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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
pcori research plan research strategy
part a background and significance

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 ageand 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 (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 noncancer 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 3 PROMIS. We will learn whether inclusion of a caregiver as part of a psychosocial intervention provides addedvalue 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 clinicallysignificant 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 followup 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 patientcentered 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 4 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  
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  
| 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   |
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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 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, posttraumatic 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 lowincome, 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.  
| Table 2. Results from Mente Sana/Cuerpo Sano Pilot Baseline PostIntervention % No longer  meeting  presumptive  criteria postintervention 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%   |
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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 (CoInvestigator) 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 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.  
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 culturallycompetent 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.
pcori research plan research strategy
part c approach (rigorous research

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 indepth 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).  
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, selfmonitoring, 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).  
Figure 1. Flow for Phase II RCT of PCI vs. UC  
  
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 10  
  
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  
  
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.  
| Table 4. Study Measures                                                                                                                | Baseline            | T1         | T2      |
|----------------------------------------------------------------------------------------------------------------------------------------|------------|------------|---------|
| Background Factors Sociodemographics                                                                                                   | X          |            |         |
| Medical History                                                                                                                        | X          | X          | X       |
| Cultural Factors Breast Cancer Stigma Religious Coping, Familismo Acculturation                                                        | X  X  X    |            |         |
| Medical-Contextual Factors Communication with Providers                                                                                | X          | X          | X       |
| Medical Mistrust                                                                                                                       | 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  X  X | X  X  X  X |         |
| Dyadic Factors Dyadic Support  Dyadic Perspective  Social Constraints                                                                  | X  X  X    |            |         |
| Process Variables Intervention Satisfaction                                                                                            | X          | X          |         |
| Fidelity Measures                                                                                                                      | X          | X          |         |
| T1 = Immediately Post Intervention; T2 = 6-Months Post  Intervention CompletionX  X  X X  X  X                                         |            |            |         |  
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 survivorprovider), 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 selfefficacy scale (see Appendix D). (b) **Caregiver self-efficacy** will be assessed with the 21-item Caregiver 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
pcori research plan research strategy
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 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.  Table 5. Estimated Number of  People Served. Nueva   Latinas  Vida, Inc. 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 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 inperson 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.  Annual # of Latino survivors or family  members serveda 4,000 1,000 2,000 1,200 8,200 Annual # Latina breast  230 70 215 300 815 cancer survivors served Annual # newly  diagnosed Latina breast  cancer survivors 70 50 80 100 300 Estimated Distribution of  Countries-of-Origin  among Latinos served DC Site CA NY  Estimated Site  Sites  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% a Through in-person, print or online support or educational programs. b Central American other than MexicanAscertainment, 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   |
|---|  
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 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 6months, 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 15 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. noncompleters 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 16 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 communitybased organizations reduces the sense of mistrust.18 Study interventionists will be bi-lingual and bi-cultural, further reducing barriers to participation.
pcori research plan research strategy
replication and reproducibility of research

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.
pcori research plan research strategy
dissemination and implementation assessment governance

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.
pcori research plan research strategy
figure overview of draft organizational

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 19 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.
pcori research plan research strategy
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.
pcori research plan research strategy
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.
pcori research plan research strategy
methods for disseminating and implementing

