Acute cancer-related symptoms and concerns among patients receiving chemotherapy: current state of the science.

PURPOSE: This study provides an updated evaluation of the prevalence and severity of acute cancer-related symptoms and quality of life (QOL) concerns among patients treated with emetogenic chemotherapy. METHODS: Patients were recruited to a larger, multi-site observational study prior to starting chemotherapy. Participants completed sociodemographic questionnaires and clinical data were abstracted via medical record review. Symptoms and QOL were assessed 5 days after starting moderately or highly emetogenic chemotherapy. Functional Assessment of Cancer Therapy - General assessed QOL concerns. Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events evaluated symptoms. Symptoms were considered severe when participants responded "severe" or "very severe." RESULTS: Participants (N = 1174) were on average 58 ± 13 years, mostly female (73%), non-Hispanic (89%), and White (87%). Most participants were diagnosed with breast (38.1%), gynecological (20%), and gastrointestinal (17.1%) cancer. The most common QOL concerns of any severity were fatigue (94%), anhedonia (89%), dissatisfaction with QOL (86%), and sleep disturbance (86%). The most common severe QOL concerns were anhedonia (44%), fatigue (40%), and inability to work (38%). Decreased appetite (74%), pain (71%), and constipation (70%) were the most common symptoms of any severity, as well as most common severe symptoms (13%, 18%, and 18%, respectively). CONCLUSION: Herein, updates are provided in regard to QOL concerns and symptoms reported by patients in the days after chemotherapy and demonstrates that concerns and symptoms have shifted in the last decade.

Metagenomics and chemotherapy-induced nausea: A roadmap for future research.

Uncontrolled chemotherapy-induced nausea and vomiting can reduce patients' quality of life and may result in premature discontinuation of chemotherapy. Although nausea and vomiting are commonly grouped together, research has shown that antiemetics are clinically effective against chemotherapy-induced vomiting (CIV) but less so against chemotherapy-induced nausea (CIN). Nausea remains a problem for up to 68% of patients who are prescribed guideline-consistent antiemetics. Despite the high prevalence of CIN, relatively little is known regarding its etiology independent of CIV. This review summarizes a metagenomics approach to the study and treatment of CIN with the goal of encouraging future research. Metagenomics focuses on genetic risk factors and encompasses both human (ie, host) and gut microbial genetic variation. Little work to date has focused on metagenomics as a putative biological mechanism of CIN. Metagenomics has the potential to be a powerful tool in advancing scientific understanding of CIN by identifying new biological pathways and intervention targets. The investigation of metagenomics in the context of well-established demographic, clinical, and patient-reported risk factors may help to identify patients at risk and facilitate the prevention and management of CIN.

Diet quality indices and changes in cognition during chemotherapy.

PURPOSE: No evidence-based prevention strategies currently exist for cancer-related cognitive decline (CRCD). Although patients are often advised to engage in healthy lifestyle activities (e.g., nutritious diet), little is known about the impact of diet on preventing CRCD. This secondary analysis evaluated the association of pre-treatment diet quality indices on change in self-reported cognition during chemotherapy. METHODS: Study participants (n = 96) completed the Block Brief Food Frequency Questionnaire (FFQ) before receiving their first infusion and the PROMIS cognitive function and cognitive abilities questionnaires before infusion and again 5 days later (i.e., when symptoms were expected to be their worst). Diet quality indices included the Dietary Approaches to Stop Hypertension (DASH), Alternate Mediterranean Diet (aMED), and a low carbohydrate diet index and their components. Descriptive statistics were generated for demographic and clinical variables and diet indices. Residualized change models were computed to examine whether diet was associated with change in cognitive function and cognitive abilities, controlling for age, sex, cancer type, treatment type, depression, and fatigue. RESULTS: Study participants had a mean age of 59 ± 10.8 years and 69% were female. Although total diet index scores did not predict change in cognitive function or cognitive abilities, higher pre-treatment ratio of aMED monounsaturated/saturated fat was associated with less decline in cognitive function and cognitive abilities at 5-day post-infusion (P ≤ .001). CONCLUSIONS: Higher pre-treatment ratio of monounsaturated/saturated fat intake was associated with less CRCD early in chemotherapy. Results suggest greater monounsaturated fat and less saturated fat intake could be protective against CRCD during chemotherapy.

