INTRODUCTION: Palliative care (PC), including hospice, can improve quality of life by helping manage distressing symptoms. PC is underutilized among people with cancer in the United States. We studied whether (1) sociode...INTRODUCTION: Palliative care (PC), including hospice, can improve quality of life by helping manage distressing symptoms. PC is underutilized among people with cancer in the United States. We studied whether (1) sociodemographics and illness burden were associated with receipt of PC, and (2) whether PC use was related to self-reported care experiences. MATERIALS AND METHODS: Using Surveillance, Epidemiology, and End Results (SEER)-Consumer Assessment of Healthcare Providers and Systems (CAHPS) data, we analyzed illness burden (using the SEER-CAHPS Illness Burden Index [SCIBI]), race/ethnicity, and self-reported care experiences in three cancer cohorts: those receiving hospice (with or without other forms of PC); PC encounters without hospice; and no PC. We included fee-for-service and Medicare Advantage beneficiaries with cancer (n = 37,025) diagnosed 2007-2017, surveyed 2007-2017, and followed up to five years post-diagnosis (through 2019). Multivariable survey-weighted logistic regression models adjusted for clinical characteristics, social determinants of health (SDoH) (dual enrollment in Medicare and Medicaid; neighborhood poverty; education; language), demographics, and clinical characteristics. RESULTS: Among 37,025 Medicare beneficiaries with cancer, 11.1 % received hospice (with or without PC) and 7.4 % received PC only. Nearly 30 % of the sample died within five years of diagnosis; fewer than one-third of decedents received hospice. Factors associated with receiving hospice included increasing age, non-Hispanic ethnicity, American Indian/Alaska Native and multiracial identities, living in higher-income neighborhoods, survey-completion proxy assistance, fair/poor general health, advanced stage at diagnosis, and more illness burden. Independent predictors of PC encounters included age 75-79, female identification, no dual enrollment, no proxy assistance, and more illness burden. Differences in care experience associated with hospice or PC use were shown for two care experience measures: doctor communication scores and doctor rating scores were higher among beneficiaries who received neither hospice nor PC relative to beneficiaries who received hospice. DISCUSSION: Variability in hospice and PC receipt across sociodemographic characteristics suggest the continued need to ensure equitable service provision. Worse doctor communication scores associated with hospice or PC encounters suggests a potential avenue for improving care experiences.
INTRODUCTION: Comprehensive geriatric assessment (CGA) is recommended for selecting intensive therapy in older patients, but concerns about time and effort hinder its use. This retrospective study aimed to evaluate assoc...INTRODUCTION: Comprehensive geriatric assessment (CGA) is recommended for selecting intensive therapy in older patients, but concerns about time and effort hinder its use. This retrospective study aimed to evaluate associations between geriatric screening tools' results and compliance, toxicity, and survival in older patients with locally advanced non-small cell lung cancer being considered for concurrent chemoradiotherapy (CCRT). MATERIALS AND METHODS: From 2012 to 2020, 108 patients aged >75, with an ECOG score of ≤1, and undergoing CCRT were included. Clinical characteristics and blood markers, including sex, Charlson Comorbidity Index (CCI), complete blood count, serum albumin, and C-reactive protein were collected within two weeks of radiotherapy initiation. Glasgow prognostic score (GPS) and Geriatric 8 (G8) scores were calculated. A G8 score of ≤14 was indicative of frailty. RESULTS: The median age was 78.5 (range, 76-85). Altogether, 47 patients (43.5 %) had a CCI of 0, while 42 (38.9 %) had a G8 of ≤14. Altogether, 96 patients (88.9 %) were compliant with the treatment plan. The median overall survival (OS) was 21 months, with two- and five-year OS of 43.5 % and 25.8 %, respectively. Two-year progression-free survival (PFS) was 25.0 %, and five-year PFS was 16.3 %, with a median of nine months. Compliance was 85.7 % for patients with a G8 score of ≤14 and 90.9 % for those with a score > 14 (p = 0.40). Compliance was 92.0 % in GPS 0 and 88.0 % in GPS 1-2 (p = 0.57). G8 ≤ 14 showed grade 3 or higher pneumonitis than G8 > 14 (16.7 % vs. 4.5 %, p = 0.034). In multivariate analysis, a G8 of ≤14 and a GPS of ≥1 were poor prognostic factors for both OS and PFS. Altogether, 65 patients (60.2 %) died of lung cancer-specific deaths (LCD) and 20 (18.5 %) died of non-lung cancer-specific deaths (NLCD). In multivariate analysis, GPS (p = 0.001) was significantly associated with LCD, while the G8 score (p = 0.048) correlated with NLCD. DISCUSSION: Both the GPS and G8 score predict survival outcomes, with GPS more strongly associated with LCD and the G8 score with NLCD. Further studies are needed to explore CGA in patients with low G8 scores to better manage these vulnerable individuals.
