Nueva Vida Intervention: Improving QOL in Latina Breast Cancer Survivors and Their Caregivers
Phase: NA
Conditions: Quality of Life, Breast Cancer
Sponsor: Georgetown University

COVER SHEET: 
 
Title of Study:  
 
Nueva Vida Intervention for Latina Breast Cancer Survivors and Caregivers 
 
NCT Number: 
NCT02222337 
 
 
Date of this document: 
12/17/12 
 
 

 
 
 
 
PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE): Graves, Kristi, Dove 
 
 
PCORI Research Plan                                                                                                                                               
 
 
 
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PCORI RESEARCH PLAN 
 
RESEARCH STRATEGY 
 
Part A: Background and Significance 
 
A. 1. Impact of the Condition on the Health of Individuals and Populations (Criterion 1) 
 
In the United States, 50.5 million people are of Hispanic/Latino origin.25 The lifetime risk for cancer among 
individuals of Latino origin is striking: 1 in 2 for men and 1 in 3 for Latino women (hereafter “Latinas”).26 With 
these rates, approximately 8.5 million Latinas will develop  cancer in their lifetime, with breast cancer as the 
most common cancer and cause of cancer death among Latinas.26 Over 17,000 Latina women are expected to 
be diagnosed with breast cancer in 2012.26 With growing numbers of Latina women diagnosed with and 
surviving breast cancer (hereafter “survivors,” which includes women from the time of diagnosis onward),27 
attention to quality of life (QOL) after diagnosis has also increased. 
 
Research evidence from our group and others and our experience as clinicians and service providers indicates 
that Latina breast cancer survivors have lower QOL compared to non-Latina survivors.2,3,28,29 The disparity in 
QOL experienced by Latinas is clinically significant in terms of depression, pain, fatigue and strained spousal 
and family relationships.1,30,31 Moreover, this symptom burden may contribute to work, financial problems and 
emotional strain among Latina survivors and their caregivers and families.32 
 
Cancer caregivers for Latina breast cancer survivors include spouses, partners, adult children, other family 
members, friends and members of their faith communities.6,10,33  Research with primarily non-Latino cancer 
caregivers indicates that they experience increased distress34 and physical symptoms9,34,35 compared to age- 
and gender-matched controls.36 Indeed, the strain of caregiving for a cancer patient can have wide reaching 
effects, including missed days at work, reduced productivity37 and impaired social functioning.38 Moreover, 
physical health outcomes of caregivers of breast cancer patients are related to the patients’ own depression 
and stress.39 Although with notable exceptions,6,10,33 few studies of cancer caregivers have explored the unique 
needs and outcomes in Latinos. Research to date has identified Mexican-American caregivers’ lack of 
confidence and self-efficacy in their ability to cope with their survivors’ illness, communication difficulties and 
concerns over management of the survivor’s distress or depression.6,10,33 We will build upon this prior research 
by including a heterogeneous Latino sample and testing an intervention developed to reflect the cultural values 
and preferences of Latino survivors and caregivers.17 Observations in the literature indicate a critical need for 
evaluation of patient-caregiver interventions to improve QOL in underserved groups like Latinos.34,40   
 
If successful, the proposed study could address several cross-cutting questions. First, study findings could 
have relevance for questions about how to best improve quality of life in other racial or ethnic minorities. For 
example, few studies describe the empirical evaluation of QOL interventions with African-American and 
Chinese-American breast cancer survivors.41,42 Likewise, results from the proposed study could suggest 
potential avenues for the design of future interventions with racial or ethnic minority caregivers or address 
questions related to how to recruit diverse breast cancer survivors into interventions when delivered in 
community settings. Second,  our study has implications for efforts to improve QOL of people with other 
chronic diseases that impact caregivers, such as diabetes ,43 heart disease44 or other types of cancer.45,46 
Specifically, future efforts could benefit from the proposed intervention’s format, topics and/or emphasis on the 
dyadic relationship between the patient and caregiver. Third, our study will provide additional information about 
the best methods to assess patient-reported outcomes in a diverse sample of mono- and bilingual Latinos. We 
propose to measure QOL outcomes using the Patient-Reported Outcomes Measurement Information System 

 
 
 
 
PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE): Graves, Kristi, Dove 
 
 
PCORI Research Plan                                                                                                                                               
 
 
 
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(PROMIS). We will administer PROMIS using a computerized-adaptive testing (CAT) delivered over the 
telephone with a trained interviewer. 
A.2. Innovation and Potential for Improvement Through Research (Criterion 2) 
A.2.1. Innovation. Our proposed research will compare an innovative patient-caregiver intervention to usual 
care among Latina breast cancer survivors and their caregivers. Importantly, our intervention was developed 
by Latina survivors and their service providers to specifically address survivor and caregiver needs. Our work 
is innovative for at least three key reasons. 
 
First, our research will be among the first to evaluate a cancer patient-caregiver intervention with an ethnically 
diverse sample. We are aware of only one published intervention study involving Latina survivors and their 
caregivers. This intervention compared health education to health education plus counseling and was delivered 
primarily to individual dyads of Mexican-American breast cancer survivors and their caregivers. Conducted by 
telephone, both intervention arms led to improvements in QOL for survivors and caregivers.6 To our knowledge, 
the proposed trial will be the only study to focus on Latinos from countries beyond Mexico. Evaluating an 
intervention with other Latino groups is important given the diversity within various Latino cultures.47 Recent 
reviews of the cancer caregiving literature indicate a striking lack of research that includes caregivers from 
diverse ethnic, socioeconomic and cultural backgrounds.34,40  Our study directly fills this gap. 
 
Second, our patient-caregiver intervention (PCI) is uniquely formatted to reflect the cultural preferences and 
values of Latina survivors and their spousal, family and friend caregivers.15,17,48  The unique format involves 
twice monthly sessions in which the survivors and caregivers arrive together, separate into small groups (e.g., 
one room with survivors, one room with caregivers), and then meet together again at the end of the session to 
share food and discussion. This format of concurrent small group sessions is derived from an award-winning 
and empirically-proven program, Mi Familia (My Family), developed by Ms. Gloria Elliott (Consultant), a breast 
cancer survivor and mental health professional, and a colleague when they worked at  La Clínica del Pueblo in 
Washington DC.49,50  Mi Familia is a program to help Latino families cope with traumatic stress based on tenets 
from Cognitive Behavioral Therapy and Social Cognitive Theory.51,52 Sessions are referred to as “workshops” 
(talleres) to reduce the cultural stigma against therapy and are viewed as a time for the family to come together 
to learn new skills and socialize with other families experiencing a similar situation. Ms. Elliott and her 
colleague then adapted Mi Familia for use with Latina breast cancer survivors and their caregivers (called the 
Cuidando/Caregiver program), referencing the work of Dr. Jacobs (Consultant).53 Caregivers of Latina cancer 
survivors and in particular, Latino men, appeared to have significant difficulties openly sharing their thoughts 
and feelings in front of survivors. The program structure provided a perfect opportunity for caregivers to 
express their concerns without the fear and worry of upsetting the Latina survivor. This format and the content–
teaching communication and coping skills–provide the caregivers with the information and techniques they 
need to best support themselves and the Latina survivor. This unique approach, developed by a Latina 
survivor based on empirical and theoretical evidence, will be formally tested for the first time as an 
intervention with ethnically and socioeconomically diverse cancer survivors and their caregivers.34,54 
 
Third, we will use an innovative approach to measure QOL outcomes through the Patient-Reported Outcomes 
Measurement Information System (PROMIS). PROMIS was initiated by the NIH in 2004 to develop 
standardized, valid, and precise measures of multiple domains for use in clinical research. Unlike traditional 
instruments, PROMIS has constructed “item banks” of a large number of items per domain that have 
undergone rigorous qualitative and quantitative testing.55,56 By using computerized-adaptive testing technology, 
items are tailored to an individual’s current level on a particular domain, resulting in lower respondent burden 
and more precision at the floor or ceiling of the trait.57 We selected PROMIS to more precisely measure 
differences and longitudinal changes in the PCI and UC groups. We will use PROMIS items that have been 
tested in Spanish.58 Use of PROMIS will allow us to compare our findings to other cancer and non-
cancer cohorts, reduce participant burden, and more precisely estimate QOL outcomes.  
 
Innovation summary. The proposed study is innovative in our inclusion of a diverse and heterogeneous 
sample of Latina survivors and caregivers, evaluation of a unique intervention and assessment of QOL using 

 
 
 
 
PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE): Graves, Kristi, Dove 
 
 
PCORI Research Plan                                                                                                                                               
 
 
 
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PROMIS. We will learn whether inclusion of a caregiver as part of a psychosocial intervention provides added-
value to the usual services available to Latina breast cancer survivors and their caregivers. 
A.2.2. Potential Improvement through Research. Based on our previous research findings, current practice 
patterns, input from diverse team perspectives, and the direct relevance our proposed intervention has for 
patients and caregivers, the proposed intervention is very likely to improve patient and caregiver outcomes.  All 
members of multidisciplinary team have provided feedback and input on the proposed research, including: 
academic researchers, breast cancer survivors, caregivers, service providers, clinicians, community-based 
leaders and patient advocates. The patient advocate group from whom we elicited feedback also indicated the 
study outcomes and our team’s community-academic partnership are very appealing to them (see Letters of 
Support). Our proposed work is a direct reflection of research priorities identified by the Institute of Medicine in 
their landmark report, “From Patient Care to Patient Survivor: Lost in Transition”59 and the National Cancer 
Institute’s monograph on “Patient-Centered Communication in Cancer Care.”30 
 
Impact of the Information to be Gained. The expected clinical benefit from the proposed study is that Latina 
survivors’ and caregivers’ QOL will be improved. We have powered the study to be able to detect a clinically-
significant difference in QOL between the PCI intervention and usual care if one exists.60 QOL and other 
patient-reported outcomes have direct links to survival and prognostic indicators.4,5,61 Likewise, improvements 
in communication between survivors and caregivers may lead to less family and caregiver strain as suggested 
by research on dyadic coping in couples facing cancer.62,63 Among non-English speaking Latinas, language 
and cultural barriers can influence treatment decision-making18,20 and adherence to guideline-consistent follow-
up care.15,26 If successful, our intervention will improve QOL and promote better communication within Latino 
families facing cancer and between a Latina survivor and her physician. We will explore whether the 
intervention also impacts adherence to guideline-concurrent follow-up care among Latina cancer survivors.  
 
If the PCI intervention does not improve QOL more than usual care, we will still have learned how to engage 
caregivers into existing support programs at community-based organizations. Regardless of the outcomes, we 
will also still learn how to administer state-of-the-art assessment for key patient-reported outcomes to a diverse 
sample of Latinos through our use of PROMIS. Finally, the organization of our community-academic 
partnership, communication strategies, and production and delivery of study products (protocols, reports, 
manuscripts) can serve as a model for other teams interested in bringing together multiple community 
organizations, stakeholder groups and academic researchers.  
 
How Study Findings Will Help Patients, Caregivers and Clinicians Make Decisions. Study findings will 
help Latina breast cancer survivors and caregivers make decisions about the best options for improving QOL 
after the family faces a breast cancer diagnosis. Group interventions such as PCI may not appeal to everyone; 
however, if a Latina survivor is facing a choice of seeking individual or group support, with or without involving 
her caregiver, then evidence from the proposed study may be useful to her decision. Likewise, caregivers who 
are uncertain about how to best support their survivor will benefit from an empirically-evaluated intervention. 
Finally, clinicians involved in the treatment and follow-up care of Latino families facing cancer will be able to 
consult scientific evidence about the types of support programs that best improve QOL and other patient-
centered outcomes. Such evidence may help some clinicians feel more confident in their referrals of women to 
support programs offered in the community.64 
 
How Study Findings Will Help Stakeholders Make Decisions that will Impact Patient-Centered 
Outcomes. Our proposed study creates a team that includes diverse perspectives and brings together four 
strong community-based organizations to partner with academic researchers. Our four community partners 
[Gilda’s Club New York City,22 Latinas Contra Cancer,24 Nueva Vida, Inc.17 and Self-Help for Women with 
Breast or Ovarian Cancer (SHARE) / LatinaSHARE]23 all offer support services to Latina breast cancer patients 
and most of them offer programs for caregivers. For three organizations, most of these services involve 
separate programs for survivors and caregivers, and few caregivers of Latina survivors participate in the 

 
 
 
 
PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE): Graves, Kristi, Dove 
 
 
PCORI Research Plan                                                                                                                                               
 
 
 
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programs. In contrast, one organization, Nueva Vida, currently offers the proposed PCI with its innovative 
format. Nueva Vida has observed specific benefits to both survivors and caregivers after participating in their 
patient-caregiver program. These observations led Nueva Vida to ask Dr. Graves (PI) to partner on the present 
submission to formally evaluate the program. Nueva Vida and the other three partners are interested in 
learning which strategies provide the most benefit to Latina survivors and their caregivers. Each day, the 
patient navigators, promotoras (health educators) and trained mental health professionals make 
recommendations to Latina survivors and their family members about different options for support. Study 
findings will provide evidence about whether inclusion of caregivers significantly improves patient-centered 
outcomes of QOL, communication and satisfaction with care. We will also explore the impact of the 
intervention on adherence to guideline-concurrent follow-up care for survivors. The evidence gained from the 
proposed study could impact the types of services offered by each of these organizations (and other 
organizations like them). If successful, study outcomes could to lead to use of an empirically-based 
intervention for the thousands of Latina survivors who receive services from our four partners.  
 
Prospects for Prompt Dissemination and Adoption of Findings into Practice. Our study team is excited 
about the potential benefits of PCI and prospects for dissemination of study findings. We have several 
strategies for dissemination of study findings that we will explore and discuss further over the course of the 
study (see Section 8, Project Plan and Time Table and the Stakeholder and Patient Engagement Plan in 
People and Places). Below we describe some of these options. 
 
First, we will disseminate study findings to study participants and to other families facing cancer who are 
served by the four partner organizations. Together, our four partners provide services and information to over 
18,000 people annually, of which over 8,000 are Latino. We will disseminate study results through each of the 
organization’s websites, newsletters and other print materials. Likewise, Gilda’s Club New York City will help 
our team share study results with other Clubhouses across the country (see Letter of Support). 
 
Second, we plan to hold an annual Community Meeting in San Jose, CA to share results with study 
participants, stakeholders, researchers and other community leaders. We have budgeted for English/Spanish 
translation and interpretation services at this Community Meeting and all planned study Team Meetings.  
 
Third, we will expand upon connections with local patient advocacy groups to disseminate study results. For 
example, the Georgetown Lombardi Breast Cancer Patient Advocacy Committee (GLBCPAC) has reviewed 
the proposed study, provided feedback and indicated support for helping to disseminate study results (see 
Letter of Support). Our Advisory Board Members also have connections and diverse perspectives we will seek, 
with representation of a medical oncologist, breast surgeon, Latina breast cancer survivor, scientifically-trained 
advocate and director of a community-agency and a caregiver to a Latina survivor.  
 
Fourth, we will be able to use the experience, connections and committee memberships of study team 
members to disseminate results to other groups. Members of our team hold committee or advisory or editorial 
board positions at a number of national organizations, including the Well Spouse Association, AARP Caregiver 
Advisory Panel, National Latina Breast Cancer Network, Cancer Today, National Breast Cancer Coalition, 
Intercultural Cancer Council, Young Survivors Coalition on Diversity, Redes En Acción, Immigrant Leadership 
Forum, American Society of Clinical Oncology Clinical Guidelines Committee, Breast Cancer Advisory Board / 
Black Women’s Health Imperative, National Coalition for Cancer Survivorship and the National Latino Hispanic 
Board of Advisors of The Lance Armstrong Foundation. We will brainstorm appropriate ways to share the study 
results with some or all of these groups during our Team Meetings and teleconferences.  
 
Fifth, we will share study findings at the biennial National Latino Cancer Summit in 2014 (and again in 2016). 
Organized by Ysabel Duron of Latinas Contra Cancer, The Summit brings together lead researchers, service 
providers, community organizations, policy makers, clinicians, promotoras, patients and advocates to discuss 
current topics related to Latinos and cancer. The Summit has drawn over 750 attendees since 2008. Team 

 
 
 
 
PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE): Graves, Kristi, Dove 
 
 
PCORI Research Plan                                                                                                                                               
 
 
 
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members from Latinas Contra Cancer and the other community-based organizations will take the lead on our 
conference submission and presentation. 
Sixth, we will work through our study team members who have connections with the Cancer Support 
Community (CSC), an international non-profit with over 50 local affiliates and 100 satellite affiliates. Gilda’s 
Club New York City is a CSC affiliate and has offered to guide our team in the best way to disseminate study 
results and discuss options for adoption of the findings into practice across the CSC network. Moreover, Dr. 
Barry Jacobs (Consultant) serves on the Cancer Caregiving Advisory Panel of the CSC and thus we expect to 
be able to share results through both internal (Dr. Jacobs) and external (affiliates) channels.  
  
Finally, we will leverage institutional resources at Georgetown University Medical Center (GUMC) to help us 
identify and efficiently use additional methods of result dissemination. For example, GUMC is part of the 
Georgetown-Howard Universities Center for Clinical and Translational Science (GHUCCTS) funded through a 
National Institutes of Health Center for Translational Science Award. GHUCCTS resources include the 
Community Engagement and Research component, which will help the study team keep the DC community 
informed about ongoing research activities and results of completed projects. Likewise, GUMC recently 
established the Center of Excellence for Health Disparities in Our Nation’s Capital (CEHD), also funded by the 
National Institutes of Health. The CEHD is part of the Georgetown Initiative to Reduce Health Disparities. Dr. 
Sheppard (Co-Investigator) is an Expert Member of this Initiative and will advise the study team on additional 
avenues of outreach, dissemination and timely methods for adoption of the intervention into practice.  
 
Preliminary Studies. Our team includes the constituencies and expertise needed to reduce disparities in QOL 
experienced by Latina cancer survivors and caregivers. Below we outline our preliminary data and experience.  
 
Interventions with Breast Cancer Survivors. We have significant experience evaluating QOL psychosocial 
interventions with cancer survivors,14,65 with a particular emphasis on interventions with Latinas.16,18 Dr. Graves 
(PI) led a study to compare an 8-week QOL intervention based on Social Cognitive Theory with expressive 
writing (F32CA97760). Dr. Nápoles (Consultant) adapted the intervention developed by Dr. Graves for use with 
Latina breast cancer survivors and is currently conducting a community-based participatory research 
randomized clinical trial (CBCR15BB-1300). Finally, Dr. Sheppard (Co-investigator) has conducted several 
interventions with breast cancer survivors. She piloted the first decision support intervention for Latinas to 
increase their self-efficacy for treatment decision-making and communication with providers.18 Data suggest 
high acceptability of the intervention and improved communication outcomes among survivors.18 Dr. Sheppard 
has also developed and tested interventions to improve patient-physician communication66 and physical 
activity and nutrition (R21CA149996) among African American breast cancer survivors. 
 
Quality of Life Outcomes in Latina Cancer Survivors. Drs. Graves, Jensen, Mandelblatt (GU), Mrs. Caicedo 
(Nueva Vida) and Ms. Jandorf (Consultant) examined the cultural and contextual factors related to QOL in 
Latina survivors. In a national cross-sectional sample, bilingual and bi-cultural staff conducted interviews with 
264 diverse Latina breast cancer survivors. Latina survivors were 1-5 years post-diagnosis and reported a 
lower mean QOL score compared to other published reports of 
non-Latina survivors (M=105; SD=19.4 on the FACT-B).67 
Culturally-based feelings of breast cancer-related stigma and 
shame were consistently related to lower overall QOL and lower 
well-being in QOL subdomains.  Social and medical contextual 
factors also were independently related to QOL; together the 
cultural and contextual factors uniquely accounted for 62% of the 
explained variance of QOL. 2 
 
Support Services for Latina Survivors and Families. Nueva 
Vida is an award-winning community-based organization that aims 
to provide support and improve QOL in Latina survivors using 
Table 1. Nueva Vida’s Partnerships with Academic 
Medical Centers 
Latina Breast Cancer Survivors’ Lived 
Experiences: Diagnosis, Treatment and Beyond 68 
Latina a Latina: Developing a Breast Cancer 
Decision Support Intervention 18 
Quality of Life among Immigrant Latina Breast 
Cancer Survivors: Realities of Culture and 
Enhancing Cancer Care 15 
Awareness of and Willingness to Participate in 
Cancer Clinical Trials among Immigrant Latinos 69 
Through the Lens of Culture: Predictors of Quality 
of Life Among Latina Breast Cancer Survivors2 

 
 
 
 
PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE): Graves, Kristi, Dove 
 
 
PCORI Research Plan                                                                                                                                               
 
 
 
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evidence-based practices (see Table 1).70 Nueva Vida provides a continuum of culturally-sensitive cancer 
support services for Latinas in Washington DC, Baltimore, MD and Richmond, VA. The only independent 
survivor-driven cancer care organization for Latinas in the area, Nueva Vida serves over 4,000 individuals and 
families, reaching countless more as a resource to regional and national healthcare partners.  
 
Guided by the topics outlined by caregiving expert Dr. Jacobs (Consultant),53 Ms. Elliott (Consultant) adapted 
the Mi Familia program to create Nueva Vida’s Cuidador (Caregiver) program for Latina families experiencing 
breast cancer.48-50 The Nueva Vida team has been offering the patient-caregiver intervention in the proposed 
format for 2 years to over 30 Latina survivor-caregiver dyads. Importantly, survivors and caregivers who attend 
Nueva Vida’s Cuidador program reported positive changes in: family life (93%), relationship with one another 
(50%), work (72%), feeling better with self (100%), being more active (93%) and their spiritual life (100%). The 
proposed work will be the first formal evaluation of Nueva Vida’s Cuidador intervention. Further, a RCT will 
allow us to test the intervention in other community settings in New York City, NY and San Jose, CA to include 
Latina survivors from multiple countries of origin (see Table 5).   
 
Psychological Interventions with Latina Immigrants. Dr. Kaltman (Co-investigator) has led several studies 
to understand and improve psychological outcomes among Latina immigrants who have experienced trauma. 
Latina immigrants in the Washington DC area report high levels of both trauma and social isolation.71 Among a 
sample of 101 Latinas, more than one third of the sample (36%) met presumptive criteria for depression, post-
traumatic stress disorder, or generalized anxiety disorder. Latina 
immigrants also reported somatic symptoms involving fatigure, 
pain and headaches.72 Based on her prior work,73 Dr. Kaltman and 
her team developed a novel mental health intervention for low-
income, trauma-exposed Latinas called Mente Sana/Cuerpo Sano 
(Healthy Mind/Healthy Body).74 A pilot test with 28 Latina 
immigrants led to reduced levels of presumptive depression and 
post-traumatic stress disorder (PTSD; Table 2). The present 
intervention builds on Dr. Kaltman’s experience providing mental 
health services to underserved Latina immigrants. 
 