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.
pcori research plan research strategy
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Muss HB, Smith TJ, Vogel VG, Wolff AC, Somerfield MR, Davidson NE. Breast cancer follow-up and management after primary treatment: American Society of Clinical Oncology Clinical Practice Guideline Update. *J Clin Oncol,* Dec 10. [Epub ahead of print].: doi: 10.1200/JCO.2012.45.9859; 2012. PM:23129741.  
111. Sabatino SA, Thompson TD, Richardson LC, Miller J. Health insurance and other factors associated with mammography surveillance among breast cancer survivors: results from a national survey. *Med* Care, 50(3):270-276; 2012. PM:22193416.  
112. Northouse LL. Social support in patients' and husbands' adjustment to breast cancer. *Nurs Res,*
37(2):91-95; 1988. PM:3347526.  
113. Northouse LL, Mood DW, Schafenacker A, Kalemkerian G, Zalupski M, Lorusso P, Hayes DF, Hussain M, Ruckdeschel J, Fendrick AM, Trask PC, Ronis DL, Kershaw T. Randomized clinical trial of a brief and extensive dyadic intervention for advanced cancer patients and their family caregivers. Psychooncology, doi: 10.1002/pon.3036. [Epub ahead of print] 2012. PM:22290823. PMCID:PMC3387514 114. Rakowski W, Ehrich B, Dube CE, Pearlman DN, Goldstein MG, Peterson KK, Rimer BK, Woolverton H.  
Screening mammography and constructs from the transtheoretical model: associations using two definitions of the stages-of-adoption. *Ann Behav Med,* 18(2):91-100; 1996.  
115. Lepore SJ, Silver RC, Wortman CB, Waymetn HA. Social constraints, intrusive thoughts, and depressive symptoms among bereaved mothers. *Journal of Personality and Social Psychology,*
70(2):271-282; 1996.  
116. Schnur JB, Valdimarsdottir HB, Montgomery GH, Nevid JS, Bovbjerg DH. Social constraints and distress among women at familial risk for breast cancer. *Ann Behav Med,* 28(2):142-148; 2004.  
PM:15454362.  
117. Dane AV, Schneider BH. Program integrity in primary and early secondary prevention: are implementation effects out of control? *Clin Psychol Rev,* 18(1):23-45; 1998. PM:9455622.  
118. Peshkin BN, Demarco TA, Graves KD, Brown K, Nusbaum RH, Moglia D, Forman A, Valdimarsdottir H,
Schwartz MD. Telephone genetic counseling for high-risk women undergoing BRCA1 and BRCA2 testing: rationale and development of a randomized controlled trial. *Genet Test,* 12(1):37-52; 2008.  
PM:18373403.  
119. Mackinnon DP, Lockwood CM, Williams J. Confidence limits for the indirect effect: distribution of the product and resampling methods. *Multivariate Behav Res,* 39(1):99; 2004. PM:20157642. PMCID:PMC2821115 120. Siminoff LA, Ravdin P, Colabianchi N, Sturm CM. Doctor-patient communication patterns in breast cancer adjuvant therapy discussions. *Health Expect,* 3(1):26-36; 2000. PM:11281909.
pcori research plan research strategy
protection of human subjects protection

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.
pcori research plan research strategy
1. risks to the subjects

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 28 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 patientcaregiver dyads, of which we expect 100 to remain enrolled and complete the study protocol through the 6month 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.
pcori research plan research strategy
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.  
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.
pcori research plan research strategy
2. adequary of protection against

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.
pcori research plan research strategy
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 30 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, domainauthenticated 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.
pcori research plan research strategy
3. potential benefits of the

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.
pcori research plan research strategy
4. importance of the knowledge

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. 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.
pcori research plan research strategy
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 patientcaregiver 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 culturallysensitive and linguistically-appropriate care and education to cancer patients and the community.  
- 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.
pcori research plan research strategy
self-help for women with breast