INTRODUCTION: Immuno-oncology (I-O) therapies have significantly improved survival outcomes in patients with non-small cell lung cancer (NSCLC). However, older patients, who account for a substantial proportion of NSCLC...INTRODUCTION: Immuno-oncology (I-O) therapies have significantly improved survival outcomes in patients with non-small cell lung cancer (NSCLC). However, older patients, who account for a substantial proportion of NSCLC cases, are frequently underrepresented in clinical trials. The complexities of aging and associated comorbidities highlight the need for tailored treatment strategies in this population. This study aimed to evaluate mortality patterns and causes of death among older patients with advanced NSCLC before and after the introduction of I-O therapies in the United States, while also investigating factors associated with competing risks of NSCLC-specific and other cause-specific deaths in both periods. MATERIALS AND METHODS: We conducted a retrospective cohort study using the 2012-2019 Surveillance, Epidemiology, and End Results (SEER)-Medicare database. Patients aged 65 years or older with advanced NSCLC were included and classified into two cohorts based on their diagnosis date: pre-I-O (January 2013 - February 2015) and post-I-O (March 2015 - December 2017). Mortality outcomes included deaths from cardiovascular disease (CVD), NSCLC, and other causes. Predictors included sociodemographic factors (e.g., race, income level) and clinical factors (e.g., histology, surgery history, comorbidities). Competing risk analyses were conducted using the Fine-Gray model, while the cause-specific Cox model was employed for sensitivity analysis. RESULTS: Among 51,612 patients (51 % male; mean age: 77 years), more than half of all deaths were attributed to NSCLC (pre-I-O: 60.32 %; post-I-O: 55.96 %). After adjusting for covariates, mortality from CVD (sub-distribution hazard ratio [sHR] = 0.81; 95 % CI: 0.72-0.90) and NSCLC (sHR = 0.80; 95 % CI: 0.79-0.82) declined in the post-I-O period compared to the pre-I-O period. Comorbidities related to CVD, including peripheral vascular disease (sHR = 1.52 in pre-I-O; sHR = 1.47 in post-I-O) and cerebrovascular disease (sHR = 1.47 in pre-I-O; sHR = 1.44 in post-I-O) were associated with significantly increased CVD mortality in both periods. DISCUSSION: This study identified significant reductions in CVD- and NSCLC-related mortality during the post-IO period compared to the pre-IO period among older patients with advanced NSCLC. However, despite these improvements, our findings underscore the continued need to manage comorbidities and address socioeconomic disparities to optimize outcomes in geriatric oncology.
INTRODUCTION: Unmet care needs in daily activities among older adults with cancer are understudied. We aimed to identify these unmet needs and estimate associated characteristics in this population. MATERIALS AND METHODS...INTRODUCTION: Unmet care needs in daily activities among older adults with cancer are understudied. We aimed to identify these unmet needs and estimate associated characteristics in this population. MATERIALS AND METHODS: We conducted secondary analyses of community-dwelling older adults with cancer (ages≥65) in the 2015-2019 National Health and Aging Trends Study (NHATS), a longitudinal cohort study. Unmet needs across 12 daily activities (e.g., eating, shopping, going outside) were classified as "difficulty performing activities independently" (for participants without caregivers) or "caregiver inability to help" (for those with caregivers). We reported the weighted prevalence of unmet needs for each year and built binary logistic regression models to identify associated participant characteristics using 2015 data. We additionally examined the association of years since cancer diagnosis with unmet care needs among participants with incident cancer from 2015 to 2019. We stratified all analyses by caregiver status. RESULTS: We included 953 participants without caregivers (mean age: 77 years) and 540 participants with caregivers (mean age: 79 years) in the 2015 NHATS. Between 2015 and 2019, 29-33 % of participants without caregivers and 17-21 % of those with caregivers reported at least one unmet care need. Among those without caregivers, significant characteristics associated with any unmet needs included being unmarried and impairments in physical function, nutritional status, and cognition. For participants with caregivers, significant characteristics included impairments in nutritional status and cognition, as well as White race. Among those with incident cancer and without caregivers, being 1-2 [(odds ratio (OR) 1.8)], 3-4 (OR 2.0) and 5+ (OR 2.3) years from diagnosis was significantly associated with any unmet care needs compared to pre-diagnosis (p for linear trend 0.02). DISCUSSION: Unmet care needs due to difficulty performing activities independently or caregiver inability to help are prevalent in community-dwelling older adults with cancer. Tailored interventions addressing these unmet needs are needed, particularly for high-risk individuals (e.g., those with impaired cognition).