Community-Based Participatory Research (CBPR). Our team has long-standing experience partnering with 
communities to conduct research. For example, Ms. Jandorf (Consultant), serves as the Project Director of the 
community-based outreach efforts at Mount Sinai School of Medicine (MSSM) including the NCI-initiated East 
Harlem Partnership of Cancer Awareness (EHPCA), the Witness Project of Harlem and Esperanza y Vida 
(EyV). The EHPCA is a coalition of hospitals, community health centers, and community agencies with the 
common goal of increasing cancer awareness and preventive care in East Harlem.75 The EHPCA acts as 
MSSM’s community advisory board and helped researchers to increase minority involvement in all aspects of 
the cancer care continuum.76-78  Two primary outreach efforts of the EHPCA are The Witness Project of Harlem 
and Esperanza y Vida (Hope and Life), which represent culturally-sensitive educational efforts that require 
strong collaboration with faith- and community-based organizations. The mission of these programs is to 
increase awareness, knowledge, screening adherence, and early detection behaviors in minority women 
(particularly African American and Latina women) to reduce the mortality and morbidity from breast and 
cervical cancer.  Results from the Esperanza y Vida project with over 120 Latinas indicated barriers to cancer 
prevention and care in the Latina community.79 This work led to existing partnerships between Ms. Jandorf, 
LatinaSHARE and Gilda’s Club New York City, two of our current community partners.  
 
The Latin American Cancer Research Coalition (LACRC; U01CA114593-05), co-led by Dr. Mandelblatt (Co-
Investigator) with involvement from Drs. Sheppard69,80-82  and Graves,2,83 aimed to improve cancer prevention 
and control outcomes among Latinas in the Washington DC area. The collaboration between Nueva Vida and 
Georgetown University Medical Center (GUMC) began as part of the LACRC, with productive results.2,15,18  
 
Table 2.  Results from Mente Sana/Cuerpo Sano Pilot 
 
Baseline 
Post-
Intervention 
 
% No longer 
meeting 
presumptive  
criteria post-
intervention 
Outcome 
Mean (SD) 
Mean (SD) 
p 
Depression 15.1 (3.5) 
7.9 (6.6) 
.001 
66.7% 
PTSD 
46.2 (11.8) 
33.0 (13.0) .001 
42.3% 

 
 
 
 
PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE): Graves, Kristi, Dove 
 
 
PCORI Research Plan                                                                                                                                               
 
 
 
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Dr. Nápoles (Consultant) currently leads the Nuevo Amanecer (New Dawn) project at the University of 
California, San Francisco, funded through the California Breast Cancer Research Program. The goal of this 
CBPR project is to culturally adapt and test a psychosocial health intervention for Latinas newly diagnosed with 
breast cancer. The original intervention for this project was developed by Dr. Graves.65 Latinas Contra Cancer 
is actively participating in Dr. Nápoles’s Nuevo Amanecer project and several Latinas Contra Cancer personnel 
are involved in that effort as trained compañeras (companion/friend). Nuevo Amanecer will be completed prior 
to study enrollment for the proposed project.  
 
Cancer Screening and Risk Awareness among Latinas. Since 1998, Dr. Warren (Co-investigator), a 
medical oncologist, has led the Celebremos la Vida (Celebration of Life) Program at Lombardi Comprehensive 
Cancer Center (LCCC) at GUMC. This clinical service program, funded by the Prevent Cancer Foundation, has 
provided breast and cervical cancer screening for over 2000 Latino women.84 In other work, Dr. Graves 
evaluated predictors of mammography among 448 Latinas at low-risk for breast cancer. The majority (81%) 
overestimated their breast cancer risk. Controlling for demographic, clinical, and perceived risk variables, only 
breast cancer knowledge predicted adherence to mammography recommendations.83 Finally, Ms. Jandorf 
(Consultant) has evaluated awareness of breast cancer risk among Latinas at increased risk for breast cancer 
based on personal and family history. This work led to the development and formative evaluation of an 
educational DVD to inform at-risk Latinas about genetic counseling for the BRCA1/2 genetic mutations.19  
 
Use of PROMIS. Drs. Jensen, Sheppard and Mandelblatt (Co-investigators) are involved in a generalizability 
study of PROMIS domains across diverse racial, ethnic, and age-specific populations of cancer survivors using 
advanced psychometric techniques (U01AR057971-01; 3U01AR057971-02S1). Dr. Jensen has supervised 
survey development and implementation.  The psychometric fundamentals behind PROMIS allow for a 
common scoring metric that is comparable across all test forms that use PROMIS items, regardless of 
administration (e.g., CAT or fixed form) and scored relative to a general U.S. population t-score metric 
(mean=50, SD=10). Of the 5,000 survivors, 1,000 will be Latino and 204 will be Latina breast cancer survivors. 
This work will allow us to easily compare the QOL outcomes in the proposed study to Latino- and non-Latino 
cancer survivors and the general population. Dr. Jensen is successfully implementing PROMIS CAT in a 
current study with a sample of patients with metastatic brain cancer. She also has experience using the 
PROMIS Assessment Center,85 which is a NIH-funded online research management tool. This software allows 
for a distinct, study-specific website URL that accommodates PROMIS items as well as other measures. 
Importantly, the software has undergone extensive testing and evaluation to determine usability.86 
 
A.3. Impact on Health Care Performance  (Criterion 3). Our proposed intervention will impact health care 
performance in three ways. First, our study findings will contribute to the evidence base of the type and format 
of interventions that most improve patient-centered outcomes of QOL among Latina survivors and their 
caregivers. Use of empirically-supported interventions by community organizations, hospitals, clinics and other 
stakeholder groups can lead to efficiencies in care that yield improved outcomes. For example, if our study is 
successful, additional counselors or mental health providers could be trained to deliver the PCI intervention 
and both survivors and caregivers will benefit. We expect that PCI will also yield improvements in 
communication. Better communication between survivors and their healthcare providers can improve the 
survivors’ experience in treatment decision making. For example, predominantly Spanish-language Latinas 
reported greater dissatisfaction with their treatment-decision making process than other survivors.87 Language 
or cultural barriers between Latina survivors and their physicians also appear to contribute to treatment delays, 
receipt of different types of treatment88 and possibly adherence to guideline-concurrent follow-up care.15,26 
Among breast cancer survivors, both younger age and greater mammography-related anxiety were associated 
with lower rates of surveillance mammography.89 Notably, Latina survivors are often younger at the time of 
diagnosis26 and may experience fears that impact on-going mammography.15 If successful, our study will 
provide evidence for an intervention to reduce existing QOL disparities in Latinas and improve 
survivor-provider communication that can impact health care.  
 

 
 
 
 
PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE): Graves, Kristi, Dove 
 
 
PCORI Research Plan                                                                                                                                               
 
 
 
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Part B: Relevance to Patients (Criterion 4) 
The proposed study has direct relevance to patients and their caregivers in response to two key questions in 
PCORI’s definition of patient-centered outcomes research. First, our study will provide information related to 
the question, “Given my personal characteristics, conditions and preferences, what should I expect will 
happen to me?” Latina survivors will have the option to participate in a program that is expected to increase 
their QOL, improve their communication with their provider and with their caregiver, and improve their 
satisfaction with their cancer care. The PCI intervention will be delivered by trained, bilingual and bicultural 
interventionists. PCI was developed by Latina survivors and mental health professionals to provide culturally-
competent care that respects Latino values and traditions. Caregivers will be able to expect a program that is 
also developed for their own needs and concerns.  
 
Second, our study is designed to help Latina breast cancer survivors, caregivers and their clinical service 
providers make decisions about the type and format of support services. We will be able to provide direct 
evidence in response to the question, “What can I do to improve the outcomes that are most important to 
me?” We anticipate that PCI will be superior to usual care in terms of the patient-centered outcomes of QOL, 
communication and satisfaction with cancer care. Directed by the needs of patients, caregivers, providers, 
national guidelines and research agencies, we aim to reduce disparities in QOL outcomes among Latina 
survivors and caregivers by comparing a linguistically- and culturally-appropriate intervention to usual care.   
 
Part C: Approach (Rigorous Research Methods) (Criterion 5) 
 
C.1. Study Design. Research Question. The proposed study is designed to answer the question, “Does an 
enhanced intervention improve QOL, communication, and satisfaction with care more than usual care 
among Latina breast cancer patients and their caregivers?” We propose to answer this question by 
focusing on strategies that align with the above patient-centered research questions. Specifically, Latina 
survivors, caregivers and providers may not be aware that different options exist to help teach them strategies 
to improve QOL, improve communication with caregivers and health-care providers, and enhance coping with 
the physical and emotional consequences of breast cancer diagnosis, treatment and follow-up care.11  
 
Choice of Comparators. We will compare a patient-caregiver intervention (PCI) to usual care. We elected to 
compare PCI to usual care for several reasons. First, PCI is an intervention developed by and for Latina 
survivors. It is being successfully used at Nueva Vida, a community organization that provides care and 
support to Latinas with breast cancer in the Washington, DC metropolitan area (see Appendix A for sample 
materials). Second, no other organizations or clinics are currently using the PCI intervention. Third, no 
research to date has evaluated a patient and caregiver intervention in an ethnically diverse sample of cancer 
survivors and caregivers.34 Fourth, our comparator of usual care is reasonable given that the other community 
organizations involved all provide support programs, navigation and educational initiatives for Latina 
survivors.22-24 If PCI performs better than usual care at improving key patient-centered outcomes, then 
community organizations and other stakeholder groups can adopt PCI into practice. We will carefully monitor 
adherence to both PCI and attendance at any services available through usual care. We will include both 
intent-to-treat and “per protocol” analyses to investigate the impact of session attendance on study outcomes 
(see Analytic Methods). Below we describe the intervention and usual care.  
 
Refinement of Intervention Materials. We will refine the PCI intervention protocols/manuals based on in-
depth interviews with 10 Latina survivors-caregiver dyads (see Appendix B). The interviews will allow us to 
refine the intervention for Latinas from different geographic regions (DC, NY or CA) and from different 
countries of origin (see Table 5). PCI is based on our current materials (Appendix A), experience,16-18,53,65,90,91 
formative work and our conceptual models.12,14,62 Team and advisory board members will provide further input 
on ways to refine PCI, reflecting perspectives from patients, caregivers, providers (clinical and counseling 
psychology, medical oncology, breast surgery, internal medicine, social work), researchers (health services, 
public health, disparities) and stakeholders (patient advocates, community partners).  

 
 
 
 
PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE): Graves, Kristi, Dove 
 
 
PCORI Research Plan                                                                                                                                               
 
 
 
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Figure 1.  Flow for Phase II RCT of PCI vs. UC   
Separate Baseline Telephone Interviews 
with Survivor and Caregiver 
Randomization 
Decliners 
Patient-Caregiver 
Intervention (PCI)  
Usual Care (UC)  
 
Separate Follow up Telephone Interviews with 
Survivors and Caregivers: Immediately Post 
Intervention and 6 Months Post-Intervention   
Reasons 
for 
Declining 
Recruitment 
 
Patient-Caregiver Intervention (PCI).  The PCI intervention will be modeled on the current Cuidador program 
at Nueva Vida. In in-depth interviews, we will elicit participants’ feedback on the existing session topics and 
format (see Table 3; Appendix B). The psychosocial format of PCI is as follows: at the beginning of each new 
intervention group, the trained interventionists will introduce themselves to the overall group of survivors and 
caregivers, explaining that the purpose is to come together and learn new skills and ways of talking with each 
other. The facilitators will indicate that at each session, the survivors and caregivers will go into different rooms 
to discuss the same topic–a format that will allow them each to express their thoughts and feelings without 
inhibitions or concerns over how  their survivor or their caregiver might respond. The specific eight topics for 
each wave of PCI participants will be determined from the larger list of possible topics. This approach has been 
used successfully in the current Cuidador program and reflects strategies to engage and involve participants in  
the intervention.92 We will track topics selected by each group to 
determine if survivors in different geographic regions opt for different 
topics. The separate survivor and caregiver groups will come back 
together at the end of each session for refreshments, socializing and a 
brief discussion of the day’s topic. Sharing of food and gathering 
together at the end of each session is important to personalismo (sense 
of connection) among Latinos. The PCI intervention will last 8 sessions, 
with sessions held twice a month for 4 months. Each session will be 2 
hours in duration. The timing of the intervention was determined based 
on Nueva Vida’s experience working with Latina survivors and their 
families. Weekly sessions are too frequent and attendance is lower 
(Personal Communication September 19, 2012, Claudia Campos, 
Nueva Vida Cuidador facilitator), while monthly sessions can lose 
continuity. The content will be delivered by the trained interventionists. 
An example of the communication session content is in Appendix A. 
The intervention will involve behavioral strategies (goal-setting, self-
monitoring, 
role-playing, 
skills-practice, 
feedback, 
homework); 
communication strategies (expression of feelings, monitoring of responses, modeling effective communication 
skills), emotional management (cognitive restructuring, recognition of negative thoughts, interdependence of 
emotional responses) and stress management (relaxation techniques, engaging in pleasant activities together). 
 
Usual Care (UC). UC will involve any current support 
services offered by the partnering community organizations 
including but not limited to patient navigation, support groups 
(held separately for survivors and caregivers), educational 
workshops, social activities, and family-based activities (e.g., 
Gilda’s Club New York City has facilitated family programs, see 
Letter of Support). Importantly, the UC services are also 
delivered with respect to survivors’ and caregivers’ needs, 
preferences, language and cultural values. Caregivers within 
the dyads randomized to UC will not necessarily attend any 
support services unless they choose to do so on their own. Of 
note, caregivers assigned by chance to UC will complete 
assessments at the same time points as their survivor. We will 
time the assessments for survivors and caregivers in UC to 
correspond to the assessment time points of those assigned to 
PCI (baseline, immediately post-intervention; 6-months post 
intervention). Survivors or caregivers interested in attending the 
combined patient-caregiver intervention will be given the option 
Table 3. Current Patient-Caregiver 
Intervention (PCI) Topics 
1. Impact of Cancer in the Family 
2. Stress Management 
3. Anger Management 
4. Improving Communication: Family, 
Friends, Providers 
5. Intimacy after Cancer: Emotional and 
Sexual 
6. Spirituality and Cancer 
7. Balancing Emotional and Physical 
Needs 
8. Role Changes 
9. End of Life Issues (Putting our Lives in 
Order) 
10. Understanding Distress 
11. Including Others in Helping Caregivers 
12. Side Effects from Cancer Treatment 

 
 
 
 
PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE): Graves, Kristi, Dove 
 
 
PCORI Research Plan                                                                                                                                               
 
 
 
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Figure 2. Dyadic 
Contextual Model 
12,62 
Proposed Mediators 
 
 
 
Improved Communication  
Self-Efficacy 
 
 
Improved Social Support 
 
 
Decreased Distress 
 
 
Primary Outcome: 
Quality of Life 
at 6-months  
 
Secondary Outcomes: 
Communication; 
Satisfaction with Care 
Aim 2 
Aim 1 
Aim 3 
  Patient-Caregiver Intervention (PCI) 
                    Culture 
 
 
Caregiver 
 
Latina 
survivor 
to do so after the final assessment at 6-months.  
 
Choice of Study Design. We propose a randomized controlled trial (RCT) comparing a patient-caregiver 
intervention (PCI) to usual care (UC). Participants will be 100 Latina breast cancer survivors and 100 
caregivers (N=200; 100 dyads). Survivors will be eligible regardless of time since diagnosis or stage of breast 
cancer. Caregivers will be a primary support person identified by the survivor. We will recruit Latina breast 
cancer survivors and their primary caregivers from our four partner organizations (Gilda’s Club New York City, 
Latinas Contra Cancer, LatinaSHARE and Nueva Vida). We will use a mixed-methods approach in two 
research phases. First, we will complete individual qualitative interviews with 10 patient-caregiver dyads (n=4 
dyads from NY, n=4 from CA, and n=2 dyads from Washington DC) to refine the intervention. This refinement 
will allow for any adjustments needed due to differences in the Latino populations of the different geographic 
regions and/or countries-of-origin. The intervention will be further revised following the team feedback at our 
initial meeting and during initial conference calls. Next, we will conduct a RCT to compare PCI to UC with QOL 
measured by PROMIS as the primary outcome (see Figure 1). After a baseline telephone interview completed 
separately by the survivor and her identified caregiver, Latina and survivor dyads will be randomized to PCI or 
UC. PCI participants (both the survivor and the caregiver) will attend eight 2-hour intervention sessions held 
twice a month at one of the four partner organizations. Intervention sessions (described as workshops or 
talleres) will be led by experienced interventionists who have attended a 2-day in-person training. Training all 
interventionists together will enhance fidelity93 (see Appendix C). Each PCI session will begin with the survivor 
and caregiver going into different rooms to form separate small groups of Latina survivors and small groups of 
caregivers. Caregiver groups will involve both men (e.g., spouses, partners, friends) and women (e.g., sisters, 
adult daughters, friends). Nueva Vida has successfully led mixed-sex caregiver groups for 2 years. At the end 
of each session, the survivor and caregiver groups will come together to share food and conversation.  
 
Conceptual Model. In addition to the empirical evidence of the key role of culture in health and psychosocial 
outcomes among Latina survivors and their family members,3,6,11,12 our proposed work is guided by two 
conceptual models. First, our work is influenced by the Contextual Model of Health-Related QOL.12 This model 
specifies individual (e.g., disease characteristics) cultural (familismo, personalismo, social support, 
acculturation) and contextual influences (dyadic relationships, communication with physicians, satisfaction with 
care) as important determinants of QOL. The dyadic component of our model is derived from Berg and 
Upchurch;62 dyadic communication, perceived stress and communication reciprocally influence outcomes for 
both the patient and their partner or caregiver (Figure 2). Our proposed work is also in direct response to 
identified needs of Latina survivors, observations by a community organization that provides direct service and 
support to Latina survivors and recent calls in the cancer and caregiving literatures to involve family and 
incorporate cultural beliefs and values into interventions for cancer survivors and their caregivers.34,40  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE): Graves, Kristi, Dove 
 
 
PCORI Research Plan                                                                                                                                               
 
 
 
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Second, our intervention strategy is informed by Social Cognitive Theory.13 A key construct in Social Cognitive 
Theory is self-efficacy, or one’s confidence in his or her ability to engage in specific behaviors. The intervention 
is designed to increase self-efficacy in communication between a survivor and her caregiver. The intervention 
is also designed to alleviate distress in terms of normalizing 
the experiences of or difficulties with coping  as a survivor or 
caregiver, providing support, giving positive feedback and 
modeling acceptance.51 Distress is changed through 
cognitive restructuring.52 We hypothesize that changes in 
QOL will be due to improved communication self-efficacy, 
improved social support and decreased distress in PCI vs. 
UC participants.  
 
Choice of Outcomes. We selected outcomes that are 
patient-centered, clinically meaningful and relevant to 
stakeholder 
decision-makers. 
Foremost, 
our 
primary 
outcome variable is QOL, an outcome valuable to Latina 
survivors,15 caregivers,34 clinicians, service-providers and 
stakeholders (see Letters of Support). Secondary outcomes 
include communication (survivor-caregiver and survivor-
provider), satisfaction with cancer care and adherence to 
guideline concurrent follow-up care. Most of the instruments 
we will use are validated in Spanish. For scales not 
previously translated/tested in Spanish, we will follow 
procedures of Dr. Nápoles, who has expertise in the 
translation and cultural adaptation of survey instruments. 
Missing data will be minimized as trained, bilingual and 
bicultural research personnel will administer assessments by 
telephone. Of note, study assessments will be completed by 
GUMC research personnel not associated with the delivery 
of the intervention. We will make every effort to blind the 
assessor to the participants’ randomization assignment.  
Background Factors. (a) Sociodemographics include sex, age, marital and insurance status, race, 
education, income. (b) Medical history includes history of co-morbidities in both the survivor and the caregiver. 
We will also assess whether participants (survivor or caregiver) have provided care to another ill person.  
Cultural Factors. (a) Breast cancer stigma will be measured using eight 5-point Likert scale items 
from the stigma subscale of the Body Image after Breast Cancer Questionnaire.94 We have translated this 
subscale into Spanish (α=0.83).2 (b) We will measure religious coping with the Religious Coping Scale.95 (c) 
Familismo will be assessed with the 5-item Familism Scale.96 Items are rated on a 10-point Likert scale and 
capture concepts such as family support and familial interconnectedness. (d) Acculturation will be measured 
with the Short-Acculturation Scale97 including language use, media preferences and ethnic social relations 
(α=.90).2   
Medical-Contextual Factors. (a) (b) Medical mistrust will be measured by the validated 12-item scale 
by Thompson and co-authored by Jandorf.78  Mediators.  (a) Communication self-efficacy will be measured 
with the communication subscale of the Cancer Behavior Inventory (CBI).98 The CBI is a valid and reliable 
scale and has been translated into Spanish. We have also developed a 5-item dyadic communication self-
efficacy scale (see Appendix D). (b) Caregiver self-efficacy will be assessed with the 21-item Caregiver 
Table 4. Study Measures 
Base-
line 
T1 
T2 
Background Factors 
Sociodemographics 
Medical History 
 
X 
X 
 
 
X 
 
 
X 
Cultural Factors 
Breast Cancer Stigma 
Religious Coping, Familismo 
Acculturation 
 
X 
X 
X 
 
X 
X 
X 
 
X 
X 
X 
Medical-Contextual Factors 
Communication with Providers 
Medical Mistrust 
 
X 
X 
 
X 
X 
 
X 
X 
Mediating Variables 
Communication Self-efficacy 
Social Support 
Distress 
 
X 
X 
X 
 
X 
X 
X 
 
X 
X 
X 
Outcome Measure 
QOL (Using PROMIS) 
 
X 
 
X 
 
X 
Secondary Outcomes 
Communication (Provider) 
Communication (Caregiver) 
Satisfaction with Care 
Adherence to Guideline- 
     Concurrent Care 
 
X 
X 
X 
X 
 
X 
X 
X 
X 
 
X 
X 
X 
X 
 
Dyadic Factors 
Dyadic Support  
Dyadic Perspective  
Social Constraints  
 
X 
X 
X 
 
X 
X 
X 
 
X 
X 
X 
Process Variables 
Intervention Satisfaction 
Fidelity Measures 
 
 
 
 
X 
X 
 
X 
X 
T1 = Immediately Post Intervention; T2 = 6-Months Post 
Intervention Completion 

 
 
 
 
PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE): Graves, Kristi, Dove 
 
 
PCORI Research Plan                                                                                                                                               
 
 
 
