX G:  PHASE I: INTRODUCTION LETTER 
APPENDIX H:  PHASE II: INTRODUCTION LETTER 
APPENDIX I: 
 FDR LAST CONTACT LETTER 
APPENDIX J: 
 PARTICIPANT PHASE 1 RECEIPT 
APPENDIX K: PARTICIPANT PHASE 2 RECEIPT 
APPENDIX L: 
EXAMPLE PHASE 2 IVR RESPONSE CARD & STICKER 
APPENDIX M:  PATIENT MATERIALS ON SKIN CANCER FROM NCI 

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IRB Number: 09-137 A(15) 
Approval date: 20-Dec-2017 
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APPENDIX N:  PROGRAM SATISFACTION SURVEY 
APPENDIX 0: 
 PATIENT STATUS FORM 
APPENDIXP: 
PAPER ASSESSMENT: PHASE II 
APPENDIX Q:  INTRO PACKET LETTER: PHASE II 
APPENDIX R: 
 DEMOGRAPHIC FORM: PHASE II 
APPENDIX S: 
 PHASE II: THANK YOU LETTER 
APPEND T: 
 2013 RECRUITMENT LETTER