Virtual Weight Loss Program for African-American Breast Cancer Survivors
Phase: NA
Conditions: Cancer Survivor, Stage IA Breast Cancer, Stage IB Breast Cancer, Stage IIA Breast Cancer, Stage IIB Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer, Stage 0 Breast Cancer
Sponsor: Rutgers, The State University of New Jersey

 
Protocol Version 8.0 – 11/5/18 
 
 
 
 
Rutgers, The State University of New Jersey 
195 Little Albany Street 
New Brunswick, NJ 08903-2681 
cinj.org 
p. 732-235-2465 
 
 
 
Virtual Weight Loss Program for African-American Breast Cancer Survivors 
 
                                                                                                                                                          
Principal Investigator: Jeanne Ferrante, M.D., M.P.H.   
Associate Professor, Department of Family Medicine and Community Health 
Rutgers-Robert Wood Johnson Medical School 
Rutgers Cancer Institute of New Jersey 
112 Paterson St., Rm 452 
New Brunswick, NJ 08901 
Telephone: (848) 932-5252: FAX: (732) 932-1451 
Email:  jeanne.ferrante@rutgers.edu 
 
Subinvestigators:  
Elisa Bandera, MD, PhD 
 
 
Katie Devine, PhD 
 
 
Pamela Ohman-Strickland, PhD 
 
 
 
 
 
 
Rutgers Cancer Institute of New Jersey  
Rutgers Cancer Institute of New Jersey  
Operations Center 
 
 
 
 
Biostatistical Center 
Office of Human Research Services  
 
Biometrics Division 
 
 
195 Little Albany Street 
 
 
 
120 Albany Street, 5th Floor 
New Brunswick, NJ 08903  
 
 
 
New Brunswick, NJ 08903 
Telephone: (732) 235-8675  
 
            Telephone: (732) 235-6791 
FAX: (732) 235-7690  
 
 
 
FAX: (732) 235-7350 
 
Supported by: National Cancer Institute, R21CA191431 
 
ClinicalTrials.gov ID: NCT02699983 
 
Drug(s) Under Investigation:  N/A 
__________________________  
 
 
 
 
 
 
CONFIDENTIAL 
This document is confidential and the property of the Rutgers Cancer Institute of New Jersey.  No part of it may be 
transmitted, reproduced, published, or used without prior written authorization from the study sponsor. 
 
 

Virtual Weight Loss Program for African-American Breast Cancer Survivors 
Jeanne Ferrante, MD, MPH 
 
Protocol Version 8.0 – 11/5/18 
 
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TABLE OF CONTENTS 
1. 
PURPOSE/SPECIFIC OBJECTIVES…………………………………………………………... 4 
2. 
BACKGROUND AND SIGNIFICANCE………………………………………………………... 4 
3. 
PARTICIPATING INSTITUTIONS…………………………………………………………….. 6 
4. 
EXPERIMENTAL DESIGN AND METHODS………………………………………………….. 6 
4.1 DURATION OF STUDY……………………………………………………………………………………………...7 
5. 
PATIENT SELECTION CRITERIA……………………………………………………………. 7 
5.1 INCLUSION CRITERIA………………………………………………………………………………………………7 
5.2 EXCLUSION CRITERIA……………………………………………………………………………………………...8 
5.3 INCLUSION OF WOMEN AND MINORITIES………………………………………………………………………….8 
5.4 PARTICIPATION OF CHILDREN……………………………………………………………………………………..8 
5.5 SOURCES OR METHODS OF RECRUITMENT………………………………………………………………………...8 
5.6 STUDY ENROLLMENT PROCEDURES……………………………………………………………………………….9 
6. 
STUDY PARAMETERS…………………………………………………………………………..9 
7. 
DATA COLLECTION AND RECORDS TO BE KEPT……………………………………….. 10 
7.1 RESEARCH CHARTS………………………………………………………………………………………………..10 
7.2 REPORTS………………………………………………………………………………………………………......10 
8. 
DATA AND SAFETY MONITORING…………………………………………………………...10 
9. 
STATISTICAL CONSIDERATIONS…………………………………………………………....10 
9.1 PRIMARY AND SECONDARY HYPOTHESES AND ENDPOINTS………………………………………………………11 
9.2 SAMPLE SIZE JUSTIFICATION……………………………………………………………………………………...11 
9.3 STATISTICAL ANALYSIS…………………………………………………………………………………………..12 
9.4 COMPLIANCE AND MISSING DATA………………………………………………………………………………..12 
10. 
HUMAN SUBJECTS……………………………………………………………………………...13 
10.1 SUBJECT POPULATION…………………………………………………………………………………………...12 
10.2 POTENTIAL RISKS………………………………………………………………………………………………..13 
10.3 CONSENT PROCEDURES………………………………………………………………………………………….14 
10.4 POTENTIAL BENEFITS……………………………………………………………………………………………14 
10.5 RISK-BENEFIT RATIO……………………………………………………………………………………………14 
10.6 GENDER AND MINORITIES……………………………………………………………………………………….15 
11. 
ECONOMIC/FINANCIAL CONSIDERATIONS………………………………………………..14 
12. 
PUBLICATION OF RESEARCH FINDINGS…………………………………………………..14 
13.     REFERENCES………………………………………………………………………………………15 

Virtual Weight Loss Program for African-American Breast Cancer Survivors 
Jeanne Ferrante, MD, MPH 
 
