Breast cancer patients in the U.S. comprise the majority of cancer survivors (about 23%) [1
]. Cancer survivors face challenges during the complex extended survivorship phase, including physical, psychological, financial, and spiritual challenges [2
]. These challenges are of special importance among Latinas who, compared to non-Hispanic Whites, are more likely to be diagnosed at an advanced cancer stage [3
]. Latina breast cancer survivors have lower survivorship knowledge and greater dissatisfaction with care information [4
], unmet physical symptom management, lack of social support, and need for formal transition to follow-up care compared to non-Latina counterparts [5
In recognition of needed support during the transition to the survivorship phase, the Institute of Medicine (IOM) recommends that upon completing treatment, cancer patients receive a comprehensive treatment summary and follow up care plans, often called a Survivorship Care Plan (SCP) [6
]. Nevertheless, since the IOM recommendation in 2005 [6
], only 20% of cancer care providers report always or almost always providing SCPs to patients [7
]. Demographic characteristics such as race/ethnicity, socio-economic status, and geographic factors may play a role in whether individuals receive an SCP. For example, rural patients may be less likely to receive an SCP than urban patients [8
] and face challenges to an optimal transition to cancer survivorship due to disproportionately low access to health care resources, low socioeconomic status, and language barriers [9
]. In addition, Latino cancer patients living in the U.S.–Mexico border region frequently seek health care on both sides of the border, which complicates care coordination [12
Intervention development and evaluation studies with Latina breast cancer survivors are needed, especially among rural Latinas where research into the unique needs for survivorship care is especially lacking. Ashing and colleagues used a community-based approach to develop a much-needed Spanish language SCP template [14
] for urban-dwelling Latinas. Additional work is needed in the SCP field to address the needs of rural low-income Latinas who may have unique linguistic, cultural, geographic, and system-level challenges to their care continuity. Culturally tailored interventions are important for reducing health disparities, yet little is known about the needs of rural Latina breast cancer patients or the effectiveness of SCP for such patients. Addressing survivors’ various concerns and unmet needs by using an SCP document alone is likely insufficient [15
]; moreover, cancer organizations have suggested developing an effective tool kit (aids) to supplement the SCP and tailor information to the specific needs and geographic location of the patient [16
]. Thus, the purpose of the present study is to describe the development of a culturally appropriate, theory driven program, called Proyecto Mariposa
(Butterfly Project) for Latina breast cancer survivors living along the U.S. side of the California and Baja California (Mexico) border. Proyecto Mariposa
included an adapted SCP document and supplemental aid.
In the current study we describe the development of Proyecto Mariposa
within the context of Intervention Mapping (IM), a systematic, theory-based approach to design, create, and implement public health programs and corresponding interventions [18
]. IM includes community-based participatory research in order to be responsive to the priorities and needs of the communities for whom the interventions are intended [19
]. To this effect, we undertook the formative research for Proyecto Mariposa
with the full participation of a rural community-based cancer organization, a cancer clinic, and input from rural Latina breast cancer survivors, their family caregivers, and clinical care team members.
The full spectrum of Intervention Mapping spans six different steps, the first four are related to the development phase (i.e., assessing community needs, creating a matrix of change objectives, application of theory and practical application, and production of the intervention), and the last two relate to the implementation and evaluation phase. This paper focuses on the development phase of the Proyecto Mariposa
SCP program (Steps 1–4) described in Table 1
where we depict the actions taken in each of the four development steps.
2.1. Step One: Needs Assessment
The first step in our IM process focused on identifying the survivorship care planning needs of Latina breast cancer survivors and the contributing factors for their active utilization of an SCP. This step involved articulating the health problem, target population, and determinants of the problem. We conducted a needs assessment using two approaches: (1) a comprehensive literature review of SCP among Latina breast cancer patients relating to patient challenges and needs for survivorship care and (2) formative qualitative research assessing determinants to utilize SCP and preferences regarding SCP layout and presentation.
