Randomized Clinical Trial of an Online Multimedia Program to Boost Coping & Function for Prostate Cancer Survivors
Phase: NA
Conditions: Prostate Cancer
Sponsor: Fox Chase Cancer Center

NCI # NCT02224482 
Document Date: 10/08/2021 
Randomized Controlled Trial of an Online Multimedia Program to Boost Coping & 
Function for Prostate Cancer Survivors 
(PROGRESS – PRostate Cancer Online Guide & Resources for Electronic  
Survivorship Service) 
 
Principal Investigator 
S. M. 
 
 
 

NCI # NCT02224482 
Document Date: 10/08/2021 
1.0 STUDY OVERVIEW  
 
Following treatment, the vast majority of Pca survivors suffer from treatment-related 
symptomatology, specifically urinary and sexual dysfunction, in addition to facing psychosocial 
and practical challenges. There is a need for comprehensive programs with demonstrated 
efficacy to help patients cope with these challenges. We propose to develop and evaluate a 
comprehensive and innovative multimedia program designed to facilitate the post-treatment 
transition into survivorship. The design of the proposed intervention, the Virtual Survivorship 
Resource Center for Prostate Cancer (VSRC-PC), will be theoretically based on the team's 
Cognitive-Social Health Information Processing Model. The VSRC-PC will focus on promoting 
adaptive coping within four key post-treatment domains: 1) Physical Dysfunction (e.g., physical 
symptoms); 2) Emotional Well- Being (e.g., fear of recurrence); 3) Interpersonal Concerns (e.g., 
sexual intimacy issues); and 4) Practical Barriers (e.g., medical follow-up challenges). Content 
for these domains will be organized in a virtual resource center and will consist of: 1) provision 
of related information through text, graphics, voiceovers, and animation; 2) videos of health care 
experts answering frequently asked questions; 3) videos of prostate cancer survivors describing 
their experiences and modeling competencies and coping strategies; and 4) skills training to 
improve communication between Pca survivors and family and healthcare providers. Program 
content will be developed through literature and evidence-based content review, expert input, 
and input from multi-ethnic survivor focus groups. To ensure adequate and appropriate program 
content and optimal functionality, an iterative process of review, revision, and user and usability 
testing will be employed. Intervention efficacy will be evaluated through a two-arm, prospective 
randomized controlled trial. A total of 600 patients (200 from Fox Chase Cancer Center) will 
complete the study. Data will be collected at baseline, and at 1-, 3- and 6- month follow-up. The 
primary outcome variable will be adaptive coping, and the secondary outcome will be 
maladaptive coping. A theory-based test of mediators of intervention effects (e.g., self-efficacy), 
and moderators (e.g., monitoring style) will also be performed. The proposed research will be 
the first RCT to evaluate not only a comprehensive but also highly disseminable and self-
sustaining intervention for facilitating post-treatment adaptation among early-stage Pca 
survivors. 
 
2.0 INTRODUCTION/RATIONALE    
 
2.1. Prevalence of Early Stage Pca Patients, their Adaptational Challenges, and the 
Availability of Interventions to Address their Survivorship Needs  
 
Prostate cancer (Pca) is the most common solid tumor malignancy among US men and the 
second leading cause of cancer mortality, accounting for an estimated 192,280 new diagnoses 
and 27,360 deaths in 2009 [1]. Pca survivors comprise 42% of the five million male cancer 
survivors in the U.S., and has been steadily growing over the past 10 years [2]. An estimated 
91% of new prostate cancer cases are diagnosed at an early stage (stages I and II, in which the 
tumor is confined to the prostate [3]), for which the 5-year relative survival rate approaches 
100% [1]. Most localized prostate cancer patients elect to undergo active treatment rather than 
watchful waiting or active surveillance; the most commonly selected treatments are radical 
prostatectomy (RP) and radiotherapy (RT) [4]. Each of these treatment modalities is likely to 
result in substantial rates of treatment-related physical complications and associated 
psychosocial morbidity [5, 6]. These complications and related adverse psychosocial challenges 
can be difficult for patients to optimally manage, especially in the absence of comprehensive 
informational and skills training programs. Indeed, Pca survivors report that their informational 
and psychosocial needs are largely neither assessed nor addressed during the transition from 
active treatment to survivorship [7-10]. Indeed, most available interventions for RP and RT 

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survivors consist of either physical or pharmaceutical aids (e.g., for erectile dysfunction) alone 
or consist of some combination of educational, informational, and psychosocial content to 
address stress management and practical matters [11-13].  These interventions, although 
partially effective in reducing distress, are often fragmented, labor and resource intensive, and 
have not been consistently adopted in clinical practice beyond the funding period. Given the 
great dissemination potentials of use of the Internet, the current study therefore proposes to 
develop and evaluate an innovative, theory-driven web-based multimedia program (a Virtual 
Survivorship Resource Center for Prostate Cancer: VSRC-PC) that comprehensively addresses 
Pca survivor-relevant domains of interest with a view to empowering Pca survivors to not only 
effectively manage treatment-related side effects and adverse psychosocial sequelae, but also 
to cope effectively with the interpersonal and practical difficulties that they often experience. 
Enhanced coping (our primary outcome), in turn, should allow patients to achieve and sustain 
better health-related quality of life (HRQoL) during the post-treatment early survivorship period, 
in the survivorship life domains outlined below (our secondary outcomes).  
 
Themes in the challenges accompanying the transition to early survivorship are remarkably 
similar across clinical, qualitative, and empirical reports, and lead us to conclude that Pca 
patients completing primary treatment are likely to benefit from educational and skills training 
information in four life domains: physical function, emotional well-being, interpersonal concerns, 
and practical barriers. These four domains have been well established in the cancer 
survivorship literature [14] and were used to guide the content of NCI’s Facing Forwarding 
brochure, the first NCI publication addressing survivorship issues.   
  
2.2. Physical Function During Early Pca Survivorship  
 
Primary, curative treatment includes radical prostatectomy (RP) and radiotherapy (RT), 
including both external beam radiation therapy (EBRT) and brachytherapy (BT) [4]. Both RP and 
RT significantly reduce disease-specific mortality, overall mortality, and the risks of local and 
distant progression of localized prostate cancer [15]. However, each type of treatment is 
associated with urinary, sexual, and bowel dysfunctions [16] causing distress or “bother” that 
has the potential to significantly undermine a patient’s HRQoL. Urinary symptoms include 
incontinence and bladder irritation resulting in urgency, pain, and frequency. For RP patients, a 
large percentage (~50%) experience moderate levels of urinary incontinence at 2 months post-
surgery [17]. Sexual symptoms include depressed libido, erectile dysfunction, and difficulty in 
achieving orgasm. More than 90% of RP patients experience moderate to severe sexual 
deficits, which peak at 3 months post-surgery and then improve only minimally through 24 
months [17]. Bowel symptoms include urgency, frequency, fecal incontinence, bloody stools, 
and rectal pain. For EBRT and BT patients, a moderate (~34) to larger percentage (~45) 
experience mild urinary symptoms at 2-month post-treatment, which slightly improve from 6 
through 24 months [18].  Therefore, establishing reasonable expectancies and providing 
information about the prevalence and management of these effects of treatment regarding the 
nature of recovery is critical for Pca patient transition from active treatment into survivorship. If 
these physical effects come as a surprise, they may trigger self-imposed demands to push 
one’s misattributions about the meaning of symptoms. Persistent prevalence of physical 
dysfunctioning and information about how to manage this issue are reported by Pca patients [9, 
19, 20] 
 
2.3. Emotional Well-Being During Early Pca Survivorship  
 
The psychosocial impact of cancer is significant, including reduced quality of life, depression 
and other psychiatric disorders, distress, and adjustment difficulties [21-23]. In a large 

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cohort of localized prostate cancer patients (the overwhelming majority of whom underwent RP 
and RT), Bacon et al (2002) found that patients were substantially more distress due to sexual, 
urinary, and bowel symptoms, in comparison with pretreatment baseline levels. In another study 
in which all but 8% of participants underwent either RP or RT, there were marked differences 
between Pca patients and comparable cancer-free controls with respect to lower sexual 
intimacy, sexual confidence, and sense of masculinity [24]. In sum, Pca patients experience 
poor self-concept, embarrassment, and shame associated with urinary and bowel 
problems, often leading to an isolated lifestyle in an effort to limit social activities outside of the 
home and curtail interactions with friends and family [25-27]. The fear of rising prostate-
specific antigen levels and recurrence of cancer can also negatively affect psychosocial 
adaptation and HRQoL outcomes of Pca patients [28]. In addition, studies reported that long-
term survivors expressed concerns about getting another type of cancer at levels similar to 
concerns about recurrence, ranging from 26 to 36%, with prostate cancer survivors most likely 
to have this concern [29].   
 