INTRODUCTION: Patients with gastrointestinal cancer have a high risk of sarcopenia, which worsens prognosis. Despite evidence suggesting multiple contributing factors, the exact causes remain debated, with inconsistent f...INTRODUCTION: Patients with gastrointestinal cancer have a high risk of sarcopenia, which worsens prognosis. Despite evidence suggesting multiple contributing factors, the exact causes remain debated, with inconsistent findings. Therefore, this study aims to systematically review and synthesize the risk factors associated with sarcopenia in patients with gastrointestinal cancers based on existing literature. MATERIALS AND METHODS: A systematic search of six databases identified cohort, case-control, and cross-sectional studies. This review was registered with PROSPERO (CRD42023477999). Meta-analyses using R software estimated pooled incidence rates and effect sizes. RESULTS: 52 studies (16,468 participants, <40 % female) were analyzed. The overall prevalence of sarcopenia was 33 % (95 % CI: 28 %-38 %), with regional variations. Key risk factors included older age (OR 2.38, 95 % CI 1.79-3.17), low physical activity (OR 8.72, 95 % CI 3.15-24.11), and dependence on daily activities (OR 5.51, 95 % CI 2.20-13.83). Disease-related factors encompassed tumor staging, diabetes (OR 2.41, 95 % CI 1.35-4.29), anemia (OR 2.19, 95 % CI 1.17-4.07), and comorbidity burden (OR 1.14, 95 % CI 1.00-1.30). Nutritional risks included low BMI (OR 4.03, 95 % CI 2.71-6.00), poor nutrition (OR 4.19, 95 % CI 2.48-7.05), low albumin (OR 1.96, 95 % CI 1.20-3.21), and elevated neutrophil-to-lymphocyte ratio (OR 1.63, 95 % CI 1.31-2.03). DISCUSSION: Sarcopenia is highly prevalent in patients with gastrointestinal cancer, with diverse contributing factors. Early screening, personalized exercise programs, comorbidity management, and timely nutritional interventions are crucial for prevention and treatment.
Minami CA, Revette AC, Nava-Coulter B
… +3 more, Nguyen K, Lorentzen EH, Schonberg MA
J Geriatr Oncol
· 2026 Jan · PMID 41110389
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INTRODUCTION: Women ≥70 years with low-risk breast cancer face nuanced therapy decisions. Using qualitative analysis, we aimed to determine how oncologists and patients integrate geriatric considerations into complex tre...INTRODUCTION: Women ≥70 years with low-risk breast cancer face nuanced therapy decisions. Using qualitative analysis, we aimed to determine how oncologists and patients integrate geriatric considerations into complex treatment conversations. MATERIALS AND METHODS: We recruited women aged ≥70, newly diagnosed with clinical T1-2N0 hormone receptor-positive/HER2-negative disease between October 2020 and March 2023 from a large cancer center and audio-recorded and transcribed their consults with surgical, medical, and radiation oncologists. We identified geriatric issues included in conversational content and the dynamics of patient/oncologist communication. Data collection and analysis were simultaneously performed. We also assessed participant decision-making preferences, frailty, and life expectancy. RESULTS: Of 48 eligible patients approached, 27 (56 %) participated with eight surgical oncologists, 17 with 11 medical oncologists, and four with three radiation oncologists (n = 48 consultations recorded). Fourteen patients (48 %) were ≥ 75 years, 23 were non-Hispanic White (76 %). Patients preferred to share (n = 15, 58 %) or make their own treatment decisions (n = 10, 39 %), rather than defer to the oncologist. Oncologists presented an explicit treatment choice in 16 conversations (35 %). Chronological age was discussed in 27 (56 %) conversations, comorbidities in 44 (92 %), and multimorbidity in two (4 %). Other geriatric considerations were discussed in the minority of conversations [physiologic age: 20 (42 %); function: 20 (42 %); quality-of-life: 5 (10 %); life expectancy: 5 (10 %); polypharmacy: 2 (4 %)]. DISCUSSION: Despite numerous treatment options, oncologists neither commonly offer older women with low-risk breast cancer explicit treatment choices, nor discuss geriatric issues besides comorbidity. Training oncologists in communication around geriatric issues may lead to more person-centered breast cancer care.
