Testing the Efficacy of a Couple-Focused, Tailored mHealth Intervention for Symptom Self-Management Among Men With Prostate Cancer and Their Partners
Phase: NA
Conditions: Prostate Cancer
Sponsor: UNC Lineberger Comprehensive Cancer Center

LINEBERGER COMPREHENSIVE CANCER CENTER 
Health Services Research 
CLINICAL ONCOLOGY RESEARCH PROGRAM 
 
September 2014 
UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL 
 
 
LCCC  1713:  Testing The Efficacy of A Couple-focused, Tailored mHealth 
Intervention for Symptom Self-Management Among Men with Prostate Cancer 
and Their Partners 
 
 
Principal Investigator 
Lixin Song, PhD 
5102 Carrington Hall 
919-966-3612  
Email: lsong@unc.edu 
 
Principal Co-Investigator  
N/A 
 
Co-Investigator(s) 
Ronald Chen, MD, MPH 
Matt Nielsen, MD, MPH 
Tom Keyserling, MD, MPH 
Mary Palmer, PhD 
Chris Rini, PhD 
Xianming Tan, PhD 
 
 
Biostatistician(s)  
Xianming Tan, PhD 
 
Sponsor:  N/A 
 
Funding Source: National Institute of Nursing Research (JIT) 
 
Version Date: May 28, 2020 

LINEBERGER COMPREHENSIVE CANCER CENTER 
Health Services Research 
CLINICAL ONCOLOGY RESEARCH PROGRAM 
 
September 2014 
UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL 
 
LCCC  1713:  Testing The Efficacy of A Couple-focused, Tailored mHealth 
Intervention for Symptom Self-Management Among Men with Prostate Cancer and 
Their Partners 
 
 
Principal Investigator 
Lixin Song, PhD 
5102 Carrington Hall 
919-966-3612  
Email: lsong@unc.edu 
 
 
Signature Page 
 
The signature below constitutes the approval of this protocol and the attachments, and 
provides the necessary assurances that this trial will be conducted according to all 
stipulations of the protocol, including all statements regarding confidentiality, and 
according to local legal and regulatory requirements and applicable U.S. federal 
regulations and ICH guidelines. 
 
Principal Investigator (PI) Name:______Lixin Song_________________ 
 
PI Signature: ___________________ 
 
Date:____________________ 
 
 
 
Version Date: May 28,2020 
  
 

LCCC 1713 
 
CONFIDENTIAL 
PI: Lixin Song PhD 
 
UNIVERSITY OF NORTH CAROLINA 
Version/Date  May 28,2020 
 
Health Services Research September 2014 Version 
i 
TABLE OF CONTENTS 
1.0 BACKGROUND AND RATIONALE ......................................................................... 3 
1.1 Study Synopsis ...................................................................................................... 3 
1.2 Background ........................................................................................................... 3 
1.3 Purpose and Rationale .......................................................................................... 3 
2.0 STUDY OBJECTIVES/AIMS AND ENDPOINTS ..................................................... 4 
2.1 Primary Objective .................................................................................................. 4 
2.2 Secondary Objectives ............................................................................................ 4 
3.0 PATIENT ELIGIBILITY ............................................................................................. 4 
3.1 Inclusion Criteria .................................................................................................... 4 
3.2 Exclusion Criteria ................................................................................................... 5 
4.0 STUDY PLAN ........................................................................................................... 5 
4.1 Schema ................................................................................................................. 5 
4.2 Duration of Study ................................................................................................... 5 
4.3 Study Details ......................................................................................................... 6 
4.4 Expected Risks ...................................................................................................... 8 
4.5 Removal of Patients from Protocol ........................................................................ 8 
5.0 TIME AND EVENTS TABLE .................................................................................... 8 
5.1 Time and Events Table .......................................................................................... 8 
6.0 UNANTICIPATED PROBLEMS ............................................................................... 9 
6.1 Definition ................................................................................................................ 9 
6.2 Reporting ............................................................................................................... 9 
7.0 STATISTICAL CONSIDERATIONS ....................................................................... 10 
7.1 Study Design ....................................................................................................... 10 

LCCC 1713 
 
CONFIDENTIAL 
PI: Lixin Song PhD 
 
UNIVERSITY OF NORTH CAROLINA 
Version/Date  May 28,2020 
 
Health Services Research September 2014 Version 
ii 
7.2 Sample Size and Accrual .................................................................................... 10 
7.3 Data Analysis Plans ............................................................................................. 10 
7.4 Data Management/Audit ...................................................................................... 11 
8.0 STUDY MANAGEMENT ........................................................................................ 14 
8.1 Institutional Review Board (IRB) Approval and Consent ..................................... 14 
8.2 Required Documentation ..................................................................................... 14 
8.3 Registration Procedures ...................................................................................... 14 
8.4 Adherence to the Protocol ................................................................................... 15 
8.5 Amendments to the Protocol ............................................................................... 16 
8.6 Record Retention ................................................................................................. 16 
8.7 Obligations of Investigators ................................................................................. 16 
9.0 REFERENCES ....................................................................................................... 16 
10.0 APPENDICES ...................................................................................................... 33 
 
 

LCCC 1713 
 
CONFIDENTIAL 
PI: Lixin Song PhD 
 
UNIVERSITY OF NORTH CAROLINA 
Version/Date  May 28,2020 
 
Health Services Research September 2014 Version 
iii 
1.0 
BACKGROUND AND RATIONALE 
1.1 
Study Synopsis 
In this study, we propose to test the efficacy of a couple-focused, web-based tailored 
prostate cancer symptom management program (PERC) in a randomized clinical trial. 
We will use a two-group (PERC versus NCI website) randomized controlled design 
and collect data at baseline (T1) and 4 (T2), 8 (T3), and 12 months (T4) among 800 
patients  (400 patient – partner dyads)completing initial treatment for localized 
prostate cancer and their intimate partners. 
1.2 
Background 
Over 180,000 new cases of prostate cancer will be diagnosed in 2016,1 and 92% will 
have localized or regional disease. 2 Despite a favorable five-year relative survival at 
100%,3 men with localized prostate cancer experience serious prolonged side effects 
after treatment with curative intent,4 including urinary, sexual, bowel, and hormonal 
symptoms; emotional distress; and general symptoms, e.g., pain, fatigue, and sleep 
disturbance; and change in body image, all of which impair their quality of life (QOL).4 
For men in an intimate relationship, these symptoms disrupt couples’ intimacy and 
relationships; 5-8 the symptoms’ adverse effects on their intimate partners’ QOL may 
be greater than the effects on patients’ own QOL.9,10 
1.3 
Purpose and Rationale 
Despite these challenges the patients and their partners face, as well as 
national guidelines on cancer survivorship from the Institute of Medicine (IOM)11  and 
the American Cancer Society (ACS),4 management of negative treatment effects 
remains the most unaddressed supportive care need for cancer patients and their 
families.12-14 Available in-person interventions are expensive to deliver and 
inconvenient for patients with prostate cancer and their intimate partners to attend 
together.  Existing web-based programs often are not couple-focused, lack theory 
guidance, are not tailored to patient and partner needs, and are tested in studies with 
major methodological flaws. (Note: “partner caregivers/intimate partners” are replaced 
by the term “partners” sometimes in this proposal due to space limitation). 
To address the unmet care needs for survivors and their partners, Dr. Song 
(PI) led an interdisciplinary team to develop and test the usability and feasibility of a 
tailored, couple-focused mHealth intervention called Prostate Cancer Education & 
Resources for Couples (PERC). Guided by an adapted Stress and Coping 
theoretical framework, PERC was developed with contribution of stakeholders 
(patients, partners, and oncologic care providers),15 and findings from efficacious 
interventions with cancer patients and partners16,17 and empirical evidence.4,16-19 
PERC aims to improve QOL for both patients and partners by enhancing positive 
appraisals of illness and boosting self-efficacy, social support from multiple sources, 
and healthy behaviors for symptom management. PERC uses mHealth technologies 
to dramatically increase couples’ accessibility to post-treatment supportive care 
whenever and wherever they feel comfortable accessing it. 15 The three main 
components of PERC are: (1) online educational modules to provide information and 
skills training, and facilitate dyadic support; (2) a moderated online Forum to facilitate 
professional and peer support; and (3) a Resource Toolbox to provide additional local 
and national resources, and easy access to useful information and tools to improve 
symptom management.  

LCCC 1713 
 
CONFIDENTIAL 
PI: Lixin Song PhD 
 
UNIVERSITY OF NORTH CAROLINA 
Version/Date  May 28,2020 
 
Health Services Research September 2014 Version 
4 
We tested and further refined PERC in two pilot studies. Patients and their 
partners were enthusiastic about and satisfied with the PERC intervention. They 
found the website easy to use, and it provided quality information that improved their 
symptom management and QOL.15 Based on our preliminary results, we believe that 
the refined PERC mHealth intervention is ready for efficacy testing in a randomized 
clinical trial. 
2.0 
STUDY OBJECTIVES/AIMS AND ENDPOINTS  
In this randomized controlled trial, we will examine the efficacy of a couple-focused, 
web-based tailored prostate cancer symptom management program (PERC). We will 
use a two-group (PERC versus NCI website) randomized controlled design and 
collect data at baseline (T1) and 4 (T2), 8 (T3), and 12 months (T4) among 800 
patients (400 patient - partner dyads) completing initial treatment for localized 
prostate cancer and their intimate partners. 
2.1 
Primary Objective: Assess the efficacy of PERC for improving QOL (total score and 
subscale scores of the physical, social, mental, and functional domains) among 
patients and their intimate partners.   
H 1: Patients and their intimate partners randomized to PERC will report a larger 
increase in QOL scores (as assessed by the Functional Assessment of Cancer 
Treatment, FACT-G) than those randomized to the control group (usual care plus the 
National Cancer Institute prostate cancer website, the NCI website) at 4, 8, and 12 
months post-baseline  
2.1.1 Our primary outcome is the total QOL score, and each of the QOL subdomains are 
secondary outcomes. 
2.2 
Secondary Objectives: Test the effects of PERC on symptom appraisals and coping 
resources.  
H 2: Patients and their intimate partners randomized to PERC will report greater 
improvement in secondary outcomes, positive appraisals of illness and coping 
resources, i.e., self-efficacy in symptom management, greater social support, and use 
of more healthy behaviors, at follow-ups than those randomized to the control group.    
2.3 
Exploratory Objective:  Explore whether patients’ race/ethnicity, education, type of 
cancer treatment, and couples’ relationship quality at baseline moderate the effects of 
PERC on patient and partner QOL at follow-ups.   
 
3.0 
PATIENT ELIGIBILITY 
3.1 
Inclusion Criteria 
The eligible patients must  
(1) be between 40 and 75 years old. 
(2) be within 4 months after completing initial treatment for localized prostate cancer 
as confirmed by patient and biopsy pathology report) with curative intent, i.e., 
surgery or radiotherapy +/- hormonal treatment;  
(3) have no previous cancer history within the past 2 years and not currently in 
treatment for cancer, or have a concurrent cancer (excluding non-melanomatous skin 
cancer);  

LCCC 1713 
 
CONFIDENTIAL 
PI: Lixin Song PhD 
 
UNIVERSITY OF NORTH CAROLINA 
Version/Date  May 28,2020 
 
Health Services Research September 2014 Version 
5 
(4) experience prostate cancer-specific and/or general symptoms;  
(5) have a partner who is willing to participate. 
 
The eligible partners must  
(1) be 18 years or older 
(2) be identified as the partner by the patient  
(3) not have been diagnosed with cancer or receiving treatment for cancer within the 
past 12 months (non-melanomatous skin cancer diagnosis/treatment is diagnosis/ 
treatment is acceptable) so that couples can focus their efforts on managing prostate 
cancer.  
3.2 
Exclusion Criteria 
Patients and their partners will be excluded from the study if they: 
• 
Do not read and speak English (evidenced by their understanding and responses 
to screening questions and self-reported ability to read English); 
• 
Have cognitive impairment (assessed by the Short Portable Mental Status 
Questionnaire).  
4.0 
STUDY PLAN 
4.1 
Schema 
 
4.2 
Duration of Study 
In this 5-year RCT, participants randomly assigned to the PERC group (the 
experimental group) will have access to the mHealth intervention titled Prostate 
Cancer Resources for Couples (PERC). The PERC users will have the chance to 
“meet” with a nurse educator via telephone and/or zoom video conferencing every 3-5 
weeks for approximately 16-20 weeks.  These will be scheduled via phone calls, 
emails or secure text messages (see section 4.3 below) to occur at these 
approximate time points: 1 week after completing the Baseline Survey (T1), and then 
three more at 3-5 week intervals for a total duration of 16 weeks. These intervals are 
flexible so that the patient/partner schedules can be accommodated and allow all 4 
meetings to occur prior to the T2 survey. At the first intervention the Health Educator 
will describe how best to use the website and assist the couple to explore its features 
and different modules to manage post treatment symptoms whether emotional or 
physical. Participants will be encouraged to contact the Health Educator should they 
have questions. 
Participants will also be given an option to utilize a tablet provided by the research 
team. If the participant does not have internet access, a Verizon jet pack (hot spot), 
along with user guide, will also be provided to the participant so that the surveys can 
be accessed. The tablet and jet pack will be returned when study participation is 
complete.  
Content for subsequent interventions will be based on symptoms either member of 
the dyad is experiencing, making use of the PERC website for assistance in symptom 

LCCC 1713 
 
CONFIDENTIAL 
PI: Lixin Song PhD 
 
UNIVERSITY OF NORTH CAROLINA 
Version/Date  May 28,2020 
 
Health Services Research September 2014 Version 
6 
management. Dyads in the experimental group will have unlimited access to the 
PERC website after the final planned intervention. 
 
Participants in the control group will have unlimited access to the NCI prostate cancer 
website. The Health Educator will have one phone meeting with them and their 
partners and answer any questions they have on accessing and navigating the NCI 
website. The control group will then receive emails and text messages approximately 
every 3-5 weeks until sixteen weeks to remind them to access the NCI website. As 
above, these intervals are flexible to allow for 3 reminders to be sent prior to the T2 
Survey. 
 
All participants will complete 3 follow-up surveys at around 4 (T2), 8 (T3), and 
12 (T4) months post Baseline survey (T1) 
4.3 
Study Details 
We plan to recruit 400 patient-partner dyads(800 participants) with diverse 
backgrounds through the NC Central Cancer Registry rapid case ascertainment (NC 
CCR RCA). The RCA uses an accelerated process to capture new cases within a 
week of diagnosis. After receiving a report of localized prostate cancer patients from 
RCA, we will contact patients’ physicians by letter, giving them three weeks to request 
that a patient not be approached for study inclusion. In one of our studies that RCA 
facilitated, physicians opted out 81 out of 3400 patients (2.4%) due to patients’ severe 
mental and physical illnesses or insufficient English proficiency. 108 
Study participation data will be provided back to the NC Central Cancer Registry rapid 
case ascertainment (NC CCR RCA) every six months. 
 
After the 3 week window, we will mail study introduction, a brochure, an opt out letter 
and informed consent information to potential participants. Then we will call within two 
weeks to assess interest in participating, answer questions, and screen for eligibility. 
We will use the same procedure to screen partners’ eligibility after eligible patients 
give permission for us to contact their partner. We will obtain informed consent from 
eligible patients and partners via telephone. 
 