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LIST OF ABBREVIATIONS     
 
AA 
African-American 
BMI 
Body mass index 
CINJ 
Cancer Institute of New Jersey 
DCIS 
Ductal carcinoma in-situ 
DSMP 
Data Safety Monitoring Plan 
HbA1C 
Hemoglobin A1C 
HRQOL 
Health Related Quality of Life 
IRB 
Institutional Review Board 
PI 
Principal Investigator 
QoL 
Quality of life 
NCI 
National Cancer Institute 
NIH 
National Institutes of Health 
OHRS 
Office of Human Research Services 
OHRP 
Office of Human Research Protection 
RCT 
Randomized controlled trial 
RWJMS 
Robert Wood Johnson Medical School 
SCT 
Social Cognitive Theory 
WCHS 
Women’s Circle of Health Study 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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1. Purpose/Specific Objectives 
Our long-term goal is to help African-American (AA) breast cancer survivors maintain a healthy 
weight, thereby decreasing their morbidity and mortality and improving their quality of life (QoL). The 
purpose of this proposed study is to pilot test the use of a free commercial web-based weight loss 
program (SparkPeople) in AA breast cancer survivors. This program is congruent with constructs of 
Social Cognitive Theory (SCT). Although this extremely popular online program has been freely 
available since 2005, there are no prospective scientific evaluations of this program, particularly 
among AA populations, who are especially in need of efficient weight control interventions.  
 
1.1 Primary Objective 
Determine feasibility of using a free online commercial weight loss program (SparkPeople) in AA 
breast cancer survivors, as measured by: 
1. Accrual: % patients recruited and completing baseline assessments. 
2. Study retention: % patients completing 6 month follow-up assessment  
3. Intervention adherence and sustainability (measured at 3,6,9,12 months): 
a. Use of website- number of log-ins, time spent, and use of features such as food 
diaries, joining teams, posting on message boards (provided by SparkPeople) 
b. Use of Fitbit monitor- % patients who wore the monitor and synced data 
c. Satisfaction (e.g., ease of use of website, usefulness of content, extra training and 
support needed) and barriers to participation (e.g., lack of computer access, lack of 
skills, time, interest, etc.) 
 
Hypothesis: Using the online weight loss program will be feasible in AA breast cancer survivors 
(defined as > 75% recruitment rate and > 80% retention rate). 
 
1.2 Secondary Objective 
Collect preliminary data on effect sizes of changes in our outcomes and potential mediators 
associated with the use of the online weight loss program. Change from baseline to 3 and 6 months 
in:  
1. Weight, BMI, waist circumference (primary) 
2. Caloric intake and physical activity levels 
3. Cardiopulmonary fitness and cardiometabolic risk factors (blood pressure, lipids, HbA1C) 
4. Quality of life 
5. SCT constructs (social support, self-efficacy, outcome expectations, self-regulation) 
 
2. Background and Significance 
Approximately 70% of women diagnosed with breast cancer are overweight, and many women with 
pre- and postmenopausal breast cancer gain weight after diagnosis.1 Obesity, defined as a body 
mass index (BMI) > 30 kg/m2, is associated with later stage breast cancer diagnosis, higher breast 
cancer recurrence and death, higher prevalence of comorbid conditions (e.g., cardiovascular disease 
and diabetes), and poorer health and quality of life (QoL).2,3 The epidemic of obesity in the US 
presents a major pubic health challenge, particularly for African-American (AA) women, who have the 
highest prevalence of obesity (at 58.6%, and expected to rise to 71% by 2020).4,5  AA women are 
diagnosed at later breast cancer stage, which is partially explained by their higher obesity rates.6 
They also have the highest breast cancer mortality and shortest survival of any racial/ethnic group.7 
While it is unclear whether obesity in AA women contributes to their increased breast cancer 
mortality,8-10 abdominal obesity is associated with all-cause mortality in AA women,10 who have the 
highest prevalence of diabetes, diabetes-related complications (e.g., visual impairment and end-stage 
renal disease), hypertension, and death from diabetes and heart disease.11,12 Weight loss after breast 
cancer diagnosis may lower rates of recurrence,13 and it improves fitness, fatigue, and quality of life.14 
As little as 3%-5% loss of baseline weight can reduce risk of diabetes, hypertension, and 

Virtual Weight Loss Program for African-American Breast Cancer Survivors 
Jeanne Ferrante, MD, MPH 
 
Protocol Version 8.0 – 11/5/18 
 
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dyslipidemia.15 Therefore, weight management after cancer diagnosis and treatment in AA breast 
cancer survivors is crucial to reduce disparities in breast cancer outcomes and improve their QoL.  
 