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Inventory.99 This scale has been validated in Spanish. (c) Social support will be measured with the 8-item 
Duke-UNC Functional Social Support Questionnaire,100 which we have administered in Spanish with good 
reliability (α=0.87).2 (d) Distress will be measured with the 12-item Brief Symptom Inventory.101  
Outcome Variable. QOL will be measured with PROMIS (see Appendix D for sample items).  PROMIS 
was initiated to develop standardized, valid, and precise measures of QOL for use in clinical research using 
modern measurement theory (item response theory).57 Compared to traditional measures developed based on 
classical test theory (e.g., the SF-36), PROMIS item banks administered using CAT provide a more precise 
measure of QOL in both the floor and ceiling of the measure.102-105  Thus, chronically ill patients with severely 
limited functioning are asked appropriate questions (e.g., are you able to get in and out of bed?) while young 
healthy patients are asked different items (e.g., are you able to run or jog for 1 mile?).  Because all items come 
from the same PROMIS item bank, scores from different PROMIS measures that contain different items are 
able to be compared or combined together.  For each QOL domain, PROMIS measures have been validated 
against existing QOL instruments used in the field, and PROMIS has either equivalent or more precise 
measurement of a person’s level of QOL depending on where the person is located on the continuum.105  The 
PROMIS domains we will use to assess QOL are: Global Health: Summary scores of physical, mental, general 
health; Physical Health: physical function; Mental Health (individual domains): anxiety, depression, anger. 
Social Health: satisfaction with social activities, social role, sexual function and illness impact measures (e.g., 
days of missed work). The number of items on each domain varies with CAT. Short-forms for each domain 
range from 4 to 20 items. PROMIS item banks for these domains have been extensively developed and 
tested55,57 and have shown high reliability and validity in the general U.S. population and cancer-specific 
groups.106  Differences of 0.3 to 0.5 standard deviation units or greater indicate clinical significance.60,107   
Secondary Outcomes. (a) Communication with Providers will be measured with a validated 15-item 
measure.108 Participants rate providers from poor to excellent with a sample item as “Treated me with respect.” 
Communication with caregivers will be measured through several dyadic-based measures. (b) Satisfaction 
with care will be measured with 3 reliable items used by Dr. Nápoles in her prior work.  109  Finally, (c) 
Adherence to guideline-concurrent follow-up care will be based on following care guidelines of the 
American Society of Clinical Oncology 110 and measured using self-report items as done in prior work. 111  
Dyadic Factors. (a) Dyadic support will be measured with the 5-item scale by Northouse112,113 which 
assesses the perceived support received by each member of the patient-caregiver dyad. (b) Dyadic 
perspective, meaning considering another’s point of view about a specific topic like breast cancer, will be 
assessed with a modified version of the Thinking Beyond Oneself scale.114 This scale has been used in dyadic 
cancer control research.63 (c) Social constraints will be measured with the 5-item Social Constraints 
Scale.115,116 We have used a Spanish translation of this scale and obtained good internal consistency.2  
Process Variables. (a) Satisfaction. We will assess satisfaction with PCI and UC. (b) Intervention 
fidelity. We will measure adherence to intervention protocols, participants’ engagement (attendance, 
participation), exposure to intervention content, quality of intervention delivery and differentiation between PCI 
and UC arms.117,118 Staff will complete session contact logs and evaluation forms.118  
 
C.2. Analytic Methods 
 
Study Population. Inclusion/Exclusion Criteria. Latina breast cancer survivors will be eligible for this study if 
they: 1) self-identify as Latina, 2) speak English or Spanish and 3) can identify at least one primary, adult 
caregiver. Caregivers of Latina breast cancer survivors will be eligible if they are aged 21 to 80 years old and 
speak English or Spanish. Caregivers can be any adult identified by the survivor as providing care (e.g., 
spouse, adult child, friend). If a survivor has more than one primary caregiver, only one will be recruited to 
participate. We will recruit participants from our four sites. Area hospitals (St. Luke’s Hospital; Doctors 
Community Hospital) with diverse Latino populations will refer eligible participants. Exclusion criteria are (a) 
inability to understand spoken English and/or Spanish or (b) cognitive impairment that precludes informed 
consent (determined by the PIs or Co-Investigators who are mental health professionals). We expect the 
survivors who enroll in the study to be similar to the survivors who are eligible for services across the four 

 
 
 
 
PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE): Graves, Kristi, Dove 
 
 
PCORI Research Plan                                                                                                                                               
 
 
 
14
community partner sites As such, we anticipate that our findings will be generalizable to the 8,000+ Latino 
families who receive care/support through our community partners.   
Anticipated Accrual. Our four sites collectively see about 300 newly diagnosed Latina breast cancer survivors 
each 
year 
(Table 
5). 
From 
our 
prior 
recruitment 
efforts 
of 
Latinas, 
we 
conservatively estimate a minimum of 40% 
per year (n=125) will be eligible for the present 
study.   
Ascertainment and Enrollment: Interviews. 
Eligible Latina survivors and caregivers will be 
recruited from our four sites or referred by a 
collaborating hospital or clinic. Contacts at 
each site will help identify eligible Latina 
survivors and will mail a study flyer inviting 
them and a primary caregiver to be involved in 
an in-depth interview. We will also use in-
person recruitment to talk with survivors and 
caregivers at the four sites (e.g., at the time of 
patient navigation). If a survivor and/or 
caregiver is interested, a team member will 
follow up with further information about the 
study to determine eligibility and obtain 
consent from both individuals in the dyad.   
Ascertainment, Enrollment and Retention: 
RCT. With over 2 years of enrollment into the 
RCT, we anticipate a total of 750 Latina 
survivor-caregiver dyads identified at the four 
sites with a minimum of 300 eligible dyads. We will establish procedures to identify eligible women by having 
the Project Director/Project Manager (PD/PM) at each site develop an eligibility checklist for their use. The PD 
at GUMC will coordinate this process across sites to ensure consistency. The PD/PM will check in weekly with 
the PD at GUMC to provide names of women who provided permission for the team to contact them. We will 
recruit caregivers through Latina survivors, a strategy that has been very successful at Nueva Vida. We will 
enroll 125 dyads. We have retained over 80% of Latina survivors in prior work.25 We thus expect to retain 100 
survivor-caregiver dyads at 6-months. We will discuss strategies to promote retention through teleconferences 
and annual meetings. We will customize strategies to each site.  
Interventionist Training. Our team has experience conducting interventionist training for psychosocial 
interventions with breast cancer patients65 and specifically Latina breast cancer patients.16,18 Building on these 
skills, investigators will conduct a 2-day in-person training for the PCI interventionists. Training will involve a 
study overview and in-depth discussion of the intervention manual, topics for each session, therapeutic 
approaches and talking points to use during each session. Interventionist training will occur in person (DC and 
CA interventionists will travel to New York). We will have refresher interventionist training at our annual 
meetings to prevent drift.93 We will also review intervention fidelity logs during weekly team teleconferences. 
Study investigators and consultants have trained interventionists from diverse backgrounds.16,18,66,76  
 
Implementation. Baseline Interview. After study enrollment and consent, we will call survivor and caregiver 
participants to schedule separate 30-minute baseline telephone interviews. If we have not received signed 
consent documents at that time, we will describe the study again and answer questions. If the participant 
agrees, we will obtain verbal consent to conduct the interview. Participants will not be randomized until after 
baseline completion by each member of the dyad. Interviews will be conducted by a trained research assistant 
Table 5. 
Estimated Number of 
People Served. 
Nueva 
Vida, Inc. 
 Latinas 
Contra 
Cancer 
SHARE/ 
Latina 
Share 
Gilda’s 
Club 
NYC 
Totals 
Annual # of cancer 
survivors or family 
members serveda 
4,000 
1,000 
6,000 
7,300 
18,300 
Annual # of Latino 
survivors or family 
members serveda  
4,000 
1,000 
2,000 
1,200 
8,200 
Annual # Latina breast 
cancer survivors served 
230 
70 
215 
300 
815 
Annual # newly 
diagnosed Latina breast 
cancer survivors 
70 
50 
80 
100 
300 
Estimated Distribution of 
Countries-of-Origin 
among Latinos served 
DC Site 
CA 
Site 
 
NY  
Sites 
Estimated 
Study 
Distribution 
% South American 
27% 
10% 
11% 
14% 
% Central Americanb 
57% 
1% 
5% 
18% 
%Dominican Republic 
1% 
1% 
15% 
8% 
% Puerto Rican 
1% 
8% 
21% 
12% 
% Caribbean / Other 
6% 
7% 
9% 
8% 
% Mexican 
6% 
68% 
27% 
32% 
% United States 
2% 
5% 
11% 
8% 
aThrough in-person, print or online support or educational programs.  
bCentral American other than Mexican 

 
 
 
 
PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE): Graves, Kristi, Dove 
 
 
PCORI Research Plan                                                                                                                                               
 
 
 
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at GUMC using internet-based secure data entry screens through the PROMIS Assessment Center. The 
Assessment Center provides support services to investigator-initiated surveys and use of PROMIS domains 
85,86 delivered through computerized-adaptive testing. Guided by our conceptual model12 (see Figure 2) we will 
assess background factors, cultural factors, medical-contextual factors, mediating variables, QOL outcomes, 
secondary outcomes and dyadic factors (see Table 4; Appendix D). We have experience with similar 
interviews. We will minimize interviewer bias with: 1) intensive training (e.g., mock interviews, standardized 
Q&A), 2) on-going interview monitoring by the PD, and 3) interview completion before randomization. 
Participants will receive a $10 gift card. 
Randomization. After the baseline, we will randomize participants to PCI or UC via computer by the 
method of permuted blocks with blocks of size four.  We will stratify randomization by location (DC, NY, CA). 
The GUMC PD will help guide each site PD/PM on accessing/using the web-based randomization database. 
Randomization is expected to balance key demographic factors such as age, time since diagnosis and 
survivors’ stage of disease between the PCI and UC arms. We will carefully examine these factors in analyses 
and control any variables as appropriate.  
RCT Implementation. Following randomization, survivor-caregiver dyads will begin either the PCI or 
proceed with UC. PCI sessions will be held at one of the four community partner sites and led by the trained 
bilingual and bi-cultural interventionists. Interventionists will work with the PD in DC to track intervention 
delivery process measures and participant attendance. We will use rolling recruitment and begin new groups 
as we enroll participants. Groups will consist of approximately 10 survivor-caregiver dyads each (n=20 in each 
PCI wave; n=10 in each PI wave). Groups will be closed such that newly enrolled participants will wait to begin 
a group until ~10 new dyads are identified.  
Post-intervention and 6-month Follow-Up Interviews.  Follow-up interviews assess QOL, secondary 
outcomes, proposed mediating variables (communication self-efficacy, social support, distress), cultural, 
contextual and dyadic factors (Table 4). We also will assess intervention process.  Follow-up interviews will be 
25 minutes and administered by telephone and conducted by the bilingual RA using internet-based data entry 
screens through the PROMIS Assessment Center. Participants will receive $10 for each completed interview.   
 
Data Analyses. Aim 1. To evaluate the impact of the PCI intervention on Latina survivors’ and caregivers’ 
QOL. H1: Survivors and caregivers in PCI will report higher QOL compared to those assigned to UC. Aim 1 
analyses will be performed separately for the Latina survivors and carriers. With 50 Latina survivors (and 
caregivers) per arm we will have 84% power to detect a clinically significant difference in QOL of 6 points (0.6 
SD on PROMIS QOL measures) at a significance level of 0.05. Changes of PROMIS of 5 points or more are 
clinically significant.60 We will use a mixed effects model to compare the two arms with respect to QOL 
immediately post intervention and at 6-months, adjusting for statistically significant (at the 0.10 level) predictors 
of QOL identified in bivariate analyses. In addition to this intent-to-treat analysis, we will perform a “per protocol” 
comparison of intervention completers vs. non-completers (defined as attending fewer than five sessions).  We 
will use a mixed effects model to compare these groups on QOL immediately post intervention and at 6-
months, controlling for potential confounders associated with both intervention completion and QOL in bivariate 
analyses. As we expect the sample of Latina survivors and their caregivers in the present study to be 
representative of the over 8,000 individuals who seek services or information from the community 
organizations involved in the study, our findings should generalize to thousands of Latina women in the 
Washington DC, New York City and San Jose, CA areas. For the survivors we will also explore whether 
geographic region (DC, NY or CA), nationality (U.S. born vs. immigrant) or region of origin (e.g., Central 
America, South American) modifies the effect of the intervention on QOL. We will also explore whether 
caregiver gender impacts the effect of the intervention on QOL.  
 
Aim 2. To identify mediators of the PCI intervention on QOL. H2: Consistent with our experience and  
theoretical models, changes in QOL will be due to improved communication self-efficacy, improved social 
support and decreased distress among PCI participants vs. UC participants. Aim 2 analyses will be performed 
separately for the Latina survivors and caregivers. We will use the product of coefficients method to assess 

 
 
 
 
PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE): Graves, Kristi, Dove 
 
 
PCORI Research Plan                                                                                                                                               
 
 
 
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mediation effects at 6-months.119  We will use linear regression models to estimate the coefficients relating 
each mediating variable (self-efficacy, social support, and distress) to QOL at 6-months, and also the 
coefficients relating the intervention to each mediating variable. We will calculate the mediated effects as the 
products of corresponding coefficients and we will construct 95% confidence intervals according to the 
methods described by MacKinnon et al.119 With 50 subjects per arm we will have 80% power to detect 
mediation effects of moderate size (with coefficient parameters of 0.39 or more) for each mediator.119 
Aim 3. To evaluate the impact of the PCI intervention on Latina survivors’ satisfaction with their cancer 
care.  H3: Survivors in PCI will report greater satisfaction with their cancer care compared to UC participants. 
With 50 Latina survivors per arm we will have 96% power to detect a clinically significant difference in 
satisfaction with care of 8 points (0.75 SD given estimated SD of 12)120 at a significance level of 0.05. We will 
use a mixed effects model to compare the two arms with respect to satisfaction with care immediately post 
intervention and at 6-months, adjusting for statistically significant (at the 0.10 level) predictors of satisfaction 
with care identified in bivariate analyses. We will again explore whether the effect of the intervention on 
satisfaction with care is different for sub-groups of participants (e.g., whether the impact of PCI on satisfaction 
with care differs by geographic region (e.g., NY,CA) or region of origin (e.g., Central America, South American).  
Exploratory Aim: To explore the impact of the PCI intervention on Latina survivors’ adherence to 
guideline-concurrent care and surveillance. Given the exploratory nature of this aim no formal power 
calculation was performed.  We will use logistic regression models to compare the two arms with respect to the 
binary outcomes of adherence to guideline-concurrent care (hormonal therapy; chemotherapy) and 
surveillance (mammogram within 12 months), controlling for the statistically significant (at the 0.05 level) 
covariates identified in bivariate analyses. We will also perform “per protocol” analyses of completers vs. non-
completers similar to those described in Aim 1. 
 
Avoidance of Bias: Study Limitations and Strengths. The proposed study has the following limitations: 1) 
Representation of only three geographic regions (New York, CA and Washington DC); this concern is mitigated 
by the diversity of the Latino populations at these sites. 2) Issues of mixed gender caregiver groups. We will 
explore caregiver gender as a covariate in our analyses. 3) Self-report of follow-up medical care. We will use 
established and validated measures from national surveys. 4) Use of incentives to enhance session 
attendance. We opted to include modest incentives to indicate our appreciation of participant’s involvement in 
this research endeavor. Strengths include: 1) Test of an innovative, culturally-relevant intervention, 2) Inclusion 
of diverse and predominantly immigrant and monolingual Latino sample, 3) Involvement of a multi-disciplinary 
team through strong community-academic partnerships, 4) Use of PROMIS to measure QOL, 5) Attention to 
the reduction of bias through a) on-site interventionist training, b) different personnel to conduct intervention 
delivery and outcome assessment, c) efforts to blind outcome assessors to study assignment, d) use of 
strategies to promote intervention fidelity (see Appendix C), and e) prior and on-going engagement of patients, 
caregivers and key stakeholders in the development of the study questions, outcomes and implementation.  
 
Part D: Inclusiveness of Different Populations (Criterion 6). Our study includes a diverse population of 
Latina breast cancer survivors and their caregivers. Survivors are eligible regardless of their stage of breast 
cancer, the amount of time since their diagnosis, treatment received, or prior use of support services. We 
elected to include survivors ages 18 and older years old as breast cancer is not diagnosed in women under 
age 18. Caregivers can be of any race, ethnicity, or gender. We anticipate that most caregivers will be of 
Latino/a ethnicity. Caregivers also need to be over age 18 as the needs and experiences of younger caregivers 
likely differ from that of adult caregivers. We elected to focus the intervention on Latina survivors and 
caregivers for several reasons. First, our community partners all serve Latina women diagnosed with breast 
cancer and all have reported the need for the proposed intervention that aims to improve QOL for both 
survivors and caregivers. Second, breast cancer is the most common cancer diagnosed in Latina women. 
Third, Latina survivors are underrepresented in research on interventions to improve quality of life. Fourth, 
caregivers of any race or ethnicity are underrepresented in intervention research that focuses on QOL and 
uses our unique approach of concurrent yet separately held groups. Importantly, we expect that our findings 
will be relevant to cancer survivors from other racial and ethnic backgrounds. We also expect that our findings 

 
 
 
 
PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE): Graves, Kristi, Dove 
 
 
PCORI Research Plan                                                                                                                                               
 
 
 
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will generalize to the over 8,000 Latino families served by our partner organizations. Our team has overcome 
barriers to recruiting caregivers into Cuidador program at Nueva Vida, by encouraging the survivors to invite 
their caregivers themselves. The intervention sessions will be described as workshops or talleres. This 
approach has been extremely successful. In addition, the delivery of the intervention in known community-
based organizations reduces the sense of mistrust.18 Study interventionists will be bi-lingual and bi-cultural, 
further reducing barriers to participation.  

 
 
 
 
PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE): Graves, Kristi, Dove 
 
 
PCORI Research Plan                                                                                                                                               
 
 
 
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REPLICATION AND REPRODUCIBILITY OF RESEARCH AND DATA SHARING PLAN  
 
Replication of Research Findings 
Our team will prepare a complete and final study protocol within the first 12 months of the study. This protocol 
will include descriptions of the: 
 
1. Study population, including expected demographics (age, ethnicity, country of origin, gender, stage of 
disease, time since diagnosis). We will clearly define study eligibility and exclusion criteria.  
2. Primary and secondary hypotheses to be tested. We anticipate the overall study aims and hypotheses 
will remain the same, although we are open to feedback and revisions based on our initial team 
meeting.  
3. Sources and methods of measuring intervention and usual care exposure. We will describe how we will 
track intervention attendance and uptake of services through usual care. Study team members will use 
a central study database so that participant tracking is consistent across study sites.  
4. Outcomes and co-variates to be tested. We have developed a draft of our baseline assessment 
measure that includes most (although not all) items we propose to measure, including our primary 
outcome of QOL. We will provide the study survey in print form and/or provide access to the PROMIS 
Assessment Center study specific website. We will create data codebooks and clearly indicate how all 
data is labeled and coded.  
5. Coding instructions for all study variables will be provided. 
6. Qualitative interview guide. We have included a draft of our interview guide in the appendix. We will 
provide the final and complete interview guide. 
7. Analysis plan. We will create a written document of our planned analyses. This plan will also highlight 
the roles and contributions of each study team member to expected study deliverables.  
 
We will register our RCT at www.Clinicaltrials.gov prior to enrollment in the RCT.  
 
Although not required (given a budget less than $500,000 in direct costs per project year), we will be prepared 
to share study data following the approval of a Data Sharing Plan by all study team members. Below we 
provide a draft of this plan.  
 
Pending the final approval and review of the study team, we will make de-identified data available by request to 
investigators not associated with the study team. Priority for sharing of data will be given to junior faculty and/or 
faculty interested in questions related to patient-centered outcomes or interventions with Latino families facing 
cancer. We see this study as an important resource for guiding community-academic partnerships to guide 
questions relevant to the communities being studied. We will develop a formal data request process. All Site 
PIs and the GUMC PI must agree and approve the data request process. Any requests for data from non-study 
investigators will be reviewed by the GUMC and Site PIs and Advisory Board Members to ensure that it does 
not conflict with planned analyses, is otherwise respectful of the study participants, and complies with all 
relevant IRB and HIPAA regulations. When approved, we will make study data available to other investigators 
under appropriate data sharing agreements that ensure that the data will be used only for research purposes, 
that any individual participant’s de-identified data will not be disseminated, that the data will not be used to 
identify an individual participant, that data will be protected under appropriate security measures including 
encryption and password protection, and that the data will be destroyed or returned to us upon completion of 
relevant analyses. If appropriate, we will also determine whether at least one study investigator should be 
involved scientifically in any projects that result from data sharing requests. As noted, all of these procedures 
and data-sharing plans, requests and approvals will go through the Study PIs and Advisory Board.  

 
 
 
 
PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE): Graves, Kristi, Dove 
 
 
PCORI Research Plan                                                                                                                                               
 
 
 
19
 
DISSEMINATION AND IMPLEMENTATION ASSESSMENT 
 
Governance Plan 
 
We will develop a governance plan for the project so that the roles and responsibilities of team members are 
clear. We define our team as involving researchers, community organizations, patient advocacy groups, 
consultants and our advisory board. We are fortunate that the diverse perspectives of the team members and 
their respective organizations complement and extend their individual capabilities beyond what any one group 
could do on its own. In this regard, we maximize the likelihood of successfully implementing the study, 
disseminating study results and incorporating them into practice. This synergy – and the perspectives and 
expertise behind it – will provide an excellent foundation for truly impacting and improving QOL among Latino 
families facing cancer.  
 
At the first team meeting convened soon after study initiation, we will discuss the organizational structure and 
roles and responsibilities of the team members. Below we present a template for one possible structure that 
identifies the primary responsibilities of and interactions between the various groups involved in the study. 
Although Georgetown University is depicted as the “hub” as the prime institution and our experience with 
executing research studies, we are open to redefining these roles pending the input from the entire team.  
 
Figure: Overview of Draft Organizational Structure 
 
 
Resource Sharing / Fiscal and Management Coordination    
 
Each PI will be responsible for managing their own budgets, although Dr. Graves will provide oversight and 
assist as needed with budget management. Each community partner has developed their own budget and 
Community SITE PIs 
 
Gilda’s Club New 
York City (Torres) 
 
Latinas Contra 
Cancer (Duron)  
 
LatinaSHARE 
(Sampayo) 
 
Nueva Vida 
(Caicedo) 
Georgetown University Medical Center 
(Led by PI - Graves) 
 
•
Coordinate Team Members and Team Meetings 
•
Lead Protocol Development  
•
Coordinate Institutional Approvals 
•
Optimize Communication between Sites and GUMC  
•
Track Enrollment/Retention 
•
Conduct Assessments  
•
Analyze Data  
•
Coordinate Dissemination Efforts 
Additional Academic & Community Partners 
 
GUMC Co-Investigators (Jensen, Sheppard, Kaltman, Luta, Mandelblatt)  
Consultants (Jacobs, Napoles, Jandorf, Elliott)  
Community Site Key Personnel  
Georgetown Lombardi Breast Cancer Advocate Group  
Other partners: GU CTSA (GHUCCTS), Center for Excellence for Health Disparities in the 
Nation’s Capital, Existing and new community-based collaborations 
Advisory Board 
(Warren, Hampton, Perret-Gentil, Lucas, Londono) 

 
 
 
 
PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE): Graves, Kristi, Dove 
 
 
PCORI Research Plan                                                                                                                                               
 
 
 
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budget justification for the proposed study, including salary for the Site PI and key personnel, travel, supplies 
and other research expenses. The GUMC budget includes funds for annual honoraria ($1000) provided to  
Advisory Board members as well as annual Consultant stipends ($2000) and travel funds.   
 
Procedure for Resolving Conflicts 
 
If a potential conflict develops, the PIs at each site will first attempt to resolve the dispute on their own. They 
will then seek consultation from the members of the Advisory Board. However, if they are not able to resolve a 
particular dispute, the disagreement shall be referred to an arbitration committee consisting of one senior 
faculty member or administrator from each of the institutions in addition to an impartial senior executive 
mutually agreed upon by each of the PIs.  Members of this arbitration committee will not be directly involved 
with the study. Decisions about publications and new collaborations will be made by the PIs with input from the 
Co-investigators and study team personnel.  
 