2.4. Interpersonal Concerns During Early Pca Survivorship  
 
Pca patients tend to become increasingly dissatisfied with their communication with 
physicians as they continue to live with the aftereffects of treatment, highlighting the gap in 
patient-provider communication during the early survivorship phase [30]. Further, patients often 
had difficulties interacting with the medical team, including the need to navigate between the 
primary provider and the oncology specialist (e.g., when and where to call if encountering a 
troubling symptom) [31, 32]. In addition to communication with the medical team, the after-
effects of prostate cancer treatment can cause problems with interpersonal relationships that 
may significantly disrupt the lives of men and their spouses/partners. Adjustment to treatment-
related adverse effects places demands on couples’ resources and requires effective yet 
intimate communication. However, existing support services for men with prostate cancer are 
most often oriented towards the medical and related needs of the patient.  Therefore, greater 
attention is needed to the couple relationship, as well as to the social context in which patients 
find themselves [22, 33, 34]. For example, family, friends, and co-workers can promote 
unreasonable expectancies that the patient will return promptly to their old roles prior treatment 
once treatment is completed, and cancer patients often comment on the relatively sharp 
downturn in active social support at this time [35].  
 
2.5. Practical Barriers During Early Pca Survivorship  
 
There are a number of practical issues that confront Pca patients, including the difficulties of 
applying for financial assistance to cover medical costs, obtaining insurance for future 
medical care, securing legal services in cases of discriminatory workplace or accessing care 
practices [36, 37]. Pca patients also often need assistance in delineating and using a medical 
care follow-up or survivorship plan. It is important to educate patients about the importance 
of having a primary cancer treatment document and a survivorship cancer plan. In addition, Pca 
patients specifically often need assistance with regard to the purchase and use of aids, 
supplies, and materials relating to the management of their treatment-related side effects, 
e.g., for urinary, sexual, and bowel dysfunction [36]. 
 
2.6. The Role of the Internet in Providing Health-Related Information  
 
The Internet is rapidly becoming one of the most utilized dissemination channels for health-
related information. In the U.S., approximately 80% of adults report using the Internet to address 
their health information needs [38]. In particular, web-based interventions are feasible for 

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individuals seeking cancer information, of interest to individuals with cancer, and effective in 
promoting health behavior change relative to individualized print materials. Although individuals 
have become familiar with and accustomed to accessing medical information on the Internet, 
little of the information available is empirically based or theoretically guided. An exception is 
Gustafson’s Comprehensive Health Enhancement Support System (CHESS), a web-based 
information and support program that has been developed for cancer patients and other groups. 
Research has demonstrated that CHESS is user-friendly and well accepted by individuals of 
diverse demographic background [39-41]. Data with breast cancer patients and a randomized, 
controlled trial with HIV+ patients suggest positive effects on mood, quality of life, and health 
outcomes [42, 43]. Dr. Gustafson will provide his expertise for the proposed trial as a consultant. 
Our theory-guided breast cancer survivorship multimedia program demonstrates the feasibility 
of using the Internet as a delivery channel with 65% of participants spending 15-25 minutes in 
the program per access.  
 
In sum, it is important for researchers to rapidly design, produce, and evaluate interactive web-
based multimedia software products, particularly geared to offset the shortage in health care 
personnel and to capitalize on recent developments in health psychology messaging and health 
communications research. In the case of web-based multimedia interventions for cancer 
patients, most studies have focused on breast cancer [44]. Those studies that have focused on 
Pca patients have mainly focused on the diagnostic and treatment phases, but have not 
addressed prostate cancer survivorship.  
 
2.7. Use of a Theoretical Model to Inform and Guide Intervention Development  
 
One of the signature characteristics of the proposed research is that the VSRC-PC intervention 
will be informed and guided by an integrative theoretical framework (developed by the research 
team), the Cognitive-Social Health Information Processing Model (C-SHIP) [45, 46]. The C-
SHIP model identifies five key constructs, all of which are common denominators in most 
contemporary views about how individuals adapt to health challenges: 1) cancer-relevant 
interpretations; 2) beliefs and expectations about cancer treatment and disease outcomes, as 
well as beliefs about one’s own self-efficacy in dealing with heath-related challenges; 3) cancer-
relevant goals and values; 4) cancer-relevant affective and emotional states; and 5) self-
regulatory competencies and skills for generating and maintaining goal-oriented health-related 
behaviors. Consistent with our existing psychosocial programs, we will operationalize these 
theoretical constructs within the proposed intervention by: 1) providing accurate information; 2) 
creating realistic expectations and promoting self-efficacy; 3) exploring the patient’s goals and 
values and encouraging behavior consistent with them; 4) validating feelings and facilitating 
emotional support, and 5) providing information and training to maximize self-regulatory 
competencies and skills. The expected net effect of these operational components is increased 
use of adaptive coping (active coping, planning, positive reframing, acceptance, using emotional 
and instrumental support), the primary outcome variable of the trial, since the target result of 
each component is enhanced ability and predisposition to act adaptively. Our intervention 
objectives derive directly from the C-SHIP theoretical constructs and the intervention 
operationalizes achievement of the objectives. Our hypothesized moderator, monitoring style, is 
conceptualized within C-SHIP as a stable tendency for individuals to select, encode, interpret, 
react to affectively, and manage threatening medical health information in either of two 
signature ways (i.e., using a high monitoring style, characterized by scanning for and magnifying 
stress-related cues relevant to one’s health, or using a low monitoring style, characterized by 
distracting from and minimizing such cues). Research has documented that these styles predict 
individual differences in coping and cognitive-affective responses to health-related stressors 
[47-49]. Because high monitors are particularly at increased risk for the adverse consequences 

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of health threats [48], the proposed intervention is likely to have larger salutary effects among 
high monitors than low monitors because of their greater need for alleviation of such adverse 
effects and the potential of such effects to interfere with effective coping.  
 
2.8. Use of an experienced interdisciplinary team 
 
We have assembled an interdisciplinary team with expertise in individual differences in stress 
processing and adjustment among cancer survivors, theory-guided interventions and multimedia 
programs; consumer health informatics applications; cancer and communication interventions 
and disparities; psychosocial issues, quality of life, adjustment to prostate cancer, and 
multimedia development; survivorship and mixed methods research; and prostate cancer 
biology, treatment, and physical effects of treatment (clinical investigators). We will collaborate 
with Notsoldseparately, who developed our prostate cancer treatment and breast cancer 
survivorship multimedia programs during an earlier research collaboration. The research team 
has more than a decade-long history of collaborating and publishing together [45-48, 50-58].  
 
3.0 STUDY OBJECTIVES  
 
Aim 1: Develop a Virtual Survivorship Resource Center for Prostate Cancer (VSRC-PC) 
Designed to Facilitate Post-treatment Adaptation of Early-Stage Pca Patients.  The design 
of the proposed intervention is theoretically based on the team’s Cognitive-Social Health 
Information Processing Model (C-SHIP [45, 46]) and informed by our existing multimedia 
prostate cancer support system for treatment decision making at diagnosis. The VSRC will 
focus on promoting adaptive coping within four key post-treatment domains, as identified by the 
extant literature and our theoretical model: 1) Physical Function (e.g., physical symptoms); 2) 
Emotional Well-Being (e.g., fear of recurrence); 3) Interpersonal Concerns (e.g., sexual intimacy 
issues); and 4) Practical Barriers (e.g., medical follow-up challenges) [14]. Content for these 
domains will be organized in a virtual resource center and will consist of: 1) provision of related 
information through text, graphics, voice-overs, and animation; 2) videos of health care experts 
answering frequently asked questions; 3) videos of prostate cancer survivors and their families 
describing their experiences and modeling competencies and related coping strategies; and 4) 
skills training to improve communication between Pca survivors and family and healthcare 
providers. We will take full advantage of the highly interactive nature of the multimedia 
environment to encourage self-navigation and self-tailoring. Program content will be developed 
through literature and evidence-based content review, expert input, and input from diverse, 
multi-ethnic survivor focus groups. Timely software development will be implemented by a close 
collaborator (notsoldseparately.com who developed our treatment decision software). To ensure 
adequate and appropriate program content and optimal functionality, an iterative process of 
review, revision, and user and usability testing will be employed. 
 