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.
pcori research plan research strategy
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.
pcori research plan research strategy
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   |        |        |        |        |        |        |        |        |        |
|-----------------------------------------------------------------------|-----------------------|-----------------------|-----------------------|--------|--------|--------|--------|--------|--------|--------|--------|--------|
| Q1                                                                    | Q2                    | Q3                    | Q4                    | Q1     | Q2     | Q3     | Q4     | Q1     | Q2     | Q3     | Q4     |        |
| Task / Deliverable                                                    | 5/13 -                | 8/13 -                | 11/13-                | 2/14 - | 5/14 - | 8/14 - | 11/14- | 2/15 - | 5/15 - | 8/15 - | 11/15- | 2/16 - |
| 7/13                                                                  | 10/13                 | 1/14                  | 4/14                  | 7/14   | 10/14  | 1/15   | 4/15   | 7/15   | 10/15  | 1/16   | 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;                                              | X                     | X                     |                       |        |        |        |        |        |        |        |        |        |
| Intervention; Interventionist  Training Submit IRBs                   | X                     |                       |                       |        |        |        |        |        |        |        |        |        |
| Conduct In-Depth  Interviews                                          | X                     | X                     |                       |        |        |        |        |        |        |        |        |        |
| Develop Study Database  and Randomization                             | X                     | X                     |                       |        |        |        |        |        |        |        |        |        |
| Procedures                                                            |                       |                       |                       |        |        |        |        |        |        |        |        |        |
| 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 | X                     | X                     |                       |        |        |        |        |        |        |        |        |        |
| Development Paper                                                     |                       |                       |                       |        |        |        |        |        |        |        |        |        |
| 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, PostTest and Follow-up                                                                       | X                     | X                     | X                     | X      | X      | X      | X      | X      | X      |        |        |        |
| Assessments (GUMC) Submit Study Protocol /  Year 1 Report to PCORI    | X                     |                       |                       |        |        |        |        |        |        |        |        |        |
| PCORI Research Plan                                                   | 36                    |                       |                       |        |        |        |        |        |        |        |        |        |  
| PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE): Graves, Kristi, Dove Study Timeline YEAR 1: 5/13 - 4/14                                                                                                                 | YEAR 2: 5/14 - 4/15   | YEAR 3: 5/15 - 4/16   |        |        |        |        |        |        |        |        |        |        |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|-----------------------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|
| Q1                                                                                                                                                                                                                    | Q2                    | Q3                    | Q4     | Q1     | Q2     | Q3     | Q4     | Q1     | Q2     | Q3     | Q4     |        |
| Task / Deliverable                                                                                                                                                                                                    | 5/13 -                | 8/13 -                | 11/13- | 2/14 - | 5/14 - | 8/14 - | 11/14- | 2/15 - | 5/15 - | 8/15 - | 11/15- | 2/16 - |
| 7/13                                                                                                                                                                                                                  | 10/13                 | 1/14                  | 4/14   | 7/14   | 10/14  | 1/15   | 4/15   | 7/15   | 10/15  | 1/16   | 4/16   |        |
| Convene Annual Team  Meetingsa                                                                                                                                                                                        | X                     | X                     | X      |        |        |        |        |        |        |        |        |        |
| Continue Recruitment /  Troubleshoot if Low                                                                                                                                                                           | X                     | X                     | X      | X      | X      | X      | X      |        |        |        |        |        |
| Enrollment                                                                                                                                                                                                            |                       |                       |        |        |        |        |        |        |        |        |        |        |
| Continue RCT / Address  Implementation Issues as                                                                                                                                                                      | X                     | X                     | X      | X      | X      | X      | X      |        |        |        |        |        |
| needed                                                                                                                                                                                                                |                       |                       |        |        |        |        |        |        |        |        |        |        |
| Collect Quality Assurance  Data for Intervention                                                                                                                                                                      | X                     | X                     | X      | X      | X      |        |        |        |        |        |        |        |
| Fidelity Checks                                                                                                                                                                                                       |                       |                       |        |        |        |        |        |        |        |        |        |        |
| Convene Community  Meeting: CA                                                                                                                                                                                        | X                     | X                     | X      |        |        |        |        |        |        |        |        |        |
| Prepare and Submit                                                                                                                                                                                                    |                       |                       |        |        |        |        |        |        |        |        |        |        |
| Abstract for the National                                                                                                                                                                                             | X                     | X                     |        |        |        |        |        |        |        |        |        |        |
| Latino Cancer Summit                                                                                                                                                                                                  |                       |                       |        |        |        |        |        |        |        |        |        |        |
| Attend the National Latino  Cancer Summit                                                                                                                                                                             | X                     |                       |        |        |        |        |        |        |        |        |        |        |
| Submit Year 2 Report to  PCORI                                                                                                                                                                                        | X                     |                       |        |        |        |        |        |        |        |        |        |        |
| Discuss Dissemination  Strategies on Monthly                                                                                                                                                                          | X                     | X                     | X      | X      | X      | X      |        |        |        |        |        |        |
| Teleconferences and  Annual Team Meetings Write, Submit Manuscript  on Community-Academic                                                                                                                             | X                     | X                     |        |        |        |        |        |        |        |        |        |        |
| Partnerships: Latino Health Prepare for Final Team  Meeting; Invite other                                                                                                                                             | X                     | X                     |        |        |        |        |        |        |        |        |        |        |
| Interested Stakeholders to  Attend 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                                                                                                                                                                     | X                     |                       |        |        |        |        |        |        |        |        |        |        |
| PCORI                                                                                                                                                                                                                 |                       |                       |        |        |        |        |        |        |        |        |        |        |
| a Team Meetings will include community partners, researchers, Advisory Team members and patient advocates. These  groups are representative of patient, caregiver, provider, stakeholder and researcher perspectives. |                       |                       |        |        |        |        |        |        |        |        |        |        |  
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.  
APPENDIX
pcori research plan research strategy
appendix a. example pci survivor

