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BACKGROUND: Values are broadly understood to have implications for how individuals make decisions and cope with serious illness stressors, yet it remains uncertain how patients and their family and friend caregivers discuss, reflect upon, and act on their values in the post-left ventricular assist device (LVAD) implantation context. This study aimed to explore the values elicitation experiences of patients with an LVAD in the post-implantation period. METHODS: Qualitative descriptive study of LVAD recipients. Socio-demographics and patient resource use were analyzed using descriptive statistics and semi-structured interview data using thematic analysis. Adult (> 18 years) patients with an LVAD receiving care at an outpatient clinic in the Southeastern United States. RESULTS: Interviewed patients (n = 27) were 30-76 years, 59% male, 67% non-Hispanic Black, 70% married/living with a partner, and 70% urban-dwelling. Three broad themes of patient values elicitation experiences emerged: 1) LVAD implantation prompts deep reflection about life and what is important, 2) patient values are communicated in various circumstances to convey personal goals and priorities to caregivers and clinicians, and 3) patients leverage their values for strength and guidance in navigating life post-LVAD implantation. LVAD implantation was an impactful experience often leading to reevaluation of patients' values; these values became instrumental to making health decisions and coping with stressors during the post-LVAD implantation period. Patient values arose within broad, informal exchanges and focused, decision-making conversations with their caregiver and the healthcare team. CONCLUSIONS: Clinicians should consider assessing the values of patients post-implantation to facilitate shared understanding of their goals/priorities and identify potential changes in their coping.
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Coração Auxiliar , Pesquisa Qualitativa , Humanos , Coração Auxiliar/psicologia , Masculino , Pessoa de Meia-Idade , Feminino , Adulto , Idoso , Adaptação PsicológicaRESUMO
BACKGROUND: Intentional exploration, or elicitation, of patient and family values-who/what matters most-is critical to the delivery of person-centered care, yet the values elicitation experiences of family caregivers have been understudied. Understanding caregiver experiences discussing, reflecting upon, and acting on their values is critical to optimizing health decisions after left ventricular assist device (LVAD) implantation. OBJECTIVE: The aim of this study was to explore the values elicitation experiences of family caregivers of individuals with an LVAD in the postimplantation period. METHODS: This was a qualitative descriptive study of LVAD caregivers recruited from an outpatient clinic in the southeast United States. After completing one-on-one semistructured interviews, participants' transcripts were analyzed using thematic analysis. RESULTS: Interviewed caregivers (n = 21) were 27 to 76 years old, with 67% African American, 76% female, 76% urban-dwelling, and 62% a spouse/partner. LVAD implantation was an impactful experience prompting caregiver reevaluation of their values; these values became instrumental to navigating decisions and managing stressors from their caregiving role. Three broad themes of caregiver values elicitation experiences emerged: (1) caregivers leverage their values for strength and guidance in navigating their caregiving role, (2) LVAD implantation prompts (re)evaluation of relationships and priorities, and (3) caregivers convey their goals and priorities when deemed relevant to patient care. CONCLUSIONS: Having a care recipient undergo LVAD implantation prompted caregivers to reevaluate their values, which were used to navigate caregiving decisions and stressors. Findings highlight the need for healthcare professionals to engage and support caregivers after LVAD implantation.
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BACKGROUND: We aimed to describe the roles and challenges of family caregivers involved in patients' cancer treatment decision-making. METHODS: Family caregiver-reported data were analyzed from a national survey conducted in the United States by CancerCare® (2/2021-7/2021). Four select-all-that-apply caregiver roles were explored: (1) observer (patient as primary decision-maker); (2) primary decision-maker; (3) shared decision-maker with patient and (4) decision delegated to healthcare team. Roles were compared across five treatment decisions: where to get treatment, the treatment plan, second opinions, beginning treatment and stopping treatment. Ten challenges faced by caregivers (e.g., information, cost, treatment understanding) were then examined. χ2 and regression analyses were used to assess associations between roles, decision areas, challenges and caregiver sociodemographics. RESULTS: Of 2703 caregiver respondents, 87.6% reported involvement in patient decisions about cancer treatment, including 1661 who responded to a subsection further detailing their roles and challenges with specific treatment decisions. Amongst these 1661 caregivers, 22.2% reported an observing role, 21.3% a primary decision-making role, 53.9% a shared decision-making role and 18.1% a role delegating decisions to the healthcare team. Most caregivers (60.4%) faced ≥1 challenge, the most frequent being not knowing how treatments would affect the patient's physical condition (24.8%) and quality of life (23.2%). In multivariable models, being Hispanic/Latino/a was the strongest predictor of facing at least one challenge (b = -0.581, Wald = 10.69, p < .01). CONCLUSIONS: Most caregivers were involved in patients' cancer treatment decisions. The major challenge was not understanding how treatments would impact patients' physical health and quality of life. Challenges may be more commonly faced by Hispanic/Latino/a caregivers. PATIENT OR PUBLIC CONTRIBUTION: The CancerCare® survey was developed in partnership with caregiving services and research experts to describe the role of cancer family caregivers in patient decision-making and assess their needs for support. All survey items were reviewed by a CancerCare advisory board that included five professional patient advocates and piloted by a CancerCare social worker and other staff who provide counselling to cancer caregivers.