Meeting ethical challenges with authenticity when engaging patients and families in end-of-life and palliative care research: a qualitative study.

BACKGROUND: Delivering high quality, patient- and family-centered care depends upon high quality end-of-life and palliative care (EOLPC) research. Engaging patients and families as advisors, partners, or co-investigators throughout the research lifecycle is widely regarded as critical to ensuring high quality research. Engagement is not only an ethical obligation, it also raises ethical challenges of its own. We conducted a qualitative study to understand ethical challenges and potential solutions when engaging patients and families in EOLPC research. METHODS: We recruited and interviewed 20 clinical investigators and 22 patients or family caregivers through the Palliative Care Research Cooperative Group (PCRC). Interview transcripts were analyzed using constructivist grounded theory methodology. Analysis sought to identify ethical challenges and potential solutions, as well as to synthesize findings into practical recommendations tailored to engaging patients and families in EOLPC research. RESULTS: Our study identified 8 ethical challenges considered unique to the EOLPC research context and 11 potential solutions to these challenges. The most frequently described ethical challenges included the need to minimize burdens of engagement for patients and caregivers, challenges of dealing with death and illness, and paternalism or "gatekeeping" (i.e., withholding the opportunity to participate from patients or caregivers). Investigators and patients or family caregivers conceptualized ethics challenges differently; several issues appeared to fall outside a traditional research ethics paradigm and more into the ethics of relationships. We synthesized these findings into 4 practical recommendations hypothesized to support authentic engagement. CONCLUSIONS: Engaging patients and families in EOLPC research can raise unique ethical challenges. These challenges can be overcome to empower participation, minimize the unique burdens of EOLPC, and promote diversity. Whereas traditional research ethics tend to emphasize protecting research participants who may be vulnerable, an ethics approach based on authentic engagement that explores what it means for investigators and patients or family caregivers to be in a relationship may be needed. Future research is needed to explore this approach and test these recommendations in practice.

Caregiver-guided pain coping skills training for patients with advanced cancer: Results from a randomized clinical trial.

BACKGROUND: Pain is a major concern among patients with advanced cancer and their family caregivers. Evidence suggests that pain coping skills training interventions can improve outcomes, however they have rarely been tested in this population. AIM: To test the efficacy of a caregiver-guided pain coping skills training intervention. The primary outcome was caregiver self-efficacy for helping the patient manage pain. DESIGN: A randomized controlled trial compared the intervention to an enhanced treatment-as-usual control. Dyads in both conditions received pain education, and those in the intervention received three sessions of pain coping skills training. Caregiver outcomes (self-efficacy; caregiver strain, caregiving satisfaction, psychological distress) and patient outcomes (self-efficacy, pain intensity and interference, psychological distress) were collected at baseline and post-intervention. SETTING/PARTICIPANTS: Two hundred two patients with stage III-IV cancer and pain and their family caregivers were enrolled from four outpatient oncology clinics and a free-standing hospice/palliative care organization. RESULTS: Compared to those in the control arm, caregivers in the intervention reported significant increases in caregiving satisfaction (p < 0.01) and decreased anxiety (p = 0.04). In both conditions, caregivers reported improvements in self-efficacy, and patients reported improvements in self-efficacy, pain severity and interference, and psychological distress. CONCLUSIONS: This is the first study to test a pain coping skills intervention targeted to patients and caregivers facing advanced cancer. Findings suggest that pain education provides benefits for patients and caregivers, and coping skills training may be beneficial for caregivers. Further research is needed to optimize the benefits of education and pain coping skills training for improving cancer pain outcomes.Trial registration: ClinicalTrials.gov NCT02430467, Caregiver-Guided Pain Management Training in Palliative Care.

Patient Navigation: Addressing Social Challenges in Dialysis Patients.