INTRODUCTION: Pancreatic ductal adenocarcinoma (PDAC) is an aggressive malignancy with poor prognosis, particularly in older patients (≥70 years), who represent an increasing proportion of cases. However, this population...INTRODUCTION: Pancreatic ductal adenocarcinoma (PDAC) is an aggressive malignancy with poor prognosis, particularly in older patients (≥70 years), who represent an increasing proportion of cases. However, this population is underrepresented in clinical trials. This study aimed to evaluate the prognostic impact of the Geriatric 8 (G8) screening tool and the comprehensive geriatric assessment (CGA) in older patients with advanced PDAC. MATERIALS AND METHODS: We conducted a retrospective observational study of patients aged ≥70 years with locally advanced or metastatic PDAC treated at Fondazione Policlinico Gemelli IRCCS between January 2018 and August 2023. Clinical, demographic, and treatment data were extracted through structured and unstructured data mining. All patients underwent G8 screening at the start of first-line therapy; if G8 was ≤14, patients could have received CGA. Primary endpoints were progression-free survival (PFS) and overall survival (OS), analyzed through Kaplan-Meier estimates and Cox regression models. RESULTS: Of 268 eligible older patients, 210 (78.4 %) received first-line chemotherapy. Most received gemcitabine plus nab-paclitaxel (58.1 %). Median PFS and OS were 6.5 (95 % CI: 5.7-7.3) and 9.9 months (95 % CI: 9.1-11.7), respectively. Baseline Geriatric 8 score was ≤14 in 149 out of 210 (70.9 %) patients and ≥ 15 in 61 out of 210 (29.1 %). A baseline G8 score ≥ 15 was significantly associated with higher PFS (7.9 vs. 5.3 months, HR 0.57, p = 0.001) and OS (16.6 vs. 7.8 months, HR 0.39, p < 0.001), both at univariate and multivariate analyses. Among the 149 patients with a baseline G8 ≤ 14, 97 (65.1 %) were referred for CGA, and 60 (40.3 % of the overall G8 ≤ 14 population) completed the assessment. No difference in mPFS (p = 0.28) nor in mOS (p = 0.25) emerged according to CGA assessment. However, the 12-month survival rate was higher in patients who underwent CGA (31.8 %) compared with those who did not (14.2 %). DISCUSSION: First-line chemotherapy provides particular clinical benefit to older adults with PDAC with higher G8 scores, though benefit was observed across the broader cohort. The G8 score was a strong independent prognostic tool for treatment response and survival.
INTRODUCTION: Patients with metastatic lung cancer often experience significant symptom burden. This study aimed to describe baseline symptoms in adults with metastatic lung cancer at diagnosis, identify age-related diff...INTRODUCTION: Patients with metastatic lung cancer often experience significant symptom burden. This study aimed to describe baseline symptoms in adults with metastatic lung cancer at diagnosis, identify age-related differences, and examine symptom clusters and intercorrelations. MATERIALS AND METHODS: This retrospective study analyzed Edmonton Symptom Assessment System scores from patients with newly diagnosed stage IV lung cancer (2015-2016). Patients were stratified by age (<65 vs ≥65 years). Descriptive statistics, generalized linear regression analysis, principal component analysis, and network analysis were used to examine symptom profiles and clustering. RESULTS: Of the 359 included patients, 213 (58.3%) were ≥ 65 years old. Median (interquartiles) total symptom distress score was 22 (11, 39). Two main symptom clusters emerged: physical (pain, tiredness, drowsiness, nausea, lack of appetite, shortness of breath) and psychological (depression, anxiety, wellbeing). No significant differences in overall symptom burden were found between age groups, except older patients reported worse lack of appetite (p = 0.04). Network analysis identified wellbeing, tiredness, and depression as central, highly interconnected symptoms across age groups. DISCUSSION: Older and younger patients with metastatic lung cancer experience a similar high symptom burden at diagnosis. Routine comprehensive symptom assessment is important for all age groups. The identified symptom clusters and central symptoms may help guide targeted supportive care interventions to improve quality of life in this population.