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Cuidadores , Neoplasias , Humanos , Tomada de Decisões , Qualidade de Vida , Família , Neoplasias/terapiaRESUMO
BACKGROUND: The objective of this study was to assess the feasibility, acceptability, and potential efficacy of ENABLE (Educate, Nurture, Advise, Before Life Ends) Cornerstone-a lay navigator-led, early palliative care telehealth intervention for African American/Black and/or rural-dwelling family caregivers of individuals with advanced cancer (ClinicalTrials.gov identifier NCT03464188). METHODS: This was a pilot randomized trial (November 2019 to March 2021). Family caregivers of patients with newly diagnosed, stage III/IV, solid-tumor cancers were randomized to receive either an intervention or usual care. Intervention caregivers were paired with a specially trained lay navigator who delivered 6 weekly, 20-minute to 60-minute telehealth coaching sessions plus monthly follow-up for 24 weeks, reviewing skills in stress management, self-care, getting help, staying organized, and future planning. Feasibility was assessed according to the completion of sessions and questionnaires (predefined as a completion rate ≥80%). Acceptability was determined through intervention participants' ratings of their likelihood of recommending the intervention. Measures of caregiver distress and quality of life were collected at 8 and 24 weeks. RESULTS: Sixty-three family caregivers were randomized (usual care, n = 32; intervention, n = 31). Caregivers completed 65% of intervention sessions and 87% of questionnaires. Average ratings for recommending the program were 9.4, from 1 (not at all likely) to 10 (extremely likely). Over 24 weeks, the mean ± SE Hospital Anxiety and Depression Scale score improved by 0.30 ± 1.44 points in the intervention group and worsened by 1.99 ± 1.39 points in the usual care group (difference, -2.29; Cohen d, -0.32). The mean between-group difference scores in caregiver quality of life was -1.56 (usual care - intervention; d, -0.07). Similar outcome results were observed for patient participants. CONCLUSIONS: The authors piloted ENABLE Cornerstone, an intervention for African American and rural-dwelling advanced cancer family caregivers. The acceptability of the intervention and data collection rates were high, and the preliminary efficacy for caregiver distress was promising. LAY SUMMARY: To date, very few programs have been developed to support under-resourced cancer family caregivers. To address this need, the authors successfully pilot tested an early palliative care program, called Educate, Nurture, Advise, Before Life Ends (ENABLE) Cornerstone, for African American and rural family caregivers of individuals with advanced cancer. Cornerstone is led by specially trained lay people and involves a series of weekly phone sessions focused on coaching caregivers to manage stress and provide effective support to patients with cancer. The authors are now testing Cornerstone in a larger trial. If the program demonstrates benefit, it may yield a model of caregiver support that could be widely implemented.