Change in PI Location 
 
If a PI moves to a new institution, attempts will be made to transfer the relevant portion of the grant and related 
work to the new institution.  In the event that a PI cannot carry out her duties a new PI will be recruited as a 
replacement at one of the participating organizations subject to the approval of the organization and PCORI.  
 
Methods for Disseminating and Implementing Evidence-Based Interventions into Community Settings  
 
One of our team members, Dr. Anna Nápoles (Consultant) has recently submitted for review a manuscript that 
describes methods for translating evidence-based behavioral interventions into programs appropriate for 
community organizations that serve populations with heath disparities. One approach to address health 
disparities is to implement evidence-based interventions (EBI) that improve health and prevent disease and 
disabilities into community settings to reach disparity populations.  Although many such EBIs are available, 
they are not being implemented broadly, especially in vulnerable communities.  One reason is that there are 
few conceptual models of the translation processes that apply to the field of health disparities.  Most models 
assume that one EBI is translated with minor adaptations, and communities are seldom involved in the 
process.  However, successful translation into vulnerable communities usually requires numerous adaptations 
to EBIs to accommodate differences in populations, settings, and available resources.  Also, communities often 
have locally developed programs (best practices) tailored to improve the health of their communities that can 
be integrated with EBIs to provide a better fit to the community.  If our proposed research is successful in 
improving QOL outcomes for Latina breast cancer survivors and their caregivers, we will be guided by the a 
conceptual model described by Dr. Nápoles that integrates research-centered EBIs with community best 
practices. Along with feedback from our study partners and advisory board members, we will work to develop 
the PCI as a program to fit a new community context, meet the needs of a disparity population, capitalize on 
scientific evidence, and take into account the assets and limited resources characteristic of disparity 
communities.  The model, derived primarily from two published translation frameworks, specifies seven phases 
that include establishing infrastructure for translation processes, identifying multiple inputs (EBIs and best 
practices), synthesizing the information, translating and adapting these to create an intervention, developing 
necessary capacity and delivering the intervention, and evaluating it using appropriate designs and 
measures.  For each phase, we describe specific methodological steps and provide examples from the 
literature that focus on ethnic minority, low-income, and disabled disparity populations.  The model and 
methods Dr. Nápoles proposes fill a gap in the literature and should help advance our ability to design and 
conduct studies to reach vulnerable communities with potentially effective interventions to reduce health 
disparities.  
 
 

 
 
 
 
PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE): Graves, Kristi, Dove 
 
 
PCORI Research Plan                                                                                                                                               
 
 
 
21
 
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PCORI Research Plan                                                                                                                                               
 
 
 
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2007. PM:17574367. 

 
 
 
 
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cancer adjuvant therapy discussions. Health Expect, 3(1):26-36; 2000. PM:11281909. 
 
 
 
 
 
 

 
 
 
 
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PROTECTION OF HUMAN SUBJECTS 
 
PROTECTION OF HUMAN SUBJECTS 
We will obtain approval by the Joint Oncology Georgetown University Medical Center / Georgetown University 
Hospital, the St. Luke’s Breast Service Hospital Institutional Review Board (New York City) and any other 
relevant Institutional Review Boards in New York, NY or San Jose, CA. We will fully disclose the potential risks 
and benefits to all study participants and give them ample opportunity to refuse participation or skip questions 
they do not want to answer. Oral and written consent will be acquired for all participants.  Participants will be 
informed that their healthcare and related services will not be impacted if they decline to participate in the study. 
Documentation is provided here for each point relevant to the conduct of research with Human Subjects.  
 
1. RISKS TO THE SUBJECTS 
 
a. Human Subjects Involvement, Characteristics, and Design 
 
For the proposed study, we will recruit participants from local hospitals and community-based organizations 
including: LatinaSHARE (New York, NY), Nueva Vida Inc. (Washington, DC), Latinas Contra Cancer (New 
York, NY) Gilda’s Club NYC (New York, NY) and St. Luke’s-Roosevelt Hospital (New York, NY). We may also 
receive referrals to the study through existing collaborations of study team members with St. Barnabas 
Hospital (New York, NY), Doctors Community Hospital (Lanham, MD) and Signature Breast Care (Lanham, 
MD). The proposed study consists of refining the intervention and a randomized controlled trial. The study 
population will be Latina breast cancer survivors and their caregivers.  Caregivers will be a primary support 
person identified by the survivor.  We anticipate that 10 patient-caregiver dyads will participate in refining the 
intervention, and 125 patient-caregiver dyads will participate in the randomized trial (allowing for attrition, we 
expect a final sample size of 100 dyads). Latina breast cancer survivors will be eligible for this study if they: 1) 
1) self-identify as Latina, 2) have been diagnosed with breast cancer, 3) speak English or Spanish, 4) can 
provide meaningful consent (i.e. men and women with severe cognitive impairment will be excluded), 5) can 
identify at least one primary, adult caregiver. Caregivers of Latina breast cancer survivors will be eligible if 
they: 1) are aged 21 to 80 years, 2) speak English or Spanish, 3) can provide meaningful consent (i.e. men 
and women with severe cognitive impairment will be excluded). Following IRB approval and with a HIPAA 
waiver, contacts at each community site (LatinaSHARE, Nueva Vida, Latinas Contra Cancer, Gilda’s Club 
NYC) will help identify eligible Latina survivors and will mail a bilingual study invitation letter inviting them and a 
primary caregiver to be involved in refining the intervention or the randomized controlled trial. Potential 
participants will be provided with several easy ways to decline the study or opt out of additional contact. For 
example, study invitation letters will include a pre-stamped decliner postcard and a telephone number to call a 
study-dedicated line.  Those who do not decline within 2 weeks of receipt of the study letter will be contacted 
via telephone by a member of the study team.  During this initial telephone screening call, women will be 
invited to decline if they are not interested. If they are interested, the research assistant will further explain the 
study and determine initial eligibility based on self-reported cancer history, age and ethnicity. We will also use 
in-person recruitment to talk with survivors and caregivers at the four sites. If a survivor and/or caregiver is 
interested, a study team member will follow up with further information about the study to determine eligibility 
and obtain consent from both individuals in the dyad. Our community partners at Nueva Vida have had 
success recruiting caregivers into their program by encouraging the Latina survivors to invite the caregivers 
into the program. We will use this strategy and others developed by the study team to recruit both survivors 
and caregivers into the proposed project.  
 
 
Refining the Intervention. We will recruit 10 patient-caregiver dyads to complete individual and joint 
qualitative interviews to provide feedback on the intervention. The interviews will take approximately 45 

 
 
 
 
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minutes to complete, for which participants will be remunerated $20 each ($40 per survivor-caregiver dyad). 
The intervention protocol will be further revised following the feedback from these interviews and input from the 
research team, consultants and advisory board.  
 
 
Randomized Controlled Trial. For the randomized controlled trial, we anticipate enrolling 125 patient-
caregiver dyads, of which we expect 100 to remain enrolled and complete the study protocol through the 6-
month follow-up assessment interview. Involvement in the randomized controlled trial will consist of 
participation in a baseline telephone interview at initiation, two follow-up telephone interviews (one after 
completion of the intervention and another 6-months post intervention) and, for survivor-caregiver dyads 
randomized to the patient-caregiver intervention (PCI), attendance at eight 2-hour intervention sessions held 
twice a month at one of the four recruitment sites. Survivor-caregiver dyads randomized to usual care (UC) will 
be invited to take part in any and all services normally available to them through the four community 
organizations, including support groups, patient navigation, social events and educational workshops.  
 
b. Sources of Materials. 
 
The primary source for research materials will be confidential telephone-based interviews with survivors 
and caregivers. In addition, all interventionists will complete quality assessment forms after each 
intervention session. These forms will not contain protected health information, only general comments 
about topics covered, the number of attendees and length of session.  Measures include: 
sociodemographics, medical history, breast cancer stigma/shame, religious coping, familismo, 
acculturation, communication with providers, communication with caregivers, medical mistrust, 
communication self-efficacy, social support, distress, dyadic social support, dyadic perspective and social 
constraints, satisfaction with care and adherence to breast cancer follow-up care.  Data we obtain from 
community sites will include contact and basic demographic information about the potential participants: 
name, address and telephone number. This basic demographic information will not be included on the 
document containing final interview data.  
 
c. Potential Risks. 
Risks associated with participating in this study are minimal and fall into two categories: 
1.) First is the risk associated with completing the study interviews. There is a low risk of adverse 
psychological reactions to the study interviews. As noted above, we will ask participants for information 
related to sociodemographics, medical history, breast cancer stigma/shame, religious coping, 
familismo, acculturation, communication with providers, communication with caregivers, medical 
mistrust, communication self-efficacy, social support, distress, dyadic social support, dyadic perspective 
and social constraints, satisfaction with care and adherence to breast cancer follow-up care.   In our 
experience, these questions do not cause any discomfort to participants, and they will be instructed that 
they can choose to skip any question they do not wish to answer. It is possible that these questions 
may generate increased worry for some individuals. Of note, members of the research team have been 
conducting research with human subjects related to cancer for over a decade and thus have 
experience managing participant discomfort in the rare situations it arises (e.g. Dr. Graves, 13 years, 
Dr. Sheppard, 10 years). Our team also includes licensed mental health professionals who will be able 
to provide referrals as needed to any distressed participants (e.g., Drs. Jacobs, Kaltman; Ms. Torres). 
 
We also consider participation in the in-depth interviews to refine the intervention to be of minimal risk, 
as participants will be responding to questions about their opinions regarding the intervention materials, 
topics, format and procedures. For this, participants may not want to have their responses to qualitative 
interviews audiorecorded; for individuals who do not agree to audiotaping, a trained research team 
member will take written notes.  

 
 
 
 
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2.) Second, there may be risks associated with participation in the PCI intervention related to discussion of 
cancer diagnosis, treatment experience and coping skills.  Of note, these risks are no different than 
those of participants receiving usual care. All interventionists are bilingual and bi-cultural and will 
receive extensive training. If any member of the study team notes that a participant is reporting high 
levels of distress or difficulty coping with her diagnosis or treatment, we will use our established 
protocol for assessing and managing distress. Specifically, we will ask the participant’s permission to 
have a mental health professional member of our team (e.g., Drs. Kristi Graves, Stacey Kaltman or Ms. 
Torres) follow up with a telephone call to the participant. These team members have experience in 
assessing distress among participants in cancer research and/or Latina survivors and their caregivers. 
If appropriate, the participant will be provided with resources for additional psychological support. We 
have a list of consultation psychiatry services, social work services, and mental health practitioners in 
private practice that provide clinical services to patients and families. We will ensure each study site 
has this list updated and available to study team members prior to participant enrollment. 
 
2. ADEQUARY OF PROTECTION AGAINST RISKS 
 
a. Recruitment and Informed Consent 
We will take several steps to protect the autonomy of subjects and to assure that the consent is truly informed. 
Recruitment of participants will occur through notification of the study with an invitation letter or through in 
person recruitment at one of the community sites. For those who do not decline further contact, they will 
receive a follow-up telephone invitation to participate. We will then mail all participants packets with informed 
consent documents and postage paid return envelopes.  If a participant is unable to read, a member of the 
study team will read the consent document in its entirety to them over the phone. If written informed consent on 
an IRB-approved consent document has not yet been obtained prior to completion of the baseline interview for 
both intervention refinement and the randomized controlled trial, a member of the study team will obtain each 
participant’s verbal consent to conduct the interview. We have followed similar IRB-approved procedures in 
past studies. Importantly, participants will not receive their intervention assignment until we have all signed 
written consents on file. Consent will consist of a signature on a form describing the nature of the study. The 
major sections of the consent form include: (a) the research purpose and description of the study, (b) the 
potential benefits/risks of the study, (c) confidentiality of the data, (d) the voluntary nature of the study, (e) the 
freedom to refuse to answer any specific questions or to withdraw from the study at any time, (f) a statement 
that there are no costs of the study to the participant, (g) a list of persons to contact with questions or concerns, 
and (h) amount that they will be compensated per interview and per intervention session ($20 for qualitative 
interview in refining the intervention, $10 per telephone interview for randomized controlled trial and $10 per 
intervention session). Of note, participants assigned to UC will receive the same overall amount of study 
incentives over the course of the study timeline. Participants will be given a copy of the consent form, and one 
copy will be retained for study records. The PI will ensure that these forms are stored in locked filing cabinets. 
We anticipate that all signed consent documents will be returned to and retained at the GUMC study site. We 
will discuss these procedures and make adjustments as needed pending review by the study team at the initial 
study meeting.  
 
b. Protection Against Risk 
All members of the research team and personnel involved in recruitment will complete the necessary Human 
Subjects and HIPAA Training (e.g., CITI Courses), and copies of these certifications will be kept on file with the 
PI.  The GUMC Project Director will be responsible for guiding the study staff at each of our community 
partners on the training procedures (e.g., ensuring they have the right website, tracking when the training is 
complete). If at any point a participant states that they are experiencing any psychological discomfort, they will 
be given an opportunity to discontinue the study and/or provided with a list of local support services per our 

 
 
 
 
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established distress protocol. At GU, several resources exist for training in the responsible conduct of research. 
We are fortunate to have access to the full resources of the Georgetown-Howard Universities Center for 
Clinical and Translational Science (GHUCCTS). For example, GHUCCTS has a strong program in Regulatory 
and Ethics Knowledge and Support. The mission of this program is to promote and preserve research integrity 
through training and support related to the application of ethical principles to the design and implementation of 
translational research. These programs are an active part of the Training in the Responsible Conduct of 
Research and Human Subjects Protection available to all of the researchers at LCCC. When possible, we will 
make these training resources available to all study team members. For example, we may be able to include a 
presentation by a member of the GHUCCTS program in Regulatory and Ethics Knowledge and Support during 
our initial team meeting.  
 
Our plan for maintaining confidentiality is multifaceted. At Georgetown, data security measures include 256-bit 
SSL encryption, industry-standard firewall, IP address filtering, corporate anti-virus software, domain-
authenticated user controls, and daily data backups. Of note, each of the study sites has included funds to 
purchase a new computer for research purposes. Our database administrator will work with the sites to ensure 
that the computer they purchase will include the appropriate security software and infrastructure. The 
protection of privacy of participants in studies is of the utmost importance. First, we will minimize 
communications across study sites that involve names or other identifying information. Where this is 
unavoidable (e.g., sites transmitting names to LCCC for recruitment of patients), all communications will be 
made via priority overnight mail, on a study-dedicated fax machine or via encrypted connections such as 
GUShare or a study-specific and encrypted cloud-based database (as opposed to e-mail). Second, all 
research files will be kept in locked files in research team offices and identified only by a randomly generated 
study ID number. Third, at the individual sites, all clinical information will be kept in locked files and/or secured 
dedicated services. Fourth, as we have done in our prior and current work, we will obtain a federal Certificate 
of Confidentiality to protect confidentiality of study participants.  Finally, in all data sets, we will use ID numbers 
only. A separate data set linking names with ID numbers will be accessible only through password protected 
and secure data programs and available only to trained study staff.   
 
3. POTENTIAL BENEFITS OF THE PROPOSED RESEARCH TO THE SUBJECTS AND OTHERS 
We hope that participation in the proposed study will provide direct benefits to participants, including improved 
quality of life. We hope we will enable participants to learn new coping skills and strengthen their relationship 
with their caregiver. Moreover, all participants will be making a contribution to our understanding of quality of 
life and survivorship care among Latino families facing cancer. If hypotheses are supported, the intervention 
tested in the present study could be implemented at many community organizations and hospitals across the 
United States (e.g., the over 150 affiliate and satellite locations of the Cancer Support Community through our 
team members’ affiliations with this organization). In addition, these findings could be applied to a number of 
other health conductions, thus making contributions to public health in other ways.  Participants we are 
recruiting are participating on a voluntary basis and can withdraw at any time.  Participants randomized to 
receive usual care will be given the opportunity to receive the intervention after completion of the 6-month 
follow up assessment.  
 
4. IMPORTANCE OF THE KNOWLEDGE TO BE GAINED 
The goal of this project is to evaluate an empirically-supported psychosocial intervention with a diverse Latina 
survivor and caregiver community. Latina breast cancer survivors report lower quality of life than non-Latina 
survivors and the friends and family of Latina cancer patients are also significantly impacted. Few psychosocial 
interventions have been tested among Latina breast cancer survivors and their caregivers.  Our proposed 
study will help close that gap. Conduct of rigorous and theoretically-grounded research like the proposed study 
is essential to the improvement of clinical care.  

 
 
 
 
PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE): Graves, Kristi, Dove 
 
 
PCORI Research Plan                                                                                                                                               
 
 
 
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5. DATA AND SAFETY MONITORING PLAN 
1) Monitoring the progress of trials and the safety of participants: We will create a Data Safety Monitoring 
Board (DSMB) for this project. We have identified a group of faculty and community partners not 
associated with the study team to monitor study progress as needed. This team includes:  
 
a. LCCC faculty: Sherrie Wallington, Ph.D. (Community Research; Health Disparities)  
b. Georgetown University Hospital: Ruth He, M.D. (Medical Oncology), Georgeen Newland, RN 
(Oncology nurse) 
c. Local experts from Community Organizations:  
i. Jose Mendoza, M.D. (Patient Advocate for Latinos, Colon Cancer Alliance) 
ii. Florencia Gonzales (Community-Based Research with Latinos) 
This team will review our project enrollment, risk procedures, adverse event procedures, and quality assurance 
procedures twice each year by reviewing any adverse events reported and adherence to our eligibility 
monitoring rules. Further, the project director and the PI will be responsible for monitoring and reported 
participants’ responses during the telephone interviews and intervention sessions. In particular, participants’ 
responses to the interventions will be closely assessed at all time points through weekly GUMC meetings held 
with the PI, project director and other relevant study personnel. Likewise, we will review key events as 
appropriate during monthly teleconferences and/or at annual team meetings.  
2) Plans for assuring compliance with requirements regarding adverse event reporting: Adverse events 
will be reported by the PI to Georgetown University IRB and to the appropriate PCORI offices. 

 
 
 
 
PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE): Graves, Kristi, Dove 
 
 
PCORI Research Plan                                                                                                                                               
 
 
 
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CONSORTIUM/CONTRACTUAL ARRANGEMENTS 
 
 
Georgetown University Medical Center (GUMC) has developed arrangements for subcontracts with each of the 
four community organizations: Gilda’s Club New York City, NY; Latinas Contra Cancer, San Jose, CA; Nueva 
Vida Inc., Washington, DC; and SHARE, LatinaShare, New York, NY.  
 
Each of these four partners will participate in all aspects of the proposed study, from refining the intervention at 
study initiation to disseminating results and identifying practical strategies for incorporating the patient-
caregiver intervention into clinical practice at organizations, clinics and hospitals across the country. Each 
partner brings numerous strengths to the proposed work, as highlighted below and elsewhere throughout the 
application. Of note, each of our partners has won awards for their work with Latina breast cancer survivors 
and their families and provides support and care in linguistically- and culturally-sensitive ways. Personnel at 
each site are bilingual in English and Spanish. Further, each partner serves its clients/members in slightly 
different ways, allowing for the evaluation of our patient-caregiver intervention to be conducted in real-world 
settings, with diverse patients and caregivers and carried out by different types of interventionists.  
 
Gilda’s Club New York City, NY (GCNYC): GCNYC opened their doors in June 1995 to create a welcoming 
and supportive community for anyone affected by cancer. GCNYC’s free program has offered support and 
networking groups, educational lectures, workshops and social events to over 7,300 members. The proposed 
project fits well with GCNYC’s current support services. For example, two of the GCNYC’s programs, Team 
Convene and Family Focus, provide forums in which our members and their family and friends can create 
plans for managing the illness or openly discuss concerns and fears that occur when living with cancer. Among 
other strengths, specific strengths that GCNYC brings to the overall project include: 
• 
GCNYC has a large number of members (7,300) including many Latinos facing cancer. Their 
Manhattan-based Clubhouse has had over 100,000 member visits.  
• 
GCNYC has existing programs for family and caregivers included in the support services. 
• 
GCNYC is part of a world-wide network of Clubhouses, including affiliation with the Cancer 
Support Community (CSC), which has more than 50 local CSC affiliates and 100 satellite 
locations and online serves. These Clubhouses and CSC affiliates provide support and care 
services to hundreds of thousands of people living with cancer.  
• 
GCNYC offers the strong support of CEO Lily Safani for the proposed project, including 
guidance to the study team on outreach and dissemination of results to other Gilda’s 
Clubhouses and the CSC’s network of affiliates.  
 
Latinas Contra Cancer, San Jose, CA (LCC): LCC was founded in 2003 by Ysabel Duron, a journalist and 
cancer survivor. Her diagnosis propelled her to create LCC as a non-profit organization that primarily serves 
low-income, immigrant and Spanish speaking Latinos. LCC aims to diminish the fear surrounding the word 
cancer in the Latino community and increase understanding about prevention, screening and treatment. LCC 
also seeks to engage with researchers to examine the cultural, linguistic and economic barriers to access and 
early detection.  LCC provides patient navigation services in Santa Clara County and has conducted hundreds 
of educational workshops, including culturally-focused social events which include information about cancer 
screening. Among many strengths, LCC brings the following assets to the overall project:  
• 
LCC has a large percentage of clients who are immigrants from Mexico or of Mexican-American 
origin and thus expands the representativeness of the geographic and ethnic diversity of the 
proposed sample.  
• 
LCC has trained over 100 patient navigators / promotoras in the region to provide culturally-
sensitive and linguistically-appropriate care and education to cancer patients and the community. 