Members of racial and ethnic minority groups make up nearly 50% of US patients with end-stage kidney disease and face a disproportionate burden of socioeconomic challenges (ie, low income, job insecurity, low educational attainment, housing instability, and communication challenges) compared with non-Hispanic whites. Patients with end-stage kidney disease who face social challenges often have poor patient-centered and clinical outcomes. These challenges may have a negative impact on quality-of-care performance measures for dialysis facilities caring for primarily minority and low-income patients. One path toward improving outcomes for this group is to develop culturally tailored interventions that provide individualized support, potentially improving patient-centered, clinical, and health system outcomes by addressing social challenges. One such approach is using community-based culturally and linguistically concordant patient navigators, who can serve as a bridge between the patient and the health care system. Evidence points to the effectiveness of patient navigators in the provision of cancer care and, to a lesser extent, caring for people with chronic kidney disease and those who have undergone kidney transplantation. However, little is known about the effectiveness of patient navigators in the care of patients with kidney failure receiving dialysis, who experience a number of remediable social challenges.

Treating Elderly Patients With Muscle-Invasive Bladder Cancer.

Bladder cancer is an extremely common cancer that primarily affects individuals aged >65 years. In caring for patients with bladder cancer, clinicians must also consider care of older persons in general. Management of muscle-invasive bladder cancer (MIBC) involves multidisciplinary treatment planning, because curative-intent therapy includes either surgery or radiation, with consideration of the role of systemic therapy. As clinicians develop a treatment plan, considering a geriatric oncology perspective may enhance patient care and influence outcomes for this large and growing population. Similarly, treatment plan development must also consider aspects unique to an older patient population, such as altered organ function, increased comorbidity, decreased functional reserve, and perhaps altered goals of treatment. Thus a thorough evaluation inclusive of disease assessment and geriatric assessment is essential to care planning. Population-based data show that as patients with MIBC age, use of standard therapies declines. Given the complexities of coordinating a multidisciplinary care plan, as well the complexities of treating a heterogeneous and potentially vulnerable older patient population, clinicians may benefit from upfront assessments to inform and guide the process. This review highlights the unique treatment planning considerations for elderly patients diagnosed with MIBC.

Outcomes of Patients With Cancer Discharged to a Skilled Nursing Facility After Acute Care Hospitalization.

BACKGROUND: After discharge from an acute care hospitalization, patients with cancer may choose to pursue rehabilitative care in a skilled nursing facility (SNF). The objective of this study was to examine receipt of anticancer therapy, death, readmission, and hospice use among patients with cancer who discharge to an SNF compared with those who are functionally able to discharge to home or home with home healthcare in the 6 months after an acute care hospitalization. METHODS: A population-based cohort study was conducted using the SEER-Medicare database of patients with stage II-IV colorectal, pancreatic, bladder, or lung cancer who had an acute care hospitalization between 2010 and 2013. A total of 58,770 cases were identified and patient groups of interest were compared descriptively using means and standard deviations for continuous variables and frequencies and percentages for categorical variables. Logistic regression was used to compare patient groups, adjusting for covariates. RESULTS: Of patients discharged to an SNF, 21%, 17%, and 2% went on to receive chemotherapy, radiotherapy, and targeted chemotherapy, respectively, compared with 54%, 28%, and 6%, respectively, among patients discharged home. Fifty-six percent of patients discharged to an SNF died within 6 months of their hospitalization compared with 36% discharged home. Thirty-day readmission rates were 29% and 28% for patients discharged to an SNF and home, respectively, and 12% of patients in hospice received <3 days of hospice care before death regardless of their discharge location. CONCLUSIONS: Patients with cancer who discharge to an SNF are significantly less likely to receive subsequent oncologic treatment of any kind and have higher mortality compared with patients who discharge to home after an acute care hospitalization. Further research is needed to understand and address patient goals of care before discharge to an SNF.

Puente para cuidar (bridge to caring): A palliative care patient navigator and counseling intervention to improve distress in Latino/as with advanced cancer.