Aim 2: Evaluate the Efficacy of the VSRC-PC in a Randomized Controlled Trial.  Early-
stage Pca patients who are undergoing radical prostatectomy and radiotherapy will be recruited 
at treatment completion from four sites within three institutions with diverse patient populations 
and well-established collaborative linkages. Data will be collected at baseline and 1-, 3- and 6-
months post-baseline. The control group (Group 1; n = 300) will receive NCI’s Facing Forward 
and What You Need to Know about Prostate Cancer. The intervention group (Group 2; n = 300) 
will receive the same NCI print materials as Group 1, plus the VSRC-PC. The primary outcome 
variable will be adaptive coping, which includes active coping, planning, positive reframing, 
acceptance, and the use of emotional and instrumental support. Secondary outcomes will 
consist of maladaptive coping (denial, behavioral disengagement, self-blame) and adaptation in 
the four post-treatment domains.  Hypothesis 1: Group 2 participants will show significantly 

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higher levels of adaptive coping, significantly lower levels of maladaptive coping, and greater 
adaptation than Group 1 participants in the short-term and at 3- and 6-month follow-up 
assessments.  
 
Aim 3: Conduct Mediator and Moderator Analyses of Intervention Efficacy.  Based on the 
C-SHIP framework, we will explore both mediators (self-efficacy) and moderators (monitoring) of 
intervention impact.  Hypothesis 2: Adaptive coping will be mediated by enhanced self-efficacy 
for managing treatment-related side-effects psychosocial challenges for Group 2 but not for 
Group 1. Hypothesis 3: Monitoring style will moderate the impact of the intervention: high 
monitors (who scan for and amplify threat-relevant cues) will benefit more from the intervention 
than low monitors (who distract from health threats). Innovation and Significance: The 
proposed research is innovative because: a) it will be the first RCT to evaluate a comprehensive 
intervention for facilitating post-treatment adaptation among early-stage prostate cancer 
patients; b) the design and development of the intervention will be guided and informed by an 
innovative application of a state-of-the-science theoretical framework; and c) the intervention 
can be self-sustaining.  If found effective, the program will address critical unmet needs of 
prostate cancer survivors during the initial post-treatment period, in a proactive and readily 
disseminable fashion. 
 
4.0 SELECTION OF PARTICIPANTS 
 
4.1 Individual Interviews  
In order to determine when to best implement the intervention, a total of approximately 5-10 men, 
who are actively being treated for prostate cancer, or who have already decided on their 
treatment, will be interviewed to assess the psychosocial concerns they experience during 
treatment. These intercept questions will be combined with the focus group questions to guide 
the individual interview and obtain additional data. Interviews will be audio-recorded. 
 
Participants are eligible if they:  
1) have received a diagnosis of localized disease confined to the prostate, with no regional 
lymph node or distant metastasis (stages T1, T1a, T1b, T2, T2a, T2b; [3]); 
2) are currently being treated or have decided on their treatment process (radical 
prostatectomy or radiation therapy); 
3) are 18 years of age or older;  
4) are able to communicate in English;  
5) are able to give consent. 
 
4.2. Focus Group (Phase 1) Eligibility Criteria 
Three focus groups (two from FCCC and one from MSMC) will be conducted with data from each 
group being used to inform and refine the subsequent groups.  The three focus groups will reflect 
different treatment modalities: Group 1 – Radical Prostatectomy; Group 2 – Radiation Therapy; 
Group 3 – Either therapy.  Focus groups will consist of racially and ethnically diverse prostate 
cancer survivors (N=15), with some individual interviews occurring if needed. 
 
Participants are eligible if they:  
1) received a diagnosis of localized disease confined to the prostate, with no regional 
lymph node or distant metastasis (stages T1, T1a, T1b, T2, T2a, T2b; [3])  
2) completed either radical prostatectomy (Group 1 or Group 3) or radiation therapy 
(external beam radiation therapy or brachytherapy; Group 2 or Group 3) within the past 
12 months;  
3) are 18 years of age or older;  

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4) are able to communicate in English; 
5) are able to give consent; and, 
6) are within traveling distance to FCCC and MSMC. 
 
4.3 User/Usability Testing (Phase 2) Eligibility Criteria 
A total of 20 prostate cancer survivors (5 from each site) will provide feedback on the VSRC-PC 
components. 
 
Participants are eligible if they:  
1) received a diagnosis of localized disease confined to the prostate, with no regional 
lymph node or distant metastasis (stages T1, T1a, T1b, T2, T2a, T2b; [3])  
2) completed either radical prostatectomy or radiation therapy (external beam radiation 
therapy or brachytherapy) within the past 12 months;  
3) are between 55 and 85 years of age  
4) are able to communicate in English; 
5) are able to give consent; and, 
6) are within traveling distance to FCCC, MSMC, Rutgers Cancer Institute of New Jersey, 
or TUH. 
 
4.4. RCT (Phase 3) Eligibility Criteria 
The target sample (N=600) will be men who have recently been treated for prostate cancer.  A 
multi-ethnic survivor group will be recruited from all three participating sites.  According to the 
tumor registry data, on average a total of 1000 eligible prostate cancer patients are seen per year 
at the three recruitment sites. Of these, about 50% (n=500) are expected to have Internet access 
[63]. Based on our prior experience with the prostate population [47], we assume that 48% of 
eligible patients will agree to enroll in the study, yielding a total of approximately 240 participants 
per year at the four recruitment sites. We therefore conservatively estimate that we can accrue 
20 participants per month over a 30-month period across the four sites to reach our goal of 600 
participants. In addition, if unanticipated problems with accrual occur, we will have ready access 
to recruit survivors through partner hospitals. This added source of accrual will provide us with a 
significant cushion, which has not been figured into our accrual calculations. We also project that 
we will retain approximately 80% of the participants whom we recruit, allowing us to conservatively 
estimate that 480 participants will complete the study. Power analysis indicates that with 480 
participants, the study will be powered to detect a modest effect size (0.1) with at least 84% 
statistical power (see Section 7.4). With regard to minority recruitment, we project that 
approximately 20% of the recruited participants will be African American (n=120) men. 
 
Participants are eligible if they:  
1) received a diagnosis of localized disease confined to the prostate, with no regional 
lymph node or distant metastasis (stages T1, T1a, T1b, T2, T2a, T2b, T2c, T3, T3a, T3b, 
T3c [3]); 
2) within one year  completion of either radical prostatectomy or radiation therapy (external 
beam radiation therapy or brachytherapy); 
3) have access to an IBM-compatible or Macintosh personal computer with Internet access 
(either in home or at a community center);  
4) are 18 years of age or older;  
5) are able to communicate in English; and, 
6) are able to give consent. 
 
5.0 REGISTRATION PROCEDURES 
 

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5.1. Setting 
Participants will be recruited from FCCC, MSMC, Rutgers Cancer Institute of New Jersey, and 
TUH. Each site will have a project leader and research staff. Dr. Miller, the project PI, will be 
responsible for coordinating and facilitating the research collaboration across sites. The 
research team has a decade long history of collaboration and currently collaborates on a 
program project. The proposed project will benefit from many of the communication routines that 
have been established through these past and ongoing collaborations. In addition to organizing 
bi-weekly conference calls and quarterly face-to-face meetings, Dr. Miller will ensure that a 
responsive system of communication and coordination among sites is maintained and that 
potential problems and concerns are identified in a timely manner. The FCCC research team 
will be responsible for designing, implementing, and maintaining a quality control monitoring 
system (QCMS). The QCMS will include markers of quality assurance at each site, including 
adherence to the production schedule of the intervention, competent conduct of survivor focus 
groups, accrual of target numbers of participants, adherence to the randomized trial protocol, 
tracking and responding to technical problems and inquiries conveyed by intervention 
participants, and monitoring response rates to the follow-up interviews conducted for process 
and outcome evaluation.  
 
5.2. Individual Interviews Recruitment Procedures 
Approximately 5-10 prostate cancer patients who are currently receiving treatment at FCCC or 
MSMC will be identified through the Prostate Cancer Patient Care Team, which consists of 
medical oncologists, surgeons, radiation oncologists, physician assistants. A member of the 
research staff will first meet with the prostate team to describe the research study and explain 
the eligibility criteria. The research assistant will be available during clinic hours to meet with 
potential participants identified through these sources, and the interview may be conducted in-
person or via phone at a later date. This interview will be audio-recorded.  Participants will sign 
a consent form at the time of the interview.  
 
5.3. Phase 1: Focus Group Recruitment Procedures 
Three focus groups with a total of approximately 30 racially and ethnically diverse, prostate 
cancer survivors will be conducted (two at FCCC and one at MSMC).  At FCCC, potential 
participants will be identified through the Prostate Cancer Patient Care Team, which consists of 
medical oncologists, surgeons, radiation oncologists, physician assistants, and nurses, all of 
whom will assist in the recruitment process.  A member of the research staff will first meet with 
the prostate team to describe the research study and explain the eligibility criteria.  Further, 
surgical oncologist Rosalia Viterbo and her team, and radiation oncologist Mark Buyyounouski 
and his team, will assess eligibility and interest in participation at the time of patients’ follow up 
appointments and will refer potential participants. The research assistant will be available during 
clinic hours to briefly meet with potential participants who have been identified through these 
sources, and solicit participation.  Flyers will also be distributed to patients with the research 
staff’s contact information. Patients who are interested, but who do not have the time to meet 
with the staff member, will provide their contact information and will then be contacted via phone 
by a study staff member who will describe the study in more detail and schedule a date for the 
interested patient to attend a focus group or individual interview. For patients who are available 
on site, the staff member will then describe the study and schedule a date for the focus group or 
individual interview. Participants will sign the consent form at the time of attending the focus 
group or interview.  Participants will receive a $20 gift card as compensation.  
 
