Associations between Advanced Cancer Patients\u27 Survival and Family Caregiver Presence and Burden

We conducted a randomized controlled trial (RCT) of an early palliative care intervention (ENABLE: Educate, Nurture, Advise, Before Life Ends) for persons with advanced cancer and their family caregivers. Not all patient participants had a caregiver coparticipant; hence, we explored whether there were relation- ships between patient survival, having an enrolled caregiver, and caregiver out- comes prior to death. One hundred and twenty-three patient-caregiver dyads and 84 patients without a caregiver coparticipant participated in the ENABLE early versus delayed (12 weeks later) RCT. We collected caregiver quality-of-life (QOL), depression, and burden (objective, stress, and demand) measures every 6 weeks for 24 weeks and every 3 months thereafter until the patient’s death or study completion. We conducted survival analyses using log-rank and Cox proportional hazards models. Patients with a caregiver coparticipant had sig- nificantly shorter survival (Wald = 4.31, HR = 1.52, CI: 1.02–2.25, P = 0.04). After including caregiver status, marital status (married/unmarried), their interaction, and relevant covariates, caregiver status (Wald = 6.25, HR = 2.62, CI: 1.23–5.59, P = 0.01), being married (Wald = 8.79, HR = 2.92, CI: 1.44–5.91, P = 0.003), and their interaction (Wald = 5.18, HR = 0.35, CI: 0.14–0.87, P = 0.02) were significant predictors of lower patient survival. Lower survival in patients with a caregiver was significantly related to higher caregiver demand burden (Wald = 4.87, CI: 1.01–1.20, P = 0.03) but not caregiver QOL, depres- sion, and objective and stress burden. Advanced cancer patients with caregivers enrolled in a clinical trial had lower survival than patients without caregivers; however, this mortality risk was mostly attributable to higher survival by unmarried patients without caregivers. Higher caregiver demand burden was also associated with decreased patient survival

A cluster randomized controlled trial comparing Virtual Learning Collaborative and Technical Assistance strategies to implement an early palliative care program for patients with advanced cancer and their caregivers: a study protocol

Background: Virtual Learning Collaboratives (VLC), learning communities focused on a common purpose, are used frequently in healthcare settings to implement best practices. Yet, there is limited research testing the effectiveness of this approach compared to other implementation strategies. This study evaluates the effectiveness of a VLC compared to Technical Assistance (TA) among community oncology practices implementing ENABLE (Educate, Nurture, Advise, Before Life Ends), an evidence-based, early palliative care telehealth, psycho-educational intervention for patients with newly diagnosed advanced cancer and their caregivers. Methods: Using Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) and Proctor’s Implementation Outcomes Frameworks, this two-arm hybrid type-III cluster-randomized controlled trial (RCT) will compare two implementation strategies, VLC versus TA, among the 48 National Cancer Institute Community Oncology Research Program (NCORP) practice clusters that have not historically provided palliative care to all patients with advanced cancer. Three cohorts of practice clusters will be randomized to the study arms. Each practice cluster will recruit 15–27 patients and a family caregiver to participate in ENABLE. The primary study outcome is ENABLE uptake (patient level), i.e., the proportion of eligible patients who complete the ENABLE program (receive a palliative care assessment and complete the six ENABLE sessions over 12 weeks). The secondary outcome is overall program implementation (practice cluster level), as measured by the General Organizational Index at baseline, 6, and 12 months. Exploratory aims assess patient and caregiver mood and quality of life outcomes at baseline, 12, and 24 weeks. Practice cluster randomization will seek to keep the proportion of rural practices, practice sizes, and minority patients seen within each practice balanced across the two study arms. Discussion: This study will advance the field of implementation science by evaluating VLC effectiveness, a commonly used but understudied, implementation strategy. The study will advance the field of palliative care by building the capacity and infrastructure to implement an early palliative care program in community oncology practices. Trial registration: Clinicaltrials.gov. NCT04062552; Pre-results. Registered: August 20, 2019. https://clinicaltrials.gov/ct2/show/NCT04062552?term=NCT04062552&draw=2&rank=

Association Between Palliative Care and Patient and Caregiver Outcomes: A Systematic Review and Meta-analysis

The use of palliative care programs and the number of trials assessing their effectiveness have increased