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Cuidadores , Neoplasias , Negro ou Afro-Americano , Humanos , Neoplasias/terapia , Cuidados Paliativos/métodos , Projetos Piloto , Qualidade de VidaRESUMO
OBJECTIVE: Resilience has been proposed as a primary factor in how many family caregivers of patients with advanced cancer are able to resist psychological strain and perform effectively in the role while bearing a high load of caregiving tasks. To evaluate this hypothesis, we examined whether self-perceived resilience is associated with distress (anxiety and depressive symptoms), caregiver preparedness, and readiness for surrogate decision-making among a racially diverse sample of family caregivers of patients with newly diagnosed advanced cancer. METHODS: Secondary analysis of baseline data from two small-scale, pilot clinical trials that both recruited family caregivers of patients with newly diagnosed advanced cancer. Using multivariable linear regression, we analyzed relationships of resilience as a predictor of mood, caregiving preparedness, and readiness for surrogate decision-making, controlling for sociodemographics. RESULTS: Caregiver participants (N = 112) were mean 56 years of age and mostly female (76%), the patient's spouse/partner (52%), and White (56%) or African-American/Black (43%). After controlling for demographics, standardized results indicated that higher resilience was relevantly associated with higher caregiver preparedness (beta = .46, p < .001), higher readiness for surrogate decision-making (beta = .20, p < .05) and lower anxiety (beta = - .19, p < .05), and depressive symptoms (beta = - .20, p < .05). CONCLUSIONS: These results suggest that resilience may be critical to caregivers' abilities to manage stress, be effective sources of support to patients, and feel ready to make future medical decisions on behalf of patients. Future work should explore and clinicians should consider whether resilience can be enhanced in cancer caregivers to optimize their well-being and ability to perform in the caregiving and surrogate decision-making roles.
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Cuidadores , Neoplasias , Ansiedade , Emoções , Família , Feminino , Humanos , Masculino , Neoplasias/terapia , Estresse PsicológicoRESUMO
BACKGROUND: EPIC (Empowering People to Independence in COPD) is a geriatric-palliative care telephonic, nurse coach intervention informed by Baltes' Theory of Successful Aging and adapted from the ENABLE (Educate, Nurture, Advise, Before Life Ends) intervention. EPIC, focused on improving independence, mobility, well-being, and COPD symptoms, has undergone formative and summative evaluation for adults with COPD. METHODS: The primary study aim is to assess the refined EPIC intervention's feasibility and acceptability via a pilot hybrid effectiveness-implementation randomized control trial in community-dwelling older adults with moderate to severe COPD and their family caregivers. The secondary aim is to explore the impact of EPIC on patient and caregiver outcomes. Older adults with COPD and their family caregivers (target N = 60 dyads) will be randomized to EPIC (intervention) or usual COPD care (control). EPIC includes six patient and four family caregiver weekly, telephone-based nurse coach sessions using a manualized curriculum (Charting Your Course), plus three monthly follow-up calls. Feasibility will be measured as completion of EPIC intervention and trial components (e.g., recruitment, retention, data collection). Acceptability will be evaluated using satisfaction surveys and post-study feedback interviews. A blinded data collector will assess exploratory outcomes (e.g., Life-Space mobility, quality of life, caregiver burden, emotional symptoms, loneliness, cognitive impairment, functional status, healthcare utilization) at baseline, 12, and 24 weeks. DISCUSSION: This intervention fills a gap in addressing the geriatrics and palliative care needs and equity for adults with COPD and their family caregivers. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05040386.
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Cuidadores , Cuidados Paliativos , Doença Pulmonar Obstrutiva Crônica , Qualidade de Vida , Idoso , Feminino , Humanos , Masculino , Cuidadores/psicologia , Vida Independente , Tutoria/métodos , Cuidados Paliativos/métodos , Cuidados Paliativos/organização & administração , Projetos Piloto , Doença Pulmonar Obstrutiva Crônica/terapia , Doença Pulmonar Obstrutiva Crônica/enfermagem , Telefone , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
BACKGROUND: Identifying priority challenges of older adults with chronic obstructive pulmonary disease (COPD) is critical to designing interventions aimed at improving their well-being and independence. OBJECTIVE: To prioritize challenges of older adults with COPD and those who care for them to guide refinement of a telephonic nurse coach intervention for patients with COPD and their family caregivers (EPIC: Empowering People to Independence in COPD). DESIGN: Multiphase study guided by Baltes Theory of Successful Aging and the 5Ms Framework: Phase 1: Nominal group technique (NGT), a structured process of prioritizing responses to a question through group consensus. Phase 2: Rapid qualitative analysis. Phase 3: Intervention mapping and refinement. SETTING: Ambulatory, virtual. PARTICIPANTS: Older adults with COPD, family caregivers, clinic staff (nurses, respiratory therapists), clinicians (physicians, nurse practitioners), and health system leaders. RESULTS: NGT sessions were conducted by constituency group with 37 participants (n = 7 patients, n = 6 family caregivers, n = 8 clinic staff, n = 9 clinicians, n = 7 health system leaders) (Phase 1). Participants generated 92 statements across five themes (Phase 2): (1) "Barriers to care", (2) "Family caregiver needs", (3) "Functional status and mobility issues", (4) "Illness understanding", and (5) "COPD care complexities". Supplemental oxygen challenges emerged as a critical problem, and prioritized challenges differed by group. Patients and clinic staff prioritized "Functional status and mobility issues", family caregivers prioritized "Family caregiver needs", and clinicians and health system leaders prioritized "COPD care complexities". Intervention mapping (Phase 3) guided EPIC refinement focused on meeting patient priorities of independence and mobility but accounting for all priorities. CONCLUSIONS: Diverse constituency groups identified priority challenges for older adults with COPD. Functional status and mobility issues, particularly related to supplemental oxygen, emerged as patient prioritized challenges. IMPLICATIONS: Patient-centered interventions for older adults with COPD must account for their prioritized functional and supplemental oxygen needs and explore diverse constituent perspectives to facilitate intervention enrichment.