At MSMC, The collaborating physicians, Dr. Simon Hall, the Chairman of the Department of 
Urology and Dr. Richard Stock, Chairman of Radiation Oncology and a chart review will identify 
eligible patients.  Potential participants will be contacted by Dr. Diefenbach’s research assistant 

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by phone or in person for their verbal consent for tracking their eligibility.  Once eligibility is 
confirmed, the research assistant will describe the study in more details, solicit patients’ 
participation, and schedule a date for a focus group or an interview.  Prior to the start of the 
focus groups or patients’ interviews, signed consents will be obtained from patients.  
Participants will receive a $20 gift card for their time.  
 
5.4. Phase 2:  User/Usability Testing Recruitment Procedures 
Approximately twenty participants will be recruited from the four participating sites (5 from 
Rutgers Cancer Institute of New Jersey and MSSM, up to 10 from FCCC, and up to 5 from 
TUH). At FCCC, potential participants will be identified through the Prostate Cancer Patient 
Care Team.  A member of the research staff will first meet with the medical team to describe the 
research study and explain the eligibility criteria.  Further, surgical oncologist Rosalia Viterbo 
and her team and radiation oncologist  Eric Horowitz and his team, will assess eligibility and 
interest in participation at the time of the patients’ follow up appointments and will refer potential 
participants. The research assistant will be available during clinic hours to briefly meet with 
potential participants who have been identified through these sources, and assess interest.  
Flyers will also be distributed to patients with the study staff’s contact information. Patients who 
are interested, but who do not have the time to meet with the staff member, will provide their 
contact information and will then be contacted via phone by a study staff member who will 
describe the study in more detail, and schedule a date for the interested patient to attend the 
individual interview. For patients who are available, the staff member will then describe study 
and schedule a date for the individual user testing interview. Participants who are interested will 
sign a consent form before they complete the testing. Participants will receive a $20 gift card for 
their time.   
 
At MSMC, Dr. Simon Hall, Dr. Richard Stock will identify potential participants from the patient 
roster of the Department of Urology at MSSM. Potential participants will be referred to the study.  
If they agree to participate, patients will sign a consent form before the beginning of the user 
test and will receive a $20 gift card for their time.  
 
At Rutgers Cancer Institute of New Jersey, Urologic oncologist Dr. Isaac Kim and his care team, 
as well as radiation oncologist Dr. Sung Kim and his care team, will refer potential participants 
to the study.  Additional patients identified by clinicians and staff members who are part of the 
Rutgers Cancer Institute of New Jersey Prostate Cancer Tumor Study Group are also eligible 
for study participation.  Participants will sign the consent form before they complete the testing.  
Participants will receive a $20 gift card for their time. 
 
At TUH, radiation oncologist Dr. Curtis Miyamoto and surgical oncologist Dr. Jack Mydlo and their 
teams will assess eligibility and interest in participation and refer potential participants. Potential 
participants will be informed about the study and given the flyer with study staff’s contact 
information. Drs. Miyamoto and Mydlo will inform FCCC study staff of any eligible participants 
ahead of time, study staff will routinely be available when there are eligible participants during 
clinic hours. A FCCC research assistant will briefly meet with potential participants who have been 
identified through these sources, and assess interest. Patients who express interest will be 
referred to the FCCC research team. Those patients are interested, but do not have the time to 
meet with the FCCC staff member will provide their contact information and will then be contacted 
via phone by a study staff member who will describe the study in more detail, and schedule a date 
for the interested patient to complete the individual user testing interview. In the case of the study 
staff member not being available, the patients will be directed to contact study staff and be further 
informed about the study details. Participants who are interested will sign a consent form before 

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they complete the user testing. See attachment for TUH Informed Consent Document. 
Participants will receive a $20 gift card for their time.  
 
  
5.5. Phase 3: RCT Recruitment Procedures 
A total of 600 racially and ethnically diverse prostate cancer survivors will participate in the RCT. 
At FCCC, potential participants will be identified in several ways through the Prostate Cancer 
Patient Care Team, as described above. To reach additional patients, FCCC will post contact 
information in the E-news daily newsletter which is circulated daily to the staff at FCCC 
(Appendix B). In addition, we have created a telephone message that will be played periodically 
for patients while they are on hold on the FCCC phone line. The script contains a description of 
the study and the contact information for the project manager (Appendix B). In addition, we will 
place a description on the blog run by the Center titled, “Cancer Conversations”, and on the 
Center’s Facebook and Twitter pages. The scripts provide a description of the study and provide 
contact information and a link to the study flyer (Appendix B). In addition, we will work with the 
data warehouse staff to identify patients who meet the inclusion criteria and create a list of 
potential participants.  The list of potential participants will be discussed with each provider. Any 
participants that the provider feels is not a good candidate will not be contacted. Potential 
participants will be sent a letter describing the study and asked to contact staff if they are not 
interested or they will receive a call within two weeks. Patients who are interested and found to 
be eligible will be contacted via phone using the attached phone script. The study staff member 
will then mail the potential participant the Informed Consent Document and follow the remaining 
recruitment procedures described below. 
 
A member of the research staff will first meet with the prostate team to describe the research 
study and explain the eligibility criteria. Further, surgical oncologist Rosalia Viterbo and her 
team and radiation oncologist Eric Horowitz and his team, will assess eligibility and interest in 
participation at the time of patients’ follow up appointments and will refer potential participants. 
The research assistant will be available during clinic hours to briefly meet with potential 
participants who have been identified through these sources, and assess interest. To prepare 
Dr. Rosalia Viterbo’s patients FCCC staff will send a letter informing them of the study and 
asking them to allot an additional 3-5 minutes to meet with study staff if interested in 
participating (Appendix G). Flyers will also be distributed to patients with the study staffs contact 
information. Patients who are interested, but who do not have the time to meet with the staff 
member, will provide their contact information and will then be contacted via phone by a study 
staff member. The staff member will describe the study in more detail and assess interest.  
Those patients who contact study staff via phone will be informed of further details about the 
study using the attached phone script. Those patients who are eligible but decline the study will 
be asked for the reason of their decline. Reasons for decline will be recorded and the data will 
be analyzed at the end of the study and reported in publications. The study staff member will 
then obtain written informed consent (if in person) or mail the potential participant the Informed 
Consent Document . After providing consent, eligible men who wish will be given the baseline 
assessment to complete at home with a self-addressed stamped envelope to return once 
completed. Eligible men who wish to complete the survey with assistance will be scheduled for 
a baseline assessment via phone or in person at the current or next follow up appointment. If 
interested in completing the baseline online, eligible men will be given a survey link to access 
the survey in the REDCap data system. If enrolled in the intervention group, at enrollment 
patients will receive a postcard listing their unique username and password to access the 
multimedia website during participation in the study.  Participants will receive a $20 gift card for 
each (of four) assessments completed.   
 

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At MSMC, prostate cancer survivors who presented at the Department of Urology at MSMC for 
follow-up will be recruited for the study.  Additionally, Dr. Hall and Dr. Stock will identify potential 
participants from the patient roster of the Department of Urology at MSSM.  Potential 
participants will be contacted by the research assistant who will obtain patients’ verbal consent 
for tracking their eligibility to participate in the study.   Once verbal consent is obtained, the 
research assistant will confirm patients’ eligibility, describe the study in more details, and assess 
participant’s interest in participation in the study.  Written informed consent will be provided or 
sent by mail to eligible participants. Eligible men who wish will be given the baseline 
assessment to complete at home with a self-addressed stamped envelope to return to MSMC 
once completed. Eligible men who wish to complete the survey with assistance will be 
scheduled and completed either in-person at the current or next follow up appointment or via 
phone. If interested in completing the baseline online, eligible men will be given a survey link to 
access the survey in the REDCap data system  Patients will receive a $20 gift card after the 
completion of the baseline and the 3 follow-up assessments.  
 