Losing weight is extremely difficult, and physicians are poorly trained or lack time to provide 
behavioral counseling for weight loss. In fact, rates of weight counseling in primary care have 
declined, particularly in patients with obesity.16 Intensive lifestyle interventions have shown promise in 
promoting weight loss and improving lifestyle behaviors, functional status, and QoL in breast cancer 
survivors.1 To date, only 3 trials (2 RCT and 1 single-arm) have recruited significant numbers of AA 
breast cancer survivors (mean weight loss at 6 months -2.6 kg to -5.57 kg), and all of these used 
face-to-face sessions and weekly telephone counseling.17-20 However, many patients lack access, 
financial resources, or time to participate in face-to-face weight loss programs, and the intensive 
resources needed for this mode of delivery limit its practicality, reach and sustainability. Additionally, 
many patients sometimes avoid these comprehensive programs because of need for frequent face-
to-face interactions with practitioners (including dieticians) that may express weight bias (a negative 
attitude toward, belief about, or behavior against people who are overweight or obese).21,22 Studies in 
other populations have demonstrated successful weight loss outcomes with web-based programs as 
adjuncts or replacements to face-to-face or telephone-based behavioral counseling, but these 
programs use their own privately developed online sites, which limits reproducibility.23-25 Meanwhile, 
free commercial online weight loss programs have become extremely popular, due to their 
convenience, accessibility, and social support tools. For example, SparkPeople.com, with over 13 
million hits per month, features educational and motivational articles and videos, self-monitoring tools, 
incentives, and social support communities (including discussion forums, teams, challenges, and 
expert blogs), with options for daily/weekly content delivered to members’ email. We chose this 
program, which has been freely available since 2005, because it follows the new obesity guidelines 
that recommend a comprehensive lifestyle program including reduced calorie diet, increased physical 
activity, and behavioral strategies (e.g, self-monitoring of weight, diet, physical activity).15 It 
emphasizes safe weight loss, including setting reasonable weight loss goals, exercising safely, and 
receiving medical attention regularly when needed. Additionally, it offers unique opportunities for 
social support (includes encouragement, motivation, information, and shared experiences),26 a 
component that promotes weight loss,27 including the SparkTeams Breast Cancer Survivors (995 
members) and African American Newbies (7,133 members). Members in SparkPeople value its 
convenience, anonymity, and non-judgmental interactions,26 which may make this program especially 
appealing to AA breast cancer survivors, who may not share personal health information to family and 
community members.28 The SparkPeople program is congruent with constructs of social cognitive 
theory (including behavioral capability [improving knowledge and skills through articles and videos]; 
self-efficacy [with strategies to increase confidence in one’s ability to take action including goal 
setting, self-monitoring, and reinforcements]; observational learning [through watching videos and 
learning from others on message boards]; outcome expectations [anticipated outcomes of 
behavior]; and reinforcement [incentives such as SparkPoints are awarded for using the tools and 
features on the site]).29  
 
Retrospective analyses of SparkPeople found it provided accurate information30 and valuable social 
support to its members.26 More active usage of the website was associated with greater weight loss.31 
One prospective trial, in mostly white women at increased risk for breast cancer, used telephone 
coaching and training to use SparkPeople’s self-monitoring tools.32 While this trial did not have direct 
measures of the SparkPeople website use, 64% of participants found the website helpful, and in that 
group, women lost mean 5.6 kg weight (SD 3.0) at 12 weeks and increased their total activity by 70 
min/week (SD 40). This program used accelerometers to collect physical activity at baseline and 12 
weeks, but it did not monitor activity during the trial, and the accelerometers were not web-integrated. 
There are no other prospective scientific evaluations of this website, particularly in AA breast cancer 
survivors who are especially in need of efficient weight control interventions.  Thus, this study is needed, 

Virtual Weight Loss Program for African-American Breast Cancer Survivors 
Jeanne Ferrante, MD, MPH 
 
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group participants (N=35) will also receive one 30-minute session with the research assistant for 
training on how to use the SparkPeople website (described in Significance). They may request an 
additional training session if needed. They will be instructed to self-monitor their diet at least weekly 
(using SparkPeople) and physical activity levels daily (using the Fitbit Force monitor, which integrates 
with SparkPeople website).  


Virtual Weight Loss Program for African-American Breast Cancer Survivors 
Jeanne Ferrante, MD, MPH 
 
Protocol Version 8.0 – 11/5/18 
 
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The SCT-based intervention includes an active phase (3 months SparkPeople plus reminders) and a 
maintenance phase (3 months SparkPeople without reminders). Because more active usage of the 
website (at least weekly) is associated with greater weight loss, and low compliance and high attrition 
is a main limitation of web-based weight loss programs, treatment group subjects will receive weekly 
motivational reminders (via email, text, or phone, based on patient preference) for 3 months to log 
onto the web site, do their self-monitoring, and use the social support tools. After 3 months, subjects 
enter the maintenance phase without reminders. Follow-up meetings with the research assistant 
during data collection meetings will also serve as reinforcements. After 6 months, control group 
participants (N~35) will receive the SparkPeople treatment, while those in the original treatment group 
will be followed for 6 months to assess sustainability. 
 
4.1 Duration of Study 
Each participant will be on study for 12 months. We estimate two years to complete the entire study, 
from IRB approval to completion of analysis. 
 