 
 
 
 
 
 
 
After consented patients and partners independently complete the baseline survey via 
telephone, dyads will be randomized to PERC or the control group using a 1:1 ratio. v 
will generate allocation sequences by computerized randomization with randomly 
permuted blocks of random sizes. The Co-I statistician (Dr. Xianming Tan) will 
generate allocation sequences by computerized randomization with randomly 
permuted blocks of random sizes. Randomization will be Randomization will be 
stratified by type of treatment, surgery or radiation with or without hormonal therapy. 
Randomization will be centrally allocated using REDCap to ensure the security of 
randomization lists from all study personnel. After randomization, dyads will be 
informed of group assignment via email, mailer and/or telephone (the communication 

LCCC 1713 
 
CONFIDENTIAL 
PI: Lixin Song PhD 
 
UNIVERSITY OF NORTH CAROLINA 
Version/Date  May 28,2020 
 
Health Services Research September 2014 Version 
7 
methods participants prefer) and study activities and invited to start either the PERC 
or NCI program. 
 
Research staff (see Data Management for details) will be blinded to the 
randomization and collect all data using telephone survey at baseline (upon 
enrollment) and at 4, 8, and 12 months post-T1. Telephone surveys (recorded) will be 
scripted with simultaneous online data entry into REDCap database system, a secure 
database for data entry and management. It should be noted that password-protected 
REDCap will be maintained in a secure network environment and comply with UNC 
security regulations. Only designated research staff and investigators can access the 
REDCap database. 
 
Participants will receive gift cards in the following amounts at the following timepoints 
for study activities:  $20 at the completion of the T1 survey; $30 at the completion of 
the T2 survey; $30 at the completion of the T3 survey; $50 at the completion of the T4 
survey. They will also receive a retention gift with an approximate value of $20 at 
around 6 months (between T2 and T3) and 10 months (between T3 and T4) after the 
T1 survey. 
 
The research team will use the new Bank of America gift card system, which allows 
the study to acquire a gift card for each participant and then load and reload it with 
varying amounts for the baseline and 3 follow-up surveys. This is a UNC approved 
system, and no participant identifying data will be shared with any entity outside of 
study staff. At the discretion of the P.I. and the research staff, we may choose instead 
to send Amazon or WalMart gift cards, which would be purchased individually by the 
study. Gift cards will be sent following the completion of each study survey (T1, T2, 
T3 and T4); retention gifts will be sent at the appropriate time points. The Project 
Manager will oversee the acquisition and delivery of all gift cards. 
 
We will use a secure online texting service to contact participants in combination with 
our landline telephone in our research office. We will send generic text message 
reminders for forthcoming surveys, giftcards, website features and use reminders, 
and health educator meetings. All Text Magic SMS messages will not contain any PHI 
and will be sent over password protected UNC Desktop computers that are located in 
a research office space at UNC School of Nursing that is designated to the project 
team. 
1. Reminder: PERC Survey scheduled with <<STAFF NAME>> on <<DATE>> at 
<<TIME>>. 
2. Thank you for participating in the PERC Study at UNC. Here is the link to your gift 
card! Contact us at unc_perc@unc.edu or 1-888-776-0037 if you have any problems 
claiming your card. 
3. Reminder: Claim your gift card, it expires in 30 days 
4. Reminder: Send back your gift card receipt to us soon please! Let us know if you 
have had any problems using your card. 
5. Reminder: Log in to the website using your login information at https://perc.unc.edu/. 
Contact the PERC team for help logging in. 
6. Reminder: Meet with the Health Educator Signup using the following link or call us 
directly to schedule your meeting!  
7. Reminder Health Educator meeting scheduled for <<DATE>> at <<TIME>>. 
8. Reminder: PERC webinar on <<Day>> at <<Time>>. Use this link to join. 

LCCC 1713 
 
CONFIDENTIAL 
PI: Lixin Song PhD 
 
UNIVERSITY OF NORTH CAROLINA 
Version/Date  May 28,2020 
 
Health Services Research September 2014 Version 
8 
9. Webinar posted to <<BLANK>> Section of the website! Check it out! 
10. Check out the new Discussion Board post here! https://perc.unc.edu/topics/all  
11. Time to schedule your survey! Let us know what times you are available. 
4.4 
Expected Risks 
The risks of this study are minimal when compared to the knowledge and skills gained 
for the participants. The proposed study represents a potential benefit to participants 
for their post-treatment survivorship care. The PERC program has been designed to 
enhance post-treatment survivorship care by providing patients and partners a tool 
and specific resources to assess their needs and tailor the care program to their 
needs. 
4.5 
Removal of Patients from Protocol  
Patients and their partners will become ineligible for further participation in this study if 
she or he is diagnosed with any type of cancer (eg breast, bowel etc) with the 
exception of non- melanomatous skin cancer or develops a condition that prevents 
them from fully participating in study activities such as scheduling and completing 
surveys, or phone meetings with the Nurse Educator. Participants will also be 
removed if they decide to withdraw from the study voluntarily. 
 
5.0 
TIME AND EVENTS TABLE 
The baseline survey will take place after the participant’s consent. The post-PERC 
survey will be about 16 weeks post baseline depending on the participant’s schedule.  
 
 
5.1 
Time and Events Table 
 
 
Baseline 
(T1) 
 
PERC & 
Control 
PERC 
Intervention 
4, 8, and 12 
months post- 
baseline (T2, T3, 
and T4) 
 
PERC & Control 
Screening 
X 
Phone and/or 
Zoom  contact, 
with 
Questionnaires 
at time points 
 
 
Informed Consent 
X 
 
Randomization  
X  
 
Quality of Life: Functional Assessment of 
Cancer Treatment (FACT-G): 176, 17*     
X 
X 
Personal factors: Demographics (age, 
race/ethnicity, income, and education) 
X 
 
 Charlson Comorbidity Index_ Brief177,178^ 
X 
X 
 PROMIS measures of pain,179 fatigue,180 sleep 
disturbance181,182 
X  
X  
 PROMIS Cancer Anxiety and Depression 
measures 182,185 
X  
X  

LCCC 1713 
 
CONFIDENTIAL 
PI: Lixin Song PhD 
 
UNIVERSITY OF NORTH CAROLINA 
Version/Date  May 28,2020 
 
Health Services Research September 2014 Version 
9 
Couple factors: Relationship quality: Dyadic 
Adjustment Scale—Brief186-188* 
X  
X  
     Holmes and Rahe Scale 
X 
X 
Cancer-related factors:  Type of treatment# 
X  
X  
      Prostate cancer symptoms: Prostate cancer 
Index Composite (EPIC) 9,189*# 
X  
x 
Cancer care Financial Toxicity: COST-FACIT 
x 
x 
Appraisal of illness: Appraisal of Illness 
scales190,191* 
X 
X 
Coping Resources:  Lewis Cancer Self-
Efficacy Scale192 
X  
X 
      PROMIS Informational, Emotional, 
instrumental193-195 and social Support196 
X  
X 
Adapted Med Diet Screening and physical 
activity201,202* 
X  
 
X 
Measure of Adult Sedentary Time (MOST) 
X  
 
X  
eHealth Literacy Scale (eHEALS) 
X 
 
X 
Modified RESIDE Physical Activity Screener 
X 
 
X 
Perceived Ease of Use and Program 
Satisfaction 203,204* 
 
 
 
Physical activity logs (health diary) 
X  
 
X  
PERC web activity (automatic tracking)  
 
 
X  
6.0 
UNANTICIPATED PROBLEMS 
6.1 
Definition 
As defined by UNC’s IRB, unanticipated problems involving risks to study subjects or 
others (UPIRSO) refers to any incident, experience, or outcome that: 
• 
Is unexpected (in terms of nature, severity, or frequency) given (a) the research 
procedures that are described in the protocol-related documents, such as the IRB-
approved research protocol and informed consent document; and (b) the 
characteristics of the subject population being studied; 
• 
Is related or possibly related to a subject’s participation in the research; and  
• 
Suggests that the research places subjects or others at a greater risk of harm 
(including physical, psychological, economic, or social harm) related to the 
research than was previously known or recognized. 
 
We anticipate minimum risk of this study. The PERC and NCI websites provide a 
series of state-of-science resources that the participants can use at their 
convenience. We will also refer them to their treating doctors and nurse practitioners 
should any serious event happen. 
6.2 
Reporting 
We will report to the UNC IRB using the IRB’s web-based reporting system any 
unanticipated problem that occurs during the conduct of this study and that meets at 
least the first two criteria listed in 6.1.   

LCCC 1713 
 
CONFIDENTIAL 
PI: Lixin Song PhD 
 
UNIVERSITY OF NORTH CAROLINA 
Version/Date  May 28,2020 
 
Health Services Research September 2014 Version 
10 
7.0 
STATISTICAL CONSIDERATIONS 
7.1 
Study Design 
This study is a two-arm, parallel group randomized controlled trial (RCT) to test the 
efficacy of PERC, a theory-based, couple-focused, tailored mHealth program aimed 
to improve the QOL of patients with prostate cancer and their partners. After baseline 
measures (T1, following consent), 250 patient-partner dyads will be randomly 
assigned to PERC or to control (usual care plus the NCI website) groups. Participants 
will complete three surveys to assess the short, intermediate, and long-term effects of 
PERC: at 4 months post-T1 (T2), 8 months post-T1 (T3), and 12 months post-T1 (T4). 
7.2 
Sample Size and Power 
We calculated power for comparing our primary outcome (overall QOL) in the Primary 
Objective using a standard approach for linear mixed models. Because we will assess 
outcomes for patients and partners separately, we applied a Bonferroni-corrected, 
two-sided alpha of 0.025 to allow for separate overall tests for patients and partners. 
This is because, although dyadic data will be modeled simultaneously, conclusions 
may differ for patients and partners. Based on our pilot test of PERC, we assumed a 
common standard deviation for the overall QOL scores of 15 points and a within-
person correlation between repeated measurements of 0.75. Also, we allowed for 
losing up to 7% of participants every 4 months, for a total attrition of 20% through 12 
months. 
 
Under these assumptions (based on our preliminary studies), we report power 
for two scenarios, first allowing for attenuating effects, and then assuming constant 
effects. For the first scenario, we assumed that, on average, PERC would result in 
improved QOL relative to the control condition, but that these benefits might 
realistically be expected to decrease somewhat over time. Assuming that the mean 
difference between groups would be 7.5 points in overall QOL scores at 4 months 
(i.e., a moderate effect size of 0.5 that would represent a clinically meaningful 
difference immediately following the intervention) and that this would decrease by 
15% every 4 months, randomizing 125 dyads per group would provide 90% power to 
reject the overall null hypothesis of no differences between groups across all time 
points. Furthermore, with this scenario, this sample size would provide 94% power for 
the 4-month comparison, 83% power for the 8-month comparison, and 51% power for 
the 12-month comparison. For the second scenario, we assumed that the intervention 
has a constant effect of 6.5 points at each time point (an effect size of 0.43). This 
sample size will provide at least 80% power for each comparison. 
7.3 
Data Analysis Plans 
A detailed analysis plan will be developed prior to initiating the study; the following is 
a summary of the proposed plan.  Unless otherwise specified, all analyses will include 
all randomized participants, in the arm to which they are randomized, regardless of 
the extent of intervention received (intention-to-treat). 
 
Primary Objective:  We will compare the longitudinal mean change in overall QOL 
between groups using analysis of covariance (ANCOVA), conducted using linear 
mixed models. Data for patients and partners will be fit together in the same model 
(accounting for within-dyad correlation), which will allow us to readily assess for 
differential treatment effects between patients and partners. Mixed models will allow 
for the inclusion of all observed data for all dyads, assuming any missing data are 

LCCC 1713 
 
CONFIDENTIAL 
PI: Lixin Song PhD 
 
UNIVERSITY OF NORTH CAROLINA 
Version/Date  May 28,2020 
 
Health Services Research September 2014 Version 
11 
missing at random. Each model will include fixed effects (separate for patient or 
partner) for group, month, group-by-month interactions, the baseline value of the 
outcome scale, baseline treatment type (surgery and radiation +/-hormonal therapy), 
number of baseline comorbidities, baseline couple relationship quality, baseline family 
disruptions, age, race/ethnicity, education, income, and number of people supported 
by the income. These covariates were selected because they are potentially 
associated with QOL. Models will include random dyad and participant nested within 
dyad effects to account for within-dyad and within-person correlations between 
longitudinal responses. For the primary comparison, separately for each participant 
type, we will first test for any differences between groups across all 3 time points 
using an appropriately specified 3 degree of freedom linear contrast. Only if this test is 
significant (p ≤ 0.025), will we test for group differences at each time point. 
 
Secondary Objectives:  We will primarily use similar models to compare each of the 
QOL subdomains groups, and to test the Secondary outcome hypotheses. We will 
explore the potential mediating effects of appraisal and coping resources using a 
longitudinal path analysis model, which will not be the primary analysis for this aim 
because it requires much stronger assumptions than randomization as a basis for 
inference. The path model will be a cross-lagged longitudinal model with paths 
connecting all appraisal and coping variables from prior visits with QOL at subsequent 
visits, and paths to determine whether a patient’s appraisal or coping might influence 
his partner’s QOL, and vice versa. The model will include all appropriate within-dyad 
and longitudinal correlations. We will assess path model fit using several fit indices: 
the root mean square error of approximation (RMSEA), along with a 90% confidence 
interval, Bollen’s incremental fit index (IFI), and the Tucker-Lewis fit index (TLI).     
 
Exploratory Objectives:  We will test appropriate experimental group-by-
characteristic interactions using similar linear mixed models as specified for the 
Primary Objective. We will only explore effects within subgroups (e.g., within race and 
ethnicity, high school or lower vs. college or above, higher vs. lower quality 
relationships, or treatment type subgroups) if the corresponding interaction terms are 
significant at the 5% level in their respective models. We will also analyze outcome 
and process data to identify critical characteristics of PERC participants, e.g., 
differences in racial/ethnic and education, in their PERC use patterns and outcomes 
(e.g., Forum users vs. non-users).  
 
7.4 
Data Management/Audit 
7.4.1 Data management.  
A. Rapid Case Ascertainment (RCA) will maintain the patient referral database for the 
proposed research project on a secure network drive at the NC Central Cancer 
Registry. Downloaded files from the RCA project database to the researcher portal 
are encrypted with PGP software by RCA staff. The encrypted files are electronically 
transferred through SFTP to the secure integrated research system on the UNC 
server. The encrypted files on the UNC server is electronically retrieved through 
SFTP by the authorized personnel who directly works on the research project, 
including the project coordinator and the health educator.  
 
B. All survey data will be collected and managed by research staff using REDCap. study 
ID numbers will indicate the identities of subjects, and this information will be 

LCCC 1713 
 
CONFIDENTIAL 
PI: Lixin Song PhD 
 
UNIVERSITY OF NORTH CAROLINA 
Version/Date  May 28,2020 
 
Health Services Research September 2014 Version 
12 
accessible only to the study investigators. All questionnaires will bear study ID 
numbers only. Research team staff will conduct all telephone survey sessions in a 
private workstation in a private office designated to the research team. The telephone 
surveys will be recorded and reviewed by the PI, research staff at the project office to 
ensure adherence to the study protocol as well as data completeness and accuracy. 
We will randomly check at least 10% of the recordings against completed data for 
adherence to protocol, data completeness, and accuracy. 
 