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.
pcori research plan research strategy
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!
pcori research plan research strategy
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
pcori research plan research strategy
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 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.
pcori research plan research strategy
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).
pcori research plan research strategy
how has your diagnosis affected

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.
pcori research plan research strategy
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
pcori research plan research strategy
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
pcori research plan research strategy
how you can help your

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.  
NOTE TO INTERVENTIONIST  
  
Ask the survivors to talk about a few of the ways they can help their family and communicate with them.  
What are some ways you can help your family?
pcori research plan research strategy
other family members and close

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).
pcori research plan research strategy
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?
pcori research plan research strategy
how you can help your

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:  
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.
pcori research plan research strategy
5.4. the importance of effective

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.  
  
**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?
pcori research plan research strategy
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.  
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.
pcori research plan research strategy
activity 5.1 practicing good communication

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
pcori research plan research strategy
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).
pcori research plan research strategy
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 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.  
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.
pcori research plan research strategy
5.5. getting the support you

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.  
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.
pcori research plan research strategy
who are the people who

To help you identify sources of support that you may not have thought about, we will do an activity together.  
44
pcori research plan research strategy
activity 5.3 people in my

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?                                                                                                                                                             |
| _____________________________________ _____________________________________ __________________________________                                                                                             | _____________________________________ _____________________________________ __________________________________                                                                                                                                                   |
pcori research plan research strategy
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?
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!
example pci caregiver session communication
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
example pci caregiver session communication
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.  
46 Some survivors may not want to cause worry in their caregiver or their family by talking about their feelings or thoughts about cancer.  
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.
example pci caregiver session communication
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).
example pci caregiver session communication
how has your friend/family member's

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.
example pci caregiver session communication
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
example pci caregiver session communication
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
example pci caregiver session communication
how you can help her/your

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.
example pci caregiver session communication
note to interventionist

Ask the caregiver to talk about a few of the ways they can help the family and communicate with them.  
What are some ways you can help her/your family?
example pci caregiver session communication
other family members and close

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  
  
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).
example pci caregiver session communication
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
example pci caregiver session communication
how you can help your

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.  
49 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.
example pci caregiver session communication
5.4. the importance of effective

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.
example pci caregiver session communication
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.  
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.  
  
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).
example pci caregiver session communication
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 pci caregiver session communication
note to interventionst

Ask the caregivers if they remember a recent time when they felt they were being criticized. Practice how they might respond.  
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.
example pci caregiver session communication
5.5. getting the support you

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.
example pci caregiver session communication
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.
example pci caregiver session communication
who are the people who

To help you identify sources of support that you may not have thought about, we will do an activity together.
example pci caregiver session communication
activity 5.3 people in my

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?                                                                                                                                                              |
| _____________________________________ _____________________________________ __________________________________                                                                                             | _____________________________________ _____________________________________ __________________________________                                                                                                                                                    |
example pci caregiver session communication
5.6. recap and schedule next

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?
example pci caregiver session communication
appendix b draft qualitative interview

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.
example pci caregiver session communication
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.  
$$\frac{\mathrm{Yes}}{\mathrm{No}\;(\mathrm{can~still})}$$  
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?  
54 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?