5. Patient Selection Criteria 
Seventy AA long-term breast cancer survivors with BMI at least 25 kg/m2 will be recruited via two 
methods: (1) among participants in an on-going population-based case-control study of breast cancer 
in AA women based at Rutgers Cancer Institute of New Jersey, the Women’s Circle of Health Study 
(WCHS; Bandera, PI; IRB protocol# 2-2004-5053) and (2) via distribution of study flyers at cancer 
support group organizations and community clinics in New Jersey. Only WCHS cases agreeing to 
participate in future studies will be invited to participate in this new study and asked to signed a new 
informed consent specific for this protocol.  In WCHS, cases are identified through the New Jersey 
State Cancer Registry using rapid case ascertainment. Cases are age 21-75 years, residing in ten 
counties in NJ, able to understand and read English, with no cognitive impairments and no previous 
history of cancer other than non-melanoma skin cancer, and diagnosed with primary, histologically 
confirmed invasive breast cancer (Stage I-III) or ductal carcinoma in situ (DCIS or Stage 0).  As of 
2012, there were 289 AA invasive breast cancer cases in this study (99% Stage 0 to III), of which 221 
were obese (BMI > 30). For the community recruitment method, flyers will be mailed and emailed to 
cancer support group organizations (e.g., Sister’s Network), other community organizations (e.g., 
churches), community practices and clinics in New Jersey, and academic or other health care 
organizations (e.g., the Cancer Institute of New Jersey, Robert Wood Johnson Medical School,  New 
Jersey Medical School). Flyers will be posted at these sites both physically at their location and 
digitally on their social media platforms and/or distributed to members/patients to decide if they are 
interested in participating. Interested patients who see the study flyer in the community may directly 
contact the study team by phone or email or by mailing the cut-off portion of the flyer indicating their 
interest and contact information. A follow-up call will be placed to these interested patients. To be 
eligible, participants must have home Internet access or a smartphone.  While reaching 100% of the 
target population is not feasible, the use of smart phones and home broadband connection is 
exponentially increasing in all race/ethnic groups. According to recent PEW data, 80% of African-
Americans (AAs) use the internet, and 72% of AAs have home broadband internet connection or a 
smartphone. Internet use is relatively high even among AAs with low education (63%) or household 
income <$30,000 (75%).33 
 
5.1 Inclusion Criteria 
A patient/subject is eligible for enrollment if all of the following inclusion criteria are met: 
a. Patient is 21-75 years old 
b. Patients must have evidence of histologically confirmed breast cancer, Stage 0 (DCIS), I, 
II or III, and be at least 2 years post diagnosis. 
c. Patient is self-identified as African-American. 
d. Patient is overweight or obese (BMI > 25 kg/m2).  

Virtual Weight Loss Program for African-American Breast Cancer Survivors 
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Protocol Version 8.0 – 11/5/18 
 
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e. Patient is able to understand and read English. 
f. Patient must have home Internet or smartphone access. 
g. Patient must give informed consent for this new study. 
 
5.2 Exclusion Criteria 
A patient /subject will not be eligible for this study if any of the following exclusion criteria 
are met: 
a. Patient has a serious medical condition (e.g., stroke, liver or renal failure, congestive heart 
failure, myocardial infarction or cardiac surgery in past year, angina pectoris) that would 
compromise the safety of the patient or compromise the patient’s ability to complete the 
study, at the discretion of the investigator. 
b. Patient has serious psychiatric condition (e.g., bipolar disorder, schizophrenia or other 
psychosis, bulimia or anorexia nervosa, suicide attempt within 6 months or current active 
suicidal ideation) that would compromise the patient’s ability to complete the study, at the 
discretion of the investigator. 
c. Patient has severe disabilities limiting moderate physical activity, such as severe 
orthopedic conditions. 
d. Patient is planning major surgery within the next 6 months.  
e. Patient is taking medications or supplements for weight loss currently or within the past 3 
months. 
f. Patient has successfully lost 5% of body weight in the previous 6 months or has had 
bariatric surgery. 
g. Patient is pregnant, breastfeeding, has given birth within the last 3 months or planning 
pregnancy within the next 12 months. If participant becomes pregnant during the course of 
the study, she will be removed from further participation. 
h. Patient is anticipating leaving the area within the next 12 months.   
 
5.3 Inclusion of Women and Minorities 
This study’s target population is African-American breast cancer survivors with obesity. Patient 
participants will only include women, as breast cancer occurs predominantly in women. All of the 
women will be African-American. We are targeting African-American women because they have the 
highest prevalence of obesity, breast cancer mortality, and highest rates of obesity-related 
comorbidities of any racial/ethnic group. 
 
5.4 Participation of Children 
Children (individuals under 21) will be excluded from the proposed research as the main research 
topic to be studied (obesity in breast cancer survivors) is not relevant to children. 
 
5.5 Sources or Methods of Recruitment 
Seventy AA long-term breast cancer survivors with BMI at least 25 kg/m2 will be recruited via two 
methods: (1) among participants in an on-going population-based case-control study of breast cancer 
in AA women based at Rutgers Cancer Institute of New Jersey; and (2) via distribution of study flyers 
at cancer support group organizations (e.g., Sister’s Network), other community organizations (e.g., 
churches), community practices and clinics in New Jersey, and academic or other health care 
organizations (e.g., the Cancer Institute of New Jersey, Robert Wood Johnson Medical School,  New 
Jersey Medical School, Rutgers Cancer Institute of New Jersey at University Hospital). Only eligible 
women in the WCHS (Bandera, PI, IRB protocol# 2-2004-5053) who have expressed permission to 
be contacted for future studies will be sent an invitational letter with a brochure, informing them that 
they will receive a telephone call from research staff to confirm receipt of the letter and to further 
explain the study. Breast cancer survivors, who see the study flyer in the community, may directly 
contact the study team or mail back the cut-off portion of the flyer indicating their interest and contact 

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Jeanne Ferrante, MD, MPH 
 
Protocol Version 8.0 – 11/5/18 
 
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information. In the proposed study, we will recruit long-term early stage survivors (Stage 0 to Stage 
III) after 2 years of diagnosis, so that they have completed all primary treatment, which may cause 
side effects that affect nutritional, physical, and psychological well-being, and interfere with 
participant’s motivation and success in a weight loss intervention. All patients who are interested and 
meet eligibility requirements will be sent a medical release form and patient informed consent form. A 
research assistant will make a follow up call to review the forms with the potential subjects. 
 