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BACKGROUND: Family caregivers play an increasing role in cancer treatment decision-making. We examined bias reported by family caregivers in the support they and their patient received from their healthcare team when making these decisions, including associations with distress. METHODS: Analysis of 2021 national survey data of family caregivers of patients with cancer (N = 2703). Bias experienced in decision support was assessed with the item: "Have you felt that the support you and the person with cancer have received for making cancer-related decisions by your doctor or healthcare team has been negatively affected by any of the following?" Check-all-that-apply response options included: age, race, language, education, political affiliation, body weight, insurance type or lack of insurance, income, religion, sexual orientation, and gender/sex. Chi-square and regression analyses assessed associations between bias and caregiver distress (GAD-2, PHQ-2). RESULTS: Of 2703 caregiver respondents, 47.4% (n = 1281) reported experiencing ≥1 bias(es) when receiving decision support for making cancer-related decisions. Bias was more prevalent among younger caregivers, males, transwomen/men or gender non-conforming caregivers, racial/ethnic minorities, and those providing care over a longer time period. The odds of having high anxiety (GAD-2 scores ≥ 3) were 2.1 times higher for caregivers experiencing one type of bias (adjusted OR, 2.1; 95% CI, 1.6-2.8) and 4.2 times higher for caregivers experiencing ≥2 biases (adjusted OR, 4.2; 95% CI, 3.4-5.3) compared to none. Similar results were found for high depression scores (PHQ-2 scores ≥ 3). CONCLUSIONS: Nearly half of caregivers involved in their care recipients' cancer-related decisions report bias in decision support received from the healthcare team. Experiencing bias was strongly associated with high psychological distress.
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Neoplasias , Médicos , Humanos , Masculino , Feminino , Cuidadores/psicologia , Ansiedade , Viés , Família/psicologia , Neoplasias/terapiaRESUMO
CONTEXT: Early, concurrent palliative care interventions in chronic obstructive pulmonary disease (COPD) are limited. Project EPIC (Early Palliative Care In COPD) is a multiphase mixed methods study working to fill this gap. OBJECTIVES: To conduct a formative and summative evaluation of EPIC, a telephonic nurse coach-led early palliative care intervention for COPD adapted from the ENABLE© intervention in cancer. METHODS: Phase I Formative Evaluation: Patients with moderate-to-very-severe COPD, family caregivers, and pulmonary and palliative care clinicians rated the acceptability and feasibility of EPIC (≥4 out of five on a Likert-scale survey). Phase II Summative Evaluation: Patients and family caregivers in Phase I participated in a pilot of the three month EPIC prototype to evaluate intervention and data collection feasibility (≥70% completion) and to seek qualitative feedback. RESULTS: Phase I Formative Evaluation: Patients (n=10), family caregivers (n=10), pulmonary clinicians (n=6), and palliative care clinicians (n=6) found EPIC acceptable and feasible to support adaptation, while priority early palliative care needs in COPD from our prior research mapped well to the EPIC prototype. Phase II Summative Evaluation: Patients (n=5; ages 49-72, 40% moderate COPD, 40% Black) and their family caregivers (n=5; ages 51-73, 40% Black) completed 100% of EPIC prototype components, including weekly telephone sessions, a one month follow-up call, Advance Directive, palliative care clinic attendance, and 95% of monthly phone data collection sessions. Feedback from participants about EPIC was all positive. CONCLUSION: EPIC was acceptable and feasible in patients with COPD and their family caregivers. Larger feasibility and effectiveness trials are warranted.