At Rutgers Cancer Institute of New Jersey, patients who undergo routine prostate cancer 
treatment at Rutgers Cancer Institute of New Jersey and Robert Wood Johnson University 
Hospital (RWJUH) will be recruited.  Urologic oncologist Dr. Isaac Kim and his care team, as well 
as radiation oncologist Dr. Sung Kim and his care team, will refer potential participants to the 
study.  Additional patients identified by clinicians and staff members who are part of the Rutgers 
Cancer Institute of New Jersey Prostate Cancer Tumor Study Group are also eligible for study 
participation.  Potential participants will be contacted by Dr. Hudson’s research assistant or an 
Office of Human Research Subjects (OHRS) staff member for their verbal consent for tracking 
their eligibility and, once determined to be eligible for participation, will be contacted by phone or 
in person by a study staff member who will describe the study, confirm eligibility, and assess 
interest.  The study staff member will then obtain written informed consent (if in person) or mail 
the potential participant the Informed Consent Form.  After providing consent, eligible men who 
wish will be given the baseline assessment to complete at home with a self-addressed stamped 
envelope to return to Rutgers once completed. Eligible men who wish to complete the survey with 
assistance will be scheduled for a baseline assessment via phone or in-person at the current or 
next follow up appointment. If interested in completing the baseline online, eligible men will be 
given a survey link to access the survey in the REDCap data system Participants will receive a 
$20 gift card for each (of four) assessments completed. 
 
At TUH, prostate cancer survivors who undergo routine prostate cancer treatment at this site will 
be recruited. Urologic oncologist Dr. Adam Reese and radiation oncologist Dr. Curtis Miyamoto 
and their teams will refer potential participants to the study. The research assistant will be 
available during clinic hours to briefly meet with potential participants who have been identified 
through these sources, and assess interest.  Patients who express interest will be referred to the 
FCCC research team. Flyers will also be distributed to patients with the study staff contact 
information (see Appendix F). Patients who are interested, but do not have the time to meet with 
the FCCC staff member, will provide their contact information and will then be contacted via phone 
by a study staff member. The staff member will describe the study in more detail and solicit 
participation.  The study staff member will then obtain written informed consent (if in person) or 
mail the potential participant the TUHS Informed Consent Document (see attachment for the 
Informed Consent Documents).  After providing consent, eligible men who wish will be given the 
baseline assessment to complete at home with a self-addressed stamped envelope to return to 
FCCC once completed. Eligible men who wish to complete the survey with assistance will be 
scheduled for a baseline assessment via phone or in person at the present or next follow up 
appointment. If interested in completing the baseline online, eligible men will be given a survey 

NCI # NCT02224482 
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link to access the survey in the REDCap data system. Participants will receive a $20 gift card for 
each (of four) assessments completed. 
 
At FCCC satellite sites in Plymouth Meeting (Dr. Joann Chalal) and Buckingham (Dr. Shelly 
Hayes), providers will assess eligibility and interest in participation during the final week of the 
patient’s radiation treatment. The research assistant will be available during clinic hours to briefly 
meet with potential participants who have been identified through these sources, and assess 
interest. Flyers will also be distributed to patients with the research staff’s contact information (see 
Appendix F). Patients who are interested, but who do not have the time to meet with the staff 
member, will provide their contact information and will then be contacted via phone by a study 
staff member. The staff member will describe the study in more detail and solicit participation.  
The study staff member will then obtain written informed consent (if in person) or mail the potential 
participant the Informed Consent Document (see attachment for the Informed Consent 
Document).  After providing consent, eligible men will be given the baseline assessment to 
complete at home with a self-addressed stamped envelope to return to FCCC once completed. 
Eligible men who wish to complete the survey with assistance will be scheduled for a baseline 
assessment via phone or in person at the current or next follow up appointment. If interested in 
completing the baseline online, eligible men will be given a survey link to access the survey in the 
REDCap data system  Participants will receive a $20 gift card for each (of four) assessments 
completed.  Recruitment scripts for FCCC appear in Appendix A.   
  
Partner hospitals of FCCC, Rutgers Cancer Institute of New Jersey, MSMC, and TUH may provide 
an additional source of accrual during the RCT.  Procedures for recruitment and data collection 
will be submitted to the IRB in the form of an amendment prior to patient contact at these additional 
sites. 
 
6.0 RESEARCH DESIGN/METHODS: 
 
6.1. Study Overview  
The study will develop and test a prostate cancer survivorship program, uniquely designed to 
comprehensively assess and address patient domains of concerns, and that is also readily 
disseminable through use of a multimedia format as an adjunct to care.  The developmental 
process will entail a series of focus groups, user and usability testing, and refinement and final 
production. Based on social-cognitive theory and health communications best practice 
approaches, as well as our previous experience with print, telephone, and multimedia 
approaches, the development process will use a rigorous vetting and user testing to ensure that 
the materials and messages are relevant, evidence-based, and easily understandable.  The 
actual program elements, as well as the usability of the program prototype, will be user-tested 
prior to the RCT.  Once the program is developed, it will be tested during a six-month RCT with 
600 ethnically and racially diverse prostate cancer survivors. 
 
6.2. Phase 1: Survivor Content Theme Identification Focus Groups Overview 
Following an update of our systematic review of the literature to integrate extant findings into a 
comprehensive description of survivor needs, nine multi-ethnic focus groups with survivors (10 
in each focus group) will be recruited, with individual interview occurring if needed.  Each will 
provide input based on their retrospective experiences as patients, with particular reference to 
the early survivorship phase after treatment completion.  The audiotaped record of focus group 
proceedings will be transcribed and the transcript analyzed to identify relevant content 
concerning the post-treatment phase.  This information will be used to assist in the development 
of VSRC-PC content.   

NCI # NCT02224482 
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6.2.1. Focus Group Assessments 
Participants will be asked open-ended questions about their post-treatment experience.  Topics 
will include physical symptoms, emotional symptoms, interpersonal concerns, and 
communication difficulties.  Additionally, participants will be asked open-ended questions 
concerning the importance of the proposed components of the VSRC-PC.   
 
6.3. Phase 2: Evaluation of the Prototype through User/Usability Testing 
To facilitate the development and refinement of the program prototype, user testing will be 
conducted to elicit input from the target audience. We will conduct pretesting of the content, 
visuals, and approaches of the VSRC-PC with a wide variety of populations, including diverse 
ethnic groups and patients within the different age brackets in which prostate cancer is 
diagnosed.  We will recruit 15 individuals to gather adequate representation to inform production 
decisions.  In addition, each contract team will conduct limited pretesting with survivors at their 
affiliated cancer centers.  We will also conduct alpha and beta usability testing of the VSRC-PC 
to test the functioning of the software, using observation techniques recommended by NCI's 
own usability laboratory (www.usability.gov).  Participants will be asked to use the “Think Aloud” 
technique to provide insight into how individuals use and interact with the program. Weaknesses 
in the user interface can be readily detected using this technique, along with information gaps 
and software errors.  It is generally assumed that a small number of individuals (< 6 individuals) 
are sufficient to detect more than 80% of potential software errors, glitches, and gaps in a 
program.  The different pretesting and usability testing phases will recycle throughout the 18 
months of the development timeline. We will track the recommendations and usability testing 
results and will work closely with Notsoldseparately to produce the final version of the VSRC-
PC. 
 
6.3.1. User/Usability Testing Assessments 
After interacting with a particular VSRC-PC component, participants will be asked open-ended 
and close-ended questions regarding quality and ease of use. As participants navigate the 
VSRC-PC, measures will include time to complete, expressions of frustration, time spent 
"wandering" with mouse, navigation errors, and 'back' button clicks.  Participants will also be 
asked questions about individual VSRC-PC components.   
 
6.4. Phase 3: RCT Overview 
Telephone or in person assessment will be used to perform baseline screening at the 
completion of treatment for eligibility/exclusion, as well as baseline assessment of all outcome, 
potential moderator, and mediator variables, and follow-up assessments. If recruited by phone, 
the consent form will be mailed, along with an addressed, stamped envelope. When the consent 
form is received, the participant will be contacted and baseline assessments will be completed.  
Upon completion of the baseline assessment, the participant will be randomly assigned to the 
intervention or control group and mailed the appropriate materials. The participant will be 
contacted by phone three additional times (at 1-, 3- and 6- months post baseline assessment).  
Phone interviewers will be unaware of condition assignment. Participants may complete the 
follow up assessments via phone, mail or online via the REDCap data system. Table 1 displays 
the variables, measures, and time points of administration. See Appendix C for measures and 
their questions.  Each assessment will take approximately 45 minutes to complete.  
 
6.5.1 Randomization Protocol and Assessment  

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Programmed into the baseline assessment will be stratification and randomization algorithms that 
will equalize the stratified groups across experimental conditions (n = 300/group). The 
Biostatistics and Bioinformatics Facility at FCCC will be responsible for programming all of the 
telephone assessments, including the stratification and randomization algorithms for the baseline 
telephone assessment. Within one week after the baseline assessment, participants will receive 
mailed materials pertaining to their assigned interventions. Control participants will receive the 
two NCI brochures described below.  Intervention participants will receive the brochures as well 
as a package with detailed information concerning the objectives of the VSRC-PC and its content 
coverage and functionality, as well as information about how to access the website, including the 
unique passcode assigned.   
 
