Early Supportive Versus Standard Care in Phase I Cancer Trials: A Randomized Controlled Trial.

BackgroundCrimean Congo haemorrhagic fever (CCHF) is a tick‐borne disease that occurs in parts of Asia, Europe and Africa. Since 2000 the infection has caused epidemics in Turkey, Iran, Russia, Uganda and Pakistan. Good‐quality general supportive medical care helps reduce mortality. There is uncertainty and controversy about treating CCHF with the antiviral drug ribavirin.ObjectivesTo assess the effects of ribavirin for treating people with Crimean Congo haemorrhagic fever.Search methodsWe searched the Cochrane Infectious Diseases Group Specialized Register; the Central Register of Controlled Trials (CENTRAL); MEDLINE (PubMed); Embase (OVID); Science Citation Index‐Expanded, Social Sciences Citation index, conference proceedings (Web of Science); and CINAHL (EBSCOHost). We also searched the WHO International Clinical Trials Registry Platform (ICTRP) and ClinicalTrials.gov for trials in progress. We conducted all searches up to 16 October 2017. We also contacted experts in the field and obtained further studies from these sources.Selection criteriaWe evaluated studies assessing the use of ribavirin in people with suspected or confirmed Crimean Congo haemorrhagic fever. We included randomised control trials (RCTs); non‐randomised studies (NRSs) that included more than 10 participants designed as cohort studies with comparators; and case‐control studies.Data collection and analysisTwo review authors assessed eligibility, risk of bias, and extracted data. For non‐randomized studies we used the ROBINS‐I tool to assess risk of bias. The main effects analysis included all studies where we judged the risk of bias to be low, moderate or high. We summarized dichotomous outcomes using risk ratios (RRs) and continuous outcomes using mean differences (MDs), and used meta‐analyses where appropriate. We carried out a subsidiary appraisal and analysis of studies with critical risk of bias for the primary outcome, as these are often cited to support using ribavirin.Main resultsFor the main effects analysis, five studies met our inclusion criteria: one RCT with 136 participants and four non‐randomized studies with 612 participants. We excluded 18 non‐randomized studies with critical risk of bias, where none had attempted to control for confounding.We do not know if ribavirin reduces mortality (1 RCT; RR 1.13, 95% confidence interval (CI) 0.29 to 4.32; 136 participants; very low‐certainty evidence; 3 non‐randomized studies; RR 0.72, 95% CI 0.41 to 1.28; 549 participants; very low‐certainty evidence). We do not know if ribavirin reduces the length of stay in hospital (1 RCT: mean difference (MD) 0.70 days, 95% CI ‐0.39 to 1.79; 136 participants; and 1 non‐randomized study: MD ‐0.80, 95% CI ‐2.70 to 1.10; 50 participants; very low‐certainty evidence). We do not know if it reduces the risk of patients needing platelet transfusions (1 RCT: RR 1.23, 95% CI 0.77 to 1.96; 136 participants; very low‐certainty evidence). For adverse effects (including haemolytic anaemia and a need to discontinue treatment), we do not know whether there is an increased risk with ribavirin in people with CCHF as data are insufficient.We do not know if adding ribavirin to early supportive care improves outcomes. One non‐randomized study assessed mortality in people receiving ribavirin and supportive care within four days or less from symptom onset compared to after four days since symptom onset: mortality was lower in the group receiving early supportive care and ribavirin, but it is not possible to distinguish between the effects of ribavirin and early supportive medical care alone.In the subsidiary analysis, 18 studies compared people receiving ribavirin with those not receiving ribavirin. All had a critical risk of bias due to confounding, reflected in the mortality point estimates favouring ribavirin.Authors' conclusionsWe do not know if ribavirin is effective for treating Crimean Congo haemorrhagic fever. Non‐randomized studies are often cited as evidence of an effect, but the risk of bias in these studies is high.

The aim of this review is to discuss the relationship between cachexia in lung cancer and the role of supportive and palliative care. A recent meta-analysis has shown that early supportive and palliative care improves outcome in patients with lung cancer. This includes benefits in survival, quality of life, mood and need for less aggressive end of life care. However, we examine how this is impacted by cachexia. Cachexia is a pro inflammatory syndrome causing loss of weight, muscle and function. The level of cachexia likely impacts early supportive and palliative care goals for individual patients. It is suggested that supportive and palliative care is a key component of managing patients with lung cancer and should be routine practice.