 REDCap online database will be managed by the TraCS Clinical Research Data 
Management Service. NC TraCS is a key initiative of the Biomedical Informatics core 
of the UNC-Chapel Hill CTSA.  The purpose is to provide a system and associated 
support resources, to enable efficient and high-quality collection and management of 
research data that is standards-based in design, development and implementation.  
Standard features of electronic clinical research data management systems are 
available in the web-based systems provided with the service.  These include 
interactive data entry with real-time field validation, lab data imports, audit logs to 
record database modifications, database integrity checks, security (in logins, 
permissions based on need, and encryption), reporting, forms inventory, and exports 
to common statistical packages for analysis. Logging tracks all data entered in 
REDCap so that it can be traced back to the person who entered it.  No data can be 
changed without showing who has made the changes. This allows the study team to 
ensure there is security and integrity of the data collected and submitted, there are 
controls surrounding this aspect.  REDCap also provides for principle investigator to 
sign off on the data, as required in FDA studies.  Although users can modify data 
based on their permissions, they cannot delete the subject or history of that subject.  
Requests to delete a subject must be made to the REDCap system administrator. Our 
database system provides for secure web-based data entry with the data stored on 
servers that staff at NC TraCS maintain.  The data is encrypted during transmission.  
The servers are located in a secure campus area with all the appropriate physical 
security measures in place.  The web and database servers are monitored by the 
TraCS IT staff, patched frequently, and scanned by a third-party vendor to ensure that 
they are protected against known vulnerabilities.  The scanning application is the 
standard service for the entire campus.  Access is by individual user id and is 
restricted to the forms and/or functions that the user needs to have.  The applications 
themselves are written using open source tools and have also been scanned by 
campus security office to ensure that the applications also are protected from known 
exploits.  The data is backed up to electronic media on a daily basis.  The electronic 
media is secured by ITS stored in a secure area separate from the servers. 
 
C. The study website for PERC and NCI landing is hosted and maintained by the 
Communication for Health Applications and Interventions (CHAI) of the UNC 
Lineberger Comprehensive Cancer Center. The web activity data of all participants 
will be deidentified (using randomly assigned user IDs) and automatically tracked via 
a built-in feature of the study website. The de-identified web activity data from the 
PERC website and the NCI website landing page at CHAI will be automatically 
electronically transferred through SFTP to the research office at the School of Nursing 
on a weekly basis. 
 
D. All administrative data (including randomization, referral data) will be centrally 
managed using REDCap at the PI’s research office at the School of Nursing and 
accessed only to the study investigators and research staff. These administrative data 

LCCC 1713 
 
CONFIDENTIAL 
PI: Lixin Song PhD 
 
UNIVERSITY OF NORTH CAROLINA 
Version/Date  May 28,2020 
 
Health Services Research September 2014 Version 
13 
will be managed separately from the deidentified, password protected, encrypted and 
securely transferred data including surveys and web activity data. The PI and project 
coordinator will examine weekly the accuracy of the data files and completeness of 
the data. 
 
7.4.2. Data Monitoring/Audit.  
Per our consultation with the DSMB at UNC School of Medicine, although this is a 
randomized clinical trial, a DSMB is not needed because this study is of such low risk. 
With a primary outcome of change in quality of life (QOL) between the PERC 
intervention and the usual care plus NCI website control groups, there would not be 
anything significant to provide to the DSMB that might signal a reason for the DSMB 
to stop a study. However, we will implement a data and safety-monitoring plan to 
ensure the safety of participants as well as the validity and integrity of the data. The 
data monitoring plans are as follows: 
 
A.Oversight for this study will be provided by the PI with input and advice from 
the team. An Adverse Event Monitoring Committee oversees the conduct of the 
study. Chaired by the Dr. Song (PI), the committee will be comprised of all of the Co-
investigators: Drs. Rini, Palmer, Chen, Nielsen, Tan, Keyserling, and Northouse. Dr. 
Song will chair the committee, which will meet as needed to review the activities of the 
study including management, personnel, recruitment, performance, and any emerging 
problems.  
The research staff will ensure all entry criteria are met prior to the initiation of the 
protocol and all study procedures and reporting of adverse events and unanticipated 
events will be performed according to the IRB-approved protocol. Any actions taken 
and associated follow-up activities will be recorded in the study database. All 
intervention-related adverse events will be reported by the PIs to the IRB within 3-7 
days.  The PI will submit necessary reports to NINR. The PI and the Adverse Event 
Monitoring Committee will assess the level of risk from adverse events as mild (no 
interference in usual activities); moderate (some interference in usual activities); or 
severe (usual activities were significantly interrupted).  The PI and the Adverse Event 
Monitoring Committee will rate the assessment of attribution to the study as not 
related, unlikely, possible, probable, or definite.   
 
B.An Independent monitor, Dr. Ray Tan (UNC Urologist), will be independent from the 
present study design and implementation and will be available as needed to advise 
oversight committees 
 
To protect the confidentiality of participant data, the research team will 
conduct all research activities related to data processing involving identifiable data in 
a private office at the University of North Carolina-Chapel Hill School of Nursing 
(UNC-CH SON) that is dedicated to the project. This study has minimum hardcopy 
research records; the PI and the Safety Officer will ensure all records to be saved in a 
locked cabinet in the locked private office. With most data and documents being 
electronic, the PI and the Safety Officer will ensure that the identifiable and de-
identified data and documents are saved separately in different project folders in the 
password-protected and encrypted, shared drive at the UNC-CH SON, which is on a 
secure UNC server.  Only authorized key study personnel will have access to the 
identifiable information. 
The de-identified electronic data will include survey recordings and the 
recordings of monthly meetings between the educator and study participants for 

LCCC 1713 
 
CONFIDENTIAL 
PI: Lixin Song PhD 
 
UNIVERSITY OF NORTH CAROLINA 
Version/Date  May 28,2020 
 
Health Services Research September 2014 Version 
14 
quality control, survey data, study progress data and documents, and web activity 
tracking data. The PI and the Safety Officer will ensure that these data are tracked 
using study ID with no patient identifiable information attached. As a part of the UNC 
network and complying with UNC security regulations, the IT staff at SON works 
closely with the campus IT and other technology groups to ensure both security and 
efficiency for the proposed study. 
Adverse event reports and annual summaries will not include participant- 
identifiable material. Each will include the identification code only. 
 
8.0   
STUDY MANAGEMENT 
8.1  
Institutional Review Board (IRB) Approval and Consent 
It is expected that the IRB will have the proper representation and function in 
accordance with federally mandated regulations.  The IRB should approve the 
consent form and protocol. 
 
In obtaining and documenting informed consent, the investigator should comply with 
the applicable regulatory requirement(s), and should adhere to Good Clinical Practice 
(GCP) and to ethical principles that have their origin in the Declaration of Helsinki. 
 
 
 
Before recruitment and enrollment onto this study, we will mail study brochure and 
consent information to potential participants referred by the NC Central Cancer 
Registry. The patient and his partner will also be given a full explanation of the study 
and will be given the opportunity to review the study information and the consent form 
via telephone. Each consent form will include all the relevant elements currently 
required by the UNC IRB or state regulations. Once this essential information has 
been provided to the patient and his partner the investigator is assured that they 
understand the implications of participating in the study, they will be asked to give 
consent to participate in the study by consenting verbally the IRB-approved consent 
form when potential participants interviewed and screened via telephone. All consent 
processes will be recorded and saved in a file separate from other deidentified study 
materials in password protected, encrypted shared drive on the UNC server. 
8.2 
Required Documentation 
Before the study can be initiated at any site, the following documentation must be 
provided to the Clinical Protocol Office (CPO) at the University of North Carolina. 
• 
A copy of the official IRB approval letter for the protocol and informed 
consent 
• 
CVs and medical licensure for the principal investigator and any associate 
investigators who will be involved in the study 
• 
A copy of the IRB-approved consent form 
8.3 
Registration Procedures 
REDCap will be used to keep track of participants’ recruitment and other project 
activities. We have used REDCap to manage our patient recruitment and project 
activities in the past We will register all enrolled participants in OnCore. We have also 
registered this project on CT.gov.  

LCCC 1713 
 
CONFIDENTIAL 
PI: Lixin Song PhD 
 
UNIVERSITY OF NORTH CAROLINA 
Version/Date  May 28,2020 
 
Health Services Research September 2014 Version 
15 
8.4 
Adherence to the Protocol 
Except for an emergency situation in which proper care for the protection, safety, and 
well-being of the study patient requires alternative treatment, the study shall be 
conducted exactly as described in the approved protocol.   
8.4.1 Emergency Modifications 
UNC investigators may implement a deviation from, or a change of, the protocol to 
eliminate an immediate hazard(s) to trial subjects without prior UNC IRB approval.  
8.4.2 Single Patient/Subject Exceptions 
Any request to enroll a single subject who does not meet all the eligibility criteria of 
this study requires the approval of the UNC Principal Investigator and the UNC IRB.  
 
No  
8.4.3 Other Protocol Deviations/Violations 
According to UNC’s IRB, a protocol deviation is any unplanned variance from an IRB 
approved protocol that:  
• 
Is generally noted or recognized after it occurs 
• 
Has no substantive effect on the risks to research participants 
• 
Has no substantive effect on the scientific integrity of the research plan or 
the value of the data collected  
• 
Did not result from willful or knowing misconduct on the part of the 
investigator(s).  
 
An unplanned protocol variance is considered a violation if the variance meets any of 
the following criteria:  
• 
Has harmed or increased the risk of harm to one or more research 
participants. 
• 
Has damaged the scientific integrity of the data collected for the study. 
• 
Results from willful or knowing misconduct on the part of the 
investigator(s). 
• 
Demonstrates serious or continuing noncompliance with federal 
regulations, State laws, or University policies. 
 
If a deviation or violation occurs please follow the guidelines below: 
 
Protocol Deviations: UNC personnel will record the deviation in OnCore® (or other 
appropriate database set up for the study), and report to any sponsor or data and 
safety monitoring committee in accordance with their policies.  Deviations should be 
summarized and reported to the IRB at the time of continuing review. 
 
Protocol Violations: Violations should be reported by UNC personnel within one (1) 
week of the investigator becoming aware of the event using the same IRB online 
mechanism used to report UPIRSO.   
 
Unanticipated Problems Involving Risks to Subjects or Others (UPIRSO: 

LCCC 1713 
 
CONFIDENTIAL 
PI: Lixin Song PhD 
 
UNIVERSITY OF NORTH CAROLINA 
Version/Date  May 28,2020 
 
Health Services Research September 2014 Version 
16 
Any events that meet the criteria for “Unanticipated Problems” as defined by UNC’s 
IRB (see section 6.1) must be reported by the Study Coordinator using the IRB’s web-
based reporting system.   
8.5 
Amendments to the Protocol 
Should amendments to the protocol be required, the amendments will be originated 
and documented by the Principal Investigator at UNC.  It should also be noted that 
when an amendment to the protocol substantially alters the study design or the 
potential risk to the patient, a revised consent form might be required.   
 
The written amendment, and if required the amended consent form, must be sent to 
UNC’s IRB for approval prior to implementation.   
8.6 
Record Retention 
Study documentation includes all Case Report Forms, data correction forms or 
queries, source documents, Sponsor-Investigator correspondence, monitoring 
logs/letters, and regulatory documents (e.g., protocol and amendments, IRB 
correspondence and approval, signed patient consent forms). 
 
Source documents include all recordings of observations or notations of clinical 
activities and all reports and records necessary for the evaluation and reconstruction 
of the clinical research study. 
 
Government agency regulations and directives require that all study documentation 
pertaining to the conduct of a clinical trial must be retained by the study investigator.  
In the case of a study with a drug seeking regulatory approval and marketing, these 
documents shall be retained for at least two years after the last approval of marketing 
application in an International Conference on Harmonization (ICH) region.  In all other 
cases, study documents should be kept on file until three years after the completion 
and final study report of this investigational study. 
8.7 
Obligations of Investigators 
The Principal Investigator is responsible for the conduct of the clinical trial at the site 
in accordance with Title 21 of the Code of Federal Regulations and/or the Declaration 
of Helsinki.  The Principal Investigator is responsible for personally overseeing the 
treatment of all study patients.  The Principal Investigator must assure that all study 
site personnel, including sub-investigators and other study staff members, adhere to 
the study protocol and all FDA/GCP/NCI regulations and guidelines regarding clinical 
trials both during and after study completion. 
 
The Principal Investigator at each institution or site will be responsible for assuring 
that all the required data will be collected and entered onto the Case Report Forms. 
Periodically, monitoring visits will be conducted and the Principal Investigator will 
provide access to his/her original records to permit verification of proper entry of data. 
At the completion of the study, all case report forms will be reviewed by the Principal 
Investigator and will require his/her final signature to verify the accuracy of the data. 
 
9.0 REFERENCES 
 
1. American Cancer Society. Cancer Facts & Figures 2016. Atalanta, 2016. 

LCCC 1713 
 
CONFIDENTIAL 
PI: Lixin Song PhD 
 
UNIVERSITY OF NORTH CAROLINA 
Version/Date  May 28,2020 
 
Health Services Research September 2014 Version 
17 
2. Siegel R, DeSantis C, Virgo K, Stein K, Mariotto A, Smith T, Cooper D, Gansler T, Lerro C, 
Fedewa S, Lin C, Leach C, Cannady RS, Cho H, Scoppa S, Hachey M, Kirch R, Jemal A, 
Ward E. Cancer treatment and survivorship statistics, 2012. CA Cancer J Clin. 
2012;62(4):220-41. Epub 2012/06/16. doi: 10.3322/caac.21149. PubMed PMID: 22700443. 
3. National Cancer Inistitute. SEER Cancer Statistics Factsheets: Prostate Cancer. U.S. National 
Institutes of Health: National Cancer Institute; 2014. 
4. Skolarus TA, Wolf AM, Erb NL, Brooks DD, Rivers BM, Underwood W, 3rd, Salner AL, Zelefsky 
MJ, Aragon-Ching JB, Slovin SF, Wittmann DA, Hoyt MA, Sinibaldi VJ, Chodak G, Pratt-
Chapman ML, Cowens-Alvarado RL. American Cancer Society prostate cancer survivorship 
care guidelines. CA Cancer J Clin. 2014;64(4):225-49. Epub 2014/06/12. doi: 
10.3322/caac.21234; PMCID: 24916760 
5. O'Brien R, Rose P, Campbell C, Weller D, Neal RD, Wilkinson C, McIntosh H, Watson E. "I wish 
I'd told them": a qualitative study examining the unmet psychosexual needs of prostate 
cancer patients during follow-up after treatment. Patient education and counseling. 
2011;84(2):200-7. Epub 2010/08/13. doi: 10.1016/j.pec.2010.07.006. 
6. Hanly N, Mireskandari S, Juraskova I. The struggle towards 'the New Normal': a qualitative insight 
into psychosexual adjustment to prostate cancer. BMC Urol. 2014;14(1):56. Epub 
2014/07/31. doi: 10.1186/1471-2490-14-56. 
7. Letts C, Tamlyn K, Byers ES. Exploring the impact of prostate cancer on men's sexual well-being. 
J Psychosoc Oncol. 2010;28(5):490-510. Epub 2010/08/24. doi: 
10.1080/07347332.2010.498457. PubMed PMID: 20730661. 
8. Galbraith ME, Fink R, Wilkins GG. Couples Surviving Prostate Cancer: Challenges in Their Lives 
and Relationships. Seminars in Oncology Nursing. 2011;27(4):300-8. doi: 
http://dx.doi.org/10.1016/j.soncn.2011.07.008. 
9. Northouse LL, Mood D, Montie JE, Sandler HM, Forman JD, Hussain M, Pienta K, Smith DC, 
Sanda MG, Kershaw T. Living with Prostate Cancer: Patients' and Spouses' Psychosocial 
Status and Quality of Life. Journal of Clinical Oncology. 2007;25:4171-7. 
10. Song L, Northouse LL, Braun TM, Zhang L, Cimprich B, Ronis DL, Mood DW. Assessing 
longitudinal quality of life in prostate cancer patients and their spouses: a multilevel modeling 
approach. Qual Life Res. 2011;20(3):371- 
81. Epub 2010/10/12. doi: 10.1007/s11136-010-9753-y. PubMed PMID: 20927648. PMCID: 
PMC3888242 
11. Hewitt M, Greenfield S, Stovall EL. From cancer patient to cancer survivors: lost in 
transition2005. 
12. Viswanathan M, Halpern M, Swinson Evans T, Birken SA, Mayer DK, Basch E. Models of 
Cancer Survivorship Care 2014. Report No.: 14-EHC011-EF 
13. Hoekstra RA, Heins MJ, Korevaar JC. Health care needs of cancer survivors in general practice: 
a systematic review. BMC family practice. 2014;15:94. Epub 2014/06/03. doi: 10.1186/1471-
2296-15-94; PMCID: Pmc4031325. 
14. Bazzell JL, Spurlock A, McBride M. Matching the Unmet Needs of Cancer Survivors to 
Resources Using a Shared Care Model. J Cancer Educ. 2014. Epub 2014/08/12. doi: 
10.1007/s13187-014-0708-9. 
15. Song L, Rini C, Deal AM, Nielsen ME, Chang H, Kinneer P, Teal R, Johnson DC, Dunn MW, 
Mark B, Palmer MH. Improving Couples’ Quality Of Life Through A Web-Based, Couple-
Oriented Prostate Cancer Education Intervention. Oncology Nursing Forum. 2015;42(2):183-
92. doi: doi: 10.1188/15.ONF.183-192. PMCID: PMC5123564 
16. Northouse LL, Mood DW, Schafenacker A, Montie JE, Sandler HM, Forman JD, Hussain M, 
Pienta KJ, Smith DC, Kershaw T. Randomized clinical trial of a family intervention for 
prostate cancer patients and their spouses. Cancer. 2007;110(12):2809-18. PubMed PMID: 
17999405. 