 
 
 
 
PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE): Graves, Kristi, Dove 
 
 
PCORI Research Plan                                                                                                                                               
 
 
 
34
• 
LCC is under the strong leadership of Ysabel Duron, a visible and connected advocate for issues 
related to Latino health and cancer. 
• 
LCC organizes the biennial Latina Cancer Summit, a national conference established in 2008 that 
brings together leaders, advocates, promotoras, patient navigators, researchers, public health 
workers and policy makers to address issues relevant to Latinos and cancer. In 2014 and 2016, 
The Summit will be an important avenue for dissemination of study results and potential training for 
other organizations to incorporate the patient-caregiver intervention into the services they provide to 
Latinos facing cancer.  
Nueva Vida, Inc., Washington DC: Nueva Vida, Inc. was founded in 1996 by a group of Latina breast cancer 
survivors and health care professionals in the Mid-Atlantic region. Led by executive director Larisa Caicedo, 
Nueva Vida provides a broad continuum of culturally sensitive cancer support services for Latinas in the 
Washington DC, Baltimore and Richmond metropolitan areas. As the only independent survivor-driven cancer 
care organization for Latinas in the area, Nueva Vida serves over 4,000 individuals and their families, and 
reaches countless more as a resource to local and national healthcare partners seeking to improve care for 
Latinas. These services include patient navigation and assistance from diagnosis and treatment to recovery, 
survival and end of life care, community outreach and education, support groups for patients and their families, 
and collaboration with local and national cancer researchers. Below we enumerate a few of the many strengths 
that Nueva Vida brings to the overall project:   
 
• 
Nueva Vida co-founder Gloria Elliott (Consultant) developed the patient-caregiver intervention to be 
tested in the proposed work.  
• 
Nueva Vida currently implements the intervention with Latina survivors and caregivers.  
• 
Nueva Vida and GUMC have partnered for more than a decade. 
• 
Nueva Vida has won national awards that recognize its implementation of empirically-based programs 
to improve health in underserved communities.  
• 
Nueva Vida has offices in Baltimore, MD and Richmond, VA and thus has a broad catchment area in 
the Mid-Atlantic region.   
Self-Help for Women with Breast or Ovarian Cancer (SHARE), LatinaSHARE, New York City, New York: 
SHARE is group of and for breast and ovarian cancer survivors and their caregivers, founded in 1976. 
SHARE’s mission is to create and sustain a supportive network and community of women affected by breast or 
ovarian cancer. SHARE brings these women and their families and friends together with others who have 
experienced breast or ovarian cancer, and provides participants with the opportunity to receive and exchange 
information, support, strength and hope. LatinaSHARE was started in the late 1980’s to provide support, 
information, education and advocacy opportunities for the Latino community.  LatinaSHARE’s work focuses on 
empowerment, education and advocacy to bring about better health care, an improved quality of life, and a 
cure for these diseases. LatinaSHARE, co-directed by Jennie Santiago (Project Manager on the proposed 
study), offers telephone support, support groups, patient navigation and educational programs in Spanish for 
women in the greater New York area. LatinaSHARE brings a number of strengths to the overall project, 
including:  
• 
LatinaSHARE provides support and services to women with breast or ovarian cancer through a trained 
peer-support model. 
• 
LatinaSHARE’s partnership in the proposed project is led by Ivis Sampayo, a recognized leader in 
patient advocacy and participant on numerous national panels and committees related to reducing 
disparities and improving Latina cancer outcomes.  
• 
LatinaSHARE has developed online and print novellas to help educate Latina women about breast 
cancer. These experiences and products may serve as models for dissemination of study results and 
avenues to train other organizations on how to incorporate the intervention into practice.  

 
 
 
 
PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE): Graves, Kristi, Dove 
 
 
PCORI Research Plan                                                                                                                                               
 
 
 
35
Inter-Organizational Agreement Information 
 
Key personnel for the proposed work include the Site Principal Investigator at each of the subcontract 
organizations, a Project Manager/Director and then any other key personnel deemed necessary for completion 
of the work at each specific site. Budget and budget justification details are provided for each of the 
subcontracting organizations in the Budget section of the uploaded application.  
 
Each partner organization has submitted the following documents to GUMC: 
 
1) Letter of Intent – This document indicates the intent of both GUMC and the subcontractor to establish the 
structural and financial arrangements needed to carry out the proposed work. In addition, this document 
indicates the subcontractor’s agreement to follow GUMC’s policies related to disclosure of any potential 
conflicts of interest specific to this study. Each Letter of Intent has been signed by the authorized officials at 
each of GUMC and each of the collaborator community organizations. 
 
2) Statement of Work – This document indicates the scope of work to be carried out by each of the 
collaborator community organizations. These details include: participating in annual team meetings, 
conference calls and interventionist training; implementing the patient-caregiver intervention; and reporting 
and tracking of potential and enrolled participants and the expected number of enrolled participants 
recruited at each site during each of the study years. The estimates for the number of participants to be 
enrolled at each site were established through discussion with each of the subcontractors to reflect the 
realistic capacity to carry out the proposed research within the specific time and fiscal constraints. All four 
organizations will implement the patient-caregiver intervention and will participate fully in all aspects of the 
study, including use of a GUMC-central randomization system to randomize participants to either the 
intervention or usual care. This document was signed and dated by each of the subcontract PIs and Dr. 
Graves from GUMC.  
 
3) Budget and Budget Justification – As required by both the PCORI submission guidelines and GUMC 
processes for subcontractors, each subcontract site submitted a detailed budget for each of the years of 
the proposed study along with an accompanying budget justification. Each site prepared and submitted to 
GUMC for review their budget and budget justification. As evident from the budget documents submitted 
from the four organizations, each one identified the administrative and personnel structure and organization 
that would work best for their individual site.  
 
 

 
 
 
 
PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE): Graves, Kristi, Dove 
 
 
PCORI Research Plan                                                                                                                                               
 
 
 
36
 
PROJECT PLAN AND TIMELINE 
 
 
Below is our study timeline, with study tasks, milestones and deliverables and their estimated dates of 
submission or completion. Deliverables are highlighted in the left-hand column with shading.  
Study Timeline 
YEAR 1: 5/13 – 4/14 
YEAR 2: 5/14 – 4/15 
YEAR 3: 5/15 – 4/16 
 
Task / Deliverable 
Q1 
Q2 
Q3 
Q4 
Q1 
Q2 
Q3 
Q4 
Q1 
Q2 
Q3 
Q4 
5/13 -
7/13 
8/13 - 
10/13 
11/13-
1/14 
2/14 - 
4/14 
5/14 - 
7/14 
8/14 - 
10/14 
11/14- 
1/15 
2/15 - 
4/15 
5/15 - 
7/15 
8/15 - 
10/15 
11/15- 
1/16 
2/16 - 
4/16 
Notify Team / Confirm 
Initial Team Meeting Dates 
X 
 
 
 
 
 
 
 
 
 
 
 
Hire and Train GUMC 
Research Staff 
X 
 
 
 
 
 
 
 
 
 
 
 
Conduct and Monitor Staff 
Training: NY, CA 
X 
X 
X 
 
 
 
 
 
 
 
 
 
Convene Initial Team 
Meetinga 
X 
 
 
 
 
 
 
 
 
 
 
 
Hold Monthly Team 
Teleconferences 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Refine Protocols for 
Interviews; Recruitment; 
Intervention; Interventionist 
Training 
X 
X 
 
 
 
 
 
 
 
 
 
 
Submit IRBs 
 
X 
 
 
 
 
 
 
 
 
 
 
Conduct In-Depth 
Interviews 
 
X 
X 
 
 
 
 
 
 
 
 
 
Develop Study Database 
and Randomization 
Procedures 
 
X 
X 
 
 
 
 
 
 
 
 
 
Refine Intervention 
Protocol / Surveys 
 
X 
X 
 
 
 
 
 
 
 
 
 
Conduct Interventionist 
Training: New Yorkb 
 
 
X 
 
 
 
 
 
 
 
 
 
Conduct Interventionist 
Training: CAc 
 
 
X 
 
 
 
 
 
 
 
 
 
Beta Test PROMIS  
CAT Systemd 
 
 
 
 
 
 
 
 
 
 
 
 
Write and Submit 
Intervention Protocol 
Development Paper 
 
 
X 
X 
 
 
 
 
 
 
 
 
Amend IRBs as needed 
 
 
X 
X 
 
 
 
 
 
 
 
 
Register RCT at 
www.Clincialtrials.gov 
 
 
X 
 
 
 
 
 
 
 
 
 
RCT Recruitment 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Initiate and Conduct RCT 
 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
 
Complete Baseline, Post-
Test and Follow-up 
Assessments (GUMC) 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Submit Study Protocol / 
Year 1 Report to PCORI 
 
 
 
 
 
X 
 
 
 
 
 
 
 
 

 
 
 
 
PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE): Graves, Kristi, Dove 
 
 
PCORI Research Plan                                                                                                                                               
 
 
 
37
Study Timeline 
YEAR 1: 5/13 – 4/14 
YEAR 2: 5/14 – 4/15 
YEAR 3: 5/15 – 4/16 
Task / Deliverable 
Q1 
Q2 
Q3 
Q4 
Q1 
Q2 
Q3 
Q4 
Q1 
Q2 
Q3 
Q4 
5/13 -
7/13 
8/13 - 
10/13 
11/13-
1/14 
2/14 - 
4/14 
5/14 - 
7/14 
8/14 - 
10/14 
11/14- 
1/15 
2/15 - 
4/15 
5/15 - 
7/15 
8/15 - 
10/15 
11/15- 
1/16 
2/16 - 
4/16 
Convene Annual Team 
Meetingsa 
X 
 
 
 
 
X 
 
 
 
 
X 
 
Continue Recruitment / 
Troubleshoot if Low 
Enrollment 
 
 
 
X 
X 
X 
X 
X 
X 
X 
 
 
Continue RCT / Address 
Implementation Issues as 
needed 
 
 
 
X 
X 
X 
X 
X 
X 
X 
 
 
Collect Quality Assurance 
Data for  Intervention 
Fidelity Checks 
 
 
 
X 
 
X 
 
X 
 
X 
 
X 
Convene Community 
Meeting: CA 
 
 
 
X 
 
 
 
X 
 
 
X 
 
Prepare and Submit 
Abstract for the National 
Latino Cancer Summit 
 
 
X 
X 
 
 
 
 
 
 
 
 
Attend the National Latino 
Cancer Summit 
 
 
 
 
X 
 
 
 
 
 
 
 
Submit Year 2 Report to 
PCORI 
 
 
 
 
 
 
 
X 
 
 
 
 
Discuss Dissemination 
Strategies on Monthly 
Teleconferences and 
Annual Team Meetings 
 
 
X 
 
 
X 
 
X 
X 
X 
X 
 
Write, Submit Manuscript 
on Community-Academic 
Partnerships: Latino Health 
 
 
 
 
 
 
X 
X 
 
 
 
 
Prepare for Final Team 
Meeting; Invite other 
Interested Stakeholders to 
Attend 
 
 
 
 
 
 
 
 
 
X 
X 
 
Data QA Checks  
 
 
X 
 
 
X 
 
X 
 
X 
 
X 
Prepare and Analyze RCT 
Data 
 
 
 
 
 
 
 
X 
X 
X 
X 
 
Write RCT Manuscript 
(Submit 5/16) 
 
 
 
 
 
 
 
 
 
 
X 
X 
Submit Year 3 Report and 
Final Study Protocol to 
PCORI 
 
 
 
 
 
 
 
 
 
 
 
X 
aTeam Meetings will include community partners, researchers, Advisory Team members and patient advocates. These 
groups are representative of patient, caregiver, provider, stakeholder and researcher perspectives.  
bThe GUMC PI and specific Co-Investigators, along with each Site PI and Project Director and key interventionists will 
lead / participate in the interventionist training. For cost reasons, not all of the CA study team will attend the training in 
NY. The CA Site PI will travel to the NY training. 
cWe will follow-up the in-person interventionist training in NY with training of CA personnel. Trainers will be the same for 
each session and training will follow a manual.  
dAssessments will be conducted using the PROMIS Assessment Center and computerized-adaptive testing technology. 
Our team has experience with the programming and use of the Assessment Center for development of study-specific 
assessments that include PROMIS items.  

 
 
 
 
PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE): Graves, Kristi, Dove 
 
 
PCORI Research Plan                                                                                                                                               
 
 
 
38
 
APPENDIX 
 
 
 
Appendix A. Example PCI Survivor Session: Communication  
 
The information below is based on the intervention delivered by Nueva Vida and also adapted from the Nuevo 
Amancer intervention developed by Dr. Anna Nápoles (Consultant) that is currently being implemented with 
women recruited through Latinas Contra Cancer in San Jose, CA. Intervention content is based on tenets of 
improving self-efficacy, communication and social support as guided by Social Cognitive Theory.  Sessions are 
delivered in Spanish by trained Spanish monolingual or Spanish/English bilingual and bicultural interventionists.  
 
Overview:  
In this section we will learn about how cancer may affect you, your caregiver, other family and friends and how 
you communicate with one another. Good communication can help keep your relationships strong and healthy!  
 
What we will do: 
 
Today we will talk about some things you can do to keep good communication. We will discuss and practice 
how to express your feelings and what you need in a way that is respectful to you and to others. We will also 
talk about asking for help, which is not always easy when we are the ones to usually take care of things! 
 
Core Learning Questions:  
 
 How do I talk to my family about my cancer?  
 How do I express my feelings and needs in a way that is respectful? 
 How do I get the support I need to cope with my cancer and treatment?  
 
Activities for Communication Session:  
 
 Activity 1 Practicing Good Communication Skills 
 Activity 2 People in My Life and the Ways They Support Me 
 
 CANCER AND YOUR FAMILY  
 
A diagnosis of cancer affects the entire family, and they may feel many of the same emotions (fear, panic, 
anger, sadness, depression) as the person diagnosed with cancer.  Many changes can take place.  Some 
changes may be difficult, and some may be positive. For example:  
 Roles and responsibilities within the family may change. 
 Those who provide a steady income for their families may face economic problems.  

 
 
 
 
PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE): Graves, Kristi, Dove 
 
 
PCORI Research Plan                                                                                                                                               
 
 
 
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 Some family members may resent the way in which breast cancer has changed their lives, or some 
family members may realize that they cannot take you or their own health for granted in the future. 
 Older children may have to leave school to work to help the family. 
 Some family members may feel unsure about how to help and what to say. 
 Some survivors may not want to cause worry in their caregiver or their family by talking about their 
feelings or thoughts about cancer.  
 An illness can increase tension and conflicts that may have existed prior to the diagnosis, or 
sometimes an illness can bring family members closer together. 
 Having sexual relations with your partner may become difficult, or some partners grow closer with 
increased communication. 
 
How has your diagnosis affected your family or husband/partner?  
 
Children 
Children have different verbal skills and different abilities to understand concepts, such as illness, depending 
on their age.  For example, a child who is 5 years old will have difficulty understanding how long a week or a 
month is.  On the other hand, older children or teenagers who have a good understanding of these concepts 
will feel talked down to if they are not provided with the information they need to understand what is going on in 
their family. 
 
Young children 
 
Children as young as 2 feel the impact of a cancer diagnosis.  Many times parents will try to protect their 
children by not talking about their illness.  However, even young children will sense that something in the home 
has changed.  Additionally, young children go through a period in which they feel responsible for everything 
that happens around them.  It is therefore important for parents to reassure their children that their illness is not 
their fault. 
 
A mother knows her children better than anyone else, and can better judge if there are drastic changes in her 
child.  The following are changes to look out for in young children: 
 Bed-wetting or thumb sucking when they have outgrown these behaviors 
 Hitting their brothers or sisters or aggression toward classmates 
 Nightmares or problems sleeping 
 Over-clinging to mother 
 Sadness, being withdrawn 
 Drastic changes in appetite 
NOTE TO INTERVENTIONIST 
Ask the survivors how their diagnoses have affected their families.  For survivors with children, ask 
about their ages (review sections that apply).  

 
 
 
 
PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE): Graves, Kristi, Dove 
 
 
PCORI Research Plan                                                                                                                                               
 
 
 
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Teenagers 
 
Adolescence is a critical time in a teenager’s development and support is vital to help them adjust.  Although 
teens go through a phase where they need to be more independent, they still have a very strong need to feel 
safe within their family.  Therefore, teens may have a more complicated emotional reaction to a parent’s illness.  
The following are changes to look for in teens: 
 
 Changes in school performance (drop in grades)  
 Skipping school 
 Substance abuse (alcohol or drugs) 
 Anger 
 Depression 
How you can help your children 
 
Although it may seem difficult, you need to talk openly with your children about your cancer.  Here are some 
things you can do to help your children deal with your illness. 
 
 Talk openly to your children in language they understand. 
 Prepare your children for physical changes that may occur 
because of your cancer treatment such as hair loss, weight loss, 
or fatigue. 
 You can increase the psychological well-being of your children by 
increasing your own. 
 Try to maintain the family’s normal routine.  
 If you see extreme changes in behaviors, consult an expert who has experience in working with 
children. 
What are some ways you can help your family? 
 
Other family members and close friends 
 
Other family members, like siblings, parents, cousins and even close friends are also affected by your cancer 
diagnosis. They may be upset and concerned about your health and if you will get better. They may also want 
to help but be unsure of the best way how. For you, it may be difficult to talk with others in your family or your 
close friends for fear of worrying them too much or feeling like you need to stay strong for them. Some 
survivors may not want to show their emotions to others about something so personal like breast cancer. You 
may want to be able to do the same things as always—and perhaps for you that meant being the one who took 
care of others. These changes can be hard for everyone, but there are ways to make it easier to talk about 
difficult topics (see section 5.4). 
NOTE TO INTERVENTIONIST  
Ask the survivors to talk about a few of the ways they can help their family and communicate with 
them.  

 
 
 
 
PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE): Graves, Kristi, Dove 
 
 
PCORI Research Plan                                                                                                                                               
 
 
 
41
Husbands or partners 
 
Treatment for breast cancer may result in changes in your body.  Unpleasant side effects because of a 
mastectomy, lumpectomy or chemotherapy can be difficult.  These side effects can change how you feel 
physically and emotionally.  Some of these side effects may include hair loss, breast removal, depression, or 
loss of sexual urge.  Women may feel less feminine and less attractive. Women with partners or spouses may 
worry that their partner may no longer find them attractive or that their partner will leave them if they are not 
interested in sexual intimacy.   Sometimes these feelings are difficult to talk about with your partner. 
Sometimes, partners do not want you to talk about your illness to other people or even to other family 
members.    
 
Are you worried about how your body may change because of your cancer treatments? 
 
Examples:  I worry about… 
 Gaining or losing weight 
 Having one or both breasts removed 
 Scarring – feeling disfigured 
 Feeling less like a woman 
 My hair not coming back in the same way  
What feelings do you have related to the changes in your body?  
 
Examples 
 None 
 I feel depressed about my hair loss 
 I feel less of a woman without one (two) breasts 
 I don’t feel attractive anymore 
 I worry my partner will not find me attractive 
 I’ve lost my sexual urge 
 I worry that I will not find someone who will find me attractive 
 
What are some things that you like about yourself? Are there any areas of your life that are not 
impacted by your cancer diagnosis and treatment?  
 
How you can help your partner 
 
Miscommunication with our partners can lead to misunderstandings and resentments. Partners who feel they 
do not know what to say often stop communicating altogether or keep their distance.  Some women may 
interpret their partner’s silence as being insensitive and non-supportive. They may worry that their partner no 
longer finds them attractive, or that they have to be intimate with their partner just to maintain the relationship. 
Here are some tips on how to communicate with your partner:  
 

 
 
 
 
PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE): Graves, Kristi, Dove 
 
 
PCORI Research Plan                                                                                                                                               
 
 
 
42
 
Create a safe space.  Make sure the place you choose for your talk is private. 
 
Pick a time to talk when you and your partner are not stressed out, exhausted and won’t be interrupted 
by phone calls or children.  
 
Don’t talk about your feeling before, during or after having sexual relations.   
 
Discuss fears of rejection with your partner. 
 
Set aside some special time for just the two of you.  
 
Talk about ways to put more fun into your sexual relations. 
 
Help each other understand what you do and do not enjoy. If you just want to kiss, hug and cuddle 
without sexual relations, let your partner know. There are many ways to feel close and connected. 
 
If you feel your relationship is in trouble, talk openly about the problems that exist rather than pretending 
everything is fine. 
 
 
5.4. THE IMPORTANCE OF EFFECTIVE COMMUNICATION 
 
Remember that during your cancer treatment, you may not be able to take care of everyone else like you 
usually do.  If you hold in all your questions and worries to protect the ones you love, you may feel more 
depressed and anxious.  The sooner you are better, the sooner you will be able to go back to your normal 
activities. 
 
You have a right to your feelings and a right to talk about them.  You also have a right to ask for help when you 
need it.  Below are some suggestions that may help you communicate better with others: 
 
 Stay calm:  Try to remain calm so that you do not forget what you want to say.  
 Maintain eye contact:  Look into their face to get their attention.  They may not take you seriously 
or they might stop listening if you are looking in another direction.  
 Use a clear voice:  Speak in a tone of voice that is clear and firm.  If you speak too softly or shout 
and yell the person will stop listening. 
 Learn how to express your feelings:  Express your feelings using “I” 
statements and avoid using “you” statements.  The following statement 
can help you when talking about your feelings. 
“I am worried about____.  I would like to talk with you about this.  I 
feel____ when you____.  I’d prefer if____.” 
 
 Learn to say “no”:  Sometimes we have a difficult time saying “no” to our loved ones and friends.  
We may feel guilty because we are unable to do what we usually do.  During your cancer treatment, 
it is important not to push yourself beyond your physical or emotional limits. 
Example:  I feel badly that I cannot play with you today, but I am not feeling well now.  Please play 
with your aunt.  We can play in a few days when I’m feeling better.  
 

 
 
 
 
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PCORI Research Plan                                                                                                                                               
 
 
 
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 Ask others for help when you need it:  If you need help with housework, cooking or taking care of 
your children, it is important to ask for help from your partner, mother, sister, aunt, or friend. 
Example: I feel badly that I am unable to cook the first few days after my chemotherapy.  Can you 
cook today or ask your mother to cook on the days after my treatment? 
 
 
We will now have you practice your communication skills. Take out Activity 5.1 “Practicing Good 
Communication Skills.”  Now think of a situation in which you had trouble communicating your concerns or 
needs related to your cancer with one of your family members.  Answer the following questions about that 
situation.  I will help you by writing down your answers for you if you like.   
 
Activity 5.1 Practicing Good Communication Skills 
 
Instructions:  Think of a situation in which you had trouble communicating your concerns or needs related to 
your cancer with one of your family members.  Answer the following questions about that situation.   
 
 
1. Describe a situation in which you have had thoughts or concerns about your cancer that you would like to 
share with one of your family members, but have had trouble doing that. 
_____________________________________________________________________________________
_____________________________________________________________________________________ 
 
2. How might you start the conversation with them? 
 
_____________________________________________________________________________________
_____________________________________________________________________________________ 
 
3. List the positive and negative things that might happen if you share this with others. 
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________ 
 
 
4. After you talk with the other person, list the positive and negative things that actually happened. 
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________ 
 
Talking about cancer with my family  
 
 
NOTE TO INTERVENTIONIST  
Next you will help the survivors practice their communication skills.  Take out Activity 5.1 “Practicing 
Good Communication Skills.” Ask them to talk about a situation in which they had trouble 
communicating their concerns or needs related to their cancer with one of their family members.   
NOTE TO INTERVENTIONIST  
Have the survivors role play the situation that they described in Activity 5.1 “Practicing Good 
Communication Skills.” Give her positive feedback for following the communication tips in this 
section (stay calm, clear voice). 

 
 
 
 
PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE): Graves, Kristi, Dove 
 
 
PCORI Research Plan                                                                                                                                               
 
 
 
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How to deal with criticism 
 
No one likes to be criticized, but it happens.  At one time or another, a family member or friend will criticize us 
either fairly or unfairly.  The following are things that you can do that may help you when someone criticizes 
you: 
 
 Listen objectively to what they have to say  
 Stay relaxed. Take deep breaths 
 Decide whether the criticism is justified or not 
 Summarize what you have heard to be sure you understand 
 Tell them you would like to think about it and discuss it at a later time 
 Ask for specific examples of the behavior which is being criticized 
 Ask for suggestions in how to change the behavior if you feel they are right  
 If you disagree, tell them you respect their opinion, but don’t agree 
 
Example 
 If you agree, you can say, “Yes, I do that sometimes.” 
 If you disagree, you can say, “No, I don’t agree that I am taking advantage of my illness.” 
Remember by expressing what you want and how you feel in a respectful way, you can improve your 
relationships with others. 
 
 
5.5. GETTING THE SUPPORT YOU NEED 
 
We all need support from others.  Support can come from family, friends, neighbors, co-workers, support 
groups, spiritual leaders and/or healthcare providers.  In general, the stronger your support system, the better 
you will be able to face tough situations and address any problems. 
 