3634 Background: Phase 1 clinical trials are the first step in developing new cancer therapeutics. Patients enrolled in these studies have typically exhausted standard therapies and are at a point in their disease trajectory where they often are choosing between a phase 1 clinical trial and hospice care. These patients may have significant symptom burden, which can result in early trial discontinuation and confound phase 1 trial outcomes, including toxicity profiles, which may influence further drug development. This study aimed to determine the palliative care needs of patients enrolled on phase 1 clinical trials and their caregivers (CGs), along with differences in study duration, adverse event (AE) and symptom profiles, and quality of life (QOL) between those receiving structured palliative care vs usual supportive care. Methods: 68 patients enrolled on phase 1 clinical trials were randomly assigned to receive structured palliative care or usual supportive care. 39 of their CGs were enrolled and assigned to the same arm as the patient. Quality of life metrics were obtained monthly: the Functional Assessment of Cancer Therapy-General and Memorial Symptom Assessment Scale -Short Form for patients, and The Quality of Life in Life Threatening Illness - Family Carer Version and Caregiver Reaction Assessment for CGs. Palliative care resources utilized were assessed for those in the palliative care arm, and referrals to supportive care services assessed in those in the usual care arm. AEs recorded on the Phase 1 trials were evaluated & compared between arms. Results: Mean duration on phase 1 study was 132 days in the palliative care arm vs 114 days in the usual care arm (p = 0.55). Total weighted AE rate (# of AE [x] AE grade per month) was 26.9 in the palliative care arm vs 34.0 in the usual care arm (p = 0.53). Patients in the palliative care arm experienced better QOL and lower symptom burden, as did their CGs, compared to those in the usual care arm. While the differences in outcomes were not statistically significant, all results favored structured palliative care. Conclusions: Phase 1 patients and their CGs have physical and psychosocial needs which warrant palliative care services. Preliminary results suggest structured palliative care is associated with increased duration on study (by nearly 3 weeks), improved patient and CG QOL, and reduced patient symptom and CG burden. A larger study is warranted to confirm these results and further develop the ideal palliative care intervention in these populations. Clinical trial information: NCT02543541 .

Heart failure is a disease with survival estimates of around 10% after 10 years of the disease. Being a chronic and debilitatingillness, it is important to investigate the potential efficacy of a palliative care approach for these patients. The aim of this study is to systematically review the efficacy of integrating palliative care in patients with advanced heart failure, including the outcomes overall quality of life and well-being, overall symptom burden and possible specific symptoms, hospital admission rates and mortality. The MEDLINE, Cochrane, EMBASE and CINAHL databases were searched for articles published between January 2010 and December 2020 about palliative care interventions in patients with heart failure. Clinical studies with humans with symptomatic heart failure were included, comparing the integration of palliative care with usual cardiac care. The search protocol resulted in seven eligible studies for review and qualitative synthesis. The overall risk of bias within studies was moderate to high. Most studies demonstrated improvements with the integration of palliative care in terms of quality of life and reduction of admission rates. The evidence to support a significant improvement in overall symptom burden was not so robust among studies. Palliative care interventions seem, overall, to be significantly effective in patients with heart failure. Future studies with more rigorous study designs are needed, in order, to further develop the role of palliative care in heart failure patients.

P3.05-012 Assessment of the Impact of Palliative Care on the Quality of Life in Advanced Non-Small Cell Lung Cancer Patients - A Longitudinal Study: Topic: Symptoms, Therapeutic Interventions

Unmet Supportive Care Needs in U.S. Dialysis Centers and Lack of Knowledge of Available Resources to Address Them

190 Background: Inpatient supportive care interventions are targeted to patients with advanced solid tumors due to perceived higher symptom burden. Yet, few studies have characterized symptom prevalence in hospitalized patients with curable cancers. We aimed to describe and compare symptom burden and palliative care utilization in hospitalized patients with curable and incurable cancers to determine the allocation of such supportive care resources. Methods: We conducted a single center study of 1549 patients (238 curable hematologic, 239 curable solid, 123 incurable hematologic, 949 incurable solid cancers) who experienced an unplanned hospitalization between 9/14 - 4/17. On admission, we assessed patients’ physical symptoms (Edmonton Symptom Assessment System) and psychological distress (Patient Health Questionnaire - 4 and Primary Care PTSD Screen). Results: The median number of moderate to severe symptoms reported by patients with curable hematologic, curable solid, incurable hematologic, and incurable solid cancers were 5 [3-6], 5 [3-7], 5 [4-6], and 6 [4-7], respectively. Most patients reported moderate to severe fatigue (83.6%, 82.9%, 81.3%, 86.9%). Table 1 depicts rates of psychological distress. In adjusted analyses patients with incurable solid cancers reported higher symptom burden (β = 7.6, p < 0.01), depression (β = 0.4, p = 0.01), and anxiety (β = 0.3, p = 0.03) symptoms, but no difference in PTSD symptoms. Among patients in top quartile of symptom burden, palliative care was consulted in 16.2%, 7.9%, 23.8%, and 49.6% (p < 0.01) of patients with curable hematologic, curable solid, incurable hematologic, and incurable solid cancers, respectively. Conclusions: Hospitalized patients with solid and hematologic cancers experience substantial physical and psychological symptoms regardless of the curability of their illness. Palliative care is rarely consulted for highly symptomatic patients with curable cancers. Inpatient supportive care interventions should target the needs of all highly symptomatic patients with cancer. [Table: see text]