2.1.1. Participants and Procedure
The setting in which this study took place is a rural area, and vastly medically underserved region located in Southern California on the U.S.–Mexico border. This area’s cancer-related mortality rates are similar to statewide rates [20
], but there are only two medical oncology clinics and one radiation clinic in the 4500 square mile county.
We conducted a qualitative study using focus groups and individual interviews with stakeholders. These included eight focus groups (n = 40) comprised of: breast cancer survivors (2 groups), family caregivers (2 groups), nurses (2 groups), medical assistants (1 group), and social work patient navigators (1 group). Individual interviews were conducted with four physicians (two oncologists and two primary care physicians). The interview guides focused on (a) participant preferences and opinions regarding types of SCP materials and layout, (b) preference for an SCP visual aid to facilitate understanding and relevance of the SCP (e.g., fotonovela, animated video, or pamphlet), and (c) other cultural considerations regarding framing of SCP messaging. From the focus groups with health care providers, we also elicited recommendations on how to optimize the clinician and patient navigator collaboration in SCP implementation.
Research team members conducted the focus groups in Spanish or English and sessions lasted up to one hour. All focus groups and individual interviews were audio-taped with participant consent and then transcribed and translated into Spanish by the research assistant. This study implemented a formative approach to develop an intervention program. The San Diego State University Institutional Review Board (IRB) reviewed and granted exemption from full IRB review. Although the study was deemed exempt, investigators chose to include a voluntary and informed consent procedure as a means to further support ethical intent for participants in their decision to participate or not. San Diego State University IRB reviewed the consent form.
2.1.2. Data Analysis of the Formative Focus Group Research
Data were analyzed using thematic analysis [21
]. Our a priori
themes included: (1) personal determinants (e.g., knowledge) and environmental factors (e.g., clinic staffing) and (2) preferences for SCP document and SCP aid. The research team reviewed all transcripts and developed and achieved a consensus on the initial coding and revised the codes as needed to achieve the final coding scheme. All research team members then independently hand coded the data. Data were later entered into Atlas.ti (v.8) [22
] to facilitate the retrieval of coded text for the selection of representative quotes. Findings were then used to guide subsequent development of the SCP document and aid as we describe in the results.
2.2. Step Two: Specifying Program Outcomes and Creating a Matrix of Change Objectives
This step described the specific desired program outcomes (e.g., behavioral, environmental), articulated the mechanism or process that was to be targeted (i.e., performance objectives), and how it would be targeted to promote the desired outcome. We then created a matrix of the program outcome by performance objectives and determinants. Who will and what is needed to achieve performance objectives for each determinant were also specified in the Matrix of Change Objectives.
2.3. Step Three: Selecting Theory-Based Methods and Design Practical Applications
We designed the program using behavioral theories that underlie the methods and practice application for behavior change. The application of theoretical constructs is important because it helps to understand and guide practical application to successfully deliver the intervention [18
]. These theoretical constructs guide us to better understand the issues related to patients’ mechanisms for SCP use, optimize factors that promote behavior change, and further suggest solutions and outcomes [18
]. In this step, theory and evidence-based methods were selected in response to determinants and performance objectives.
2.4. Step Four: Program Production
Program production involved designing and creating the Proyecto Mariposa
program by drafting SCP materials and refining a manual on how the SCP intervention would be delivered. The SCP and animated video development were responsive to cultural preferences expressed by the breast cancer survivors and their families, embodying elements of cultural tailoring that are necessary to develop culturally effective interventions [23
]. Step 4 builds on Steps 1–3 where we developed and culturally-tailored the intervention based on participant stated preferences and recommendations. Program production included conducting confirmatory focus groups with the same stakeholders from the first round of focus groups. A draft of the SCP document and a storyboard for the animated video were presented in the focus groups eliciting final feedback and suggestions prior to finalizing the intervention production. Participant recommendations were summarized and implemented to improve the SCP document and video. Once the video script was completed, we conducted a readability test using INFLESZ (v1.0). [24
] to promote patient comprehension of the content.