OBJECTIVE: Interventions are needed to improve mental health (ie, depression, anxiety) and palliative care (ie, symptoms, goals of care, and advance care planning) outcomes in Latino/as with advanced cancer. METHODS: An interprofessional study team used the ecological validity model and a participatory approach to adapt an evidence-based counseling intervention for Latino/as and integrate the counseling intervention with an evidence-based patient navigator intervention. Next, a small pilot study was conducted to understand and improve the feasibility of the integrated puente para cuidar intervention. RESULTS: Adaptations were made to language, literacy, and content of the counseling intervention, and video vignettes of the counseling case studies were produced on the recommendation of Latino/a stakeholders. Bicultural, bilingual patient navigators were used as "cultural brokers" between Latino/a patients and the counselor. The pilot study of puente para cuidar demonstrated feasibility based on participant perception of helpfulness and acceptability and nearing goal visit completion rates. CONCLUSIONS: A culturally adapted intervention to address mental health and palliative care needs in Latino/as with advanced cancer was developed from prior evidenced-based interventions using a cultural adaptation model and a participatory approach. The intervention is ready for effectiveness testing.

Persistent opioid use after radiation therapy in opioid-naive cervical cancer survivors.

OBJECTIVES: Opioids are first-line therapy for cancer-related pain, but their use should be minimized in disease-free survivors. We sought to describe rates and identify predictors of persistent opioid use among previously opioid-naive cervical cancer survivors treated with radiation. METHODS: Opioid-naive cervical cancer patients treated primarily with radiation and chemosensitization at a single institution, between January 2011 and December 2015, were identified. Charts were reviewed for demographics, disease, and treatment characteristics, and opioid prescriptions. Primary outcome was persistent opioid use, defined as continued opioid prescription use, 6 months after radiation; patients recurring within 6 months were excluded. Groups were compared using χ2 or Fisher's exact test. Multivariable logistic regression identified predictors of persistent opioid use. RESULTS: A total of 96 patients were included, with a median age of 49 years (range 27-84). Most patients (59%) at diagnosis had International Federation of Gynecology and Obstetrics (FIGO) stage I or II cervical cancer. The most common histology was squamous cell carcinoma (72%) and most (94.7%) patients received radiation with chemosensitization. Rates of persistent opioid use at 3 and 6 months after treatment were 29% and 25%, respectively. Persistent users were more likely to be <40 years old, have disease outside the pelvis at diagnosis, and have had a history of substance abuse, depression or anxiety (p<0.05). In multivariable analysis, a history of substance abuse (adjusted OR 6.21, 95% CI 1.08 to 35.67) and depression or anxiety (aOR 6.28, 95% CI 1.70 to 23.30) were independently associated with persistent opioid use. CONCLUSION: Our study showed that 25% of patients with cervical cancer were still using opioids 6 months after radiation. History of substance abuse and depression or anxiety, all known risk factors for opioid misuse, were associated with persistent use. The goal in the disease-free survivor population should be opioid independence.

Caregiver-guided pain coping skills training for patients with advanced cancer: Background, design, and challenges for the CaringPals study.

BACKGROUND/AIMS: Pain is a major concern of patients with advanced cancer and their caregivers. There is strong evidence that pain coping skills training interventions based on cognitive-behavioral principles can reduce pain severity and pain interference. However, few such interventions have been tested for patients with advanced cancer and their family caregivers. This study aims to test the efficacy of a caregiver-guided pain coping skills training protocol on patient and caregiver outcomes. METHODS: A total of 214 patients age ≥18 with Stage III-Stage IV cancer and moderate to severe pain, along with their family caregivers, are being identified and randomized with a 1:1 allocation to the caregiver-guided pain coping skills training intervention or enhanced treatment-as-usual. Dyads in both conditions receive educational resources on pain management, and the caregiver-guided pain coping skills training intervention includes three weekly 60-min sessions conducted with the patient-caregiver dyad via videoconference. Measures of caregiver outcomes (self-efficacy for helping the patient manage pain, caregiver strain, caregiving satisfaction, psychological distress) and patient outcomes (self-efficacy for pain management, pain intensity and interference, psychological distress) are collected at baseline and post-intervention. Caregiver outcomes are also collected 3 and 6 months following the patient's death. The study is enrolling patients from four tertiary care academic medical centers and one free-standing hospice and palliative care organization. The primary outcome is caregiver self-efficacy for helping the patient manage pain. RESULTS: This article describes challenges in the design and implementation of the CaringPals trial. Key issues for trial design include the identification and recruitment of patients with advanced cancer and pain, and the follow-up and collection of data from caregivers following the patient's death. CONCLUSION: The CaringPals trial addresses a gap in research in pain coping skills training interventions by addressing the unique needs of patients with advanced cancer and their caregivers. Findings from this study may lead to advances in the clinical care of patients with advanced cancer and pain, as well as a better understanding of the effects of training family caregivers to help patients cope with pain.