5.6 Study Enrollment Procedures  
A research assistant will call the potential subjects and thoroughly explain all aspects of the research 
study, assure confidentiality, and answer any patient questions. Subjects will sign the informed 
consent and release of medical information form for us to obtain medical clearance from their 
physician to participate in the study. It is necessary to obtain informed consent by telephone prior to 
commencing any research procedures because we are obtaining medical clearance (which contains 
PHI) from the subjects’ physician prior to collecting any baseline data. They will mail the forms back 
to the research team in a pre-paid, addressed envelope. The research team will then fax the medical 
release and medical clearance form to the physician for completion. After informed consent and 
medical clearance are obtained, the subject will meet with a research assistant for baseline data 
collection and measurements (described below in Section 6). During this meeting, the research 
assistant will confirm understanding of the research study and answer any further questions. Subjects 
will also receive a Fitbit physical activity monitor, trained on its use, and instructed to perform their 
usual activity over the next week to obtain their baseline activity level. After all baseline data are 
collected, the participant will be randomized to the treatment or wait-list control group. To avoid 
selection and assignment bias, our biostatistician will develop 2 randomization schedules, one for 
each age strata, with assignment kept in separately sealed envelopes (approximately 35 subjects per 
treatment group split within strata). After completion of the baseline assessment, the research 
associate will open an envelope in designated order and assign patients. Control participants will be 
told they will get an internet treatment in 6 months, but they will not be told about SparkPeople. All 
subjects will be given a lab order for blood sample collection at Quest Laboratories unless their 
physician provided lab results that were taken within the past 12 months. Treatment group subjects 
will schedule a second meeting with the research assistant for the hands on training of SparkPeople. 
Control group participants will meet again with the research assistant at 3, 6, 9, and 12 months, for 
collection of outcome measures and completion of researcher administered surveys and interviews. 
Intervention group participants will meet with the research assistant again at 3, 6, and 12 months. At 
9 months, the intervention group participants will receive a phone call to update their contact and 
clinical information, and answer selected questions from the survey (Strategies used to lose weight 
and satisfaction and barriers with Fitbit and SparkPeople website.)    
 
6. Study Parameters/Measures 
In addition to demographic and clinical information, the following will be collected at 0, 3, 6, 9 and 12 
months from control group participants and at 0,3,6,12 months from intervention group participants: 
 
Outcome Measures  
• 
Weight (goal of at least 5% decrease within 6 months),15 height, BMI, waist circumference- 
Anthropometric measurements will be taken using the WCHS protocol and measuring 
instruments (measuring tape, Tanita® BF-684W scale), as described in detail elsewhere.34 
PRIMARY OUTCOME 
• 
Caloric intake- measured by 24-hour recall administered by research assistant using 
Sparkpeople.com tool. Goal is to have a reduced calorie diet to induce an energy deficit >500 
kcal/day.15 
• 
Physical activity levels- direct data downloads from the Fitbit server via the Fitabase research 
platform provide the research team an objective assessment of daily activity of participants. 

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Goal is for at least 150 minutes per week of moderate-high intense activity, per current 
guidelines.15, 35 
• 
Cardiopulmonary fitness- changes in cardiopulmonary fitness will be measured by the 6-min 
walk test.36 
• 
Cardiometabolic risk factors- Blood pressure will be measured following standardized 
procedures. Fasting serum lipids, glucose and HbA1C will be obtained through Quest 
Laboratory  (no more than 30 ml blood) 3 times during the year (at 0, 6, 12 months). 
• 
Quality of life- using Quality of Life in Adult Cancer Survivors Scale, which measures physical, 
psychological, social, and spiritual domains, and has good reliability (internal consistency ICC 
0.98), concurrent validity, and responsiveness to change in health status.37,38,39  
• 
Social Cognitive Theory variables- The Health Beliefs Survey measures nutrition and 
physical activity-related self-efficacy, outcome expectations, self-regulation, and social 
support. It has good reliability (cronbach’s alpha 0.72-0.96), predictive validity, and 
sensitivity to change.40,41 
 
 
Process Measures 
• 
Accrual: % patients recruited and completing baseline assessments. 
• 
Study retention: % patients completing follow-up assessments at 6-months.  
• 
Intervention adherence (at 3 and 6 months in treatment group, 9 and 12 months in control 
group) and sustainability (at 9, 12 months in treatment group) by tracking: 
1. Use of website- number of log-ins to website, time spent on site, and use of features 
such as food diaries, joining teams, posting on message boards (objective data provided 
by SparkPeople) 
2. Use of Fitbit monitor- % patients who wore the monitor and synced data 
3. Satisfaction (e.g., ease of use of website, usefulness of content, extra training and support 
needed), barriers to participation (e.g., lack of computer access, lack of skills, time, 
interest, etc.), and any use of internet tools or other strategies outside of intervention will 
be measured by semi-structured interviews. If control subjects use SparkPeople on their 
own, their activity can also be monitored. 
 