This article describes the application of an intervention mapping approach (development phases: Step 1 to Step 4) to develop a theory-based breast cancer SCP and educational aid for rural Latina breast cancer survivors. There was participant consensus that SCP plays an important role in filling patient information gaps and guiding patients on improved communication with their clinicians (i.e., asking question) for their survivorship care. Preferences for the SCP format (e.g., print vs. web-based) may vary by age group; however, in our breast cancer survivor focus groups, we did not find differences in preferences by age (M = 51.7; ranges 28–67 years). The SCP can provide a clinically useful summary and communication tool for both the patient and clinicians with whom the patient interacts. Stakeholder input deepened our understanding about socio-cultural and structural challenges survivors encountered and their feedback and insights directly informed the development of the SCP document itself and the educational video. A previous study with Latino cancer survivors [41
] found that addressing cultural values and concepts (e.g., familismo
) is vital to the development of a culturally effective intervention. Cultural adaptation that is responsive to a border setting is imperative for these Latina breast cancer survivors, given that they hold strong cultural values and beliefs, and many lead binational lives. Although we did not develop the SCP intervention specifically for binational use, the availability of the SCP document in Spanish can perhaps facilitate patient sharing of clinical information with their clinicians in Mexico and thereby facilitate improved continuity of care.
Through the application of entertainment education in the form of an educational video, Proyecto Mariposa
employed a theoretically driven approach to its mass communication strategy to influence Latina breast cancer survivors’ social and behavioral change to improve survivorship planning. Culturally tailored health messages with graphics and images such as those we used in Proyecto Mariposa
is particularly beneficial for individuals with low health literacy [42
]. Our video included culturally relevant and sensitive characters and storylines to which many Latina viewers could relate. This tailoring enhances the likelihood that the target population will successfully engage with this educational entertainment [44
capitalizes on the important role of the patient navigator to engage the patient in their care. Navigator-led patient activation is a key behavioral method which builds patient confidence and ability to manage their health and health care, especially among underserved cancer patients [45
]. For example, our work supported proactive behavior, an area that prior research has identified as challenging for some Latinas who have low self-efficacy regarding patient–provider communication [47
]. Our intervention is designed to facilitate patient-navigators’ support of patient self-efficacy to openly discuss difficulties and needs about their survivorship care with their providers. Patient navigators are in a unique position to go beyond traditional patient navigation activities by facilitating patient-centered care and responding to patients’ needs for information and coordination of community resources in a timely manner [45
]. Supplemental aids used by the patient navigator (e.g., animated video) could provide not only information but also a model of the elements of activation through its characters which will result in producing better cancer outcomes for patients including ethnic/racial minorities and low-income patients.
This study has important limitations that bear reflection. This study is formative, qualitative research with a limited sample size that may not reflect the survivorship care needs and educational preferences of other Latina populations in other geographic regions. Nevertheless, this study is one of few theory-based interventions that embraced the IM process, including continuous feedback loops with survivors and health care providers. Although we planned and approached SCP document adaption systematically eliciting stakeholders’ input, we cannot say with certainty to what extent the adaption is sound until it is tested. Our work expands the knowledge on culturally tailoring an SCP intervention. Proyecto Mariposa will be implemented following Step 5, and the evaluation of program (Step 6) will be reported in the subsequent paper upon completing the intervention.
IM provided a clear and reproducible approach to identify specific steps in the behavioral intervention process, with the flexibility to be fully responsive to and meet the needs of our target population and community. The cultural adaption of an intervention is a complex process involving addition, deletion, or modification of intervention components to best meet the needs of the target population. The process we undertook, and the detailed documentation we described on the development and cultural tailoring of this SCP intervention for rural Latina breast cancer survivors expands the knowledge base on key factors that clinicians should consider to better serve Latinas in their breast cancer survivorship, particularly those who may receive health care from different health systems, such is the case in a binational, U.S.–Mexico border context. Proyecto Mariposa will be implemented and undergo evaluation to complete the IM process, and findings will be reported in a subsequent paper.