 
 
Who are the people who give you support and help you when you have problems? 
 
To help you identify sources of support that you may not have thought about, we will do an activity together.  
NOTE TO INTERVENTIONST  
Ask the survivors if they remember a recent time when they felt they were being criticized.  Practice 
with them how they might tell the person they disagrees in a respectful way. 
NOTE TO INTERVENTIONIST  
For Activity 5.3 “People in My Life and the Ways They Support Me” you will ask the survivor to identify 
their sources of support (people) for each square.  It’s ok to have the same person in more than one 
square. 

 
 
 
 
PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE): Graves, Kristi, Dove 
 
 
PCORI Research Plan                                                                                                                                               
 
 
 
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Activity 5.3 People in My Life and the Ways They Support Me 
INSTRUCTIONS:  Each square is for a different type of support that people can give you.  Think about the 
people who fit each square and write their names in the square. The same person can be written in more than 
one square.  
 
PRACTICAL SUPPORT  
Who will you ask to:  
- drive you to the hospital?  
- call to help you with chores?  
 
_____________________________________
_____________________________________
__________________________________ 
ADVICE OR INFORMATION  
Who will you ask for advice/information  
- when you don’t feel well?  
- when you don’t understand how to do 
something?  
_____________________________________
_____________________________________
__________________________________ 
COMPANIONSHIP  
Who will:  
- walk around the park with you?  
- spend the afternoon with you?  
 
_____________________________________
_____________________________________
__________________________________ 
EMOTIONAL SUPPORT  
Who will you look to for: 
- encouragement?  
- help you when you are feeling down?  
 
_____________________________________
_____________________________________
__________________________________  
 
 
5.6. RECAP  
 
Thank you for continuing with the program.  It is very important that you finish the whole program.  Let’s briefly 
go over what we have covered this section.   
 
 Do you remember some of the ways you can help your family deal with your illness? 
 What are some good tips for expressing your feelings to others? 
 Who can you ask for help when you need it? 
 
 

 
 
 
 
PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE): Graves, Kristi, Dove 
 
 
PCORI Research Plan                                                                                                                                               
 
 
 
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Example PCI Caregiver Session: Communication 
 
Overview:  
In this section we will learn about how cancer may affect you, the person you are caring for, other family and 
friends and how you communicate with one another. Good communication can help keep your relationships 
strong and healthy!  
 
What we will do: 
 
Today we will talk about some things you can do to keep good communication. We will discuss and practice 
how to express your feelings and what you need in a way that is respectful to you and to others. We will also 
talk about asking for help, which is not always easy when we are the ones to usually take care of things! 
 
Core Learning Questions:  
 
 How do I talk to the person I’m caring for about her cancer?  
 How do I express my feelings and needs in a way that is respectful? 
 How do I get the support I need to cope with my caregiving responsibilities?  
 
Activities for Communication Session:  
 
 Activity 1 Practicing Good Communication Skills 
 Activity 2 People in My Life and the Ways They Support Me 
 
 CANCER AND YOUR FAMILY  
 
A diagnosis of cancer affects the entire family, and they may feel many of the same emotions (fear, panic, 
anger, sadness, depression) as the person diagnosed with cancer.  Many changes can take place.  Some 
changes may be difficult, and some may be positive. For example:  
 Roles and responsibilities within the family may change. 
 Those who provide a steady income for their families may face 
economic problems.  
 Some family members may resent the way in which breast 
cancer has changed their lives, or some family members may 
realize that they cannot take their family member’s or their own 
health for granted in the future. 
 Older children may have to leave school to work to help the family. 
 Some family members may feel unsure about how to help and what to say. 
 Some survivors may not want to cause worry in their caregiver or their family by talking about their 
feelings or thoughts about cancer.  

 
 
 
 
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PCORI Research Plan                                                                                                                                               
 
 
 
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 Some caregivers may themselves feel tired or over stressed but may not want to share these 
feelings with the survivor for fear of making her feel bad. 
 An illness can increase tension and conflicts that may have existed prior to the diagnosis, or 
sometimes an illness can bring family members closer together. 
 Some couples may have difficulties with sexual intimacy while others grow closer with increased 
communication. For male caregivers, there may be concern over whether they will still be attracted 
to their partners after her breast cancer treatment.  
 
 
How has your friend/family member’s diagnosis affected her family or husband/partner?  
 
Children 
Children have different verbal skills and different abilities to understand concepts, such as illness, depending 
on their age.  For example, a child who is 5 years old will have difficulty understanding how long a week or a 
month is.  On the other hand, older children or teenagers who have a good understanding of these concepts 
will feel talked down to if they are not provided with the information they need to understand what is going on in 
their family. 
 
Young children 
 
Children as young as 2 feel the impact of a cancer diagnosis.  Many times parents will try to protect their 
children by not talking about their illness.  However, even young children will sense that something in the home 
has changed.  Additionally, young children go through a period in which they feel responsible for everything 
that happens around them.  It is therefore important for parents to reassure their children that their illness is not 
their fault. 
 
A parent knows their children better than anyone else, and can better judge if there are drastic changes in the 
child.  The following are changes to look out for in young children: 
 Bed-wetting or thumb sucking when they have outgrown these behaviors 
 Hitting their brothers or sisters or aggression toward classmates 
 Nightmares or problems sleeping 
 Over-clinging to mother 
 Sadness, being withdrawn 
 Drastic changes in appetite 
 
 
 
 
NOTE TO INTERVENTIONIST 
Ask the caregivers how their family member or friend’s diagnoses have affected their families.  For 
families with children, ask about their ages (and review sections that apply).  

 
 
 
 
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PCORI Research Plan                                                                                                                                               
 
 
 
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Teenagers 
 
Adolescence is a critical time in a teenager’s development and support is vital to help them adjust.  Although 
teens go through a phase where they need to be more independent, they still have a very strong need to feel 
safe within their family.  Therefore, teens may have a more complicated emotional reaction to a parent’s illness.  
The following are changes to look for in teens: 
 
 Changes in school performance (drop in grades)  
 Skipping school 
 Substance abuse (alcohol or drugs) 
 Anger 
 Depression 
 
How you can help her/your children 
 
Although it may seem difficult, you need to talk openly with the children about your friend/family member’s 
cancer.  Here are some things you can do to help her/your children deal with her illness. 
 
 Talk openly to the children in language they understand. 
 Prepare the children for physical changes that may occur 
because of cancer treatment such as hair loss, weight loss, 
or fatigue. 
 You can increase the psychological well-being of the children 
by increasing your own. 
 Try to maintain the family’s normal routine.  
 If you see extreme changes in behaviors, consult an expert who has experience in working with 
children. 
 
 
 
 
 
What are some ways you can help her/your family? 
 
Other family members and close friends 
 
Other family members, like siblings, parents, cousins and even close friends are also affected by the survivor’s 
cancer diagnosis. You may be upset and concerned about the survivor’s health and if she will get better. You 
may also want to help but be unsure of the best way how. It may be difficult for you to talk with the survivor or 
others in your family for fear of causing more worry. You may be taking on some of the tasks or roles that the 
survivor had before, or you may feel like you need to be the strong person in the family. You may not want to 
show your emotions to others – or you may not want the survivor to share her emotions or tell others about her 
NOTE TO INTERVENTIONIST  
Ask the caregiver to talk about a few of the ways they can help the family and 
communicate with them.  

 
 
 
 
PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE): Graves, Kristi, Dove 
 
 
PCORI Research Plan                                                                                                                                               
 
 
 
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cancer since it is so personal. These changes can be hard for everyone, but there are ways to make it easier 
to talk about difficult topics (see section 5.4). 
 
Husbands or partners 
 
Treatment for breast cancer may result in changes in your partner’s body.  Unpleasant side effects because of 
a mastectomy, lumpectomy or chemotherapy can be difficult.  These side effects can change how she feels 
physically and emotionally.  Some of these side effects may include hair loss, breast removal, depression, or 
loss of sexual urge.  Women may feel less feminine and less attractive.  Sometimes these feelings are difficult 
for her to talk about with you. Sometimes, you may not want her to talk about her illness to other people or 
even to other family members.    
 
Are you worried about how your partner’s body may change because of her cancer treatments? 
Examples:  I worry that she will… 
 Gain or lose weight 
 Have one or both breasts removed 
 Have a scar 
 Not be attractive to me 
 Lose all of her hair or not have her hair grow back the same way 
What feelings do you have related to the changes in her body?  
 
Examples 
 None 
 I feel depressed about her hair loss 
 I feel she is less of a woman without one (two) breasts 
 I don’t feel attracted to her anymore 
 I’ve lost my sexual urge 
 
How you can help your partner 
 
Miscommunication with our partners can lead to misunderstandings and resentments. Partners who feel they 
do not know what to say often stop communicating altogether or keep their distance.  Some women may 
interpret their partner’s silence as being insensitive and non-supportive.  Here are some tips on how to 
communicate with your partner:  
 
 Create a safe space.  Make sure the place you choose for your talk is private. 
 Pick a time to talk when you and your partner are not stressed out, exhausted and won’t be 
interrupted by phone calls or children.  
 Don’t talk about your feeling before, during or after having sexual relations.   
 Discuss fears of rejection with your partner. 

 
 
 
 
PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE): Graves, Kristi, Dove 
 
 
PCORI Research Plan                                                                                                                                               
 
 
 
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 Set aside some special time for just the two of you.  
 Talk about ways to put more fun into your sexual relations. 
 Help each other understand what you do and do not enjoy. If you 
just want to kiss, hug and cuddle without sexual relations, let your 
partner know. There are many ways to feel close and connected. 
 If you feel your relationship is in trouble, talk openly about the 
problems that exist rather than pretending everything is fine. 
 
5.4. THE IMPORTANCE OF EFFECTIVE COMMUNICATION 
 
You have a right to your feelings and a right to talk about them.  You also have a right to ask for help from 
others when you need it.  Below are some suggestions that may help you communicate better with others: 
 
 Stay calm:  Try to remain calm so that you do not forget what you want to say.  
 Maintain eye contact:  Look into their face to get their attention.  They may not take you seriously 
or they might stop listening if you are looking in another direction.  
 Use a clear voice:  Speak in a tone of voice that is clear and firm.  If you speak too softly or shout 
and yell the person will stop listening. 
 Learn how to express your feelings:  Express your feelings using “I” statements and avoid using 
“you” statements.  The following statement can help you when talking about your feelings. 
“I am worried about____.  I would like to talk with you about this.  I feel____ when you____.  I’d 
prefer if____.” 
 
 Learn to say “no”:  Sometimes we have a difficult time saying “no” to our loved ones and friends.  
We may feel guilty because we are unable to do what we usually do.  Caregiving is a difficult job 
and it is important not to push yourself beyond your physical or emotional limits. 
Example:  I feel badly that I cannot get together with you today, but I am 
very busy with other responsibilities. We can get together in a couple of 
weeks when things have calmed down.  
 
 Ask others for help when you need it:  If you need help with housework, 
cooking or taking care of your children, it is important to ask for help from 
your family or friends. 
 
We will now have you practice your communication skills. Take out Activity 5.1. Think of a situation in which 
you had trouble communicating your concerns or needs to someone.  Answer the following questions about 
that situation.  
NOTE TO INTERVENTIONIST  
Next you will help the caregiver practice his/her communication skills.  Take out Activity 5.1 
“Practicing Good Communication Skills.” Ask him/her to talk about a situation in which he/she had 
trouble communicating his/her concerns or needs related to his/her caregiving with one of her family 
members or friends.  Help him/her by writing down his/her answers for him/her.   

 
 
 
 
PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE): Graves, Kristi, Dove 
 
 
PCORI Research Plan                                                                                                                                               
 
 
 
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Activity 5.1 Practicing Good Communication Skills 
 
Instructions:  Think of a situation in which you had trouble communicating your concerns or needs related to 
your cancer with one of your family members.  Answer the following questions about that situation.   
 
 
 Describe a situation in which you have had thoughts or concerns about your cancer that you would like to 
share with one of your family members, but have had trouble doing that. 
_____________________________________________________________________________________
_____________________________________________________________________________________ 
 
 How might you start the conversation with them? 
 
_____________________________________________________________________________________
_____________________________________________________________________________________ 
 
 List the positive and negative things that might happen if you share this with others. 
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________ 
 
 
 After you talk with the other person, list the positive and negative things that actually happened. 
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________ 
 
Talking about cancer with my family/friends  
 
 
NOTE TO INTERVENTIONIST  
Have the caregivers role play the situations that they described in Activity 5.1 
“Practicing Good Communication Skills.” Give positive feedback for following the 
communication tips you in this section (stay calm, clear voice). 

 
 
 
 
PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE): Graves, Kristi, Dove 
 
 
PCORI Research Plan                                                                                                                                               
 
 
 
52
How to deal with criticism 
 
No one likes to be criticized, but it happens.  At one time or another, a family member or friend will criticize us 
either fairly or unfairly.  The following are things that you can do that may help you when someone criticizes 
you: 
 
 Listen objectively to what they have to say  
 Stay relaxed. Take deep breaths 
 Decide whether the criticism is justified or not 
 Summarize what you have heard to be sure you understand 
 Tell them you would like to think about it and discuss it at a later time 
 Ask for specific examples of the behavior which is being criticized 
 Ask for suggestions in how to change the behavior if you feel they are right  
 If you disagree, tell them you respect their opinion, but don’t agree 
 
Example 
 If you agree, you can say, “Yes, I do that sometimes.” 
 If you disagree, you can say, “No, I don’t agree that I am not doing enough to help. 
Remember by expressing what you want and how you feel in a respectful way, you can improve your 
relationships with others. 
 
5.5. GETTING THE SUPPORT YOU NEED 
 
We all need support from others.  Support can come from family, friends, neighbors, co-workers, support 
groups, spiritual leaders and/or healthcare providers.  In general, the stronger your support system, the better 
you will be able to face tough situations and address any problems. 
 
 
 
Who are the people who give you support and help you when you have problems? 
 
To help you identify sources of support that you may not have thought about, we will do an activity together.  
 
NOTE TO INTERVENTIONST  
Ask the caregivers if they remember a recent time when they felt they were being criticized.  Practice 
how they might respond.  
NOTE TO INTERVENTIONIST  
For Activity 5.3 “People in My Life and the Ways They Support Me” you will ask the caregivers to 
identify their sources of support (people) for each square.  It’s ok to have the same person in more than 
one square. 

 
 
 
 
PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE): Graves, Kristi, Dove 
 
 
PCORI Research Plan                                                                                                                                               
 
 
 
53
 
Activity 5.3 People in My Life and the Ways They Support Me 
INSTRUCTIONS:  Each square is for a different type of support that people can give you.  Think about the 
people who fit each square and write their names in the square. The same person can be written in more than 
one square.  
 
 
PRACTICAL SUPPORT  
Who will you ask to:  
- help with getting the survivor to the hospital?  
- call to help you with chores?  
 
_____________________________________
_____________________________________
__________________________________ 
ADVICE OR INFORMATION  
Who will you ask for advice/information  
- when you feel overwhelmed?  
- when you don’t understand how to do 
something?  
_____________________________________
_____________________________________
__________________________________ 
COMPANIONSHIP  
Who will:  
- walk around the park with you?  
- spend the afternoon with you?  
 
_____________________________________
_____________________________________
__________________________________ 
EMOTIONAL SUPPORT  
Who will you look to for: 
- encouragement?  
- help you when you are feeling down?  
 
_____________________________________
_____________________________________
__________________________________  
 
 
5.6. RECAP AND SCHEDULE NEXT SESSION 
 
Thank you for continuing with the program.  It is very important that you finish the whole program.  Let’s briefly 
go over what we have covered this section.   
 
 Do you remember some of the ways you can help your family/friends deal with your family 
member/friend’s illness? 
 What are some good tips for expressing your feelings to others? 
 Who can you ask for help when you need it? 
 
 
 

 
 
 
 
PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE): Graves, Kristi, Dove 
 
 
PCORI Research Plan                                                                                                                                               
 
 
 
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Appendix B: Draft Qualitative Interview Guide 
 
Conducted in person or by telephone by trained bilingual and bicultural interviewer. Guide will be refined at 
initial team meeting with input from all team members.  
 
Qualitative Interview with Survivor-Caregiver Dyads 
 
Thank you again for being a part of this study.  I will begin today by talking with you both individually and then 
we will complete a joint interview together.   
 
Please remember that you can skip any question you do not want to answer.  Also, I would like to tape record 
this interview to help us get down everything that you say. Only an ID number will be associated with this 
information. After we are done getting down the comments today, we will destroy this tape. 
 
 Is it ok to tape our interview now?    ____ Yes           
                                                           ____ No (can still proceed, but without taping interview) 
 
Thanks, ok, let’s begin. 
 
First, I will start with the individual interview with the survivor (have caregiver go into another room or get off of 
the telephone). 
 
1.  When you think about your diagnosis of cancer, what comes to mind as being most important for your 
current health? Why? 
a. Probe: Mental Health? Physical Health? Spiritual Health? 
2. When you think about the people in your life, who do you turn to when you want to talk about things? 
Who provides you with help? What type of help do they provide? What type of support has been most 
helpful for you? 
a. Probe: Emotional support? Help getting places, groceries, cleaning etc (instrumental support)? 
3. In what ways, if any, has your relationship with [Caregiver’s name] changed since you were diagnosed? 
a. Probe: Tell me what is the same about how you two talk now?  Tell me what is different about 
how you two talk now? 
b. How deeply are you able to share your feelings and thoughts about things going on in your life 
with [Caregiver’s name]? 
4. How has your level of stress been since your diagnosis / treatment? What things do you do to help you 
feel better? What happens in your life to make things worse? 
 
 
Thank you so much for sharing your thoughts and feelings.  I will now conduct the individual interview with 
[Caregiver’s name] (have survivor leave room or get off of the telephone). After that is completed, we will 
complete a joint interview with both of you.  
 
1. When you think about your current health, what factors come to mind as being most important? Why? 
a. Probe: Mental Health? Physical Health? Spiritual Health? 
2. When you think about the people in your life, who do you turn to when you want to talk about things? 
Who provides you with help? What type of help do they provide? What type of support has been most 
helpful for you? 
a. Probe: Emotional support? Help with getting places, grocers, etc (instrumental support)? 
3. In what ways, if any, has your relationship with [Survivor’s name] changed since she was diagnosed? 

 
 
 
 
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PCORI Research Plan                                                                                                                                               
 
 
 
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a. Probe: Tell me what is the same about how you two talk now?  Tell me what is different about 
how you two talk now? 
b. How deeply are you able to share your feelings and thoughts about things going on in your life 
with [Survivor’s name]? 
4. How has your level of stress been since [Survivor’s name] diagnosis / treatment? What things do you 
do to help you cope? What happens in your life to make things worse? 
 
Thank you so much for sharing your thoughts and feelings (bring survivor back into the room or have her get 
back on the telephone).   
 
Great, I will now conduct the joint interview with both of you.  
 
1. What has been most helpful for both of you in coping with [Survivor’s name] diagnosis and treatment?  
a. Probe: Treatment and support from doctors? Support from family and friends? Support from 
colleagues? Faith or religious community? 
2. Tell me your thoughts about talking with doctors about [Survivor’s name] diagnosis and treatment.  
a. Probe: What information was easy to understand? What information was hard to understand? 
Was there anything you found particularly helpful or confusing? 
3. Tell me about the sources of support that have been most helpful to you.  
a. Probe: Patient advocate or navigator? Nurses or doctors? Support group? Family or friends? 
Colleagues? Faith or religious community? 
4. To the caregiver: What would you want to tell other Latina women who get diagnosed with breast 
cancer? 
5. To the survivor: What would you want to tell other caregivers for Latina breast cancer survivors? 
6. For both: Share with me how cancer has impacted your relationship.  
7. Now I would briefly like to show you [read to you] a list of topics we are thinking about for a program to 
help Latina breast cancer survivors and their caregivers. As you look through [listen], I would like for 
you to think about if there are any other topics that might be helpful for us to include in the program.  
1. The impact of cancer in the family 
2. Stress management 
3. Anger management 
4. Improving communication: family, friends, providers 
5. Intimacy after cancer: emotional and sexual 
6. Spirituality and cancer 
7. Balancing emotional and physical needs 
8. Role changes 
9. End of life issues (putting our lives in order) 
10. Understanding distress 
11. Including others in helping caregivers 
8. Are there topics we have left out?  
9. What topics do you think would be most important to you [read list again as needed]. 
 
 
 
Those are all of my questions.  Do you have any other comments or questions for me that you would like to 
share? Any feedback on how we can better support Latina breast cancer survivors and their caregivers? 
 
Thank you again for your time and participation.  As a small thank you, we do provide a $20 gift card in 
appreciation of your time.  Would you prefer one for Safeway Foods (or local store), Amazon or Target? 
 

 
 
 
 
PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE): Graves, Kristi, Dove 
 
 
PCORI Research Plan                                                                                                                                               
 
 
 
56
 
Appendix C: Treatment Fidelity Plan 
 
STRATEGIES TO ENHANCE TREATMENT FIDELITY 
 
Design of Study 
Goal 
 
Strategies for Implementation 
 
 
Monitor treatment 
dose for survivors 
in PCI and UC 
conditions. 
Trained interventionists will follow manualized treatment 
protocols for PCI and will complete quality assessment forms 
following each session. Length of session and number of 
attendees at each session will be tracked for all participants. 
Trained study personnel will closely monitor use of any support 
services by UC survivors and UC caregivers. We will also track 
usage of any support services or programs through study 
assessments.  
 
 
Plan for 
implementation 
setbacks. 
Identify experienced bilingual and bi-cultural individuals who 
can be trained as needed if one of the study interventionists 
becomes unavailable. Additional training resources to be 
provided by institutional support from GUMC as needed. This 
plan will ensure adequate interventionist training and coverage. 
Monitoring and 
Improving 
Interventionist 
Training 
Goal 
 
Strategies for Implementation 
 
 
Standardize 
training. 
Conduct training in-person at the same time. The 2-day training 
session will include a study overview and mock sessions with 
interventionists. GU PI and Co-Investigators and Site PIs will 
observe and provide feedback of mock training sessions, with 
input from co-investigators and consultants. Training will use 
standardized training manuals for all research personnel. 
 
 
Ensure 
interventionist skill 
acquisition. 
Interventionists will complete two mock sessions during 
training. Sessions will be scored for adherence according to an 
a priori checklist. Intervention delivery checklists will be 
reviewed by team investigators at weekly team meetings.  
 
Minimize “drift” in 
interventionists’ 
skills. 
Conduct annual booster training sessions to review 
interventionist identified problems and review protocol. Conduct 
weekly meetings with research staff.  
 
 
Accommodate team 
members’ 
differences. 
Evaluate effectiveness of assessment interviews of research 
assistants via periodic monitoring of telephone interviews. 
Provide intensive training to all study personnel according to 
needs, background, or clinical experience. Review 
interventionist experiences in team meetings and address as 
needed. 

 
 
 
 
PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE): Graves, Kristi, Dove 
 
 
PCORI Research Plan                                                                                                                                               
 
 
 
57
 
Monitoring and 
Improving Delivery 
of Treatment 
Goal 
Strategies for Implementation 
 
Control for 
interventionists’ 
differences. 
Assess participants’ perceptions of interventionists’ warmth and 
credibility via self-report satisfaction questionnaire and provide 
feedback to interventionists. Include in analyses if appropriate. 
Monitor participant complaints.  Have different co-investigators 
evaluate session notes and intervention delivery checklists.  
 