7. Data Collection and Records to be Kept  
 
 
7.1 Research Charts 
Information obtained from all subjects will include demographic, medical history, self-report 
questionnaire and recall responses, anthropometric measurements, cardiopulmonary fitness, blood 
pressure, blood measurements, physical activity data downloaded from the Fitbit server, and use of 
SparkPeople website provided by SparkPeople. All data for each participant will be identified with an 
identification number, and the key linking patient name and identification number will be kept 
password protected in a separate file. The key that links patient names with identification numbers will 
be kept only as long as specific use requires and then will be destroyed when all necessary linkages 
between data collection instruments have been accomplished.  
 
All data will be entered or scanned into a relational database on a firewall-protected Rutgers-RWJMS 
server. Rutgers-RWJMS employs Virtual Local Area Networks (VLAN) and Virtual Private Networks 
(VPN), in conjunction with Intrusion Detection Systems (IDS), encryption techniques and virus 
protection and detection controls.  Access to the server is only allowed for users with authorization 
and a user-specific password in order to log in the system.  The data kept on this server is in a folder 
with the Project name.  Access to this folder is restricted to the PI and system administrator.  Access 
by anyone else to the PI’s data folder has to be specifically authorized by the PI and executed by the 
system administrator.  All subsets of the original database that are created for analyses will be 

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created on this server. At the request of the PI, access will be granted to the research team to 
download the dataset to his/her workstation.  These workstations are connected to the Rutgers-
RWJMS server and are password protected.  As soon as analyses are completed, the results will be 
moved to the PI’s data folder on the server and removed from the workstation.  
 
7.2 Reports 
Publications and annual reports for submission to the IRB will be written by the PI, co-investigator, or 
study personnel using the data captured in the study.  
 
8. Data and Safety Monitoring 
There are no adverse events anticipated from this pilot intervention that deviate from procedures 
ordinarily encountered in daily life or during the performance of routine physical examinations. 
Lifestyle interventions with diet, exercise, and behavioral therapy are already being widely used for 
behavior change among patients. The SparkPeople website is accessed by over 13 million members 
monthly, and it has been shown to provide accurate information. All unexpected and/or serious 
adverse events occurring during the active portion of the intervention will be reported to the Rutgers 
CINJ Office of Human Research Services and the Rutgers IRB in accordance with IRB policy.   
 
All data, including scanned copies of signed consent forms, will be entered into the University 
secured server described above. Data will not contain personal identifiers. The PI and the 
biostatistician will oversee all data management. The data safety and monitoring plan will be reviewed 
and approved by the Rutgers Institutional Review Board prior to accrual of human subjects. 
 
9. Statistical Considerations 
 
9.1 Primary and Secondary Hypotheses and Endpoints 
Aim 1: Is the intervention trial feasible?  
Hypothesis: Using the online SparkPeople program will be feasible in AA breast cancer survivors 
(defined as > 75% recruitment rate and > 80% retention rate). 
Other web-based obesity interventions found a recruitment rate of 50%,42 however, we expect our 
rate to be higher as the study sample is an activated population who have already participated in a 
previous study, met eligibility criteria, and have expressed interest in future studies. 
 
AIM 2: What is the potential effect size of changes in our outcomes (at 3 and 6 months)? 
The purpose is to calculate effect sizes for a larger randomized trial, as this feasibility study is not 
powered to detect an intervention effect. However, with 35 participants per treatment arm and 
standard deviations equal to those observed in Longin et al’s 2012 on-line weight loss program 
(SD=6.3 kg),43 we have 80% power to detect an effect of intervention on weight loss such that the 
intervention arm participants’ weights decrease, on average, 4.3 kgs more than the wait list 
participants’ weight decrease.  With respect to percent weight loss from baseline (Longin et al., 
SD=5.9%), we have 80% power to detect a decrease at least 4.0% more among the intervention arm.  
With only 25 subjects, these effect sizes would become 5.0 kg and 4.7%, respectively. Longin et al.’s 
one-armed trial resulted in an average weight loss of 5.0 kg or 4.9% from baseline among obese 
participants, similar to our detectable level with only 25 subjects. In fact, we expect a dropout rate 
much closer to 18% (average attrition rates of other web-based lifestyle interventions),24 rather than 
this much higher dropout rate of 28.6 percent. Thus, we should have sufficient power to detect an 
intervention effect unless the control group sees significant weight loss. 
 
9.2 Sample Size Justification  
We plan to recruit a maximum of 70 eligible women.  If 70 women are enrolled and complete baseline 
surveys by the time 107 possible participants are approached and at least 50 of these participants 

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complete follow-up surveys, then we will declare the study feasible. We chose the sample size and 
decision rules so that the probability of declaring feasibility would be approximately 5% under 
unacceptable rates of acceptance and retention and exceed 95% under acceptable rates of 
acceptance and retention. If the true recruitment and retention rates are 57% and 60%, respectively, 
which we consider to be too low to warrant further research, then the probability of declaring 
feasibility would be 5%. If the true recruitment and retention rates are 75% and 80%, respectively, 
which we consider large enough to warrant further research, then the probability of declaring 
feasibility would be over 95% (Table 2). The planned sample size provides sufficient power to declare 
feasibility.   
 