Opioid use in gynecologic oncology in the age of the opioid epidemic: Part I - Effective opioid use across clinical settings, a society of gynecologic oncology evidence-based review.

As the only oncologists that provide both medical and surgical oncologic care, gynecologic oncologists encounter an exceptionally broad range of indications for prescribing opioids, from management of acute post-operative pain to chronic cancer-related pain to end-of-life care. If we are to balance opioid efficacy, safety and accessibility for our patients, we must be intimately familiar with appropriate clinical use of opioids in a range of settings, and engage in the national conversation around opioid misuse and how associated regulations and legislation may impact us and our patients. This article examines the appropriate use of opioids across the range of clinical settings encountered in gynecologic oncology.

Opioid use in gynecologic oncology in the age of the opioid epidemic: Part II - Balancing safety & accessibility.

As the only oncologists that provide both medical and surgical care, gynecologic oncologists encounter an exceptionally broad range of indications for prescribing opioids in clinical situations ranging from management of acute post-operative pain to chronic cancer-related pain to end-of-life care. While opioids are essential to the practice of gynecologic oncology, they can also have significant side effects and can be misused. Due to the explosive growth of opioid prescriptions and opioid-related overdoses and deaths during the first decade of the 21st century, there has been a recent concerted public health effort to prevent and treat opioid misuse through both legislation and education [1]. The first article in this two part series focused on appropriate use of opioids across clinical settings. This article addresses both the clinical and regulatory aspects of balancing opioid safety and accessibility for patients with gynecologic cancer.

Prediction of chemotherapy-induced nausea and vomiting from patient-reported and genetic risk factors.

PURPOSE: Chemotherapy-induced nausea and vomiting (CINV) is common among cancer patients. Early identification of patients at risk for CINV may help to personalize anti-emetic therapies. To date, few studies have examined the combined contributions of patient-reported and genetic risk factors to CINV. The goal of this study was to evaluate these risk factors. METHODS: Prior to their first chemotherapy infusion, participants completed demographic and risk factor questionnaires and provided a blood sample to measure genetic variants in ABCB1 (rs1045642) and HTR3B (rs45460698) as well as CYP2D6 activity score. The M.D. Anderson Symptom Inventory was completed at 24 h and 5-day post-infusion to assess the severity of acute and delayed CINV, respectively. RESULTS: Participants were 88 patients (55% female, M = 60 years). A total of 23% experienced acute nausea and 55% delayed nausea. Younger age, history of pregnancy-related nausea, fewer hours slept the night prior to infusion, and variation in ABCB1 were associated with more severe acute nausea; advanced-stage cancer and receipt of highly emetogenic chemotherapy were associated with more severe delayed nausea (p values < 0.05). In multivariable analyses, ABCB1 added an additional 5% predictive value beyond the 13% variance explained by patient-reported risk factors. CONCLUSIONS: The current study identified patient-reported and genetic factors that may place patients at risk for acute nausea despite receipt of guideline-consistent anti-emetic prophylaxis. Additional studies examining other genetic variants are needed, as well as the development of risk prediction models including both patient-reported and genetic risk factors.

Apoyo con Cariño (support with caring): RCT protocol to improve palliative care outcomes for Latinos with advanced medical illness.

Latinos are more likely to experience uncontrolled pain, and institutional death, and are less likely to engage in advance care planning. Efforts to increase access to palliative care must maximize primary palliative care and community based models to meet the ever-growing need in a culturally sensitive and congruent manner. Patient navigator interventions are community-based, culturally tailored models of care that have been successfully implemented to improve disease prevention, early diagnosis, and treatment. We have developed a patient navigation intervention to improve palliative care outcomes for seriously ill Latinos. We describe the protocol for a National Institute of Nursing Research-funded randomized controlled trial designed to determine the effectiveness of the manualized patient navigator intervention. We aim to enroll 240 Latino adults with non-cancer, advanced medical illness from both urban and rural clinical sites. Participants will be randomized to the intervention group (five palliative care patient navigator visits plus bilingual educational materials) or control group (usual care plus bilingual educational materials). Outcomes include quality of life (Functional Assessment of Chronic Illness Therapy), advance care planning (Advance Care Planning Engagement survey), pain (Brief Pain Inventory), symptom management (Edmonton Symptom Assessment Scale-revised), hospice utilization, and cost and utilization of healthcare resources. This culturally tailored, evidence-based, theory-driven, innovative patient navigation intervention has significant potential to improve palliative care for Latinos, and facilitate health equity in palliative and end-of-life care.