LCCC 1713 
 
CONFIDENTIAL 
PI: Lixin Song PhD 
 
UNIVERSITY OF NORTH CAROLINA 
Version/Date  May 28,2020 
 
Health Services Research September 2014 Version 
18 
17. Northouse LL, Mood D, Kershaw T, Schafenacker A, Mellon S, Walker J, Galvin E, Decker V. 
Quality of life of women with recurrent breast cancer and their family members. Journal of 
Clinical Oncology 2002;20:4050-64. PubMed PMID: 2003035728. 
18. Oncology Nursing Society. Putting evidence into practice. A pocket guide to cancer symptom 
management. Pittsburgh, Pennsylvania: Oncology Nursing Society; 2016. 
19. NCCN Clinical Practice Guidelines in Oncology (NCCN Guideline): Prostate Cancer [Internet]. 
National Comprehensive Cancer Network. 2014. 
20. Gore JL, Kwan L, Lee SP, Reiter RE, Litwin MS. Survivorship beyond convalescence: 48-month 
quality-of-life outcomes after treatment for localized prostate cancer. Journal of the National 
Cancer Institute. 2009;101(12):888-92. Epub 2009/06/11. doi: 10.1093/jnci/djp114. PubMed 
PMID: 19509365. 
21. Sanda MG, Dunn RL, Michalski J, Sandler HM, Northouse L, Hembroff L, Lin X, Greenfield TK, 
Litwin MS, Saigal CS, Mahadevan A, Klein E, Kibel A, Pisters LL, Kuban D, Kaplan I, Wood 
D, Ciezki J, Shah N, Wei JT. Quality of life and satisfaction with outcome among prostate-
cancer survivors. New England Journal of Medicine. 2008;358(12):1250-61. PubMed PMID: 
18354103. 
22. Chen RC, Zhang Y, Chen MH, McMahon E, Loffredo M, McPherson CP, Nguyen AU, Nguyen 
PL, D'Amico AV. Patient-reported quality of life during radiation treatment for localized 
prostate cancer: results from a prospective phase II trial. BJU international. 
2012;110(11):1690-5. Epub 2012/04/17. doi: 10.1111/j.1464-410X.2012.11117.x. PubMed 
PMID: 22502770. 
23. Matthew AG, Alibhai SM, Davidson T, Currie KL, Jiang H, Krahn M, Fleshner NE, Kalnin R, Louis 
AS, Davison BJ, Trachtenberg J. Health-related quality of life following radical prostatectomy: 
long-term outcomes. Qual Life Res. 2014;23(8):2309-17. Epub 2014/03/13. doi: 
10.1007/s11136-014-0664-1. 
24. Prabhu V, Lee T, McClintock TR, Lepor H. Short-, Intermediate-, and Long-term Quality of Life 
Outcomes Following Radical Prostatectomy for Clinically Localized Prostate Cancer. Rev 
Urol. 2013;15(4):161-77. Epub 2013/01/01; PMCID: PMC3922321. 
25. Crook JM, Gomez-Iturriaga A, Wallace K, Ma C, Fung S, Alibhai S, Jewett M, Fleshner N. 
Comparison of Health-Related Quality of Life 5 Years After SPIRIT: Surgical Prostatectomy 
Versus Interstitial Radiation Intervention Trial. Journal of Clinical Oncology. 2011;29(4):362-
8. doi: 10.1200/jco.2010.31.7305. 
26. van Tol-Geerdink JJ, Leer JWH, van Oort IM, van Lin EJNT, Weijerman PC, Vergunst H, Witjes 
JA, Stalmeier PFM. Quality of life after prostate cancer treatments in patients comparable at 
baseline. British journal of cancer. 2013;108(9):1784-9. doi: 10.1038/bjc.2013.181. 
27. Bourke L, Smith D, Steed L, Hooper R, Carter A, Catto J, Albertsen PC, Tombal B, Payne HA, 
Rosario DJ. Exercise for Men with Prostate Cancer: A Systematic Review and Meta-analysis. 
European urology. 2016;69(4):693-703. Epub 2015/12/04. doi: 10.1016/j.eururo.2015.10.047. 
PubMed PMID: 26853923. 
28. Harrison J, Young J, Price M, Butow P, Solomon M. What are the unmet supportive care needs 
of people with cancer? A systematic review. Supportive Care in Cancer. 2009;17(8):1117-28. 
doi: 10.1007/s00520-009-0615-5. 
29. Lev E, Eller L, Gejerman G, Kolassa J, Colella J, Pezzino J, Lane P, Munver R, Esposito M, 
Sheuch J, Lanteri V, Sawczuk I. Quality of life of men treated for localized prostate cancer: 
outcomes at 6 and 12 months. Supportive Care in Cancer. 2009;17(5):509-17. doi: 
10.1007/s00520-008-0493-2. 
30. Reeve BB, Chen RC, Moore DT, Deal AM, Usinger DS, Lyons JC, Talcott JA. Impact of 
comorbidity on health related quality of life after prostate cancer treatment: combined 
analysis of two prospective cohort studies. BJU international. 2014. Epub 2014/03/05. doi: 
10.1111/bju.12723. PubMed PMID: 24588845. 

LCCC 1713 
 
CONFIDENTIAL 
PI: Lixin Song PhD 
 
UNIVERSITY OF NORTH CAROLINA 
Version/Date  May 28,2020 
 
Health Services Research September 2014 Version 
19 
31. Epstein MM, Edgren G, Rider JR, Mucci LA, Adami HO. Temporal trends in cause of death 
among Swedish and US men with prostate cancer. Journal of the National Cancer Institute. 
2012;104(17):1335-42. Epub 2012/07/28. doi: 10.1093/jnci/djs299; PMCID: PMC3529593. 
32. Carneiro A, Sasse AD, Wagner AA, Peixoto G, Kataguiri A, Neto AS, Bianco BA, Chang P, 
Pompeo AC, Tobias-Machado M. Cardiovascular events associated with androgen 
deprivation therapy in patients with prostate cancer: a systematic review and meta-analysis. 
World journal of urology. 2015;33(9):1281-9. Epub 2014/11/13. doi: 10.1007/s00345-014-
1439-6. PubMed PMID: 25921545. 
33. Nguyen PL, Je Y, Schutz FA, Hoffman KE, Hu JC, Parekh A, Beckman JA, Choueiri TK. 
Association of androgen deprivation therapy with cardiovascular death in patients with 
prostate cancer: a meta-analysis of randomized trials. Jama. 2011;306(21):2359-66. Epub 
2011/12/08. doi: 10.1001/jama.2011.1745. 
34. Edwards BK, Noone AM, Mariotto AB, Simard EP, Boscoe FP, Henley SJ, Jemal A, Cho H, 
Anderson RN, Kohler BA, Eheman CR, Ward EM. Annual Report to the Nation on the status 
of cancer, 1975-2010, featuring prevalence of comorbidity and impact on survival among 
persons with lung, colorectal, breast, or prostate cancer. Cancer. 2014;120(9): 1290-314. 
Epub 2013/12/18. doi: 10.1002/cncr.28509; PMCID: PMC3999205. 
35. Cheville AL, Kollasch J, Vandenberg J, Shen T, Grothey A, Gamble G, Basford JR. A home-
based exercise program to improve function, fatigue, and sleep quality in patients with Stage 
IV lung and colorectal cancer: a randomized controlled trial. J Pain Symptom Manage. 
2013;45(5):811-21. Epub 2012/09/29. doi:10.1016/j.jpainsymman.2012.05.006. PubMed 
PMID: 23017624; PMCID: PMC4524515. 
36. Mishra SI, Scherer RW, Geigle PM, Berlanstein DR, Topaloglu O, Gotay CC, Snyder C. Exercise 
interventions on health-related quality of life for cancer survivors. The Cochrane database of 
systematic reviews. 2012;8:Cd007566. Epub 2012/08/17. doi: 
10.1002/14651858.CD007566.pub2. PubMed PMID: 22895961. 
37. Kenfield SA, DuPre N, Richman EL, Stampfer MJ, Chan JM, Giovannucci EL. Mediterranean diet 
and prostate cancer risk and mortality in the Health Professionals Follow-up Study. European 
urology. 2014;65(5):887-94. Epub 2013/08/22. doi: 10.1016/j.eururo.2013.08.009. PubMed 
PMID: 23962747; PMCID: PMC4157361. 
38. Lopez-Guarnido O, Alvarez-Cubero MJ, Saiz M, Lozano D, Rodrigo L, Pascual M, Cozar JM, 
Rivas A. Mediterranean diet adherence and prostate cancer risk2015(1699-5198 
(Electronic)). 
39. Moller E, Galeone C, Andersson TM, Bellocco R, Adami HO, Andren O, Gronberg H, La Vecchia 
C, Mucci LA, Balter K. Mediterranean Diet Score and prostate cancer risk in a Swedish 
population-based case-control study. Journal of nutritional science. 2013;2:e15. Epub 
2013/01/01. doi: 10.1017/jns.2013.2; PMCID: PMC4153088. 
40. Hooper L, Abdelhamid A, Moore HJ, Douthwaite W, Skeaff CM, Summerbell CD. Effect of 
reducing total fat intake on body weight: systematic review and meta-analysis of randomised 
controlled trials and cohort studies. BMJ (Clinical research ed). 2012;345:e7666. Epub 
2012/12/12. doi: 10.1136/bmj.e7666. PubMed PMID: 
22147380; PMCID: PMC3516671. 
41. Dinu M, Abbate R, Gensini GF, Casini A, Sofi F. Vegetarian, vegan diets and multiple health 
outcomes: a systematic review with meta-analysis of observational studies. Critical reviews in 
food science and nutrition. 2016:0. Epub 2016/02/09. doi: 10.1080/ 10408398.2016.1138447. 
PubMed PMID: 25387877. 
42. Castro I, Waclawovsky G, Marcadenti A. Nutrition and physical activity on hypertension: 
implication of current evidence and guidelines. Current hypertension reviews. 2015;11(2):91-
9. Epub 2015/04/30. PubMed PMID: 23220130. 

LCCC 1713 
 
CONFIDENTIAL 
PI: Lixin Song PhD 
 
UNIVERSITY OF NORTH CAROLINA 
Version/Date  May 28,2020 
 
Health Services Research September 2014 Version 
20 
43. Ervik B, Nordøy T, Asplund K. In the Middle and on the Sideline: The Experience of Spouses of 
Men With Prostate Cancer. Cancer nursing. 2013;36(3):E7-E14 
0.1097/NCC.0b013e31824fe1ef. 
44. Kershaw T, Mood D, Newth G, Ronis DL, Sanda M, Vaishampayan U, Northouse LL. 
Longitudinal analysis of a model to predict quality of life in prostate cancer patients and their 
spouses. Annals of Behavioral Medicine. 2008;36(2):117-28. 
45. Hagedoorn M, Sanderman R, Bolks HN, Tuinstra J, Coyne JC. Distress in couples coping with 
cancer: a metaanalysis and critical review of role and gender effects. Psychological Bulletin. 
2008;134(1):1-30. PubMed PMID:18193993. 
46. National Comprehensive Cancer Network. NCCN Guidelines for Patients: Prostate Cancer. 
2014. 
47. Skolarus TA, Holmes-Rovner M, Northouse LL, Fagerlin A, Garlinghouse C, Demers RY, Rovner 
DR, Darwish-Yassine M, Wei JT. Primary care perspectives on prostate cancer survivorship: 
Implications for improving quality of care. Urologic oncology. 2011;31(6):727-32. Epub 
2011/07/22. doi: 10.1016/j.urolonc.2011.06.002. PubMed 
PMID: 21775171; PMCID: 3213312. 
48. Ezer H, Chachamovich JL, Chachamovich E. Do men and their wives see it the same way? 
Congruence within couples during the first year of prostate cancer. Psycho-oncology. 
2011;20(2):155-64. Epub 2010/09/30. doi: 10.1002/pon.1724. 
49. Cockle-Hearne J, Faithfull S. Self-management for men surviving prostate cancer: a review of 
behavioural and psychosocial interventions to understand what strategies can work, for 
whom and in what circumstances. Psychooncology. 2010;19(9):909-22. Epub 2010/02/02. 
doi: 10.1002/pon.1657. 
50. Garrett BM, Oliffe JL, Bottorff JL, McKenzie M, Han CS, Ogrodniczuk JS. The value of prostate 
cancer support groups: a pilot study of primary physicians' perspectives. BMC family 
practice. 2014;15:56. Epub 2014/03/29. doi: 10.1186/1471-2296-15-56. PubMed PMID: 
24754582; PMCID: PMC3972516. 
51. Silveira MJ, Given CW, Cease KB, Sikorskii A, Given B, Northouse LL, Piette JD. Cancer 
Carepartners: Improving patients' symptom management by engaging informal caregivers. 
BMC palliative care. 2011;10:21. Epub 2011/11/29. doi: 10.1186/1472-684x-10-21. PubMed 
PMID: 22117890; PMCID: 3295676. 
52. O'Toole MS, Zachariae R, Renna ME, Mennin DS, Applebaum A. Cognitive behavioral therapies 
for informal caregivers of patients with cancer and cancer survivors: a systematic review and 
meta-analysis. Psycho-oncology. 2016. Epub 2016/05/06. doi: 10.1002/pon.4144. 
53. Anderson CA, Omar MI, Campbell SE, Hunter KF, Cody JD, Glazener CM. Conservative 
management for postprostatectomy urinary incontinence. The Cochrane database of 
systematic reviews. 2015;1:Cd001843. Epub 2015/01/21. doi: 10.1002/14651858. 
CD001843.pub5. 
54. Campbell SE, Glazener CM, Hunter KF, Cody JD, Moore KN. Conservative management for 
postprostatectomy urinary incontinence. The Cochrane database of systematic reviews. 
2012;1:Cd001843. Epub 2012/01/20. doi: 10.1002/14651858.CD001843.pub4. 
55. Campbell LC, Keefe FJ, Scipio C, McKee DC, Edwards CL, Herman SH, Johnson LE, Colvin 
OM, McBride CM, Donatucci C. Facilitating research participation and improving quality of life 
for African American prostate cancer survivors and their intimate partners. A pilot study of 
telephone-based coping skills training. Cancer. 2007;109(2 Suppl):414-24. PubMed PMID: 
17173280. 
56. McCaughan E, Prue G, McSorley O, Northouse L, Schafenacker A, Parahoo K. A randomized 
controlled trial of a self-management psychosocial intervention for men with prostate cancer 
and their partners: a study protocol. J Adv Nurs. 2013;69(11):2572-83. Epub 2013/03/27. doi: 
10.1111/jan.12132. PubMed PMID: 23528148. 