 
Table 2.  Probability of declaring feasibility under various assumptions 
 
Feasibility 
Component 
 
Unacceptable 
Rate 
 
Acceptable 
Rate 
 
Decision rule for claiming 
feasibility per outcome 
Prob. Declare 
Feasible under 
Unacceptable Rates 
Prob. 
Declare 
Feasible 
under 
Acceptable 
Rates 
Accrual Rate 
57% 
75% 
If 70 women have completed 
baseline surveys by the 107th  
(inclusive) reached 
5% 
99% 
Retention 
Rate 
60% 
80% 
If 50/70 participants complete 
follow-up surveys at 6 months  
3% 
97% 
 
9.3 Statistical Analysis 
In order to plan for a larger randomized clinical trial, we will characterize changes in outcomes using 
standard methods (percentages, means, medians) stratified by study arm. In exploratory analyses, 
we will utilize mixed linear models to assess differences between treatment arms in changes in 
weight, caloric intake, physical activity, cardiopulmonary fitness, cardiometabolic risk factors, quality 
of life, and SCT constructs. We will also assess correlations among outcomes, examine potential 
moderators and mediators of outcomes (e.g., patient demographics, baseline BMI, QoL, SCT 
constructs), and characterize the patterns of missing data. The percent variation explained and the 
significance of potential mediators will be examined by combining effects from component regression 
models.44,45 In particular, the product of the two regression coefficients governing the mediating path 
(from intervention group to mediating variable and mediating variable to outcome) will be multiplied 
together and compared to the overall effect of intervention group. Bootstrap procedures will be 
utilized to formally test for significance of the mediating pathway. 
 
9.4 Compliance and Missing Data 
We will measure intervention adherence (at 3 and 6 months in treatment group, 9 and12 months in 
control group) and sustainability (at 9,12 months in treatment group) by tracking:  
1. Use of website (number of log-ins to website, time spent on site, and use of features such as 
food diaries, joining teams, posting on message boards (objective data provided by 
SparkPeople); 
2. Use of Fitbit monitor (% subjects who wore the monitor and synced data). 
3. Satisfaction (e.g., ease of use of website, usefulness of content, extra training and support 
needed), barriers to participation (e.g., lack of computer access, lack of skills, time, interest, 
etc.), and any use of internet tools or other strategies outside of intervention will be measured 
by semi-structured interviews. 
 
Weekly motivational messages will be sent and additional training with use of the SparkPeople site 
will be provided as needed. Information about barriers and reasons for drop out will be collected, 
making us well-positioned to comment on the support needed to maintain adherence with a free 

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commercial online program. To minimize loss to follow up, multiple contact information of participants 
(cell/home phone numbers and email addresses) as well as contact information for up to 3 close 
relatives/friends and patient’s primary care doctor and oncologist will be obtained at baseline and 
verified at follow-up time points. If participants cannot complete a follow-up visit, they will be asked to 
complete the questionnaires by phone or online. They may also be given the option to meet at their 
physician’s office to complete the anthropometric measurements. 
 
10. Human Subjects 
This human subject research meets the definition of a clinical trial, as it is a randomized controlled 
trial comparing an online program (SparkPeople) to a control group in decreasing weight among 70 
African-American breast cancer survivors with obesity. This research is not an NIH-defined Phase III 
clinical trial as the SparkPeople program with its lifestyle recommendations is already being widely 
used for weight loss and behavior change among the general public. However, this program has 
never been scientifically evaluated. 
 
10.1 Subject Population  
The proposed study subject population (N~ 70) will be recruited among participants in an on-going 
population-based case-control study of breast cancer in AA women based at Rutgers Cancer Institute 
of New Jersey, the Women’s Circle of Health Study (Bandera, PI), or recruited from the community, 
as described above under section 5. To be eligible, participants must be 21-75 years old, black race, 
overweight or obese (BMI > 25), long-term early stage breast cancer survivors (Stage 0 to Stage III) 
after 2 years of diagnosis, so that they have completed all initial therapies and have returned to their 
usual life. They must speak and understand English, and have home internet access or a 
smartphone. We will exclude individuals with serious medical (e.g., stroke, liver or renal failure, 
congestive heart failure, myocardial infarction or cardiac surgery in past year, angina pectoris) or 
psychiatric conditions (e.g., bipolar disorder, schizophrenia or other psychosis, bulimia or anorexia 
nervosa, suicide attempt within 6 months or current active suicidal ideation), and severe disabilities 
limiting moderate physical activity and basic functional exercises, such as severe orthopedic 
conditions. Other persons excluded include: those planning major surgery, taking medications or 
supplements for weight loss within the past 3 months, those who have successfully lost 5% of body 
weight in the previous 6 months or have had bariatric surgery, are pregnant, breastfeeding, given 
birth within the last 3 months or planning pregnancy within the next 2 years, or are anticipating 
leaving the area within the next 1 year.  
 
All subjects will receive a handout of their goals for weight loss, diet, and physical activity based on 
current American Heart Association recommended management of obesity guidelines. Additionally all 
subjects will receive a Fitbit activity monitor to measure their activity levels. Treatment group 
participants (N=35) will receive in-person training on use of the SparkPeople website and instructed 
to self-monitor their diet (using SparkPeople) and physical activity levels, using a Fitbit monitor, which 
integrates with the SparkPeople website. At baseline, 3, 6, 9 (control participants only) and 12 
months, all subjects will answer questions on a survey and undergo measurements of weight, % body 
fat, waist circumference, cardiopulmonary fitness, and blood pressure. The intervention group 
participants will receive a phone call at 9 months to update their contact and clinical information, and 
answer selected questions from the survey (Strategies used to lose weight and satisfaction and 
barriers with Fitbit and SparkPeople website.)  Additionally, blood will be collected at Quest 
Laboratories for lipids, glucose and hemoglobin A1C.  
 