The Project ENABLE Cornerstone Randomized Controlled Trial: Study Protocol for a Lay Navigator-led, Early Palliative Care Coaching Intervention for African American and Rural-dwelling Advanced Cancer Family Caregivers

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

An integrated review of interventions to improve psychological outcomes in caregivers of patients with heart failure

Purpose of reviewThis article examines interventions aimed at improving psychological outcomes (e.g., caregiver burden, quality of life, anxiety, depression, perceived control, stress mastery, caregiver confidence and preparedness, and caregiver mastery) in family caregivers of patients with heart failure.Recent findingsEight studies meeting the inclusion criteria were included in the review. The most common intervention involved psychoeducation facilitated by a nurse (6/8) and supplemented with a combination of follow-up face-to-face sessions (2/6), home visits (2/6), telephone calls (3/6), and telemonitoring (3/6). Two studies used a support group intervention of four to six sessions. Half of the interventions reported a significant effect on one or more primary outcomes, including caregiver burden (n=4), depressive symptoms (n=1), stress mastery (n=1), caregiver confidence and preparedness (n=1), and caregiver mastery (n=1).SummaryCompared with dementia and cancer family caregiving, few interventions have been evaluated in caregivers of patients with heart failure. Of the existing interventions identified in this review, considerable variability was observed in aims, intervention content, delivery methods, duration, intensity, methodological rigor, outcomes, and effects. Given this current state of the science, direct comparison of heart failure caregiver interventions and recommendations for clinical practice are premature. Thus, research priority is strongly warranted for intervention development and testing to enhance heart failure caregiver support and education.Funding Agencies|National Heart, Lung, and Blood Institute [1R01HL093466-05]; Swedish Research Council for Medicine and Health; Swedish Research Council for Health, Working Life and Welfare</p

“What Were They Thinking?”: Patients’ Cognitive Representations of Heart Failure Self-Care

Heart failure (HF) is the largest palliative care population in the United States. Self-care patient education is a class I recommendation in HF clinical guidelines. Self-care is a 2-step decision-making process of maintenance and management, yet little is known about the thought processes or cognitive representations used. The purpose of this study was to identify and examine patients’ cognitive representations in HF self-care with a unique, theoretically derived approach in a descriptive, exploratory study. Purposive sampling targeted hospitalized HF patients. Open-ended conceptual cognitive mapping approach elicited patient-generated items providing a visual display of cognitive representations. Recruitment continued until no new items were elicited. Thirteen white, primarily male (n = 11) patients reported 124 items when describing daily HF care. For self-care maintenance, diet, medication, and exercise were the most endorsed items. Patients also added items such as relaxation, distraction, or denial, not part of self-care guidelines. For self-care management, patient’s items diverged widely from guidelines. A thematic analysis revealed a majority of the items were existential involving reflecting on their mortality and impact on families. Patients have an internal cognitive map with which they manage their HF. Palliative care nurses need to design care that takes this into account

Strategies and checklist for designing and conducting palliative care research with family carers: EAPC international expert elicitation study

Background: Palliative care services seek to improve the wellbeing of family carers of people living with serious and life-limiting illness. To help achieve this goal, systematic reviews have recommended priority areas for family carer research and the need to improve the quality of study design. Policy makers have also advocated for enhanced family carer support. However, there are specific methodological considerations and challenges in designing and conducting carer research conducted during the course of the serious illness trajectory and in bereavement. Aim: To develop strategies to improve the design and conduct of research with family carers. Design: Expert elicitation study using an adapted version of the ‘Identify, Discuss, Estimate and Aggregate’ elicitation protocol, supplemented with strategies from peer-reviewed literature. Setting/participants: Nine members of the management committee of the European Association for Palliative Care’s Reference group on family carer research, comprising international senior research academics in family caregiving. Results: A compilation of recommended strategies and checklist was created to: (a) help researchers plan research involving family carers focussing on: preparation, conduct and dissemination and (b) assist ethics committees and funding bodies to evaluate proposals. Conclusions: The strategies and checklist for conducting research with family carers may enhance methodologically rigorous research. Consequently, researchers, practitioners and policy makers will not only gain a more comprehensive understanding of the unmet needs of family carers but also promote the development of empirically sound interventions