6.5.2 Description of the Control Group Intervention  
The control group  will receive Facing Forward: Life after Cancer Treatment, the NCI’s manual 
for cancer survivors. This 61-page, recently-revised manual (NCI, 2006) includes major sections 
on Getting Follow-up Medical Care, Ways to Manage Physical Changes, Body Changes and 
Intimacy, Your Feelings, Social and Work Relationships, and Reflection. These topics intersect 
well with the four survivorship domains we have identified which makes this an ideal comparison 
intervention to control for attention and preparation for the survivorship transition. While the 
appropriate life domains are presented, and thus of relevance to survivors, Facing Forward 
does not contain detailed information specifically for men with prostate cancer. Hence, in order 
to ensure that control participants receive prostate cancer-specific information and thereby 
increase comparability with the intervention condition, they will also receive What You Need to 
Know about Prostate Cancer (NCI, 2003), a pamphlet that provides useful information regarding 
prostate cancer diagnosis and treatment. However, neither of the print materials contains such 
features as specific recommendations for using active coping strategies and promoting self-
efficacy, skills provision and training exercises, nor the interactive capability, self-tailoring, and 
multi channel presentation  (e.g., video) offered in the VSRC-PC.  
 
6.5.3. Description of the VSRC-PC  
The VSRC-PC will facilitate early post-treatment survivorship by providing a comprehensive 
resource to meet the information, competency and skills building, and psychosocial needs of 
target users in a proactive fashion. It is theoretically-guided to assess and adress the four 
identified domain challenges of prostate cancer suriviors (physical function, emotional well-
being, interpersonal concerns, practical barriers), based on health communication best practices 
and social-cognitive theory.  An outline of the VSRC-PC is presented in Table 1. The VSRC is 
designed along three dimensions: content, modules for content delivery, and contextual setting. 
The content consists of the information, competencies, skills, and coping strategies required for 
optimal adjustment. The modules for content delivery include text, graphics, voice-overs, and 
animation; videoclips of doctors and other content experts addressing selected topics through 
explanation, instruction, and answers to user-selected questions from dropdown menus; 
prostate cancer survivors describing their experiences and modeling domain competencies, 
skills, and coping strategies; and a communication module providing training in communicating 
with spouse, physicians, familily,and friends. The contextual setting involves the use of a 
metaphor of a virtual health center, consisting of a reception area, library, physician offices, and 
a group meeting room; and the presence of a Virtual Cancer Navigator (VCN), who greets the 
user in the reception area, provides an introduction to the early survivorship phase, and serves 
as a guide to navigating and using the program. Intervention program features include a tutorial 
program to facilitate program use and navigation; use of dropdown menus to provide for 
interactivity; a needs assessment component to support self-tailoring of program use through 
guidance to personally relevant program areas; provision for identification of common 
misinformation and misconceptions about prostate cancer and post-treatment symptoms and 

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recovery; a program component that elicits patient survivorship values and goals and supports 
patient behaviors consistent with them; inclusion of normalizing messages and encouragement 
throughout the program to foster psychological adjustment; and inclusion of a help desk for 
provision of technical assistance in use of the program.   
6.5.4. RCT Assessments 
Following informed consent, a Research Assistant will conduct the initial baseline assessment in 
person or by phone.  Following baseline assessment, participants will be mailed materials 
pertaining to their assigned condition.  Participants will be informed that they will be contacted at 
1-, 3-, and 6-months post-baseline.  All assessments will take approximately 45 minutes.  These 
follow-up assessments will take place by phone. 
 
6.5.5. RCT Study Retention and Program Engagement Strategies  
We will use various approaches to maximize initial and follow-up rates of intervention use and 
thereby enhance study completion: 1) monetary incentives ($20) to reimburse for time and effort 
for each assessment; 2) maintaining current contact information, including home phone and cell 
numbers and email addresses for follow-up purposes; 3) monthly postcards to participants in 
both groups to encourage the use of intervention materials; and 4) for VSRC intervention 
participants who provide their email addresses, monthly tickler emails will be sent to both 
groups in order to promote intervention use. We will also employ evidence-based 
recommendations [64] for encouraging web-based engagement using marketing messages. For 
example, we will rotate the program modules or topics to be highlighted in each monthly tickler 
to sustain and attract participants’ continuous use.     
 
6.5.6. RCT Measures 
All measures are listed in Table 1. Except where noted, all measures were given at baseline 
and each follow-up assessment. 
Table 1. Measures and times of assessment (*denotes primary outcome measure) 
 
VARIABLE 
 
MEASURE 
TIME OF ASSESSMENT 
Baseline 
1 mo 
3 mo 
6 mo 
OUTCOMES 
Coping 
Use of  Adaptive 
Coping* 
 
Cancer Coping 
Questionnaire  
X 
X 
X 
X 
Physical 
Functioning 
Disease-specific 
quality of life   
EPIC-26-SF (subscales: 
urinary, bowel, sexual 
dysfunctions) 
X 
X 
X 
X 
Emotional and 
Social Well-
being 
Bother from 
physical 
dysfunctions 
EPIC-26-SF 
X 
X 
X 
X 

NCI # NCT02224482 
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Background/Moderator Variables 
1) Demographics. Age, education, race/ethnicity and prostate cancer diagnosis and initial 
treatment information will be assessed at baseline only.  
2) Comorbid conditions.  At baseline only, this will be assessed with the Charlson 
Comorbidity Index [65], a weighted index that takes into account the number and 
seriousness of comorbid diseases (e.g., liver disease, diabetes).  
3) Monitoring style.  This will be assessed with the Monitoring-Blunting Style Scale 
(MBSS), which measures high monitoring style versus low monitoring style [49]. 
Interpersonal 
Concerns 
Medical team    
   
 
      
CARES-SF Medical 
Interaction Subscale 
(subscales: difficulty 
communicating with 
medical team,  problems 
obtaining information 
from medical team) 
X 
X 
X 
X 
Marital problems   CARES-SF 
(marital problems 
subscale) 
X 
X 
X 
X 
Practical Barriers 
Practical 
concerns 
Author-Constructed 
Practical Concerns Scale 
and Selected items from 
FOCUS  
X 
X 
X 
X 
MODERATORS 
Background 
variables       
Age, education, 
race/ethnicity, 
Prostate Cancer 
diagnosis and initial 
treatment information, 
Charlson Co-Morbidity 
Index** 
X 
X 
X 
X 
Monitoring Style 
MBSS CES-D-SF 
X 
 
 
 
Negative 
affect/general 
distress  
 
POMS Short Form – 
Depression and vigor-
activity subscales 
/Anxiety Subscales 
/Anger/Frustration items 
X 
X 
X 
X 
Health Literacy 
Chew 3-item scale 
X 
 
 
 
MEDIATORS 
Self-Efficacy for 
the survivorship     
phase 
Self-Efficacy for Re-Entry 
Scale 
X 
X 
X 
X 
Patient 
Activation 
 
Measure of Current 
Status Patient Activation 
Measure 
X 
X 
X 
X 
PROCESS EVALUATION 
Intervention 
Component Use 
and Satisfaction  
Author-constructed 
scales 
 
X 
X 
X 

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4) Affect.  Negative affect/distress will be assessed with the depression-dejection, tension-
anxiety  and vigor-activity subscales of the short form of the Profile of Mood States 
(POMS) [66] and also using the Center for Epidemiological Studies Depression 
Symptoms short-form scale (CES-D-SF) [67].. 
5) Health Literacy. This will be assessed with three questions from Brief Questions to 
Identify Patients with Inadequate Health Literacy [68].  
 
Outcome Variables 
1) Use of Coping. The Cancer Coping Questionnaire will be used to measure active and 
adaptive coping. The subscales include Individual scale items: Coping (items 2, 6, 7, 11, 
12), Positive Focus (items 1, 9, 14), Diversion (items 3, 4, 8), and Planning (items 5, 10, 
13), and interpersonal scale items (15-21) [69] 
2) Physical Functioning. This will be measured using the Expanded Prostate Cancer 
Index Composite – Short Form (EPIC 26-SF), a 26 item shortened version of EPIC, a 61 
item questionnaire for assessing urinary, bowel, sexual, and hormonal dysfunction and 
distress/bother in prostate cancer patients [70]. Only the urinary, bowel, and sexual 
subscales will be included because hormonal dysfunctions have not been documented 
for RP and RT patients. Both dysfunction subscale scores and an equally weighted 
additive composite of such scores will be employed to assess Disease-Specific Quality 
of Life. The distress/bother items will be included in the scale because of their use in the 
Emotional Well-Being domain, but will be excluded from the physical functioning score.].  
3) Interpersonal Concerns. Satisfaction with communication in medical interactions will be 
assessed with two subscales from the Cancer Rehabilitation Evaluation System 
(CARES; [71]): difficulty communicating with the medical team, and problems obtaining 
information from the medical team. The marital problems subscale of CARES will assess 
marital problems.  
4) Practical barriers. This will be assessed with an author-constructed Practical Concerns 
Scale supplemented with relevant items from the Follow-up Care Use Among Survivors 
(FOCUS) study [72]. 
 