Apoyo con Cariño: Strategies to Promote Recruiting, Enrolling, and Retaining Latinos in a Cancer Clinical Trial.

Background: We present and describe tailored strategies to address known barriers to minority participation in clinical trial research. The strategies used allowed our team to engage communities and successfully recruit, enroll, and retain a diverse underserved population of Latinos with advanced cancer for this clinical trial. Methods: Participants were recruited from 3 urban and 7 rural sites. We identified 4 critical barriers to recruitment for this underserved population: (1) mistrust; (2) language and communication barriers; (3) lack of access to academic cancer center; and (4) inability to participate due to transportation, childcare, or work responsibilities. We developed tailored strategies to engage referring sites and patients to participate in the clinical trial. Results: We identified 318 potentially eligible participants; 34 were found to be ineligible, and 223 consented to participate in the study, representing a 79.0% enrollment rate. All patients (100%) self-identified as Latino, and 47.5% spoke Spanish as their primary language. Patients were socioeconomically disadvantaged: 53.6% had an annual income <$15,000 USD, and 50.2% had less than a high school education. A total of 177 participants completed the 3-month follow-up; 26 died before the 3-month follow interview, and 20 did not complete the follow-up evaluation (9% withdrawal rate). Conclusions: Our community-informed strategies were highly effective for recruiting, enrolling, and retaining an underserved diverse population of Latinos. The barriers we identified and the strategies we used have the potential to inform research to increase minority participation in cancer clinical trials. ClinicalTrials.gov identifier: NCT01695382.

Experiences and Values of Latinos with End Stage Renal Disease: A Systematic Review of Qualitative Studies.

Patients with end stage renal disease (ESRD) experience a high symptom burden and poor quality of life as part of their advanced illness. Latinos experience a higher prevalence of ESRD compared to non-Latino whites; however, they are underrepresented in existing ESRD literature. We conducted a systematic review of qualitative studies that include Latino patients with ESRD and their caregivers in the United States. Of 694 citations published through August 2014, six met inclusion criteria. Four major themes emerged: 1) Losses, 2) Heightened awareness of death, 3) Barriers to quality communication and care, and 4) Mediating Latino traditions and values. A thematic schema was developed.

Association Between Patient Portal Activities and End-of-Life Outcomes Among Deceased Patients in the Last 12 Months of Life.

Objective: The objective of this study was to examine the association between portal use and end-of-life (EOL) outcomes in the last year of life. Methods: A retrospective cohort (n = 6,517) study at Kaiser Permanente Colorado among adults with serious illness deceased between January 1, 2016, and June 30, 2019. Portal use was categorized into engagement types: no use, nonactive, active without a provider, and active with a provider. EOL outcomes were hospitalizations in the month before death, last-year advance directive completion, and hospice use. Association between EOL outcomes and levels of portal use was assessed using χ2 statistics and generalized linear models. Results: Higher portal engagement types were associated with higher rates of hospitalizations (p = 0.0492), advance directive completion (p = 0.0226), and hospice use (p = 0.0070). Conclusion: Portal use in the last year of life was associated with increases in a poor EOL outcome, hospitalizations, and beneficial EOL outcomes, advance directives, and hospice care.

A Process Evaluation of a Palliative Care Social Work Intervention for Cancer Patients in Skilled Nursing Facilities.