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Enfermagem de Cuidados Paliativos na Terminalidade da Vida , Doença Pulmonar Obstrutiva Crônica , Telemedicina , Humanos , Pessoa de Meia-Idade , Idoso , Cuidados Paliativos/métodos , Doença Pulmonar Obstrutiva Crônica/terapia , Cuidadores , Telemedicina/métodosRESUMO
PURPOSE: Values are critical to how individuals make decisions and cope, yet the values of heart failure (HF) patients and their family caregivers (FCGs) remain understudied. We sought to report the state of the science on how values are discussed, reflected upon, and acted on by patients with HF, their FCGs, or both related to health-related decision making and coping. METHOD: A scoping review was conducted of empirical studies using the following keywords: "heart failure," "values," "decision-making," and "coping." PubMed, PsycINFO, and Scopus were searched from inception to June 2022 in English. Included articles reported values as a key finding (outcome/theme) in their abstract. RESULTS: Of 448 articles screened for eligibility, 16 met the inclusion criteria. Twelve articles reported findings addressing patient values, 3 addressed patient and FCG values, and 1 addressed FCG values. Values were reported to influence patient self-care behaviors and left ventricular assist device (LVAD) implantation decisions, although their prioritization varied across time and contexts. When prioritized values conflicted with recommended self-care activities, some patients modified their approach to achieving the value. Others modified or abandoned tasks in favor of the value and accompanying goals. Low motivation and alignment between unhealthy behaviors and values often led to nonadherent decisions. Five of 8 articles focusing on cardiac devices reported patient survival as the most prioritized value during implantation decisions. FCG values were rarely reported or evaluated separately from patient values. Patients leveraged several coping strategies, although the processes through which values affected coping was not described. CONCLUSIONS: Prioritized values influenced HF-related decisions, including self-care and LVAD implantation. While several articles reported on coping and values, none described processes through which values affect coping, which highlights a research gap. HIGHLIGHTS: Family caregiver values were rarely reported or evaluated separately from patient values, highlighting a gap in the literature.
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Insuficiência Cardíaca , Coração Auxiliar , Humanos , Cuidadores , Adaptação Psicológica , Pacientes , Insuficiência Cardíaca/terapiaRESUMO
Prioritizing patient values-who/what matters most-is central to palliative care and critical to treatment decision making. Yet which factors are most important to family caregivers in these decisions remains understudied. Using data from a U.S. national survey of cancer caregivers (N = 1661), we examined differences in factors considered very important by caregivers when partnering with patients in cancer treatment decision making by cancer stage and caregiver sociodemographics. Fifteen factors were rated on a 4-point Likert-scale from 'very unimportant' to 'very important.' Descriptive statistics were used to characterize caregiver factors and tabulate proportions of importance for each. Generalized linear mixed effect modeling was used to examine the importance of factors by cancer stage, and chi-square analyses were performed to determine associations between caregiver sociodemographics and the five most commonly endorsed factors: quality of life (69%), physical well-being (68%), length of life (66%), emotional well-being (63%), and opinions/feelings of oncology team (59%). Significant associations (all p's < 0.05) of small magnitude were found between the most endorsed factors and caregiver age, race, gender, and ethnicity, most especially 'opinions/feelings of the oncology team'. Future work is needed to determine the best timing and approach for eliciting and effectively incorporating caregiver values and preferences into shared treatment decision making.