Mediator Variables 
1) Self-efficacy for the survivorship phase. This will be assessed with the Self-Efficacy 
for Re-Entry Scale, an adapted version of a measure developed and used in one our 
previous and ongoing work (CISRC project 3), since this construct has been shown to 
play a key role in intervention impact. 
2) Confidence in ability to manage symptoms related to prostate cancer. This will be 
assessed with the 13 items from the short form of the Patient Activation Measure [73].  
3) Perceived information utility.  The utility of the intervention components will be 
assessed with a measure adapted from information acceptability items [75]. Additional 
questions are asked to assess usage of electronic media. 
 
Process Evaluation Variables 
1)   Intervention Use and Satisfaction.  These variables include items constructed within 
our ongoing projects (CISRC Projects 1 – 3) and informed by previous intervention trials 
[39, 42] and the recommendations of the Science Panel on Interactive Communication 
and Health [76] to assess use of and usability, accessibility, and satisfaction with the 
intervention.  This measure will only be completed by participants in the intervention 
group. 
6.6. Data Management  
The Population Studies Facility (PSF) programmers will develop all software needed to execute 
this study. To facilitate follow-up assessment contact with each participant, PSF programmers will 

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develop a tickler system that reminds research staff when participants are due to receive calls. 
FCCC PSF programmers will also design, develop and maintain a relational database 
management system (RDMS) to meet the needs of this project. In the proposed study, all potential 
participants will be assigned a unique study identification number.  Data collected will be entered 
onto hard-copy data collection instruments and sent to PSF for entry into the database. Detailed 
procedures will be employed to assure data quality.  
 
7.0 STATISTICAL ANALYSIS  
7.1. Phase 1: Focus Group Data Analysis 
The nine focus groups will be audio-taped and transcribed. Information gathered from each focus 
group will be used to inform subsequent groups. Following completion of the ninth focus group, 
content analysis of the participant responses will be performed. Specifically, analyses will be 
guided by the C-SHIP model and our previous work with prostate cancer patients. A coding guide 
will be developed by identifying narrative themes related to these conceptual categories and 
existing empirical findings within each focus group transcript, as well as stable thematic patterns 
across all focus group transcripts. The research teams will code each focus group locally and a 
coding guide will be developed to process all qualitative analyses, which will be used at all sites.  
Themes and categories will be checked and rechecked by 2 research staff and one study 
investigator against each other to identify idiosyncratic patterns of individual transcripts and stable 
patterns across the study sample.  
 
Intercoder agreement will be assessed by having each coder independently review 10 of the same 
samples of text. Results of their coding will be compared for consistency using a Kappa 
coefficient. If a Kappa of less than .75 is calculated, inconsistencies will be reviewed by the coders 
and PI. This will include a review of the codebook to determine if inconsistencies are the result of 
a coding error or if they are due to difficulties with code definitions. Difficulties will be discussed 
by the PI and a study investigator. Once problems are addressed and the codebook is clarified, 
previously coded text will be re-reviewed if necessary and intercoder agreement will be checked 
again. This iterative process will continue until all text has been satisfactorily coded and a final 
coding guide has been developed.  
 
The final coding guide will be used to code all of the focus group transcripts into the designated 
categories for content analysis. Frequency of specific responses within each of these categories 
will be calculated, analyzed and reviewed by research staff to generate summary descriptions of 
the patterns obtained. Concerns and resources that are cited most frequently will be identified. 
The order in which individuals bring up and discuss specific needs and gaps in services and 
resources, and identify which themes occur in discourse closest to each other will also be noted 
as this can imply co-variation and association.   
 
7.2. Phase 2: User/Usability Testing Data Analysis 
User testing interviews (N=20) will be used to obtain feedback on program components, with 
information being used for revisions.  Participants will provide feedback regarding the quality, 
understandability, and helpfulness of individual components. Information from the interviews will 
be used to guide refinement of the program prototype. Measures will include time to complete, 
expressions of frustration, time spent "wandering" with mouse, navigation errors, and 'back' 
button clicks.  All measures, feedback, and comments will be compiled and evaluated to 
determine whether adjustments in the in the program are needed prior to the RCT. 
 

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7.3. Phase 3: Statistical Considerations for the RCT 
1) Power and sample size. The sample size should allow evaluation of efficacy for both 
primary and secondary outcomes and also should allow evaluation of moderator effects [77].  
We expect to have 240 cases per group after attrition at the 6-month follow-up. Conservatively, 
we set the nominal Type-1 error rate to 1%; the false discovery rate will be set to 5% using the 
algorithm of Benjamini and Hochberg (1995) [78]. The autocorrelation is the correlation between 
two measurements made on the same subject 
at two time points that differ by one time unit. 
Table 2 shows that we have robust power to 
detect a modest effect size of 0.10 in all cases. 
For the power analysis for the moderator 
effect, we will evaluate power for testing a two-
way interaction ANOVA model, with the 
intervention and moderator the factors.  
Because there are three time points, we will 
have three such two way ANOVAs with each at one follow-up time.  We conservatively set the 
nominal Type 1 error rate to 0.3%.  For a binary moderator with 50% data points in each 
category, we will have 92% power to detect an effect size of 0.18 for the interaction effect.  
2) Preliminary Analyses. Descriptive and exploratory analyses will be conducted for all 
baseline measures to characterize the sample and describe the inferential population.  The 
intervention and control arms will be compared using Chi-squared tests, Mann-Whitney tests or 
two-sample t-tests for nominal, ordinal, or continuous baseline measures, respectively. Factors 
significant at the 5% level will be considered confounding and will be adjusted for in further 
analyses.  
3) Primary and Secondary Outcome Variables. The primary statistical objective is to explore 
the impact of VSRC-PC on the use of adaptive coping, the primary outcome variable. 
Multivariable linear regression will be performed to examine the effect of VSRC-PC on this 
variable. Post-baseline adaptive coping score will be the response measure, and baseline 
score, intervention, and time of the assessment will be included as the covariates.  Factors 
identified as confounding in the preliminary analyses will be added to the model.  To account for 
within subject correlation of the responses, we will fit the model using Generalized Estimating 
Equations assuming an autoregressive working correlation matrix for each subject.  The same 
procedure will be repeated for the secondary analysis of maladaptive coping. We will account 
for testing multiple hypotheses using the Benjamini-Hochberg method (1995) [79] and set the 
false discovery rate at 5%. If the intervention improves adaptive and maladaptive coping, we will 
test whether the treatment effects vary over time. The interaction term between intervention and 
time will be added to the main effect model. If it is significant, the final model will include the 
interaction term. The same analyses that will be conducted on the primary outcome variable will 
be conducted on the secondary outcome variables. 
4) Mediator and Moderator Analyses. Should the intervention demonstrate the anticipated 
effects on any primary and secondary outcome, a mediational analysis will be performed. The 
following must hold to establish a mediational effect: 1) the intervention must be associated with 
the mediator; 2) the mediator must reliably predict improved coping skills; 3) the significant 
relationship between the intervention and the outcome should be attenuated when the mediator 
is added to the model. Condition 1 will have been tested for aim 1 and/or 2. Condition 2 will be 
evaluated using similar regression models with each mediator as the response measure. 
Condition 3 will be assessed by adding the concurrent mediator to the final model.  Mediation 
will be established if the correlation between intervention and the outcome is substantially 
diminished after adjusting for the mediator. We will also explore if the mediator affects the 
intervention effect over time.  If the interaction between the intervention and time is significant, 
both the mediator and the interaction term between the mediator and time will be added to the 
Table 2: Detectable effect size in 
regressions with 2-sided hypothesis tests 
and 1% nominal Type 1 error rates 
Autocorrelation 
Effect size 
power 
0.1 
0.1 
96% 
0.2 
0.1 
93% 
0.4 
0.1 
84% 

NCI # NCT02224482 
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multivariate linear regression model from the analysis for previous aims, as suggested by Muller 
(2005) [80]. If the interaction between time and the intervention is substantially diminished, we 
will conclude that the variable mediates the change of intervention effect over time.  Separate 
mediational analyses will be performed for each mediator variable.  To assess the moderating 
effect of a given variable on the relationship between the intervention and adaptive coping, the 
interaction between the moderator and the intervention will be evaluated. Both the variable and 
the interaction term will be added to the linear regression model.  Continuous variables will be 
analyzed both as a continuous variable and a binary predictor variable, with the cutoff at the 
median. If the interaction term is found to be significant, this will be interpreted as an indication 
that the variable moderates the effect of the intervention on the outcome variable, adaptive 
coping. Separate moderational analyses will be performed for each moderator variable.   
 