10.2 Potential Risks 
This is a minimal risk study, which engenders little deviation from procedures ordinarily encountered 
in daily life or during the performance of routine physical or psychological examinations or tests. 
There are no test articles (investigational new drugs, devices, or biologics) to be used in this study. 

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Lifestyle interventions with diet, exercise, and behavioral therapy are already being widely used for 
behavior change among patients. The SparkPeople website is accessed by over 13 million members 
monthly, and it has been shown to provide accurate information.  
 
There may be potential risks due to exertion of exercises recommended at SparkPeople. Though 
uncommon, these include such things as shortness of breath, abnormal blood pressure responses, 
fainting, nausea/vomiting, irregularities in heartbeat, or injury. The SparkPeople program emphasizes 
safe weight loss, including setting reasonable weight loss goals, exercising safely, and receiving 
medical attention regularly when needed. In addition, all subjects will be given handouts with goals for 
exercise and instructed to proceed slowly and as tolerated, starting with mild-moderate exercise 10 
min/day with stepwise increase in time and intensity, as per recommended guidelines. Any subjects 
that experience adverse events from exercise will be advised to contact their primary care physician.  
There may also be skin discoloration, discomfort or soreness at the venipuncture site, which typically 
resolves on its own.  
 
Breach of confidentiality of participants is another potential risk. In order to ensure the protection of 
personal health information for each subject of the study, there will be no personal identifiers on any 
of the data collection instruments. Each subject will be assigned a unique subject identification 
number and this unique identifying number will serve as a link and will be secured separately. A 
master file which links the subject identification number with personal identifiers (name, date of birth, 
address, phone number) will be maintained separately in a password protected file on the University 
secured server. These data will be kept only as long as specific use requires and then will be 
destroyed when all necessary linkages between data collection instruments have been accomplished. 
The protocol poses no other physical, psychological, financial, legal or other risk to patients.  
 
10.3 Consent Procedures  
The PI will send eligible patients from the WCHS a written letter and brochure about the study, 
informing them that they will receive a telephone call from research staff to confirm receipt of the 
letter and to further explain the study. Additionally breast cancer survivors, who see the study flyer in 
the community, may directly contact the study team or mail back the cut-off portion of the flyer 
indicating their interest and contact information. All patients who are interested and meet eligibility 
requirements will be sent informed consent and medical release authorization documents by mail. 
The research assistant will follow up with a phone call to thoroughly explain all aspects of the 
research study, assure confidentiality, and answer any patient questions. The signed, informed 
consent along with the medical release authorization will be mailed back to the research team in a 
prepaid addressed envelope. The research team will then fax the medical release authorization and 
medical clearance form to the subject's physician for completion. After informed consent and medical 
clearance are obtained, the subject will meet with a research assistant for baseline data collection 
and measurements. During this first face-to-face meeting, the research assistant will confirm 
understanding of the research study and answer any further questions. Signed, informed consent will 
be obtained before obtaining any baseline data or measurements. 
 
10.4 Potential Benefits 
This intervention, if found feasible and successful, may help breast cancer survivors with obesity lose 
weight, improve cardiac risk factors and increase their quality of life. For these patients, they may 
gain greater knowledge regarding nutrition and exercise, and improved self-efficacy in following 
healthy diet and exercise recommendations. If effective, this program offers promise as a convenient 
and efficient weight loss program that can be easily and widely disseminated to other breast cancer 
survivors.  
 

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10.5 Risk-Benefit Ratio 
The minimal risk involved in this study is reasonable in relation to the anticipated benefits of the 
research. Alternatives to participating are not participating; choosing not to participate does not affect 
patients’ medical care. Results of the proposed research will inform the feasibility and preliminary 
effectiveness of a free web-based program to decrease weight in AA breast cancer survivors with 
obesity. Data from this study will be used to generate sample size estimates and refine research 
procedures for a future R01 application that will evaluate the efficacy of the SparkPeople program in 
decreasing weight among AA breast cancer survivors. Results of the study may provide important 
tools to help reduce their comorbidities, improve quality and length of survival, and decrease health 
disparities. In relation to the importance of the knowledge that reasonably may be expected to result, 
the risks to subjects are very low.  
 
 10.6 Gender and Minorities  
All participants will be female and African-American. We are targeting African-American women 
because they have the highest prevalence of obesity, breast cancer mortality, and highest rates of 
obesity-related comorbidities of any racial/ethnic group. 
 
10.7 Compensation 
Participants will be provided with a free Fitbit physical activity monitor. In addition to receiving the 
Fitbit monitoring device as incentive, all patients will receive $25 after each completed in-person visit. 
They will also be reimbursed for parking, if needed. Additionally, participants will be rewarded with 
another $10 gift card to complete blood draws at Quest labs.  
 
11. Economic/Financial Considerations 
This study is financed through a grant from the National Cancer Institute R21CA191431. 
 
12. Publication of Research Findings 
The policies and procedures of the Rutgers University legal department (see: Investigator’s 
Handbook) will govern publication of the trial.  It is expected that the results of this study will be 
submitted for publication in a timely manner following the conclusion.  The PI and all co-authors will 
review any abstract or manuscript prior to submission or use.  
 

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