LCCC 1713 
 
CONFIDENTIAL 
PI: Lixin Song PhD 
 
UNIVERSITY OF NORTH CAROLINA 
Version/Date  May 28,2020 
 
Health Services Research September 2014 Version 
21 
57. Chambers SK, Schover L, Halford K, Clutton S, Ferguson M, Gordon L, Gardiner RA, Occhipinti 
S, Dunn J. ProsCan for Couples: randomised controlled trial of a couples-based sexuality 
intervention for men with localised prostate cancer who receive radical prostatectomy. BMC 
cancer. 2008;8:226. doi: 1186/1471-2407-8-207. PubMed PMID: 18687149. 
58. Lambert SD, Girgis A, Turner J, McElduff P, Kayser K, Vallentine P. A pilot randomized 
controlled trial of the feasibility of a self-directed coping skills intervention for couples facing 
prostate cancer: rationale and design. Health and quality of life outcomes. 2012;10:119-7525-
10-119. doi: 10.1186/1477-7525-10-119; 10.1186/1477- 
7525-10-119. 
59. Walker LM, Hampton AJ, Wassersug RJ, Thomas BC, Robinson JW. Androgen Deprivation 
Therapy and maintenance of intimacy: a randomized controlled pilot study of an educational 
intervention for patients and their partners. Contemp Clin Trials. 2013;34(2):227-31. Epub 
2012/12/12. doi: 10.1016/j.cct.2012.11.007. PubMed 
PMID: 23220254. 
60. Nelson CJ, Kenowitz J. Communication and intimacy-enhancing interventions for men diagnosed 
with prostate cancer and their partners. J Sex Med. 2013;10 Suppl 1:127-32. Epub 
2013/02/15. doi: 10.1111/jsm.12049. PubMed PMID: 23387918; PMCID: PMC4324570. 
61. Manne SL, Kissane DW, Nelson CJ, Mulhall JP, Winkel G, Zaider T. Intimacy-enhancing 
psychological intervention for men diagnosed with prostate cancer and their partners: a pilot 
study. J Sex Med. 2011;8(4):1197- 
209. Epub 2011/01/08. doi: 10.1111/j.1743-6109.2010.02163.x. PubMed PMID: 21210958; PMCID: 
3070795. 
62. Badger TA, Segrin C, Figueredo AJ, Harrington J, Sheppard K, Passalacqua S, Pasvogel A, 
Bishop M. Psychosocial interventions to improve quality of life in prostate cancer survivors 
and their intimate or family partners. Qual Life Res. 2010;20(6):833-44. Epub 2010/12/21. 
doi: 10.1007/s11136-010-9822-2. PubMed PMID: 21170682. 
63. Galvao DA, Spry N, Denham J, Taaffe DR, Cormie P, Joseph D, Lamb DS, Chambers SK, 
Newton RU. A multicentre year-long randomised controlled trial of exercise training targeting 
physical functioning in men with prostate cancer previously treated with androgen 
suppression and radiation from TROG 03.04 RADAR. European urology. 2014;65(5):856-64. 
Epub 2013/10/12. doi: 10.1016/j.eururo.2013.09.041. PubMed PMID: 24113319. 
64. Zopf EM, Braun M, Machtens S, Zumbe J, Bloch W, Baumann FT. Implementation and scientific 
evaluation of rehabilitative sports groups for prostate cancer patients: study protocol of the 
ProRehab Study. BMC cancer. 2012;12:312-2407-12-312. doi: 10.1186/1471-2407-12-312; 
10.1186/1471-2407-12-312. 
65. Slev VN, Mistiaen P, Pasman HR, Verdonck-de Leeuw IM, Uden-Kraan CF, Francke AL. Effects 
of eHealth for patients and informal caregivers confronted with cancer: A meta-review. 
International journal of medical informatics. 2016;87:54-67. Epub 2016/01/26. doi: 
10.1016/j.ijmedinf.2015.12.013. PubMed PMID: 24366061. 
66. Salonen A, Ryhanen AM, Leino-Kilpi H. Educational benefits of Internet and computer-based 
programmes for prostate cancer patients: a systematic review. Patient education and 
counseling. 2014;94(1):10-9. Epub 2013/09/12. doi: 10.1016/j.pec.2013.08.022. PubMed 
PMID: 24331342. 
67. Health Online 2013 [Internet]. Pew Research Center. 2013 [cited March 12, 2016]. Available 
from: http://www.pewinternet.org/2013/01/15/health-online-2013/. 
68. Tracking for Health [Internet]. Pew Research Center. 2013 [cited March 12, 2016]. Available 
from: http://www.pewinternet.org/2013/06/20/family-caregivers-and-health-care-info/. 
69. Bakitas MA, Elk R, Astin M, Ceronsky L, Clifford KN, Dionne-Odom JN, Emanuel LL, Fink RM, 
Kvale E, Levkoff S, Ritchie C, Smith T. Systematic Review of Palliative Care in the Rural 
Setting. Cancer control : journal of the Moffitt Cancer Center. 2015;22(4):450-64. Epub 
2015/12/19. 

LCCC 1713 
 
CONFIDENTIAL 
PI: Lixin Song PhD 
 
UNIVERSITY OF NORTH CAROLINA 
Version/Date  May 28,2020 
 
Health Services Research September 2014 Version 
22 
70. Borgmann H, Mager R, Salem J, Brundl J, Kunath F, Thomas C, Haferkamp A, Tsaur I. Robotic 
Prostatectomy on the Web: A Cross-Sectional Qualitative Assessment. Clinical genitourinary 
cancer. 2015. Epub 2016/01/30. doi: 10.1016/j.clgc.2015.12.020. PubMed PMID: 26348661. 
71. Ellimoottil C, Polcari A, Kadlec A, Gupta G. Readability of websites containing information about 
prostate cancer treatment options. The Journal of urology. 2012;188(6):2171-5. Epub 
2012/10/23. doi:10.1016/j.juro.2012.07.105. PubMed PMID: 21953578. 
72. Ogah I, Wassersug RJ. How reliable are "reputable sources" for medical information on the 
Internet? The case of hormonal therapy to treat prostate cancer. Urologic oncology. 
2013;31(8):1546-52. Epub 2012/11/13. doi: 10.1016/j.urolonc.2012.08.003. PubMed PMID: 
23930444. 
73. Sadowski DJ, Ellimoottil CS, Tejwani A, Gorbonos A. Proton therapy for prostate cancer online: 
patient education or marketing? The Canadian journal of urology. 2013;20(6):7015-20. Epub 
2013/12/18. PubMed PMID: 23141782. 
74. Berry DL, Halpenny B, Hong F, Wolpin S, Lober WB, Russell KJ, Ellis WJ, Govindarajulu U, 
Bosco J, Davison BJ, Bennett G, Terris MK, Barsevick A, Lin DW, Yang CC, Swanson G. 
The Personal Patient Profile-Prostate decision support for men with localized prostate 
cancer: A multi-center randomized trial. Urologic Oncology: Seminars and Original 
Investigations. 2013;31(7):1012-21. doi: http://dx.doi.org/10.1016/j.urolonc.2011.10.004. 
75. Davison BJ, Szafron M, Gutwin C, Visvanathan K. Using a web-based decision support 
intervention to facilitate patient-physician communication at prostate cancer treatment 
discussions. Canadian Oncology Nursing Journal. 2014;24(4):241-7. 
76. Flynn D, van Schaik P, van Wersch A, Ahmed T, Chadwick D. The utility of a multimedia 
education program for prostate cancer patients: a formative evaluation. British journal of 
cancer. 2004;91(5):855-60. Epub 2004/07/29. doi: 10.1038/sj.bjc.6602071. PubMed PMID: 
15280915; PMCID: 2409882. 
77. Davison BJ, Goldenberg SL, Gleave ME, Degner LF. Provision of individualized information to 
men and their partners to facilitate treatment decision making in prostate cancer. Oncology 
nursing forum. 2003;30(1):107-14. Epub 2003/01/08. doi: 10.1188/03.ONF.107-114 [doi]. 
PubMed PMID: 12515988. 
78. Bender JL, Yue RY, To MJ, Deacken L, Jadad AR. A lot of action, but not in the right direction: 
systematic review and content analysis of smartphone applications for the prevention, 
detection, and management of cancer. Journal of medical Internet research. 
2013;15(12):e287. Epub 2013/12/25. doi: 10.2196/jmir.2661; PMCID: 
PMC3875901. 
79. Martire LM, Schulz R, Helgeson VS, Small BJ, Saghafi EM. Review and meta-analysis of couple-
oriented interventions for chronic illness. Annals of behavioral medicine : a publication of the 
Society of Behavioral Medicine. 2010;40(3):325-42. Epub 2010/08/11. doi: 10.1007/s12160-
010-9216-2. PubMed PMID: 20697859. 
80. Franek J. Self-management support interventions for persons with chronic disease: an evidence-
based analysis. Ontario health technology assessment series. 2013;13(9):1-60. Epub 
2013/11/07. PubMed PMID: 22769228; PMCID: PMC3814807. 
81. Li Q, Loke AY. A systematic review of spousal couple-based intervention studies for couples 
coping with cancer: direction for the development of interventions. Psycho-oncology. 
2014;23(7):731-9. Epub 2014/04/12. doi:10.1002/pon.3535. PubMed PMID: 24279379. 
82. Regan TW, Lambert SD, Girgis A, Kelly B, Kayser K, Turner J. Do couple-based interventions 
make a difference for couples affected by cancer?: a systematic review. BMC cancer. 
2012;12(1):279-. doi: 10.1186/1471-2407-12-279. 
83. Deetjen U, Powell JA. Informational and emotional elements in online support groups: a 
Bayesian approach to large-scale content analysis. Journal of the American Medical 
Informatics Association : JAMIA. 2016. Epub 2016/02/26. doi: 10.1093/jamia/ocv190. 
PubMed PMID: 26541826. 

LCCC 1713 
 
CONFIDENTIAL 
PI: Lixin Song PhD 
 
UNIVERSITY OF NORTH CAROLINA 
Version/Date  May 28,2020 
 
Health Services Research September 2014 Version 
23 
84. Loiselle CG, Edgar L, Batist G, Lu J, Lauzier S. The impact of a multimedia informational 
intervention on psychosocial adjustment among individuals with newly diagnosed breast or 
prostate cancer: a feasibility study. Patient education and counseling. 2010;80(1):48-55. 
Epub 2009/10/27. doi: 10.1016/j.pec.2009.09.026. 
85. Northouse L, Schafenacker A, Barr KL, Katapodi M, Yoon H, Brittain K, Song L, Ronis DL, An L. 
A tailored Web-based psychoeducational intervention for cancer patients and their family 
caregivers. Cancer nursing. 2014;37(5):321-30. Epub 2014/06/20. doi: 
10.1097/ncc.0000000000000159; PMCID: Pmc4164300. 
86. Porter LS, Pollak KI, Farrell D, Cooper M, Arnold RM, Jeffreys AS, Tulsky JA. Development and 
implementation of an online program to improve how patients communicate emotional 
concerns to their oncology providers. Supportive care in cancer : official journal of the 
Multinational Association of Supportive Care in Cancer. 2015;23(10):2907-16. Epub 
2015/02/24. doi: 10.1007/s00520-015-2656-2; PMCID: PMC4545743. 
87. Head KJ, Noar Sm Fau - Iannarino NT, Iannarino Nt Fau - Grant Harrington N, Grant Harrington 
N. Efficacy of text messaging-based interventions for health promotion: a meta-analysis. 
Social science &amp; medicine (1982). 2013;97(1873-5347 (Electronic)):41-8. 
88. Noar SM, Benac CF, Harris MS. Does tailoring matter? Meta-analytic review of tailored print 
health behavior change interventions. Psychological Bulletin. 2007;133(0033-2909 
(Print)):673–93. 
89. Noar SM, Black HG, Pierce LB. Efficacy of computer technology-based HIV prevention 
interventions: a metaanalysis. AIDS. 2009;23(1):107-15. doi: 
10.1097/QAD.0b013e32831c5500. 
90. Lustria MLA, Noar SM, Cortese J, Van Stee SK, Glueckauf RL, Lee J. A Meta-Analysis of Web-
Delivered Tailored Health Behavior Change Interventions. Journal of health communication. 
2013;18(9):1039-69. doi: 10.1080/10810730.2013.768727. 
91. Schover LR, Canada AL, Yuan Y, Sui D, Neese L, Jenkins R, Rhodes MM. A randomized trial of 
internet-based versus traditional sexual counseling for couples after localized prostate cancer 
treatment. Cancer. 2012;118(2):500-9. Epub 2011/09/29. doi: 10.1002/cncr.26308. PubMed 
PMID: 21953578. 
92. Goode PS, Burgio KL, Johnson TM, 2nd, Clay OJ, Roth DL, Markland AD, Burkhardt JH, Issa 
MM, Lloyd LK. Behavioral therapy with or without biofeedback and pelvic floor electrical 
stimulation for persistent postprostatectomy incontinence: a randomized controlled trial. 
JAMA : the journal of the American Medical Association. 2011;305(2):151-9. doi: 
10.1001/jama.2010.1972; 10.1001/jama.2010.1972. 
93. Badger TA, Segrin C, Figueredo AJ, Harrington J, Sheppard K, Passalacqua S, Pasvogel A, 
Bishop M. Who benefits from a psychosocial counselling versus educational intervention to 
improve psychological quality of life in prostate cancer survivors? Psychology &amp; health. 
2012. Epub 2012/10/11. doi: 10.1080/08870446.2012.731058. PubMed PMID: 23045995. 
94. Digital Readiness Gaps [Internet]. Pew Research Center. 2016. Available from: 
http://www.pewinternet.org/2016/09/20/digital-readiness-gaps/. 
95. Zickuhr K, Madden M. Older Adults and Internet Use. Pew Research Center’s Internet & 
American Life Project: Pew Internet & American Life Project; 2012. 
96. Older adults and technology use [Internet]. Pew Research Center. 2014. Available from: 
http://www.pewinternet.org/2014/04/03/older-adults-and-technology-use/. 
97. Americans’ Internet Access: 2000-2015 [Internet]. Pew Research Center. 2016. Available from: 
http://www.pewinternet.org/2015/06/26/americans-internet-access-2000-2015/. 
98. Redeker NS, Anderson R, Bakken S, Corwin E, Docherty S, Dorsey SG, Heitkemper M, 
McCloskey DJ, Moore S, Pullen C, Rapkin B, Schiffman R, Waldrop-Valverde D, Grady P. 
Advancing Symptom Science Through Use of Common Data Elements. J Nurs Scholarsh. 
2015;47(5):379-88. Epub 2015/08/08. doi: 10.1111/jnu.12155. 
PubMed PMID: 26250061; PMCID: PMC4618317. 