Reduce differences 
within treatment. 
Use treatment manual and handouts for PCI condition.  
 
Ensure adherence 
to treatment 
protocol. 
Interventionists will complete a checklist of intervention 
components delivered after each session for all groups. 
 
Minimize 
contamination 
between conditions. 
Emphasize in training sessions the rationale for keeping 
conditions separate. As survivors and caregivers in the UC 
condition are not exposed to in any way to manualized group 
sessions, contamination concerns are lessened. We will track 
usage of other support programs by all participants.  
Monitoring and 
Improving Receipt 
of Treatment 
Goal 
Strategies for Implementation 
 
Ensure participant 
comprehension. 
Assess skills and functioning at baseline (e.g., self-efficacy for 
communication, social support, distress). Intervention includes 
the practice of skills and behavioral strategies within each 
group session. Have interventionist ask questions/use prompts 
that ask participants to paraphrase/summarize content. Record 
interventionists’ perceptions of participant understanding after 
each session. 
 
Maximize 
participant ability to 
use skills. 
Measure mediating variables immediately post-intervention and 
6-months post intervention.  Ask participants to provide 
feedback on their ability to understand and use materials. 
Monitoring and 
Improving 
Enactment of 
Treatment Skills 
Goal 
Strategies for Implementation 
 
Ensure participant 
ability to perform 
behavioral skills. 
Monitor homework completion and engagement in session 
discussion.  
 
Strategies adapted from recommendations provided in Bellg AJ, Borrelli B, Resnick B, Hecht J, Minicucci DS, 
Ory M, Ogedegbe G, Orwig D, Ernst D, Czajkowski S, et al. Enhancing treatment fidelity in health behavior 
change studies: best practices and recommendations from the NIH Behavior Change Consortium. Health 
Psychol 2004;23(5):443-451. PMID:15367063. 
 
 
 
 
 

 
 
 
 
PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE): Graves, Kristi, Dove 
 
 
PCORI Research Plan                                                                                                                                               
 
 
 
58
Appendix D: Draft Baseline Interview 
 
INSTRUCTIONS READ BY RESEARCH ASSISTANT: This questionnaire is for Latina Breast Cancer survivors 
and their caregivers. Remember that you can skip any question you do not want to answer. We will not have 
your name or information with your responses. There are no right or wrong answers. Thank you.  
 
                              
SECTION A:   BREAST CANCER MEDICAL QUESTIONS – Survivors Only 
 
When you were diagnosed with breast cancer, and where did you live at the time of diagnosis?   
 
 
 
Date  _______/ _______          State and Country ______________ 
                        Month / Year 
 
How old were you when you were diagnosed? ________ years 
  
Please choose one response, indicating, Yes or No. 
 
Was your cancer bilateral (in both breasts)? 
Yes 
No  
Unsure 
N/A 
Do you remember the grade or stage of your cancer when it was diagnosed?  
   (Grade 0,  1,  2,  3, 4  / Stage 0, I, II, III, IV) 
        If Yes, what grade or stage was the cancer at the time of 
diagnosis ?_______ 
Yes 
No  
Unsure 
N/A 
Did your cancer spread to your lymph nodes?   
Yes 
No  
Unsure 
N/A 
Do you remember the size of your tumor?    
        If Yes, what was the size of your tumor? ____ 
 
Yes 
No  
Unsure 
N/A 
Have you ever been diagnosed with breast cancer a second time?  
 
        If Yes, how old were you at your 2nd diagnosis? _____ years 
 
        Was this a recurrence of the original cancer or a new primary diagnosis?  
 
        ______ Recurrence     _____ New Primary     ______ Don’t know 
Yes 
No  
Unsure 
N/A 
Have you had any other type of cancer?  If Yes, please specify: 
_______________ 
Yes 
No  
Unsure 
N/A 
Did you have radiation therapy for your breast cancer?     
Yes 
No  
Unsure 
N/A 
Are you still receiving radiotherapy?    
Yes 
No  
Unsure 
N/A 
Did you have chemotherapy for your breast cancer?    
 
Yes 
No  
Unsure 
N/A 
Are you still receiving chemotherapy?     
Yes 
No  
Unsure 
N/A 
Did you take any hormone treatment for your breast cancer  
     (For example, Tamoxifen, Femara, Arimidex or Aromasin)?      
               If Yes, for how long? __________ (months / years) 
               
               If Yes, are you currently taking a hormone? _____ Yes    ____ No 
                   Which one? ____________    For how long? ___________ (months 
/ years)  
Yes 
No  
Unsure 
N/A 

 
 
 
 
PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE): Graves, Kristi, Dove 
 
 
PCORI Research Plan                                                                                                                                               
 
 
 
59
Had you had surgery to treat your breast cancer?   
 
Which type of surgery have you had? 
_____  Mastectomy _____    Bilateral Mastectomy _____  Lumpectomy      
Yes 
No  
Unsure 
N/A 
Have you had reconstruction or plastic surgery? 
              If Yes, what type of reconstruction? 
_____ Breast implants    
_____ Removed tissue from other part of your body  (eg. tram flap) 
______Other (Specify): _________________________________ 
Yes 
No  
Unsure 
N/A 
Had you gone through menopause (“the change of life”) before your diagnosis?   Yes  No 
Unsure 
N/A 
Is mammography a source of stress for you? 
Yes 
No 
Unsure 
N/A 
Are your regular appointments for your follow up a source of stress?  
Yes 
No 
Unsure 
N/A 
Do your regular appointments for your follow up interfere with your usual daily 
activities? 
Yes 
No 
Unsure 
N/A 
Do you experience side effects from your breast cancer treatment that interfere 
with your regular daily activities? 
Yes 
No 
Unsure 
N/A 
Has your doctor made any specific recommendations regarding foods to eat?  
Yes 
No 
Unsure 
N/A 
Has your doctor made any specific recommendations on exercising? 
Yes 
No 
Unsure 
N/A 
 
 
SECTION B:  MEDICAL HISTORY – Survivors and Caregivers  
The next group of questions is about your medical history. I will read the list to you. Please indicate whether 
you have these problems, indicating yes or no as I read each one. 
 
Yes No 
Unsure 
Arthritis (rheumatoid and osteoarthritis) 
 
 
 
Osteoporosis 
 
 
 
Asthma 
 
 
 
Chronic obstructive pulmonary disease (COPD), acquired respiratory distress syndrome 
(ARDS) or emphysema 
 
 
 
Angina 
 
 
 
Congestive heart failure (or heart disease) 
 
 
 
Heart attack (myocardial infarct) 
 
 
 
Neurological disease (such as multiple sclerosis or Parkinson’s) 
 
 
 
Stroke or TIA 
 
 
 
Peripheral vascular disease 
 
 
 
Diabetes—types I and II 
 
 
 
Upper gastrointestinal disease (ulcer, hernia, reflux) 
 
 
 
Depression 
 
 
 
Anxiety or panic disorders 
 
 
 
Visual impairment (i.e. cataracts, glaucoma, macular degeneration) 
 
 
 
Hearing impairment (very hard of hearing, even with hearing aids) 
 
 
 
Degenerative disc disease (back disease, spinal stenosis or severe chronic back pain) 
 
 
 
Obesity and/or body mass index > 30 
 
 
 
 

 
 
 
 
PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE): Graves, Kristi, Dove 
 
 
PCORI Research Plan                                                                                                                                               
 
 
 
60
SECTION C:  ACCULTURATION – Survivors and Caregivers  
 
We would like to ask you some questions about languages you speak. Please choose one response. I will read 
the question and then the answer choices.   
 
 
Only 
Spanish 
More Spanish 
than English 
Both 
Equally 
More English 
than Spanish   
Only 
English 
Other? 
In general, what language(s) do 
you read and speak? 
1 
2 
3 
4 
5 
6 
What was the language(s) you 
used as a child 
1 
2 
3 
4 
5 
6 
What language(s) do you usually 
speak at home? 
1 
2 
3 
4 
5 
6 
In which language(s) do you 
usually think? 
1 
2 
3 
4 
5 
6 
What language(s) do you usually 
speak with your friends? 
1 
2 
3 
4 
5 
6 
In what language(s) are the T.V. 
and Radio programs you usually 
watch? 
1 
2 
3 
4 
5 
6 
 
The next questions are about your friends. Please circle your answer. 
 
 
All 
Latinos/Hispanics 
More Latinos 
than 
Americans      
About 
Half & 
Half 
More 
Americans 
than Latinos 
All 
Americans 
Other? 
Your closest friends are 
 
1 
2 
3 
4 
5 
6 
You prefer going to social 
gatherings/parties at 
which the people are 
1 
2 
3 
4 
5 
6 
If you could choose your 
children’s friends you 
would want them to be 
1 
2 
3 
4 
5 
6 

 
 
 
 
PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE): Graves, Kristi, Dove 
 
 
 
Please rate the next items about the visits with your health care provider where you talked about your breast 
cancer treatment and survivorship care plans. Please choose one answer for each item and answer every 
question.  There is no right or wrong answer; just tell us how you feel. 
 
 
 
SECTION D: COMMUNICATION WITH PROVIDERS—Survivors Only 
 
How was your health care provider at… 
 
N/A 
 
Poor 
 
Fair 
 
Good 
 
Very Good 
 
Excellent 
 
Fully understanding your fears (telling you 
that he/she really understands your fears; 
not ignoring things) 
 
 
 
 
 
 
 
 
 
 
 
 
 
Showing care and kindness (being truly 
interested; not being cold or uncaring) 
 
 
 
 
 
 
 
 
 
 
 
 
 
Being positive (having a positive way of 
talking with you; a good attitude; being 
honest but not negative about your illness) 
 
 
 
 
 
 
 
 
 
 
 
 
 
Telling you things clearly (fully 
understanding your questions, tell you 
things in a way you understand, giving you 
good and helpful information) 
 
 
 
 
 
 
 
 
 
 
 
 
 
Helping you to take control (talking with 
you about what you can do to make your 
health better; being helpful and not 
scolding you) 
 
 
 
 
 
 
 
 
 
 
 
 
 
Making a plan of action with you (talking 
about the options; including you in making 
choices as much as you want to be 
included; not ignoring your thoughts and 
feelings on things) 
 
 
 
 
 
 
 
 
 
 
 
 
 
Helping you feel calm (friendly and warm 
to you, treating you with respect, not cold 
or rushed) 
 
 
 
 
 
 
 
 
 
 
 
 
 
Letting you tell your story (letting you talk 
about your illness or fears, not interrupting 
you) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Really listening (paying close attention to 
you and what you were saying)  
 
 
 
 
 
 
 
 
 
 
 
 
 
Being interested in you as a whole person 
(asking/knowing important details about 
your life and illness, you are not “just a 
number”) 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE): Graves, Kristi, Dove 
 
 
 
I will read a list of things that other people do for us or give us that may be helpful or supportive.  Please listen to each 
statement carefully and indicate an answer that is closest to your situation.  Answering “1” would mean that you get that 
type of support “much less than you would like” and answering “5” would mean that you get that type of support “as 
much as you would like.” Answer each item as best as you can. There are no rights or wrong answers.  
 
Much less  
than I would like 
 
 
As much 
as I 
would 
like 
I have people who care about what happens to me. 
1 
2 
 3 
     4 
5 
I get love and affection. 
1 
2 
  3 
     4 
5 
I get chances to talk to someone about problems at 
work or with my homework. 
1 
2 
  3 
     4 
5 
I get chances to talk to someone I trust about my 
personal and family problems. 
1 
2 
  3 
     4 
5 
I get chances to talk about money matters. 
1 
2 
  3 
     4 
5 
I get invitations to go out and do things with other 
people. 
1 
2 
  3 
     4 
5 
I get useful advice about important things in life. 
1 
2 
  3 
     4 
5 
I get help when I’m sick in bed. 
1 
2 
  3 
     4 
5 
 
Sometimes, even when people have good intentions, they may say or do things that upset you. Think about 
the last two weeks and indicate how often the most important person in your life did the following things. Use 
the scale that ranges from: 1=Never, 2=Rarely, 3=Sometimes, 4=Often. Please circle only one response for 
each question. 
 
  
Never Rarely Sometimes Often 
How often did you feel that you had to keep your feelings about your 
breast cancer to yourself, because they made the most important 
person in your life feel uncomfortable?    
 
1 
 
2 
 
3 
 
4 
How often when you talked about your breast cancer, did the most 
important person in your life give you the idea that he/she didn't want 
to hear about your cancer?    
 
1 
 
2 
 
3 
 
4 
How often did the most important person in your life let you down by 
not showing you as much love and concern as you would have liked?   
 
1 
 
2 
 
3 
 
4 
How often has the most important person in your life really got on 
your nerves?  
1 
2 
3 
4 
 
In the previous questions can you tell me who did you rate as the most important person in your life? 
 
___ A friend   ____ Spouse    ____ Mother    ____ Father    ____Sister   _____ Other (Specify) ___________ 
 
SECTION E: SOCIAL SUPPORT – Survivors and Caregivers   
 
SECTION F: SOCIAL CONSTRAINTS—Survivors Only 

 
 
 
 
PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE): Graves, Kristi, Dove 
 
 
 
 
 
 
 
SECTION G: DYADIC COPING – Survivors and Caregivers 
 
 
 
Never true 
 
Seldom true 
Sometimes 
true 
Often True 
Always True 
My family member is willing to listen 
to me when I just need to talk 
 
 
 
 
 
 
 
 
 
 
My family member gives me a great 
deal of affection and warmth. 
 
 
 
 
 
 
 
 
 
 
My family member ignores or makes 
light of my concerns. 
 
 
 
 
 
 
 
 
 
 
My family member supports me as I 
try to cope with the illness. 
 
 
 
 
 
 
 
 
 
 
When around my family member, I 
pretend things are going better than 
they really are. 
 
 
 
 
 
 
 
 
 
 
My family member and I work as a 
team to manage the effects of the 
illness. 
 
 
 
 
 
 
 
 
 
 
My family member gives me positive 
feedback for my attempts to cope 
with the illness. 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE): Graves, Kristi, Dove 
 
 
 
 
Global Health 
Please respond to each item by choosing only one answer for each question.  
 
 
Completely 
Mostly 
Moderately 
A Little 
Not at All 
To what extent are you able to carry 
out your everyday physical activities 
such as walking, climbing stairs, 
carrying groceries, or moving a 
chair? 
 
 
 
 
 
 
Please indicate how true each statement has been for you during the past 7 days. 
 
Never 
Rarely 
Sometimes 
Often 
Always 
How often have you been bothered 
by emotional problems such as 
feeling anxious, depressed or 
irritable? 
 
 
 
 
 
 
 
None 
Mild 
Moderate 
Severe 
Very 
Severe 
How would you rate your fatigue on 
average? 
 
 
 
 
 
 
 
No 
pain 
0 
 
 
1 
 
 
2 
 
 
3 
 
 
4 
 
 
5 
 
 
6 
 
 
7 
 
 
8 
 
 
9 
Worst 
imaginable 
pain 
10 
How would you rate your pain on 
average? 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
SECTION H: QUALITY OF LIFE (PROMIS) – Survivors and Caregivers  
NOTE: These are sample items. Computerized Adaptive Testing (CAT) will generate the specific items for 
each participant based on their prior answers. This approach allows for the most precise estimates. 

 
 
 
 
PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE): Graves, Kristi, Dove 
 
 
 
Social Health 
 
Physical Health 
The following questions ask about your ability to stand and move with and without support. “Support” means 
using items such as canes, walking sticks, walkers and leg braces, or other people.  
 
Can you walk 25 feet on a level surface (with or without support)?  
Yes 
 
No 
Yes Participant receives all items;  
NoParticipant skips to question “Are you able to wash and dry your body? 
 
 
 
 
 
Excellent 
Very 
Good 
Good 
Fair 
Poor 
In general, would you say your health is: 
 
 
 
 
 
 
 
 
 
 
In general, would you say your quality of life 
is: 
 
 
 
 
 
 
 
 
 
 
In general, how would you rate your physical 
health? 
 
 
 
 
 
 
 
 
 
 
In general, how would you rate your mental 
health, including your mood and your ability 
to think? 
 
 
 
 
 
 
 
 
 
 
In general, how would you rate your 
satisfaction with your social activities and 
relationships? 
 
 
 
 
 
 
 
 
 
 
In general, please rate how well you carry 
out your usual social activities and roles. 
(This includes activities at home, at work and 
in your community and responsibilities as a 
parent, child, spouse, employee, friends, 
etc).  
 
 
 
 
 
 
 
 
 
 
 
Never 
Rarely 
Sometimes 
Usually 
Always 
I have trouble doing all of my regular 
leisure activities with others 
 
 
 
 
 
I have trouble doing all of the family 
activities that I want to 
 
 
 
 
 
I have trouble doing all of my usual 
work (include work at home) 
 
 
 
 
 
I have trouble doing all of the 
activities with friends that I want to do 
 
 
 
 
 
I have to limit my regular activities 
with friends 
 
 
 
 
 
I have to limit my regular family 
activities 
 
 
 
 
 
I have trouble doing all of the work 
that is really important to me (include 
work at home) 
 
 
 
 
 

 
 
 
 
PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE): Graves, Kristi, Dove 
 
 
 
 
Physical Health, continued
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Without any 
difficulty 
With a little 
difficulty 
With some 
difficulty 
With much 
difficulty 
Unable to 
do 
Are you able to walk a block on flat 
ground? 
 
 
 
 
 
 
 
 
 
 
Are you able to walk up and down 
two steps? 
 
 
 
 
 
 
 
 
 
 
Are you able to run at a fast pace for 
two miles? 
 
 
 
 
 
 
 
 
 
 
Are you able to do yard work like 
raking leaves, weeding, or pushing a 
lawn mower? 
 
 
 
 
 
 
 
 
 
 
 
Not at all 
Very little 
Somewhat 
Quite a lot 
Cannot do 
Does your health now limit you in 
doing strenuous activities such as 
backpacking, skiing, playing tennis, 
bicycling or jogging? 
 
 
 
 
 
 
 
 
 
 
 
Without any 
difficulty 
With a little 
difficulty 
With some 
difficulty 
With much 
difficulty 
Unable to 
do 
Are you able to wash and dry your 
body? 
 
 
 
 
 
Are you able to get in and out of bed? 
 
 
 
 
 
Are you able to bend down and pick 
up clothing from the floor? 
 
 
 
 
 
Are you able to push open a heavy 
door? 
 
 
 
 
 
Are you able to reach and get down 
an object (such as a can of soup) 
from above your head? 
 
 
 
 
 
Does your health now limit you in 
doing eight hours of physical labor? 
 
 
 
 
 

 
 
 
 
PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE): Graves, Kristi, Dove 
 
 
 
 
 
SECTION I: MENTAL HEALTH (BSI) – Survivors and Caregivers 
 
 
Now I am going to read a list of problems and complaints that people sometimes have.  Please tell me how 
much discomfort that problem has caused you in the last two weeks. Your answer choices are not at all, slightly, 
moderately or extremely.  
 
 
 
 
 
 
 
 
 
          Not at All  
Slightly    Moderately   Extremely 
 
 
 
 
 
 
 
 
             
 
 
 
 
 
Nervousness or shakiness inside ................................ 1 
2 
3 
 
4 
 
 
Suddenly scared for no reason .................................... 1 
 2 
3 
 
4 
 
Feeling lonely .............................................................. 1 
 2 
3 
 
4 
 
Feeling fearful ............................................................. 1 
2          
3 
 
4 
 
Feeling blue ................................................................. 1 
2               
3 
 
4 
 
Feeling not interested in things .................................... 1 
2               
3 
 
4 
 
Feeling tense or keyed up ........................................... 1 
2               
3 
 
4 
 
Spells of terror or panic ............................................... 1 
2               
3 
 
4 
 
Feeling hopeless about the future ............................... 1 
2               
3 
 
4 
 
Feeling so restless you couldn’t sit still.....................  .. 1   
2               
3 
 
4 
 
Feeling of worthlessness ............................................. 1 
2               
3 
 
4 
 
 

 
 
 
 
PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE): Graves, Kristi, Dove 
 
 
 
 
SECTION J: CANCER RELATED DISTRESS – Survivors and Caregivers 
 
I'm going to read a list of comments made by some people who have cancer in their family.  Please tell me 
how frequently these comments were true for you during the past seven days.  [READ STATEMENT]  
Would you say this occurred...not at all, rarely, sometimes, or often? 
 
 
 
 
Not 
 
 
Some- 
at All     Rarely 
times 
     Often 
 
I thought about it when I didn't mean to............... 
0..................1…….............3………...........5 
 
I avoided letting myself get upset when I thought about  
it or was reminded of it................................. 
0..................1…….............3………...........5 
 
I had tried to remove it from memory......................... 
0..................1…….............3………...........5 
 
I had trouble falling asleep or staying sleep, because  
of pictures or thoughts about it that came into my mind 
0..................1…….............3………...........5 
 
I had waves of strong feelings about it..................      
0..................1…….............3………...........5 
 
I had dreams about it...............................................     
0..................1…….............3………...........5 
 
I stayed away from reminders of it........................      
0..................1…….............3………...........5 
 
I felt as if it hadn't happened or it wasn't real........ 
0..................1…….............3………...........5 
 
I tried not to talk about it...................................... 
0..................1…….............3………...........5 
 
Pictures about it popped into my mind................. 
0..................1…….............3………...........5 
 
 
Other things kept making me think about it.........  
0..................1…….............3………...........5 
 
I was aware that I still had a lot of feelings about it,  
but I didn't deal with them....................... 
0..................1…….............3………...........5 
 
I tried not to think about it.......................................    
0..................1…….............3………...........5 
 
 
 
Any reminder brought back feelings about it........       
0..................1…….............3………...........5 
 
My feelings about it were kind of numb................  
0..................1…….............3………...........5

 
 
 
 
PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE): Graves, Kristi, Dove 
 
 
 
SECTION K: STIGMA SCALE—Survivors Only  
 
The following questions pertain to your feelings about your breast or mastectomy site. Please indicate the way each 
statement pertains to you personally.  When answering consider how you felt over the past month.  Using the scale 
below we would like for you to answer on a scale of 1 to 5, where 1 is never and 5 is always.  Please circle only one 
answer for each question.  
 
S: I avoid looking at my scars from breast 
surgery 
 
Never 
Almost 
never 
Sometime
s 
Almost 
always 
Always 
 
I feel less feminine since cancer 
Never 
Almost 
never 
Sometime
s 
Almost 
always 
Always 
 
I avoid physical intimacy 
Never 
Almost 
never 
Sometime
s 
Almost 
always 
Always 
 
I feel part of me must remain hidden 
Never 
Almost 
never 
Sometime
s 
Almost 
always 
Always 
 
I am afraid of touching the scars from breast 
surgery 
Never 
Almost 
never 
Sometime
s 
Almost 
always 
Always 
 
I avoid close physical contact such as hugging 
Never 
Almost 
never 
Sometime
s 
Almost 
always 
Always 
 
I would keep my chest covered during sexual 
intimacy 
Never 
Almost 
never 
Sometime
s 
Almost 
always 
Always 
 
I feel sexually attractive when I am nude 
Never 
Almost 
never 
Sometime
s 
Almost 
always 
Always 
 
 
SECTION L: MEDICAL EXPERIENCES – Survivors and Caregivers  
 
Thinking about the relationship between race or ethnicity and the American medical system in general – not just 
specific to the care you received during your breast cancer experiences—please rate how strongly you agree or 
disagree with the following statements. Your answer choices are: strongly disagree, disagree, neutral, agree, 
strongly agree, unsure, or prefer not to answer. 
 