Background: Assessing and Listening to Individual Goals and Needs (ALIGN) is a palliative care social work intervention that aims to improve delivery of goal-concordant care for hospitalized older adults with cancer discharged to skilled nursing facilities. Objective: Explore processes through which ALIGN may improve delivery of goal-concordant care to substantiate the conceptual model grounding the intervention and to inform mechanistic hypotheses of how the intervention might be effective. Design: A process evaluation triangulating findings from patient and caregiver interviews with a matrix analysis of ALIGN social worker notes. Setting/Participants: Patients (n = 6) and caregivers (n = 13) who participated in a single-arm pilot study of ALIGN in the United States and 113 intervention notes (n = 18 patients) written by 2 ALIGN social workers. Measurement: Qualitative thematic content analysis Results: Themes included the following: (1) ALIGN helped reconcile participants' misaligned expectations of rehabilitation with the reality of the patient's progressive illness; (2) ALIGN helped participants manage uncertainty and stress about forthcoming medical decision making; (3) the longitudinal nature of ALIGN allowed for iterative value-based goals of care discussions during a time when patients were changing their focus of treatment; and (4) ALIGN activated participants to advocate for their needs. Conclusions: ALIGN offers support in prognostic understanding, communication, and decision making during a pivotal time when patient and caregivers' goals have not been met and they are reassessing priorities. A larger trial is needed to understand how these processes may improve the ability of participants to make value-based decisions and aide in delivery of goal-concordant care. Clinical Trial Registration Number: NCT04882111.

Patient Navigator Intervention to Improve Palliative Care Outcomes for Hispanic Patients With Serious Noncancer Illness: A Randomized Clinical Trial.

Importance: Disparities persist across the trajectory of serious illness, including at the end of life. Patient navigation has been shown to reduce disparities and improve outcomes for underserved populations. Objective: To determine the effectiveness of a lay patient navigator intervention, Apoyo con Cariño, in improving palliative care outcomes among Hispanic patients. Design, Setting, and Participants: This was a multicenter randomized clinical trial that took place across academic, nonprofit, safety-net, and community health care systems in urban, rural, and mountain/frontier regions of Colorado from January 2017 to January 2021. Self-identifying Hispanic adults with serious noncancer medical illness and limited prognosis were recruited. Data were collected and analyzed from July 2022 to July 2023. Interventions: Participants randomized to the intervention group received 5 home visits from a bilingual, bicultural lay patient navigator; participants randomized to control received care as usual. Both groups received culturally tailored educational materials. Investigators/outcome accessors remained blinded to participant assignment. Main Outcomes and Measures: Change in score from baseline to 3 months on the Functional Assessment of Chronic Illness Therapy (FACIT) General quality of life (QOL) scale (primary outcome), Advance Care Planning (ACP) Engagement Survey, Brief Pain Inventory, Edmonton Symptom Assessment Scale, and FACIT Spiritual Well-Being subscale; at 6 months, advance directive (AD) documentation; and at 46 months or death, hospice utilization and length of stay, as well as aggressiveness of care at end of life. Results: Of 209 patients enrolled (mean [SD] age, 63.6 [14.3] years; 108 [51.7%] male), 105 patients were randomized to control and 104 patients to the intervention. There were no statistically significant differences in the change in mean (SD) QOL score between the intervention and control groups (5.0 [16.5] vs 4.3 [15.5]; P = .75). Participants in the intervention group, compared with the control group, had statistically significant greater increases in mean (SD) ACP engagement (0.8 [1.3] vs 0.1 [1.4]; P < .001) and were more likely to have a documented AD (62 of 104 [59.6%] vs 28 of 105 [26.9%]; P < .001). There were no statistically significant differences in mean (SD) change in pain intensity score (0-10) between patients in the intervention group compared with control (-0.4 [2.6] vs -0.5 [2.8]; P = .79), nor pain interference (-0.2 [3.7] vs -0.4 [3.7]; P = .71). Patients receiving the intervention were more likely to be referred to hospice compared with patients receiving control (19 of 43 patients [44.2%] vs 7 of 33 patients [21.2%]; P = .04) and less likely to receive aggressive care at end of life (27 of 42 patients [64.3%] vs 28 of 33 patients [84.8%]; P = .046). Conclusion and Relevance: In this randomized clinical trial, a culturally tailored patient navigator intervention did not improve QOL for patients. However, the intervention did increase ACP engagement, AD documentation, and hospice utilization in Hispanic persons with serious medical illness. Trial Registration: ClinicalTrials.gov Identifier: NCT03181750.