INTRODUCTION: Diffuse large B-cell lymphoma (DLBCL) is the most prevalent subtype of non-Hodgkin lymphoma (NHL), accounting for 31% of NHL cases in Western populations with a median diagnosis age of 70.4 years. Despite t...INTRODUCTION: Diffuse large B-cell lymphoma (DLBCL) is the most prevalent subtype of non-Hodgkin lymphoma (NHL), accounting for 31% of NHL cases in Western populations with a median diagnosis age of 70.4 years. Despite the efficacy of standard treatments, older patients, particularly those aged 75 years and older, often face under-treatment and poor outcomes. This study examines treatment patterns and outcomes among older adults with DLBCL within the Veterans Health Administration (VHA), which provides a unique opportunity to analyze a cohort of older adults in a large integrated health care system. MATERIALS AND METHODS: Data was analyzed from the VHA and Department of Defense Joint Longitudinal Viewer (JLV). Between January 1, 2011 and December 31, 2021, 6,266 patients were diagnosed with DLBCL. Patients were categorized into four age groups: <65, 65-74, 75-84, and ≥ 85 years. Patients were excluded if they had incomplete demographic, treatment, or survival data within the JLV, or if diagnosis could not be confirmed in structured fields. Chi-squared tests assessed differences among age groups. Overall survival (OS) was analyzed using Kaplan-Meier method and hazard ratios calculated using the Cox Proportional Hazard model. RESULTS: A total of 3176 patients met inclusion criteria for analysis out of 6266 patients diagnosed with DLBCL between January 1, 2011 and December 31, 2021. Among the included cohort, 33.2% were aged <65, 40.8% aged 65-74, 19.2% aged 75-84, and 6.8% aged ≥85. The median OS was 143 months for <65 years, 72 months for 65-74 years, 43 months for 75-84 years, and 14 months for ≥85 years (p < 0.001). The likelihood of receiving first-line chemotherapy decreased significantly with increasing age, with 30.0% of patients aged 85 years or older receiving no chemotherapy. Among patients who received chemotherapy, completion rates declined with age. Palliative care consultations and hospice enrollment increased with age. DISCUSSION: Our findings highlight significant disparities in treatment initiation and completion among older patients with DLBCL. Advanced age negatively impacted survival outcomes. There is an urgent need for tailored treatment approaches and inclusion of geriatric patients in clinical trials to ensure equitable access to innovative therapies. Comprehensive geriatric assessments should guide treatment decisions to enhance outcomes in this vulnerable population.
Professional societies such as the International Society of Geriatric Oncology (SIOG) and the American Society of Clinical Oncology (ASCO) recommend geriatric screening and assessment for all older adults being considere...Professional societies such as the International Society of Geriatric Oncology (SIOG) and the American Society of Clinical Oncology (ASCO) recommend geriatric screening and assessment for all older adults being considered for cancer treatment, to optimize cancer treatment selection and develop a supportive care plan to optimize outcomes such as reducing their risk of treatment toxicity, hospitalisations, and improvements in function and quality of life. In many centres, nurses and allied health professionals play key leadership roles in conducting geriatric screening and assessment, developing individualized care plans and monitoring their implementation. However, most nurses and allied health professionals working with older adults with cancer receive little training related to geriatric screening and assessment and require education regarding tools selection for geriatric screening and assessment. Therefore, there is a need for an up-to-date overview of geriatric screening and assessment tools for nurses and allied health professionals. In this review, we update the previous SIOG Nursing and Allied Health (NAH) Interest Group opinion paper to reflect the latest evidence related to geriatric screening and assessment. We suggest tools to assist geriatric screening and assessment (GA) as well as suggested interventions based on geriatric assessment results for the following domains: functional status, falls, nutrition, medication-related issues, distress, cognition, delirium, social support and financial status, and comorbidity. This updated overview aims to raise awareness and make accessible supports for nurses and allied health professionals on how to integrate GA and interventions into routine cancer care.