People of my ethnic group cannot trust 
doctors and health care workers  
Strongly 
Disagree 
Disagree Neutral 
Agree 
Strongly 
Agree 
Unsure  
 Prefer 
not to 
answer   
Doctors and health care workers treat 
people of my ethnic group like “guinea 
pigs” 
Strongly 
Disagree 
Disagree Neutral 
Agree 
Strongly 
Agree 
Unsure  
 Prefer 
not to 
answer   
People of my ethnic group receive the 
same medical care from doctors and health 
care workers as people from other groups 
Strongly 
Disagree 
Disagree Neutral 
Agree 
Strongly 
Agree 
Unsure  
 Prefer 
not to 
answer   
Doctors and health care workers do not 
take the medical complaints of people of 
my ethnic group seriously 
Strongly 
Disagree 
Disagree Neutral 
Agree 
Strongly 
Agree 
Unsure  
 Prefer 
not to 
answer   
I have personally been treated poorly or 
unfairly by doctors or health care workers 
because of my ethnicity 
Strongly 
Disagree 
Disagree Neutral 
Agree 
Strongly 
Agree 
Unsure  
 Prefer 
not to 
answer   
If you don’t speak English fluently you will 
not receive the same type of care that the 
people who speaks English well 
Strongly 
Disagree 
Disagree Neutral 
Agree 
Strongly 
Agree 
Unsure  
 Prefer 
not to 
answer   

 
 
 
 
PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE): Graves, Kristi, Dove 
 
 
 
 
 
SECTION M: MEDICAL CARE EXPERIENCES – Survivors and Caregivers 
In this section, we list some more things people said about medical care. I’d like to remind you that all of your 
answers are confidential and there are no right or wrong answers to any questions. We are interested in your 
opinion. We are interested in how good or bad you feel about the overall medical care you have received from 
the doctor you see the most often. For caregivers: If you have not received care recently, think about what you 
would expect if you needed care today. Please indicate how strongly you agree or disagree with each of the 
following statements. Please choose only one response option for each question. 
 
Doctors are good about explaining the reasons for 
medical tests 
Strongly 
Disagree 
Disagree Uncertain 
Agree 
Strongly 
Agree 
I think my doctor’s office has everything needed to 
provide complete medical care. 
Strongly 
Disagree 
Disagree Uncertain 
Agree 
Strongly 
Agree 
The medical care I have been receiving is just about 
perfect. 
Strongly 
Disagree 
Disagree Uncertain 
Agree 
Strongly 
Agree 
Sometimes doctors make me wonder if their diagnosis is 
correct.  
Strongly 
Disagree 
Disagree Uncertain 
Agree 
Strongly 
Agree 
I feel confident that I can get the medical care I need 
without being set back financially.  
Strongly 
Disagree 
Disagree Uncertain 
Agree 
Strongly 
Agree 
When I go for medical care, they are careful to check 
everything when treating and examining me.  
Strongly 
Disagree 
Disagree Uncertain 
Agree 
Strongly 
Agree 
I have to pay for more of my medical care than I can 
afford. 
Strongly 
Disagree 
Disagree Uncertain 
Agree 
Strongly 
Agree 
I have easy access to the medical specialists I need.  
Strongly 
Disagree 
Disagree Uncertain 
Agree 
Strongly 
Agree 
Where I get medical care, people have to wait too long 
for emergency treatment. 
Strongly 
Disagree 
Disagree Uncertain 
Agree 
Strongly 
Agree 
Doctors act too businesslike and impersonal toward me.  
Strongly 
Disagree 
Disagree Uncertain 
Agree 
Strongly 
Agree 
My doctors treat me in a very friendly and courteous 
manner.  
Strongly 
Disagree 
Disagree Uncertain 
Agree 
Strongly 
Agree 
Those who provide my medical care sometimes hurry 
too much when they treat me.  
Strongly 
Disagree 
Disagree Uncertain 
Agree 
Strongly 
Agree 
Doctors sometimes ignore what I tell them. 
Strongly 
Disagree 
Disagree Uncertain 
Agree 
Strongly 
Agree 
I find it hard to get an appointment for medical care right 
away. 
Strongly 
Disagree 
Disagree Uncertain 
Agree 
Strongly 
Agree 
I am dissatisfied with some things about the medical 
care I receive. 
Strongly 
Disagree 
Disagree Uncertain 
Agree 
Strongly 
Agree 
I am able to get medical care whenever I need it. 
Strongly 
Disagree 
Disagree Uncertain 
Agree 
Strongly 
Agree 
 
 
 
 
 
 

 
 
 
 
PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE): Graves, Kristi, Dove 
 
 
 
                     
SECTION N: RCOPE – RELIGION AND SPIRITUALITY – Survivors and Caregivers 
 
Think about how you try to understand and deal with the worst problems in your life. Please listen to the items 
below and think about whether these statements apply to you. Please choose only one answer to indicate how 
often you have done these things to understand or deal with the worst problems in your life.  
 
I thought about how my life is part of a large spiritual force  
Not at 
all 
Somewhat 
Quite a 
bit 
A great 
deal 
I worked together with God as partners to go through the difficult 
times  
Not at 
all 
Somewhat 
Quite a 
bit 
A great 
deal 
I looked to God for strength, support, and guidance 
Not at 
all 
Somewhat 
Quite a 
bit 
A great 
deal 
I felt that the stressful situations are a way for God to punish me for 
my sins or my lack of spirituality 
Not at 
all 
Somewhat 
Quite a 
bit 
A great 
deal 
I wondered whether God had abandoned me  
Not at 
all 
Somewhat 
Quite a 
bit 
A great 
deal 
I tried to make sense of the situation without relying on God 
Not at 
all 
Somewhat 
Quite a 
bit 
A great 
deal 
Until what point does your religion play a role in understanding and 
deal with the stressful situations? 
Not at 
all 
Somewhat 
Quite a 
bit 
A great 
deal 
 
 
The next few questions are about your thoughts and opinions about learning about cancer and its impact. I will 
read you the question and then the answer choices.  
 
Learning about cancer and its impact is important for 
both my spouse and I. 
Strongly 
Disagree 
Disagree Uncertain 
Agree 
Strongly 
Agree 
Whether my [name of other person’s role: spouse/ 
partner/ sister/ mom/daughter] learns about cancer 
and its impact could affect my future too. 
Strongly 
Disagree 
Disagree Uncertain 
Agree 
Strongly 
Agree 
If my [spouse/ partner/ sister/ mom/ daughter] plans to 
learn about cancer and its impact, I would say that 
is a good idea. 
Strongly 
Disagree 
Disagree Uncertain 
Agree 
Strongly 
Agree 
I can think of reasons learning about cancer and its 
impact is important to my [spouse/ partner/ sister/ 
mom/ daughter] 
Strongly 
Disagree 
Disagree Uncertain 
Agree 
Strongly 
Agree 
          
 
 
 
SECTION O: THINKING BEYOND ONESELF - Survivors and Caregivers 

 
 
 
 
PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE): Graves, Kristi, Dove 
 
 
 
 
The following questions ask about your communications with your caregiver. On a scale of 1 to 10, 1 meaning 
“not at all confident” and 9 meaning “totally confident”, please tell me how confident you are that you can talk 
with your caregiver about the following things. 
 
SURVIVORS: I am confident in my ability to… 
How confident are 
you? 1 to 10 
N/A 
Talk with my caregiver about my cancer 
 
 
Talk with my caregiver about changes in my body due to treatment 
 
 
Talk with my caregiver (if a spouse or partner) about our sexual 
relationship 
 
 
Talk with my caregiver about my fears 
 
 
Talk with my caregiver about future appointments with my doctor 
 
 
Talk with my caregiver about getting a will or other end of life 
documents 
 
 
Talk with other members of my family about my breast cancer 
 
 
Talk with my caregiver to ask for extra help or support 
 
 
 
CAREGIVERS: I am confident in my ability to… 
How confident are 
you? 1 to 10 
N/A 
Talk with the survivor about her cancer 
 
 
Talk with the survivor caregiver about changes in her body due to 
treatment 
 
 
Talk with the survivor (if a spouse or partner) about our sexual 
relationship 
 
 
Talk with the survivor about my own fears 
 
 
Talk with the survivor about future appointments with her doctors 
 
 
Talk with the survivor about getting a will or other end of life 
documents 
 
 
Talk with other members of my family about the survivor’s breast 
cancer 
 
 
Talk with other members of my family to ask for extra help or support 
in providing care to the survivor.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
SECTION P: COMMUNICATION SELF-EFFICACY—Survivors and Caregivers  

 
 
 
 
PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE): Graves, Kristi, Dove 
 
 
 
 
The next questions are about things you might do when receiving treatment for cancer. On a scale of 1 to 9, 1 
meaning “not at all confident” and 9 meaning “totally confident, please tell me how confident you are that you 
can accomplish each behavior. 
 
 
Not at all 
confident 
 
 
 
Moderately 
confident 
 
 
 
Totally 
confident 
Maintaining independence. 
 1 
 
2 
 
3 
 
4 
 5 
 
6 
 
7 
 
8 
 9 
Maintaining a positive attitude. 
 1 
 
2 
 
3 
 
4 
 5 
 
6 
 
7 
 
8 
 9 
Accepting that I have cancer.  
 1 
 
2 
 
3 
 
4 
 5 
 
6 
 
7 
 
8 
 9 
Maintaining work activity. 
 1 
 
2 
 
3 
 
4 
 5 
 
6 
 
7 
 
8 
 9 
Asking nurses questions. 
 1 
 
2 
 
3 
 
4 
 5 
 
6 
 
7 
 
8 
 9 
Remaining relaxed throughout treatments and 
not allowing scary thoughts. 
 1 
 
2 
 
3 
 
4 
 5 
 
6 
 
7 
 
8 
 9 
Seeking support from people & groups 
outside the family. 
 1 
 
2 
 
3 
 
4 
 5 
 
6 
 
7 
 
8 
 9 
Maintaining a daily routine.  
 1 
 
2 
 
3 
 
4 
 5 
 
6 
 
7 
 
8 
 9 
Asking technologists questions. 
 1 
 
2 
 
3 
 
4 
 5 
 
6 
 
7 
 
8 
 9 
Using denial. (Putting things out of my mind 
at times) 
 1 
 
2 
 
3 
 
4 
 5 
 
6 
 
7 
 
8 
 9 
Remaining relaxed throughout treatment 
(chemotherapy, radiation). 
 1 
 
2 
 
3 
 
4 
 5 
 
6 
 
7 
 
8 
 9 
Coping with physical changes. 
 1 
 
2 
 
3 
 
4 
 5 
 
6 
 
7 
 
8 
 9 
Ignoring things that cannot be death with. 
 1 
 
2 
 
3 
 
4 
 5 
 
6 
 
7 
 
8 
 9 
Actively participating in treatment decisions. 
 1 
 
2 
 
3 
 
4 
 5 
 
6 
 
7 
 
8 
 9 
Sharing feelings of concern.. 
 1 
 
2 
 
3 
 
4 
 5 
 
6 
 
7 
 
8 
 9 
Remaining relaxed while waiting at least one 
hour for my appointment. 
 1 
 
2 
 
3 
 
4 
 5 
 
6 
 
7 
 
8 
 9 
Expressing personal feelings of anger or 
hostility. 
 1 
 
2 
 
3 
 
4 
 5 
 
6 
 
7 
 
8 
 9 
Keeping busy with activities. 
 1 
 
2 
 
3 
 
4 
 5 
 
6 
 
7 
 
8 
 9 
Finding an escape (“getting away from it all” 
at times). 
 1 
 
2 
 
3 
 
4 
 5 
 
6 
 
7 
 
8 
 9 
Reducing any anxiety with getting my blood 
drawn. 
 1 
 
2 
 
3 
 
4 
 5 
 
6 
 
7 
 
8 
 9 
 
SECTION Q: CANCER BEHAVIOR INVENTORY (MERLUZZI)—Survivors  
NOTE: We will adapt the following items based on experiences of Nueva Vida and Dr. Nápoles in 
administering these items to Latina survivors 

 
 
 
 
PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE): Graves, Kristi, Dove 
 
 
 
 
Not at all 
confident 
 
 
 
Moderately 
confident 
 
 
 
Totally 
confident 
Maintaining a sense of humor. 
 1 
 
2 
 
3 
 
4 
 5 
 
6 
 
7 
 
8 
 9 
Accepting physical changes or limitations 
caused by cancer treatment. 
 1 
 
2 
 
3 
 
4 
 5 
 
6 
 
7 
 
8 
 9 
Seeking consolation. 
 1 
 
2 
 
3 
 
4 
 5 
 
6 
 
7 
 
8 
 9 
Reducing any nausea associated with 
treatment (chemotherapy, radiation). 
 1 
 
2 
 
3 
 
4 
 5 
 
6 
 
7 
 
8 
 9 
Maintaining hope. 
 1 
 
2 
 
3 
 
4 
 5 
 
6 
 
7 
 
8 
 9 
Asking physicians questions. 
 1 
 
2 
 
3 
 
4 
 5 
 
6 
 
7 
 
8 
 9 
Doing something, anything. 
 1 
 
2 
 
3 
 
4 
 5 
 
6 
 
7 
 
8 
 9 
Managing pain. 
 1 
 
2 
 
3 
 
4 
 5 
 
6 
 
7 
 
8 
 9 
Managing nausea and vomiting. 
 1 
 
2 
 
3 
 
4 
 5 
 
6 
 
7 
 
8 
 9 
Controlling my negative feelings about 
cancer. 
 1 
 
2 
 
3 
 
4 
 5 
 
6 
 
7 
 
8 
 9 
 
 
SECTION R: FAMILISM SCALE – Survivors and Caregivers 
 
The following questions pertain to your perception of family support. Using the scale below, we would like for 
you to answer to the next statements on a scale of 1 to 10, where 1 is strongly disagree and 10 strongly agree.   
 
 
Strongly 
disagree 
 
 
 
 
 
 
 
Strongly  
agree 
A person should always live near 
his or her parents and spend time 
with them on a regular basis. 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
A person should always support 
members of the extended family, 
for example, aunts, uncles, and in-
laws, if they are in need even it is a 
big sacrifice. 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
A person should rely on his or her 
family if the need arises 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
A person should often do activities 
with his or her immediate and 
extended families, for example, eat 
meals, play games, or go 
somewhere together. 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
A person should help his or her 
elderly parents in times of need, for 
example, helping financially or 
sharing a house. 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 

 
 
 
 
PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE): Graves, Kristi, Dove 
 
 
 
 
SECTION S: CAREGIVER INVENTORY –Caregivers Only 
 
The next questions are about things you might do when caring for a person with an illness.  We are interested 
in how confident you are that you can do those things. Make sure your ratings reflect your confidence whether 
or not you have done these in the past. So, your rating should reflect your confidence that you could do these 
things in the future.. On a scale of 1 to 9, 1 meaning “not at all confident” and 9 meaning “totally confident, 
please tell me how confident you are that you can accomplish each behavior. 
 
 
Not at all 
confident 
 
 
 
Moderatel
y 
confident 
 
 
 
Totally 
confiden
t 
Coping with information overload. 
 1 
 
2 
 
3 
 
4 
 5 
 
6 
 
7 
 
8 
 9 
Listening and learning from the person as to 
how to care better for her. 
 1 
 
2 
 
3 
 
4 
 5 
 
6 
 
7 
 
8 
 9 
Letting go of things I can’t control.  
 1 
 
2 
 
3 
 
4 
 5 
 
6 
 
7 
 
8 
 9 
Expressing negative feelings about the 
illness. 
 1 
 
2 
 
3 
 
4 
 5 
 
6 
 
7 
 
8 
 9 
Maintaining hope. 
 1 
 
2 
 
3 
 
4 
 5 
 
6 
 
7 
 
8 
 9 
Being able to notice the “good moments” in 
caregiving when they occur. 
 1 
 
2 
 
3 
 
4 
 5 
 
6 
 
7 
 
8 
 9 
Allowing the person to have and express her 
own feelings. 
 1 
 
2 
 
3 
 
4 
 5 
 
6 
 
7 
 
8 
 9 
Assisting the person with activities, such as 
feeding, washing, dressing or using the toilet.  
 1 
 
2 
 
3 
 
4 
 5 
 
6 
 
7 
 
8 
 9 
Continuing to take care of yourself (for 
example: exercise, diet, sleep). 
 1 
 
2 
 
3 
 
4 
 5 
 
6 
 
7 
 
8 
 9 
Talking openly and honestly with the person. 
 1 
 
2 
 
3 
 
4 
 5 
 
6 
 
7 
 
8 
 9 
Continuing to engage in personal activities 
that you like to do. 
 1 
 
2 
 
3 
 
4 
 5 
 
6 
 
7 
 
8 
 9 
Talking about death and dying. 
 1 
 
2 
 
3 
 
4 
 5 
 
6 
 
7 
 
8 
 9 
Providing emotional support to the person I’m 
caring for. 
 1 
 
2 
 
3 
 
4 
 5 
 
6 
 
7 
 
8 
 9 
Understanding medical information from 
doctors, nurses or other sources.  
 1 
 
2 
 
3 
 
4 
 5 
 
6 
 
7 
 
8 
 9 
Seeking support for yourself. 
 1 
 
2 
 
3 
 
4 
 5 
 
6 
 
7 
 
8 
 9 
Dealing with feelings of helplessness. 
 1 
 
2 
 
3 
 
4 
 5 
 
6 
 
7 
 
8 
 9 
Dealing with the person expressing negative 
feelings toward you when they occur. 
 1 
 
2 
 
3 
 
4 
 5 
 
6 
 
7 
 
8 
 9 
Assisting and encouraging the person in 
following through with all treatments and 
taking all prescribed medications. 
 1 
 
2 
 
3 
 
4 
 5 
 
6 
 
7 
 
8 
 9 

 
 
 
 
PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE): Graves, Kristi, Dove 
 
 
 
 
Not at all 
confident 
 
 
 
Moderatel
y 
confident 
 
 
 
Totally 
confiden
t 
Asking physicians and nurses questions. 
 1 
 
2 
 
3 
 
4 
 5 
 
6 
 
7 
 
8 
 9 
Dealing with criticism from others. 
 1 
 
2 
 
3 
 
4 
 5 
 
6 
 
7 
 
8 
 9 
Maintaining a close relationship with the 
person I’m caring for. . 
 1 
 
2 
 
3 
 
4 
 5 
 
6 
 
7 
 
8 
 9 
 
This is the last section. We have some questions about you. You can skip any question you do not wish to 
answer; however this information is important for our study. 
 
What is your birth date?     _____/_____/_____ (MM/DD/YY) 
 
Which is your ethnicity? Please choose one answer. 
 
 
What is your race? I will read a list and please tell me which one best describes you.  
 
 
Check below 
Black or African American 
 
White or Caucasian 
 
American Indian/Alaska Native 
 
Asian 
 
Native Hawaiian or other Pacific Islander 
 
More than One Race 
 
Don’t Know/Unsure 
 
Prefer Not to Answer 
 
 
 
 
What is the highest grade or level of schooling you have completed? Have you completed… 
 
 
SECTION T: DEMOGRAPHICS 
Hispanic/Latino 
 1 
Non-Hispanic/Latino 
2 
 
Check below  
Check 
below 
No formal schooling 
 
11th grade 
 
1st grade 
 
12th grade 
 
2nd grade 
 
College 1 year 
 
3rd grade 
 
College 2 years 
 
4th grade 
 
College 3 years 
 
5th grade 
 
College 4 years 
 
6th grade 
 
College 5 years 
 
7th grade 
 
College 6 years  
 
8th grade 
 
Training after high school  
 
9th grade 
 
Other. Specify: ___________________ 
 
10th grade 
 
 
 

 
 
 
 
PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE): Graves, Kristi, Dove 
 
 
 
Where or in which country where you born? Were you born in…. 
 
 
 
 
How many years have you lived in the United States? _______________ 
 
What is your current work status? Please select one.  Are you… 
 
  Working part time 
  Working full time 
  Full- or part-time student 
  Retired 
  Never worked 
  Unemployed/looking for work 
 Receiving disability 
 
What is your average yearly household income (combined income of everyone living in your house)? Please 
choose the response that fits best. 
 
 
  Less than $9,999                                          $60,000-$69,999                                Don’t know 
  $10,000-$19,999                                          $70,000-$79,999                              
  $20,000-$29,999                                          $80,000-$89,999 
  $30,000-$39,999                                          $90,000-$99,999 
  $40,000-$49,999                                          More than $100,000 
  $50,000-$59,999                                          Prefer not to answer 
 
What is your current marital status? (Select one) 
 
 
 
  Single 
  Separated 
  Divorced 
  Widowed 
            Married 
           Living with a partner 
 
Do you have a doctor (primary care, family doctor) that you see regularly (routine check-ups, treatment of colds 
or minor health concerns)?        ___ Yes             ____ No 
 
Are you currently covered by health insurance?      ____ Yes           ____ No   
 
If no, skip next question. 
 
Check Below 
 
Check 
Below 
Argentina 
  
México  
 
Bolivia  
 
Nicaragua 
 
 
 
Brasil 
 
Perú 
 
 
Colombia 
  
Puerto Rico 
 
Chile  
 
Republica Dominicana 
 
Ecuador 
  
United States. Which generation you are (first, second, 
third?) Specify: _________________________ 
 
El Salvador 
 
 Other (specify) 
 
Guatemala 
 
 
 

 
 
 
 
PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE): Graves, Kristi, Dove 
 
 
 
If yes, why were you denied insurance? 
_____________________________________________________________________________
___________________________ 
What type of health insurance do you have? 
 
 
______ Group insurance (through my work or my partner’s work) 
 
 
______ Government insurance (Medicare, Medicaid) 
 
 
______ Military insurance     ______ Private insurance    
 
 
______ Not applicable; I do not currently have health insurance 
 Have you ever been denied health insurance for any reason? 
 
 
_____ Yes 
 
 
_____ No 
 
 
Is there any other thing that we hadn’t asked you that you want to share with us about what impacts our quality 
of life and your general wellness as a breast cancer survivor or caregiver? 
 
 
May we contact you in the future for other research studies? You would be free to participate or decline at 
that time.     
 ______ Yes, you may contact me about future research 
______ No, I prefer not to be contacted about future research 
 
If Yes: Can you give us other additional telephone numbers or an email address where we can contact 
you? Please note this information will not be connected with your study data.  
_____________________________________________________________________________________ 
 
 
 
 
To thank you for your time, please indicate which gift card you would like to receive:  
 
  Target Stores 
  Safeway Foods (or other local grocery store) 
  Amazon.com 
 
NOTE: These stores may change based on feedback from the team. 
 
These are all the questions that we had for you today. Thank you for taking the time to participate in this 
study. We hope that this will help other survivors and caregivers in the future.