Table 3. Univariate analyses of demographics and outcome variables by 
condition. 
 
Intervention 
Control 
 
N (%) or M (SD) 
N (%) or M (SD) 
Age 
63.8 (6.7) 
63.3 (7.5) 
Race/ethnicity 
 
 
Non-Hispanic White 
160 (73.7) 
143 (67.5 
Black 
40 (18.4) 
51 (24.1) 
Other 
17 (7.8) 
18 (8.5) 
PSA at diagnosis (ng/ml) 
14.0 (49.0) 
8.6 (10.7) 
Treatment completed 
 
 
Surgery Only 
130 (61.0) 
131 (61.8) 
Radiation Only 
59 (27.7) 
50 (23.6) 
Other (multiple 
treatments) 
24 (11.3) 
31 (14.6) 
Cancer Coping 
 
 
Baseline 
2.22 (0.637) 
2.22 (0.673) 
1 month 
2.23 (0.623) 
2.18 (0.673) 
3 months 
2.35 (0.597) 
2.15 (0.633) 
6 months 
2.22 (0.626) 
2.17 (0.643) 
Profile of Mood States 
 
 
Baseline 
102.8 (14.5) 
100.4 (12.8) 
1 month 
101.9 (14.2) 
99.5 (13.4) 
3 months 
100.2 (12.7) 
100.5 (13.4) 
6 months 
100.2 (14.3) 
102.1 (13.7) 
Medical Interactions 
 
 
Baseline 
2.7 (3.3) 
2.4 (3.1) 
1 month 
2.4 (2.7) 
2.2 (2.7) 
3 months 
2.5 (2.7) 
1.9 (2.3) 
6 months 
2.1 (2.2) 
2.0 (2.7) 
EPIC  
 
 
Urinary incontinence 
 
 
Baseline 
63.4 (29.7) 
62.6 (30.1) 
1 month 
69.2 (27.0) 
67.4 (26.3) 

NCI # NCT02224482 
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3 months 
76.4 (23.8) 
74.2 (24.4) 
6 months 
78.6 (22.3) 
76.7 (23.2) 
Urinary irritative 
 
 
Baseline 
78.6 (19.0) 
79.5 (19.4) 
1 month 
83.0 (17.4) 
84.8 (13.5) 
3 months 
84.8 (15.7) 
86.7 (13.2) 
6 months 
87.4 (15.1) 
88.8 (12.7) 
Bowel 
 
 
Baseline 
88.7 (15.8) 
89.8 (14.4) 
1 month 
91.5 (12.3) 
91.9 (11.1) 
3 months 
92.1 (13.0) 
93.0 (10.9) 
6 months 
92.6 (13.3) 
91.4 (13.1) 
Sexual 
 
 
Baseline 
32.1 (29.2) 
31.4 (29.7) 
1 month 
34.0 (28.9) 
33.5 (31.0) 
3 months 
35.6 (29.4) 
34.7 (29.4) 
6 months 
34.2 (29.4) 
36.4 (28.4) 
 
 
 

NCI # NCT02224482 
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8.0. STUDY PARAMETERS/TIMELINE 
 
9.0. OFF-STUDY CRITERIA  
Participants will be removed from this study if a recurrence of prostate cancer occurs.  
 
10.0. RECORDS TO BE KEPT 
All information collected for this study will be kept confidential. Participants will be told that all 
information will be kept in strict confidence. All data will be stored on computer files or in locked 
filing cabinets to which only select members of the research staff will have access.  
 
11.0. PROTECTION OF HUMAN SUBJECTS: DATA SAFETY AND MONITORING 
 
11.1 Oversight of Monitoring. Two FCCC committees - the Research Review Committee (RRC) 
and the Institutional Review Board (IRB) - monitor the protection of human subjects and the safe 
and secure collection and storage of data. These committees assess all proposed FCCC studies 
before initiation and then review protocols annually. These committees ensure the scientific, 
technical, and statistical soundness of the research and guarantee that methods for the ethical 
and safe treatment of human subjects are in place. The committees scrutinize the scientific and 
ethical aspects of protocols and provide for an objective and ongoing assessment of the study’s 
scientific and ethical integrity.  Similar oversight committees also operate at MSMC and Rutgers 
Cancer Institute of New Jersey.  In addition, as this is a phase III multi-site trial per NIH designation 
we will convene a Data Safety and Monitoring Board (DSMB) specifically for this application.   
 
11.2. Minimization of Assessment and Intervention Adverse Effects. All possible adverse 
emotional reactions will be explained to participants in the informed consent document.  If upon 
assessment or during the intervention the participant exhibits severe psychiatric symptoms or 
clinically high levels of emotional distress, the case will be referred to Dr. S. M., a clinical 
Table 4. Timeline  
Months 
Specific Tasks 
1- 
6 
7-
12 
13-
16 
17-
24 
25-
30 
31-
36 
37-
42 
43-
48 
49-
54 
55-
60 
Aim 1 
 
 
 
 
 
 
 
 
 
 
Focus groups – approaches & design  
 
 
 
 
 
 
 
 
 
 
Literature 
review 
and 
content 
identification 
 
 
 
 
 
 
 
 
 
 
Development of text, visuals, and pilot 
testing 
 
 
 
 
 
 
 
 
 
 
Plan and script videos 
 
 
 
 
 
 
 
 
 
 
Iterative user and usability testing 
 
 
 
 
 
 
 
 
 
 
Continue program refinement  
 
 
 
 
 
 
 
 
 
 
Final production of VSRC 
 
 
 
 
 
 
 
 
 
 
Aim 2 
 
 
 
 
 
 
 
 
 
 
Finalize study measures  
 
 
 
 
 
 
 
 
 
 
Study recruitment  
 
 
 
 
 
 
 
 
 
 
Assess baseline, 2 weeks, 2, 6, 12 
months follow-up  
 
 
 
 
 
 
 
 
 
 
RCT evaluation  
 
 
 
 
 
 
 
 
 
 
Aim 3 
 
 
 
 
 
 
 
 
 
 
Exploratory aim evaluation  
 
 
 
 
 
 
 
 
 
 
Manuscript preparation  
 
 
 
 
 
 
 
 
 
 

NCI # NCT02224482 
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psychologist who will, if the need is warranted, offer an appropriate referral for mental health 
services. In addition, with regard to potential adverse emotional reactions to the interventions, 
possible adverse emotional reactions will be explained to the participant in the informed consent 
document. Study staff will assess for adverse emotional reactions during initial data collection and 
during longitudinal follow-up.  
 
11.3. Procedures for Handling Adverse Events  
The protocol will employ the following mechanisms for adverse event reporting: 1) alert the study 
site review committees of any and all reports of adverse events; 2) inform all members of the 
study team of any and all reports of adverse events. If three or more adverse events are reported, 
the study team will assess potential causes of the adverse events and, if events are clearly linked 
to study participation, discontinue the study.  
 
11.4. Quality Assurance Procedures and Participant Confidentiality.  
Information about study subjects will be kept confidential and managed according to the 
requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). Those 
regulations require a signed subject authorization informing the subject of the following: The 
protected health information (PHI) that will be collected from patient; Who will have access to that 
information and why; Who will use or disclose that information; The rights of a research subject 
to revoke their authorization for use of their PHI. In the event that a respondent revokes 
authorization to collect or use PHI, the investigator, by regulation, retains the ability to use all 
information collected prior to the revocation of subject authorization. To ensure confidentiality is 
maintained at all times, respondent data will not include name. A unique study identifier will be 
recorded and used with electronic data collected and all records will be secured in a locked 
location.   
 
We have obtained approval from our primary site for a partial waiver of HIPAA authorization for 
access to the medical records of prospective participants for the randomized controlled trial 
phase of the study. This partial waiver has been approved based on the need to prescreen 
prospective participants with respect to medical eligibility requirements prior to contacting them 
for recruitment purposes. Such prior determination of eligibility against medical requirements is 
in accordance with the protocol for the randomized controlled trial phase of the study and serves 
to facilitate participant accrual (see section 5.5, RCT Recruitment Procedures). 
 
12.0. PARTICIPANT INFORMED CONSENT 
See separate Informed Consent Documents. 
 
 

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