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BACKGROUND: Patients with advanced cancer face numerous decisions when diagnosed and often receive decision support from family caregivers. The CASCADE (CAre Supporters Coached to be Adept DEcision partners) factorial trial intervention aims to train caregivers in skills to provide effective decision support to patients and identify most effective intervention components. METHODS: This is a 2-site, single-blind, 24 factorial trial to test components of the CASCADE decision support training intervention for family caregivers of patients with newly-diagnosed advanced cancer delivered by specially-trained, telehealth, palliative care lay coaches over 24 weeks. Family caregivers (target N = 352) are randomly assigned to one of 16 combinations of four components with two levels each: 1) psychoeducation on effective decision partnering principles (1 vs. 3 sessions); 2) decision support communication training (1 session vs. none); 3) Ottawa Decision Guide training (1 session vs. none) and 4) monthly follow-up (1 call vs. calls for 24 weeks). The primary outcome is patient-reported decisional conflict at 24 weeks. Secondary outcomes include patient distress, healthcare utilization, caregiver distress, and quality of life. Mediators and moderators (e.g., sociodemographics, decision self-efficacy, social support) will be explored between intervention components and outcomes. Results will be used to build two versions of CASCADE: one with only effective components (d ≥ 0.30) and another optimized for scalability and cost. DISCUSSION: This protocol describes the first factorial trial, informed by the multiphase optimization strategy, of a palliative care decision-support intervention for advanced cancer family caregivers and will address the field's need to identify effective components that support serious illness decision-making. TRIAL REGISTRATION: NCT04803604.
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Cuidadores , Neoplasias , Humanos , Cuidadores/educação , Qualidade de Vida , Método Simples-Cego , Cuidados Paliativos/métodos , Neoplasias/terapia , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
AIM: To conduct a concept analysis of values elicitation in the context of health care and treatment decision-making and formulate a conceptual definition. BACKGROUND: Values elicitation is a commonly cited term for an activity to help patients identify values and evaluate their application in health care decision-making, yet it remains ambiguous and difficult to differentiate from similar concepts. DESIGN: Concept analysis. DATA SOURCE: Three databases, including PubMed, CINAHL Plus, and Scopus, were searched from inception to February 2021. REVIEW METHODS: Walker and Avant's eight-stage method was used to identify attributes, cases, antecedents, consequences, and empirical referents and formulate a conceptual definition. RESULTS: The concept analysis identified 3 attributes, 10 consequences, 7 antecedents, and 3 empirical referents. Our analysis defines values elicitation as an intentional process whereby individuals explore their core beliefs, alone or with others, to (1) determine their preference, or a lack thereof, between health or treatment options, and (2) frame decisions. CONCLUSIONS: The findings have the potential to influence the identification, discussion, and measurement of values elicitation by nurses and researchers across disciplines. Further exploration of this concept is warranted as the literature continues to emerge.
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Formação de Conceito , Adulto , HumanosRESUMO
BACKGROUND: Family caregivers play a vital, yet stressful role in managing the healthcare needs and optimizing the quality of life of patients with advanced cancer, from the time they are newly diagnosed until end of life. While early telehealth palliative care has been found to effectively support family caregivers, little work has focused on historically under-resourced populations, particularly African American and rural-dwelling individuals. To address this need, we developed and are currently testing Project ENABLE (Educate, Nurture, Advise, Before Life Ends) Cornerstone, a lay navigator-led, early palliative care coaching intervention for family caregivers of African American and rural-dwelling patients with newly diagnosed advanced cancer. METHODS: This is a 2-site, single-blind, hybrid type I implementation-effectiveness trial of the Cornerstone intervention versus usual care. Cornerstone is a multicomponent intervention based on Pearlin's Stress-Health Process Model where African American and/or rural-dwelling family caregivers of patients with newly diagnosed advanced cancer (target sample size = 294 dyads) are paired with a lay navigator coach and receive a series of six, brief 20-60-min telehealth sessions focused on stress management and coping, caregiving skills, getting help, self-care, and preparing for the future/advance care planning. Subsequent to core sessions, caregivers receive monthly follow-up indefinitely until the patient's death. Caregiver and patient outcomes are collected at baseline and every 12 weeks until the patient's death (primary outcome: caregiver distress at 24 weeks; secondary outcomes: caregiver: quality of life and burden; patient: distress, quality of life, and healthcare utilization). Implementation costs and the intervention cost effectiveness are also being evaluated. DISCUSSION: Should this intervention demonstrate efficacy, it would yield an implementation-ready model of early palliative care support for under-resourced family caregivers. A key design principle that has centrally informed the Cornerstone intervention is that every caregiving situation is unique and each caregiver faces distinct challenges that cannot be addressed using a one-size-fits all approach. Hence, Cornerstone employs culturally savvy lay navigator coaches who are trained to establish a strong, therapeutic alliance with participants and tailor their coaching to a diverse range of individual circumstances. TRIAL REGISTRATION: ClinicalTrials.gov NCT04318886 . Registered on 20 March, 2020.