Martin C, Banks J, Battisti NML
… +4 more, Bekker H, Edwards A, Wyld L, Morgan J
J Geriatr Oncol
· 2025 Nov · PMID 41067034
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INTRODUCTION: To fully consider the preferences and information needs of older adults, cancer treatment decision-making discussions should take a patient-centred approach. Some older patients may place more value on main...INTRODUCTION: To fully consider the preferences and information needs of older adults, cancer treatment decision-making discussions should take a patient-centred approach. Some older patients may place more value on maintaining quality of life over the continuation of life-prolonging treatments, even when the cancer is early-stage and potentially curable. Decision support tools can play a role in facilitating discussions around treatment trade-offs. The objective of this review is to examine the literature on the treatment decision-making preferences of patients aged 70 and older with early-stage, potentially curable, cancer. MATERIALS AND METHODS: MEDLINE OVID, CINAHAL, APA PsycINFO, Scopus, and Cochrane databases were systematically searched in January 2025. Published literature focusing on quality and length-of-life decision-making, and the use of decision support tools aimed towards older adults diagnosed with early-stage cancer, were included. Two authors performed full-text selection and quality appraisal. Data were synthesized according to themes, using the Framework Approach. RESULTS: From 1476 screened records, a total of 14 studies were included. Five key themes were identified: Information needs; Treatment preferences; Trade-offs (treatments, quality and length-of-life); Decision-making involvement; Available decision support interventions. DISCUSSION: Evidence suggests that older patients would benefit from receiving information about both quality and length-of-life when making cancer treatment decisions. Quality of life concerns including physical wellbeing, autonomy, and symptom burden were factors considered by patients. Decision support tools have the potential to assist in trade-off discussions, however, few have been developed to balance trade-offs between quality and length-of-life. REGISTRATION:PROSPERO: CRD42025626454.
Evenden P, Cancel M, Correard F
… +6 more, Bertrand N, Falandry C, Mourey L, Couderc AL, Beauplet B, on behalf the SoFOG (French Society of Geriatric Oncology)
INTRODUCTION: Electronic patient-reported outcome (ePRO) monitoring improves cancer treatment completion, quality of life (QoL), and is now covered by several French National Health Insurances. Given that most patients d...INTRODUCTION: Electronic patient-reported outcome (ePRO) monitoring improves cancer treatment completion, quality of life (QoL), and is now covered by several French National Health Insurances. Given that most patients diagnosed with cancer worldwide are aged 65 or over, we need to take into account patients' potential frailty (e.g., mobility and history of falls, comorbidities, polypharmacy, cognitive impairment) and its negative impact on cancer treatment outcomes. The aim of this study was to make recommendations to optimise ePRO monitoring in older patients treated for cancer. MATERIALS AND METHODS: This national Delphi method targeted patients with cancer aged ≥65 and/or their primary caregivers, as well as healthcare professionals (doctors, nurses, pharmacists) using ePROs developed for oncology. Ten recommendations were developed - using national and international guidelines as well as scientific literature - based on patients' profiles, ease of use, usefulness and satisfaction. The level of agreement with each recommendation was voted by each participant using a Likert scale. Recommendations could be modified after each round based on feedback to better reflect the needs regarding ePROs for older adults. RESULTS: Among the 221 participants at the first and the 148 at the second round, the majority of participants were aged ≥65 (94.1 % and 94.6 % respectively) and over 90 % of participants were patients (91 % and 93.2 % respectively). Males were predominant in both the first and second round (59.3 % and 62.2 % respectively). Of the 10 proposed recommendations, three reached a strong agreement and six a moderate agreement. There was no consensus on the recommendation to adapt telemonitoring to an age threshold. DISCUSSION: As most of the participants were older patients, this consensus highlights their needs in terms of ePRO optimisation. Our guidelines propose a total of nine recommendations to be integrated by the ePRO monitoring systems.