LCCC 1713 
 
CONFIDENTIAL 
PI: Lixin Song PhD 
 
UNIVERSITY OF NORTH CAROLINA 
Version/Date  May 28,2020 
 
Health Services Research September 2014 Version 
24 
99. Song L, Northouse L, Mood D, Ronis D, Braun T, Cimprich B. Using Multilevel Modeling to 
Analyze a Longitudinal Study of Couples’ QOL and Related Factors in Prostate Cancer. 
Quality of Life Research.2011;20(3):371-81. doi: 10.1007/s11136-010-9753-y. PMCID: 
PMC3888242 
100. Song L, Northouse LL, Zhang L, Braun TM, Cimprich B, Ronis DL, Mood DW. Study of dyadic 
communication in couples managing prostate cancer: a longitudinal perspective. Psycho-
oncology. 2010;21(1):72-81. Epub 2010/10/23. doi: 10.1002/pon.1861. PubMed PMID: 
20967920. PMCID: PMC3875561 
101. Northouse LL, Song L. Cancer and caregiver issues. In: Gobel BH, Wujcik D, Yarbro CH, 
editors. Cancer nursing : principles and practice. Sudbury, Mass.: Jones and Bartlett 
Publishers; 2011. 
102. Rini C, Manne S, DuHamel K, Austin J, Ostroff J, Boulad F, Parsons SK, Martini R, Williams 
SE, Mee L, Sexson S, Redd WH. Social support from family and friends as a buffer of low 
spousal support among mothers of critically ill children: A multilevel modeling approach. 
Health Psychol. 2008;27(5):593-603. Epub 2008/10/01. 
doi: 2008-13168-011 [pii] 10.1037/0278-6133.27.5.593 [doi]. PubMed PMID: 18823186. 
103. Gallo MF, Macaluso M, Warner L, Fleenor ME, Hook EW, 3rd, Brill I, Weaver MA. Bacterial 
vaginosis, gonorrhea, and chlamydial infection among women attending a sexually 
transmitted disease clinic: a longitudinal analysis of possible causal links. Annals of 
epidemiology. 2012;22(3):213-20. Epub 2011/12/24. doi: 
10.1016/j.annepidem.2011.11.005. 
104. Symes Y, Song L, Heineman RG, Barbosa BD, Tatum K, Greene G, Weaver M, Chen RC. 
Involvement in Decision Making and Satisfaction With Treatment Among Partners of Patients 
With Newly Diagnosed Localized Prostate Cancer. Oncology nursing forum. 2015;42(6):672-
9. Epub 2015/10/22. doi: 10.1188/15.onf.672-679. PubMed PMID: 26488835. PMCID: 
PMC4856471 
105. Yeh CH, Chiang YC, Lin L, Yang CP, Chien LC, Weaver MA, Chuang HL. Clinical factors 
associated with fatigue over time in paediatric oncology patients receiving chemotherapy. 
British journal of cancer. 
2008;99(1):23-9. Epub 2008/06/26. doi: 10.1038/sj.bjc.6604434; PMCID: PMC2453020. 
106. Northouse LL, Katapodi MC, Song L, Zhang L, Mood DW. Interventions with family caregivers 
of cancer patients: meta-analysis of randomized trials. CA Cancer J Clin. 2010;60(5):317-39. 
Epub 2010/08/17. doi: 10.3322/caac.20081. PubMed PMID: 20709946; PMCID: 2946584. 
107. Northouse LL, Mood DW, Schafenacker A, Kalemkerian G, Zalupski M, Lorusso P, Hayes DF, 
Hussain M, Ruckdeschel J, Fendrick AM, Trask PC, Ronis DL, Kershaw T. Randomized 
clinical trial of a brief and extensive dyadic intervention for advanced cancer patients and 
their family caregivers. Psycho-oncology. 2012. Epub 
2012/02/01. doi: 10.1002/pon.3036. PubMed PMID: 22290823; PMCID: 3387514. 
108. Rini C, Lawsin C, Austin J, DuHamel K, Markarian Y, Burkhalter J, Labay L, Redd WH. Peer 
mentoring and survivors' stories for cancer patients: positive effects and some cautionary 
notes. Journal of clinical oncology: official journal of the American Society of Clinical 
Oncology. 2007;25(1):163-6. Epub 2006/12/30. doi: 25/1/163 [pii]10.1200/JCO.2006.08.8567 
[doi]. PubMed PMID: 17194913. 
109. Song L, Ji Y, Nielsen ME. Quality of life and health status among prostate cancer survivors and 
noncancer population controls. Urology. 2014;83(3):658-63. Epub 2014/03/04. doi: 
10.1016/j.urology.2013.12.009. PubMed PMID: 24581528; PMCID: PMC3947555. 
110. Rini C, Porter, L. S., Somers, T. J., McKee, D. C., & Keefe, F. J. . Retaining Critical Therapeutic 
Elements of Behavioral Interventions Translated For Delivery via the Internet: 
Recommendations and an Example Using Pain Coping Skills Training. Journal of Medical 
Internet Research (JMIR). 2014 16(12):e245. doi: 10.2196/jmir.3374. 

LCCC 1713 
 
CONFIDENTIAL 
PI: Lixin Song PhD 
 
UNIVERSITY OF NORTH CAROLINA 
Version/Date  May 28,2020 
 
Health Services Research September 2014 Version 
25 
111. Palmer MH, Fogarty LA, Somerfield MR, Powel LL. Incontinence after prostatectomy: coping 
with incontinence after prostate cancer surgery. Oncology nursing forum. 2003;30(2):229-38. 
Epub 2003/04/15. doi: 10.1188/03.onf.229-238. 
112. Palmer MH, Athanasopoulos A, Lee KS, Takeda M, Wyndaele JJ. Sociocultural and 
environmental influences on bladder health. International journal of clinical practice. 
2012;66(12):1132-8. Epub 2012/11/21. doi: 10.1111/ijcp.12029. PubMed PMID: 22343180. 
113. Keyserling TC, Samuel-Hodge CD, Pitts SJ, Garcia BA, Johnston LF, Gizlice Z, Miller CL, 
Braxton DF, Evenson KR, Smith JC, Davis GB, Quenum EL, Elliott NTM, Gross MD, 
Ammerman AS. A Community-Based Lifestyle and Weight Loss Intervention Promoting a 
Mediterranean-Style Diet Pattern evaluated in the Stroke Belt of North 
Carolina: the Heart Healthy Lenoir Study (To be published). 
114. Pitts SB, Vu MB, Garcia BA, McGuirt JT, Braxton D, Hengel CE, Huff JV, Keyserling TC, 
Ammerman AS. A community assessment to inform a multilevel intervention to reduce 
cardiovascular disease risk and risk 
disparities in a rural community. Fam Community Health. 2013;36(2):135-46. Epub 
2013/03/05. doi: 10.1097/FCH.0b013e31828212be. PubMed PMID: 23455684; PMCID: 
PMC4155752. 
115. Chen RC, Chang P, Vetter RJ, Lukka H, Stokes WA, Sanda MG, Watkins-Bruner D, Reeve BB, 
Sandler HM. Recommended patient-reported core set of symptoms to measure in prostate 
cancer treatment trials. Journal of the National Cancer Institute. 2014;106(7). Epub 
2014/07/10. doi: 10.1093/jnci/dju132. PubMed PMID: 25006192. 
116. De Gagne JC, Park S, So A, Wu B, Palmer MH, McConnell ES. A urinary incontinence 
continuing education online course for community health nurses in South Korea. Journal of 
continuing education in nursing. 2015;46(4):171-8. Epub 2015/04/10. doi: 10.3928/00220124-
20150320-02. 
117. Barone MA, Awori QD, Li PS, Simba RO, Weaver MA, Okech JO, Aduda AO, Cherutich P, 
Muraguri N, Wekesa JM, Nyanchoka J, Perchal P, Masson P, Lee R, Goldstein M, Kioko J, 
Lusi O, Sokal DC. Randomized trial of the Shang Ring for adult male circumcision with 
removal at one to three weeks: delayed removal leads to detachment. Journal of acquired 
immune deficiency syndromes (1999). 2012;60(3):e82-9. Epub 2012/02/22. 
doi:10.1097/QAI.0b013e31824ea1f2. PubMed PMID: 12692657. 
118. Raymond EG, Weaver MA, Louie KS, Dean G, Porsch L, Lichtenberg ES, Ali R, Arnesen M. 
Prophylactic compared with therapeutic ibuprofen analgesia in first-trimester medical 
abortion: a randomized controlled trial. Obstetrics and gynecology. 2013;122(3):558-64. Epub 
2013/08/08. doi: 10.1097/AOG.0b013e31829d5a33. PubMed PMID: 23163494. 
119. Chen R, Carpenter W, Kim M, Hendrix L, Agans R, Meyer A, Hoffmeyer A, Reeve B, Nielsen M, 
Usinger D, Strigo T, Jackman A, Anderson M, PA. G. Design of the North Carolina Prostate 
Cancer Comparative Effectiveness & Survivorship Study (NC ProCESS). J Comparat Effect 
Res. 2014;4(1):3-9. 
120. Song L, Chen RC, Bensen JT, Knafl GJ, Nielsen ME, Farnan L, Wallen EM, Mishel M, Pruthi 
RS, Mohler JL, Godley PA. Who makes the decision regarding the treatment of clinically 
localized prostate cancer--the patient or physician?: results from a population-based study. 
Cancer. 2013;119(2):421-8. Epub 2012/07/13. doi: 10.1002/cncr.27738. PMCID: N/A 
121. Song L, Bensen JT, Zimmer C, Sleath B, Blackard B, Fontham E, Su LJ, Brennan CS, Mohler 
JL, Mishel M. Patient-health care provider communication among patients with newly 
diagnosed prostate cancer: findings from a population-based survey. Patient education and 
counseling. 2013;91(1):79-84. Epub 2013/01/22. doi: 10.1016/j.pec.2012.12.002. PubMed 
PMID: 23332967. PMCID: PMC4238380. 
122. Song L, Tatum K, Greene G, Chen RC. eHealth Literacy And Partner Involvement In Treatment 
Decision-Making For Newly Diagnosed Localized Prostate Cancer. Oncology nursing forum. 
in Press. PMCID: N/A. 

LCCC 1713 
 
CONFIDENTIAL 
PI: Lixin Song PhD 
 
UNIVERSITY OF NORTH CAROLINA 
Version/Date  May 28,2020 
 
Health Services Research September 2014 Version 
26 
123. Keyserling TC, Ammerman AS, Samuel-Hodge CD, Ingram AF, Skelly AH, Elasy TA, Johnston 
LF, Cole AS, Henriquez-Roldan CF. A diabetes management program for African American 
women with type 2 diabetes. The Diabetes educator. 2000;26(5):796-805. Epub 2001/01/05. 
124. Samuel-Hodge CD, Headen SW, Skelly AH, Ingram AF, Keyserling TC, Jackson EJ, 
Ammerman AS, Elasy TA. Influences on day-to-day self-management of type 2 diabetes 
among African-American women: spirituality, the multi-caregiver role, and other social 
context factors. Diabetes care. 2000;23(7):928-33. Epub 2000/07/15. 
125. Keyserling TC, Samuel-Hodge CD, Ammerman AS, Ainsworth BE, Henriquez-Roldan CF, Elasy 
TA, Skelly AH, Johnston LF, Bangdiwala SI. A randomized trial of an intervention to improve 
self-care behaviors of African-American women with type 2 diabetes: impact on physical 
activity. Diabetes care. 2002;25(9):1576-83. Epub: 2002/08/28. PubMed PMID: 10895842. 
126. Pullen C, Noble Walker S. Midlife and older rural women's adherence to U.S. Dietary 
Guidelines across stages of change in healthy eating. Public health nursing (Boston, Mass). 
2002;19(3):170-8. Epub 2002/04/23. 
127. Samuel-Hodge CD, DeVellis RF, Ammerman A, Keyserling TC, Elasy TA. Reliability and 
validity of a measure of perceived diabetes and dietary competence in African American 
women with type 2 diabetes. The Diabetes educator. 2002;28(6):979-88. Epub 2003/01/16. 
PubMed PMID: 11967102. 
128. Samuel-Hodge CD, Fernandez LM, Henriquez-Roldan CF, Johnston LF, Keyserling TC. A 
comparison of self-reported energy intake with total energy expenditure estimated by 
accelerometer and basal metabolic rate in African-American women with type 2 diabetes. 
Diabetes care. 2004;27(3):663-9. Epub 2004/02/28. PubMed 
PMID: 12196430. 
129. Jilcott SB, Macon ML, Rosamond WD, Garcia BA, Jenkins LK, Cannon PM, Townsend CR, 
Tawney KW, Keyserling TC, Will JC, Ammerman AS. Implementing the WISEWOMAN 
program in local health departments: staff attitudes, beliefs, and perceived barriers. Journal 
of women's health (2002). 2004;13(5):598-606. Epub 
2004/07/20. doi: 10.1089/1540999041281089. PubMed PMID: 12526638. 
130. Jilcott SB, Keyserling TC, Samuel-Hodge CD, Johnston LF, Gross MD, Ammerman AS. 
Validation of a brief dietary assessment to guide counseling for cardiovascular disease risk 
reduction in an underserved population. Journal of the American Dietetic Association. 
2007;107(2):246-55. Epub 2007/01/30. doi: 10.1016/j.jada.2006.11.006. PubMed PMID: 
17258961. 
131. Keyserling TC, Samuel Hodge CD, Jilcott SB, Johnston LF, Garcia BA, Gizlice Z, Gross MD, 
Savinon CE, Bangdiwala SI, Will JC, Farris RP, Trost S, Ammerman AS. Randomized trial of 
a clinic-based, communitysupported, lifestyle intervention to improve physical activity and 
diet: the North Carolina enhanced WISEWOMAN project. Preventive medicine. 
2008;46(6):499-510. Epub 2008/04/09. doi: 10.1016/j.ypmed.2008.02.011. PubMed PMID: 
11140007. 
132. Samuel-Hodge CD, Keyserling TC, Park S, Johnston LF, Gizlice Z, Bangdiwala SI. A 
randomized trial of a church-based diabetes self-management program for African Americans 
with type 2 diabetes. The Diabetes educator. 2009;35(3):439-54. Epub 2009/04/23. doi: 
10.1177/0145721709333270. PubMed PMID: 14988282. 
133. Samuel-Hodge CD, Garcia BA, Johnston LF, Kraschnewski JL, Gustafson AA, Norwood AF, 
Glasgow RE, Gold AD, Graham JW, Evenson KR, Stearns SC, Gizlice Z, Keyserling TC. 
Rationale, design, and sample characteristics of a practical randomized trial to assess a 
weight loss intervention for low-income women: the Weight-Wise II Program. Contemporary 
clinical trials. 2012;33(1):93-103. Epub 2011/09/21. doi: 
10.1016/j.cct.2011.08.009. PubMed PMID: 21930244. 
134. Samuel-Hodge CD, Garcia BA, Johnston LF, Gizlice Z, Ni A, Cai J, Kraschnewski JL, 
Gustafson AA, Norwood AF, Glasgow RE, Gold AD, Graham JW, Evenson KR, Trost S, 