Saracino RM, Park EY, Onorato N
… +7 more, Pessin H, McDonald M, Demirjian C, Schofield E, Rosenfeld B, Breitbart W, Applebaum AJ
J Geriatr Oncol
· 2025 Nov · PMID 41045824
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INTRODUCTION: Patients with advanced cancer are often confronted with existential distress that, when unaddressed, may lead to increased suffering and despair. Homebound individuals face compounded existential concerns a...INTRODUCTION: Patients with advanced cancer are often confronted with existential distress that, when unaddressed, may lead to increased suffering and despair. Homebound individuals face compounded existential concerns and loss of meaning, as they must contend with loss of independence and declining opportunities for activities and social engagement. Thus, there is a need to develop strategies for delivering quality psychological interventions to homebound patients. In the United States, homecare agencies provide care to over 4.5 million patients annually, with nurses comprising over half of their employees. Given the size of this workforce and their frequent contact with homebound patients, we developed Meaning Centered Psychotherapy at Home (MCP-H) to be delivered by nurses to increase the reach of this evidence-based intervention to this population. MATERIALS AND METHODS: In Phase 1, nurse participants (n = 8-10) from VNS Health will be trained to deliver MCP-H. We will enroll 8-10 training case patients, each paired with one nurse interventionist, in a single-arm open pilot study to refine the intervention structure and procedures. In Phase 2, we will conduct a pilot randomized controlled trial to determine the feasibility, acceptability, and preliminary efficacy of MCP-H. Patients (n = 70) will be randomized to receive either MCP-H or treatment as usual. DISCUSSION: MCP-H has unique potential to increase the reach of mental health care to individuals receiving homecare, leveraging the existing infrastructure of a high-volume home health agency and nurses to address the unmet needs of these patients. If effective, it can be embedded in existing systems as a potentially widely disseminable approach to reaching historically underserved patient populations. TRIAL REGISTRATION: This study is registered under ClinicalTrials.gov (ID NCT05495737).
INTRODUCTION: The number of phase 1 clinical trials has been increasing globally over the past decade. However, patient recruitment remains skewed towards younger populations with older adults remaining underrepresented,...INTRODUCTION: The number of phase 1 clinical trials has been increasing globally over the past decade. However, patient recruitment remains skewed towards younger populations with older adults remaining underrepresented, limiting generalizability. Few studies have systematically examined the role of comorbidities as a determinant of safety outcomes in phase 1 trials. Thus, we aimed to investigate the impact of age and comorbidity on safety outcomes of phase 1 trial participants. MATERIALS AND METHODS: This retrospective analysis examined electronic health records of patients aged ≥18 years enrolled in phase 1 trials for metastatic solid malignancies between January 2020 and May 2023. Patients were stratified into two age groups (<70 years vs. ≥70 years). Patients were classified as comorbid if they had Charlson Comorbidity Index (CCI) ≥3, Elixhauser Comorbidity Index (ECI) ≥4, or modified Elixhauser Comorbidity Index (mECI) >12. Eastern Cooperative Oncology Group (ECOG) performance status was also evaluated. Logistic regression models assessed associations between age, comorbidity, and safety outcomes: serious adverse events (SAE), dose-limiting toxicities (DLT), dose reductions/interruptions (DR/DI), cessation of treatment due to toxicity (COTT), and grade 3-5 toxicities. RESULTS: We included 229 patients, of whom 51 (22%) were aged ≥70 years. Among them, 79 (34%) experienced an SAE, 109 (48%) had DR/DI, 34 (15%) had COTT, 17 (7%) had DLT, and 99 (43%) developed grade 3-5 adverse events. Age was not significantly associated with a higher likelihood of adverse safety outcomes. However, patients with ECI ≥4 had significantly higher likelihood of SAE than those with ECI <4 (50% vs. 31%, p = 0.04, OR: 2.18, 95% CI: 1.08-4.44). Patients with ECOG ≥1 had higher likelihood of SAE than those with ECOG 0 (42% vs. 29%, p = 0.06, OR: 1.75, 95% CI: 1.01-3.05, p = 0.05). Patients with ECOG ≥1 had significantly higher likelihood of grade 3-5 adverse events than those with ECOG 0 (52% vs. 36%, p = 0.03, OR: 1.89, 95% CI: 1.11-3.23, p = 0.02). Other comorbidity indices were not significantly associated with safety outcomes. DISCUSSION: Age alone was not associated with safety outcomes in phase 1 clinical trials for metastatic solid malignancies. Instead, comorbidity burden and ECOG performance status were predictors of adverse events in our cohort of patients.