LCCC 1713 
 
CONFIDENTIAL 
PI: Lixin Song PhD 
 
UNIVERSITY OF NORTH CAROLINA 
Version/Date  May 28,2020 
 
Health Services Research September 2014 Version 
27 
Keyserling TC. Translation of a behavioral weight loss intervention for mid-life, low-income 
women in local health departments. Obesity. 2013;21(9):1764- 
73. Epub 2013/02/15. doi: 10.1002/oby.20317. PubMed PMID: 19383882. 
135. Keyserling TC, Sheridan SL, Draeger LB, Finkelstein EA, Gizlice Z, Kruger E, Johnston LF, 
Sloane PD, Samuel-Hodge C, Evenson KR, Gross MD, Donahue KE, Pignone MP, Vu MB, 
Steinbacher EA, Weiner BJ, Bangdiwala SI, Ammerman AS. A comparison of live counseling 
with a web-based lifestyle and medication intervention to 
reduce coronary heart disease risk: a randomized clinical trial. JAMA internal medicine. 
2014;174(7):1144-57. Epub 2014/05/28. doi: 10.1001/jamainternmed.2014.1984. PubMed 
PMID: 24861959; PMCID: PMC4142754. 
136. Estruch R, Ros E, Martinez-Gonzalez MA. Mediterranean diet for primary prevention of 
cardiovascular disease. The New England journal of medicine. 2013;369(7):676-7. Epub 
2013/08/16. doi: 10.1056/NEJMc1306659. PubMed PMID: 18394692. 
137. Estruch R, Salas-Salvado J. "Towards an even healthier Mediterranean diet". Nutrition, 
metabolism, and cardiovascular diseases : NMCD. 2013;23(12):1163-6. Epub 2013/11/23. 
doi: 10.1016/j.numecd.2013.09.003. PubMed PMID: 23944307. 
138. Leon AC, Davis LL, Kraemer HC. The role and interpretation of pilot studies in clinical research. 
Journal of psychiatric research. 2011;45(5):626-9. Epub 2010/11/03. doi: 
10.1016/j.jpsychires.2010.10.008; PMCID: PMC3081994. 
139. Lazarus RS, Folkman S. Stress, Appraisal, and Coping. New York: Springer Publishing 
Company; 1984. 
140. Bavelas JB, Segal L. Family systems theory: Background and implications. Journal of 
Communication.1982;32(3):99. 
141. Bowen M. Family therapy in clinical practice. New York: Jason Aronson; 1978. 
142. Fingerman KL, Bermann E. Applications of family systems theory to the study of adulthood. 
International Journal of Aging & Human Development. 2000;51:5-29. PubMed PMID: 
11130612. 
143. Galvin KM, Brommel BJ. Family communication: cohesion and change. Second ed. Glenview, 
Illinois: Scott, Foresman and Company; 1986. 
144. Badr H, Taylor CLC. Sexual dysfunction and spousal communication in couples coping with 
prostate cancer. Psycho-oncology. 2009;18(7):735-46. doi: 10.1002/pon.1449. PubMed 
PMID: 42962449. 
145. Boehmer U, Clark JA. Communication about prostate cancer between men and their wives. 
Journal of Family Practice. 2001;50:226-31. PubMed PMID: 11252211. 
146. Manne S, Badr H, Zaider T, Nelson C, Kissane D. Cancer-related communication, relationship 
intimacy, and psychological distress among couples coping with localized prostate cancer. 
Journal of cancer survivorship: research and practice. 2010;4(1):74-85. PubMed PMID: 
MEDLINE:19967408. 
147. Pfeiffer EA. short portable mental status questionnaire for the assessment of organic brain 
deficit in elderly patients. J Am Geriatr Soc. 1975;23(10):433-41. 
148. Kazer MW, Harden J, Burke M, Sanda MG, Hardy J, Bailey DE. The experiences of 
unpartnered men with prostate cancer: a qualitative analysis. Journal of cancer survivorship : 
research and practice. 2010. Epub 2010/11/30. doi: 10.1007/s11764-010-0157-3 [doi]. 
PubMed PMID: 21113818. 
149. Jacobs BL, Zhang Y, Schroeck FR, Skolarus TA, Wei JT, Montie JE, Gilbert SM, Strope SA, 
Dunn RL, Miller DC, Hollenbeck BK. Use of advanced treatment technologies among men at 
low risk of dying from prostate cancer. Jama. 2013;309(24):2587-95. Epub 2013/06/27. doi: 
10.1001/jama.2013.6882. PubMed PMID: 23800935; PMCID: PMC3857348. 
150. Kapoor DA, Zimberg SH, Ohrin LM, Underwood W, 3rd, Olsson CA. Utilization trends in 
prostate cancer therapy. The Journal of urology. 2011;186(3):860-4. Epub 2011/07/27. doi: 
10.1016/j.juro.2011.04.075. 

LCCC 1713 
 
CONFIDENTIAL 
PI: Lixin Song PhD 
 
UNIVERSITY OF NORTH CAROLINA 
Version/Date  May 28,2020 
 
Health Services Research September 2014 Version 
28 
151. Mahmood U, Levy LB, Nguyen PL, Lee AK, Kuban DA, Hoffman KE. Current Clinical 
Presentation and Treatment of Localized Prostate Cancer in the United States. The Journal 
of urology. 2014. Epub 2014/06/17. doi: 10.1016/j.juro.2014.06.017. PubMed PMID: 
24931803. 
152. Reeve BB, Stover AM, Jensen RE, Chen RC, Taylor KL, Clauser SB, Collins SP, Potosky AL. 
Impact of diagnosis and treatment of clinically localized prostate cancer on health-related 
quality of life for older Americans: a population-based study. Cancer. 2012;118(22):5679-87. 
Epub 2012/05/01. doi: 10.1002/cncr.27578. PubMed PMID: 22544633; PMCID: 
Pmc3410051. 
153. Yabroff KR, Lamont EB, Mariotto A, Warren JL, Topor M, Meekins A, Brown ML. Cost of care 
for elderly cancer patients in the United States. Journal of the National Cancer Institute. 
2009;100(9):630-41. Epub 2008/05/01. doi: 10.1093/jnci/djn103. PubMed PMID: 18445825. 
154. Rhee Y, Degenholtz Hb Fau - Lo Sasso AT, Lo Sasso At Fau - Emanuel LL, Emanuel LL. 
Estimating the quantity and economic value of family caregiving for community-dwelling older 
persons in the last year of life. J Am Geriatr Soc. 2009;57(9):1654-9. . doi: doi: 
10.1111/j.1532-5415.2009.02390.x. 
155. Harrington CB, Hansen JA, Moskowitz M, Todd BL, Feuerstein M. It's not over when it's over: 
long-term symptoms in cancer survivors--a systematic review. Int J Psychiatry Med. 
2010;40(2):163-81. Epub 2010/09/21. PubMed PMID: 20848873. 
156. Cleeland CS, Zhao F Fau - Chang VT, Chang Vt Fau - Sloan JA, Sloan Ja Fau - O'Mara AM, 
O'Mara Am Fau -Gilman PB, Gilman Pb Fau - Weiss M, Weiss M Fau - Mendoza TR, 
Mendoza Tr Fau - Lee J-W, Lee Jw Fau - Fisch MJ, Fisch MJ. The symptom burden of 
cancer: Evidence for a core set of cancer-related and treatmentrelated 
symptoms from the Eastern Cooperative Oncology Group Symptom Outcomes and Practice 
Patterns study. Cancer. 2013;119(24):4333-40. doi: D - NLM: NIHMS526642D - NLM: 
PMC3860266 OTO - NOTNLM. 
157. Kozachik SL, Bandeen-Roche K. Predictors of patterns of pain, fatigue, and insomnia during 
the first year after a cancer diagnosis in the elderly. Cancer nursing. 2008;31(5):334-44. doi: 
10.1097/01.NCC.0000305769.27227.67. 
158. van Dessel N, den Boeft M, van der Wouden JC, Kleinstauber M, Leone SS, Terluin B, Numans 
ME, van der Horst HE, van Marwijk H. Non-pharmacological interventions for somatoform 
disorders and medically unexplained physical symptoms (MUPS) in adults. The Cochrane 
database of systematic reviews. 2014;11:Cd011142. Epub 2014/11/02. doi: 
10.1002/14651858.CD011142.pub2. 
159. Mayo-Wilson E, Montgomery P. Media-delivered cognitive behavioural therapy and behavioural 
therapy (selfhelp) for anxiety disorders in adults. The Cochrane database of systematic 
reviews. 2013;9:Cd005330. Epub 2013/09/11. doi: 10.1002/14651858.CD005330.pub4. 
160. Bellg AJ, Borrelli B, Resnick B, Hecht J, Minicucci DS, Ory M, Ogedegbe G, Orwig D, Ernst D, 
Czajkowski S. Enhancing treatment fidelity in health behavior change studies: best practices 
and recommendations from the NIH Behavior Change Consortium. Health Psychol. 
2004;23(5):443-51. Epub 2004/09/16. doi: 10.1037/0278-6133.23.5.443. 
161. Halder AK, Tiro JA, Glassman B, Rakowski W, Fernandez ME, Perez CA, Vernon SW. Lessons 
learned from developing a tailored print intervention: a guide for practitioners and researchers 
new to tailoring. Health Promot Pract. 2008;9(3):281-8. Epub 2006/07/11. doi: 
10.1177/1524839906289042. 
162. Beck C, McSweeney JC, Richards KC, Roberson PK, Tsai PF, Souder E. Challenges in tailored 
intervention research. Nurs Outlook. 2010;58(2):104-10. Epub 2010/04/07. doi: 
10.1016/j.outlook.2009.10.004; PMCID: Pmc3136169. 
163. Eaton LH, Doorenbos AZ, Schmitz KL, Carpenter KM, McGregor BA. Establishing treatment 
fidelity in a webbased behavioral intervention study. Nursing research. 2011;60(6):430-5. 
Epub 2011/11/04. doi: 10.1097/NNR.0b013e31823386aa; PMCID: Pmc3235349. 

LCCC 1713 
 
CONFIDENTIAL 
PI: Lixin Song PhD 
 
UNIVERSITY OF NORTH CAROLINA 
Version/Date  May 28,2020 
 
Health Services Research September 2014 Version 
29 
164. Marcotte E. Responsive Web Design. A List Apart2010. 
165. Berkman N, DeWalt D, Pignone M, Sheridan S, Lohr K, Lux L, Sutton S, Swinson T, Bonito A. 
Literacy and Health Outcomes. Evidence Report/Technology Assessment No. 87 (Prepared 
by RTI International–University of North Carolina Evidence-based Practice Center under 
Contract No. 290-02-0016). In: Department of Health and Human Services U, editor. 
Rockville, MD: Agency for Healthcare Research and Quality; 2004. 
166. Sheridan SL, Halpern Dj Fau - Viera AJ, Viera Aj Fau - Berkman ND, Berkman Nd Fau - 
Donahue KE, Donahue Ke Fau - Crotty K, Crotty K. Interventions for individuals with low 
health literacy: a systematic review. Journal of health communication. 2011;16(6:sup3)(1087-
0415 (Electronic)):30-54. 
167. Kountz DS. Strategies for improving low health literacy. Postgrad Med. 2009;121(5):171-7. 
doi: 10.3810/pgm.2009.09.2065. 
168. Abraham C, Michie S. A taxonomy of behavior change techniques used in interventions. Health 
Psychology. 2008;273(0278-6133 (Print)):379-87. 
169. Michie S, Richardson M Fau - Johnston M, Johnston M Fau - Abraham C, Abraham C Fau - 
Francis J, Francis J Fau - Hardeman W, Hardeman W Fau - Eccles MP, Eccles Mp Fau - 
Cane J, Cane J Fau -Wood CE, Wood CE. The behavior change technique taxonomy (v1) of 
93 hierarchically clustered techniques: building an international 
consensus for the reporting of behavior change interventions. Annals of behavioral medicine : 
a publication of the Society of Behavioral Medicine. 2013;46(1)(1532-4796 (Electronic)):81-
95. 
170. Fisher EB, Ayala GX, Ibarra L, Cherrington AL, Elder JP, Tang TS, Heisler M, Safford MM, 
Simmons D. Contributions of Peer Support to Health, Health Care, and Prevention: Papers 
from Peers for Progress. ANNALS OF FAMILY MEDICINE. 2015;13(1544-1717 (Electronic)). 
doi: D - NLM: PMC4648132. EDAT- 2015/08/26 06:00 MHDA- 2015/08/26 06:00 CRDT- 
2015/08/26 06:00 PMCR- 2016/02/01 00:00 AID - 13/Suppl_1/S2 [pii] AID - 
10.1370/afm.1852 [doi] PST - ppublish. 
171. Fisher EB, Mm C, Parada H, Robinette JB, Tang PY, Urlaub DM, Castillo C, Guzman-Corrales 
LM, Hino S, Hunter J, Katz AW, Symes YR, Worley HP, Xu C. Peer support in health care 
and prevention: cultural, organizational, and dissemination issues. Annu Rev Public Health. 
2014;35:363-83. doi: 10.1146/annurevpublhealth-032013-182450. 
172. Rhodes SD, Hergenrather KC, Duncan J, Vissman AT, Miller C, Wilkin AM, Stowers J, Eng E. A 
Pilot Intervention Utilizing Internet Chat Rooms to Prevent HIV Risk Behaviors Among Men 
Who Have Sex with Men. Public Health Reports. 2010;125(Suppl 1):29-37. PubMed PMID: 
PMC2788406. 
173. Betts K. Lost in Translation: Importance of Effective Communication in Online Education. 
Journal of Distance Learning Administration. 2009;XII(II). 
174. Berry DL, Ellis WJ, Woods NF, Schwien C, Mullen KH, Yang C. Treatment decision-making by 
men with localized prostate cancer: the influence of personal factors. Urologic oncology. 
2003;21(2):93-100. Epub 2003/07/15. PubMed PMID: 12856636. 
175. Tariman JD, Berry DL, Cochrane B, Doorenbos A, Schepp K. Preferred and actual participation 
roles during health care decision making in persons with cancer: a systematic review. Ann 
Oncol. 2010;21(6):1145-51. Epub 2009/11/27. doi: mdp534 [pii]10.1093/annonc/mdp534 
[doi]. PubMed PMID: 19940010. 
176. Evans S, Metcalfe C, Ibrahim F, Persad R, Ben-Shlomo Y. Investigating Black-White 
differences in prostate cancer prognosis: A systematic review and meta-analysis. Int J 
Cancer. 2008;123(2):430-5. Epub 2008/05/03. doi: 10.1002/ijc.23500 [doi]. PubMed PMID: 
18452170. 
177. Rivers BM, August EM, Gwede CK, Hart A, Jr., Donovan KA, Pow-Sang JM, Quinn GP. 
Psychosocial issues related to sexual functioning among African-American prostate cancer 

LCCC 1713 
 
CONFIDENTIAL 
PI: Lixin Song PhD 
 
UNIVERSITY OF NORTH CAROLINA 
Version/Date  May 28,2020 
 
Health Services Research September 2014 Version 
30 
survivors and their spouses. Psychooncology. 2011;20(1):106-10. Epub 2010/02/27. doi: 
10.1002/pon.1711 [doi]. PubMed PMID: 20187071. 
178. Jenkins R, Schover LR, Fouladi RT, Warneke C, Neese L, Klein EA, Zippe C, Kupelian P. 
Sexuality and healthrelated quality of life after prostate cancer in African-American and white 
men treated for localized disease. J Sex Marital Ther. 2004;30(2):79-93. Epub 2004/01/27. 
doi: MWAJ0E571BPVRTPB [pii]. PubMed PMID: 14742098. 
179. American Cancer Society. Cancer Facts & Figures 2014. Atlanta,2014. 
180. American Cancer Society. Cancer Facts & Figures for African Americans 2009-20102009. 
181. Office of Disease Prevention and Health Promotion. National Action Plan to Improve Health 
Literacy. In: U.S. Department of Health and Human Services, editor. Washington DC2010. 
182. Institute of Medicine. Health Literacy: A Prescription to End Confusion. In: Institute of Medicine 
of National Academies CoHL, Board on Neuroscience and Behavioral Health editor. 2004. 
183. Agency for Healthcare Research and Quality (AHRQ). Health Literacy Measurement Tools 
(Revised). Rockville, MD. 2016 [cited 2016 Nov 19]. Available from: 
http://www.ahrq.gov/professionals/quality-patient-safety/qualityresources/ 
tools/literacy/index.html. 
184. Song L, Mishel M, Bensen JT, Chen RC, Knafl GJ, Blackard B, Farnan L, Fontham E, Su LJ, 
Brennan CS, Mohler JL, Godley PA. How does health literacy affect quality of life among men 
with newly diagnosed clinically localized prostate cancer? Findings from the North Carolina-
Louisiana Prostate Cancer Project (PCaP). Cancer. 2012;118(15):3842-51. Epub 
2011/12/20. doi: 10.1002/cncr.26713. PubMed PMID: 22180041. PMCID: N/A. 
185. Martin LT, Ruder T, Escarce JJ, Ghosh-Dastidar B, Sherman D, Elliott M, Bird CE, Fremont A, 
Gasper C, Culbert A, Lurie N. Developing predictive models of health literacy. Journal of 
general internal medicine. 2009;24(11):1211-6. Epub 2009/09/18. doi: 10.1007/s11606-009-
1105-7; PMCID: PMC2771237. 
186. Nagler RH, Gray SW, Romantan A, Kelly BJ, DeMichele A, Armstrong K, Schwartz JS, Hornik 
RC. Differences in information seeking among breast, prostate, and colorectal cancer 
patients: results from a population-based survey. Patient education and counseling. 2010;81 
Suppl:S54-62. Epub 2010/10/12. doi: 10.1016/j.pec.2010.09.010. PubMed PMID: 20934297; 
PMCID: 2993788. 
187. Ritterband LM, Thorndike FP. The further rise of internet interventions. Sleep. 2012;35(6):737-
8. Epub 2012/06/02. doi: 10.5665/sleep.1850; PMCID: Pmc3353057. 
188. Cella D, Tulsky D, Gray G, Sarafian B, Linn E, Bonomi A, Silberman M, Yellen S, Winicour P, 
Brannon J, Eckberg K, Lloyd S, Purl S, Blendowski C, Goodman M, Barnicle M, Stewart I, 
McHale M, Bonomi P, Kaplan E, Taylor IV S, Thomas Jr. C, Harris J. The Functional 
Assessment of Cancer Therapy scale: development and validation of the general measure. 
Journal of Clinical Oncology. 1993;11:570-9. PubMed PMID: 8445433. 
189. Esper P, Mo F, Chodak G, Sinner M, Cella D, Pienta KJ. Measuring quality of life in men with 
prostate cancer using the functional assessment of cancer therapy-prostate instrument. 
Urology. 1997;50(6):920-8. PubMed PMID: 9426724. 
190. Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic 
comorbidity in longitudinal studies: Development and validation. Journal of Chronic Diseases. 
1987;40(5):373-83. doi: http://dx.doi.org/10.1016/0021-9681(87)90171-8. 
191. Quan H, Li B, Couris CM, Fushimi K, Graham P, Hider P, Januel JM, Sundararajan V. Updating 
and validating the Charlson comorbidity index and score for risk adjustment in hospital 
discharge abstracts using data from 6 countries. Am J Epidemiol. 2011;173(6):676-82. Epub 
2011/02/19. doi: 10.1093/aje/kwq433. 
192. Amtmann D, Cook KF, Jensen MP, Chen WH, Choi S, Revicki D, Cella D, Rothrock N, Keefe F, 
Callahan L, Lai JS. Development of a PROMIS item bank to measure pain interference. Pain. 
2010;150(1):173-82. Epub 2010/06/18. doi: 10.1016/j.pain.2010.04.025; PMCID: 
PMC2916053. 

LCCC 1713 
 
CONFIDENTIAL 
PI: Lixin Song PhD 
 
UNIVERSITY OF NORTH CAROLINA 
Version/Date  May 28,2020 
 
Health Services Research September 2014 Version 
31 
193. Keller S, Mangrum R, Yang M. Executive Summary of a Report by the PROMIS® Network 
Center: The Measurement of Fatigue in Rheumatoid Arthritis: Review and Identification of 
Gaps in Evidence.pdf icon Final Report: September 30, 2014. Washington, DC: American 
Institutes for Research, 2014. 
194. Yu L, Buysse DJ, Germain A, Moul DE, Stover A, Dodds NE, Johnston KL, Pilkonis PA. 
Development of short forms from the PROMIS sleep disturbance and Sleep-Related 
Impairment item banks. Behavioral sleep medicine. 2011;10(1):6-24. Epub 2012/01/19. doi: 
10.1080/15402002.2012.636266; PMCID: PMC3261577. 
195. Wagner LI, Schink J, Bass M, Patel S, Diaz MV, Rothrock N, Pearman T, Gershon R, Penedo 
FJ, Rosen S, Cella D. Bringing PROMIS to practice: brief and precise symptom screening in 
ambulatory cancer care. Cancer. 2015;121(6):927-34. Epub 2014/11/08. doi: 
10.1002/cncr.29104; PMCID: PMC4352124. 
196. Cook KF, Jensen SE, Schalet BD, Beaumont JL, Amtmann D, Czajkowski S, Dewalt DA, Fries 
JF, Pilkonis PA, Reeve BB, Stone AA, Weinfurt KP, Cella D. PROMIS measures of pain, 
fatigue, negative affect, physical function, and social function demonstrate clinical validity 
across a range of chronic conditions. Journal of clinical epidemiology. 2016. Epub 
2016/03/10. doi: 10.1016/j.jclinepi.2015.08.038. 
197. Askew RL, Cook KF, Revicki DA, Cella D, Amtmann D. Evidence from diverse clinical 
populations supports clinical validity of PROMIS pain interference and pain behavior. Journal 
of clinical epidemiology. 2016. Epub 2016/03/05. doi: 10.1016/j.jclinepi.2015.08.035. 
198. Schalet BD, Pilkonis PA, Yu L, Dodds N, Johnston KL, Yount S, Riley W, Cella D. Clinical 
validity of PROMIS Depression, Anxiety, and Anger across diverse clinical samples. Journal 
of clinical epidemiology. 2016. Epub 2016/03/05. doi: 10.1016/j.jclinepi.2015.08.036. 
199. Spanier GL. Measuring dyadic adjustment: new scales for assessing the quality of marriage 
and similar dyads Journal of Marriage and The Family 1976;38:15-28. 
200. Spanier GB, Thompson L. A Confirmatory Analysis of the Dyadic Adjustment Scale. Journal of 
Marriage and Family. 1982;44(3):731-8. 
201. Sabourin S, Valois P, Lussier Y. Development and validation of a brief version of the dyadic 
adjustment scale with a nonparametric item analysis model. Psychol Assess. 2005;17(1):15-
27. Epub 2005/03/17. doi: 10.1037/1040-3590.17.1.15. 
202. McCubbin H, Thompson A, McCubbin MA. FILE: Family Inventory of Life Events and Changes. 
1St ed. Madison, Wisconsin: University of Wisconsin Publishers; 1996. 
203. Wei JT, Dunn RL, Litwin MS, Sandler HM, Sanda MG. Development and validation of the 
expanded prostate cancer index composite (EPIC) for comprehensive assessment of health-
related quality of life in men with prostate cancer. Urology. 2000;56(6):899-905. PubMed 
PMID: 11113727. 
204. Oberst M. Appraisal of Illness Scale: Manual for Use. Detroit MI: Wayne State University; 1991. 
205. Oberst M. Appraisal of Caregiving Scale: Manual for Use. Detroit MI: Wayne State University, 
1991. 
206. Lewis FM. Family Home Visitation Study Final Report. Bethesda, MD: National Cancer Institute, 
National Institutes of Health, 1996. 
207. PROMISE Instrumental Support Instruments [Internet]2015 [cited April 12, 2016]. Available 
from: https://www.assessmentcenter.net/documents/PROMIS Instrumental Support Scoring 
Manual.pdf. 
208. PROMISE Emotional Support Instruments [Internet]2015 [cited April 12, 2016]. Available from: 
https://www.assessmentcenter.net/documents/PROMIS Instrumental Support Scoring 
Manual.pdf. 
209. PROMISE Informational Support Instruments [Internet]2015 [cited April 12, 2016]. Available 
from: https://www.assessmentcenter.net/documents/PROMIS Instrumental Support Scoring 
Manual.pdf. 

LCCC 1713 
 
CONFIDENTIAL 
PI: Lixin Song PhD 
 
UNIVERSITY OF NORTH CAROLINA 
Version/Date  May 28,2020 
 
Health Services Research September 2014 Version 
32 
210. Sarason IGL, Henry M, Basham RB, Sarason BR. Assessing social support: The Social 
Support Questionnaire. Journal of Personality and Social Psychology. 1983;44(1):127-39. 
211. Sarason IG, Sarason BR, Shearin EN, Pierce GR. A brief measure of social support: Practical 
and theoretical implications. Journal of Social and Personal Relationships. 1987;4:497-510. 
212. Carle AC, Riley W, Hays RD, Cella D. Confirmatory Factor Analysis of the Patient Reported 
Outcomes Measurement Information System (PROMIS) Adult Domain Framework Using 
Item Response Theory Scores. Medical care. 2015;53(10):894-900. Epub 2015/09/15. doi: 
10.1097/mlr.0000000000000413; PMCID: PMC4750392. 
213. Sheridan SL, Draeger LB, Pignone MP, Sloane PD, Samuel-Hodge C, Finkelstein EA, Gizlice 
Z, Vu MB, Gitterman DP, Bangdiwala SI, Donahue KE, Evenson K, Ammerman AS, 
Keyserling TC. Designing and implementing a comparative effectiveness study of two 
strategies for delivering high quality CHD prevention: methods and participant characteristics 
for the Heart to Health study. Contemporary clinical trials. 
2013;36(2):394-405. Epub 2013/08/07. doi: 10.1016/j.cct.2013.07.013. PubMed PMID: 
23916919; PMCID: PMC4115064. 
214. Kraschnewski JL, Gold AD, Gizlice Z, Johnston LF, Garcia BA, Samuel-Hodge CD, Keyserling 
TC. Development and evaluation of a brief questionnaire to assess dietary fat quality in low-
income overweight women in the southern United States. Journal of nutrition education and 
behavior. 2013;45(4):355-61. Epub 
2013/01/24. doi: 10.1016/j.jneb.2012.10.008. PubMed PMID: 23340242. 
215. Gardiner PA, Clark BK, Healy GN, Eakin EG, Winkler EA, Owen N. Measuring older adults' 
sedentary time: reliability, validity, and responsiveness. Medicine and science in sports and 
exercise. 2011;43(11):2127-33. Epub 2011/03/31. doi: 10.1249/MSS.0b013e31821b94f7. 
PubMed PMID: 21448077. 
216. Van Cauwenberg J, Van Holle V, De Bourdeaudhuij I, Owen N, Deforche B. Older adults' 
reporting of specific sedentary behaviors: validity and reliability. BMC public health. 
2014;14:734. Epub 2014/07/22. doi: 10.1186/1471-2458-14-734. PubMed PMID: 25042423; 
PMCID: PMC4223385. 
217. Davis FD. Perceived usefulness, perceived ease of use, and user acceptance of information 
technology. MIS Q. 1989;13(3):319-40. doi: 10.2307/249008. 
218. Brooke J. SUS: a ‘‘quick and dirty’’ usability scale. . In: Jordan PW, Thomas B, Weerdmeester 
BA, AL M, editors. Usability Evaluation in Industry. London: Taylor and Francis; 1996. 
219. PROMISE Pain Interference Instrument [Internet]2015 [cited April 12, 2016]. Available from: 
https://www.assessmentcenter.net/documents/PROMIS Instrumental Support Scoring 
Manual.pdf. 
220. PROMISE Pain Intensity Instruments [Internet]2015 [cited April 12, 2016]. Available from: 
https://www.assessmentcenter.net/documents/PROMIS Instrumental Support Scoring 
Manual.pdf. 
221. PROMIS Fatigue Instruments [Internet]. PROMIS. 2015 [cited April 12, 2016]. Available from: 
https://www.assessmentcenter.net/documents/PROMIS Depression Scoring Manual.pdf. 
222. PROMISE Sleep Disturbance Instruments [Internet]2015 [cited April 12, 2016]. Available from: 
https://www.assessmentcenter.net/documents/PROMIS Instrumental Support Scoring 
Manual.pdf. 
223. PROMIS anxiety instruments [Internet]. PROMIS. 2015 [cited April 12, 2016]. Available from: 
https://www.assessmentcenter.net/documents/PROMIS Anxiety Scoring Manual.pdf. 
224. PROMIS Depression Instruments [Internet]. PROMIS. 2015 [cited April 12, 2016]. Available 
from: https://www.assessmentcenter.net/documents/PROMIS Depression Scoring 
Manual.pdf. 
225. Mellon S, Northouse LL, Weiss LK. A population-based study of the quality of life of cancer 
survivors and their family caregivers. Cancer nursing. 2006;29:120-31. PubMed PMID: 
16565621. 

LCCC 1713 
 
CONFIDENTIAL 
PI: Lixin Song PhD 
 
UNIVERSITY OF NORTH CAROLINA 
Version/Date  May 28,2020 
 
Health Services Research September 2014 Version 
33 
226. Skolarus TA, Holmes-Rovner M, Northouse LL, Fagerlin A, Garlinghouse C, Demers RY, 
Rovner DR, Darwish-Yassine M, Wei JT. Primary care perspectives on prostate cancer 
survivorship: implications for improving quality of care. Urologic oncology. 2013;31(6):727-32. 
Epub 2011/07/22. doi: 10.1016/j.urolonc.2011.06.002; PMCID: 
PMC3213312. 
227. Movsas TZ, Yechieli R, Movsas B, Darwish-Yassine M. Partner's Perspective on Long-term 
Sexual Dysfunction After Prostate Cancer Treatment. American journal of clinical oncology. 
2014. Epub 2014/04/02. doi: 10.1097/coc.0000000000000067. 
228. Northouse LL, Rosset T, Phillips L, Mood DW, Schafenacker A, Kershaw T. Research with 
families facing cancer: The challenges of accrual and retention. Research in Nursing & 
Health. 2006;29:199-211. 
229. Older Adults and Technology Use [Internet]2014. Available from: 
http://www.pewinternet.org/2014/04/03/olderadults-and-technology-use/. 
230. The Smartphone Difference 2015. Available from: http://www.pewinternet.org/2015/04/01/us-
smartphone-use-in-2015/. 
231. Technology Device Ownership: 2015 [Internet]. Pew Research Center. 2015. Available 
from:http://www.pewinternet.org/2015/10/29/technology-device-ownership-2015. 
232. Senn S. Testing for baseline balance in clinical trials. Stat Med. 1994;13(17):1715-26. Epub 
1994/09/15. 
233. Kelloway EKa. Using Mplus for structural equation modeling : a researcher's guide. Los 
Angeles: SAGE; 2015. 
234. Bollen KA. Structural Equations with Latent Variables New York: John Wiley & Sons; 1989. 514 
p. 
235. Littell RC, Milliken GA, Stroup WW, Wolfinger RD, Schabenberger O. SAS for mixed models 
[electronic resource]. Littell RC, editor. Cary, N.C.: SAS Institute, Inc.; 2006. 
236. Norman GR, Sloan JA, Wyrwich KW. Interpretation of changes in health-related quality of life: 
the remarkable universality of half a standard deviation. Medical care. 2003;41(5):582-92. 
Epub 2003/04/30. doi: 
10.1097/01.mlr.0000062554.74615.4c. 
237. (Holmes & Rahe, 1967).