Background: Treatment-related side effects (e.g., pain, fatigue, nausea/vomiting) are commonly reported among cancer patients and impact patients' health-related quality of life (HRQOL) and treatment adherence. While there is extensive literature documenting disparities in cancer treatment and outcomes, less is known about racial and educational differences in symptom burden and access to supportive care services during treatment. As part of a National Cancer Institute-funded research study, Cancer Health Accountability for Managing Pain and Symptoms (CHAMPS), we examined racial and educational variations in symptom reports and supportive care referrals among breast cancer patients undergoing chemotherapy at two cancer centers. Methods: We surveyed 61 Black and White stages I-III breast cancer patients undergoing chemotherapy at one academic and one community-based cancer center during 2016-2018. Survey items assessed patient sociodemographics, HRQOL and symptoms, supportive care, and care satisfaction. Using a community-based participatory research approach, our community/academic/medical partnership administered patient surveys and evaluated symptom burden and supportive care referrals stratified by race (Black vs. White) and education (less than a college degree vs. college degree or higher). Results: Overall, the most commonly reported HRQOL/symptom concerns included employment interference (44.3%), social life interference (39.3%), financial difficulties (34.4%), worry (29.5%), skin toxicities (26.2%), and pain (26.2%). Compared with White patients, Black patients were more likely to report moderate-to-severe anxiety (41.2% vs. 20.5%, p=.05) and vomiting (17.6% vs. 2.3%, p=.03). Patients with less than a college degree were more likely to report moderate-to-severe constipation than patients with a college degree or higher (20.0% vs. 0.0%, p=.028). In terms of supportive care services, patients were most often referred to cancer support groups (83.9%), nutrition/dietary consultations (54.1%), and financial counseling (54.1%). Black patients were less likely to be referred to supportive services for cancer-specific communication with their families than their White counterparts (16.7% vs. 38.6%, p=.04). No statistically significant educational differences in supportive care referrals were observed. Conclusions: Breast cancer patients experience a range of HRQOL/symptom concerns and supportive care needs during treatment; however, racial and educational differences exist in these cancer care outcomes. Given longstanding disparities in cancer care outcomes, and the survival and HRQOL benefits of supportive care services, future research should examine barriers to equitable supportive care and opportunities for improvement Citation Format: Cleo A. Samuel, Jennifer Schaal, Olive M. Mbah, Wendi Elkins, Eugenia Eng, Linda Robertson, Stephanie Baker, Kristin Z. Black, Crystal Dixon, Katrina Ellis, Fatima Guerrab, Lauren Jordan, Alexandra F. Lightfoot, Neda R. Padilla, Christina Younge, Samuel Cykert. Racial and educational differences in symptom burden and supportive care among breast cancer patients undergoing chemotherapy [abstract]. In: Proceedings of the Eleventh AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2018 Nov 2-5; New Orleans, LA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2020;29(6 Suppl):Abstract nr B026.

e14025 Background: Patients’ needs are still underestimated during cancer course. The development of a simple and accessible screening tool to identify supportive care needs is an innovative approach to improve the cancer care pathway. Supportive Scale sCore (SCC) is a new tool developed to trigger alert in main need of supportive care such as social, nutritional, physical, pain or psychological disorders. This study aimed to develop and validate the SCC tool for detecting supportive care needs. Methods: The SCC, the Edmonton Symptom Assessment System (ESAS), a symptom scale and the EQ-5D (for Quality Of Life) was distributed to cancer patients over a week, in an ambulatory hospital of oncology department. The acceptability was assessed by the fill rate. The validity of alerts generated by the SCC scale was assessed by their consistency with ESAS and EQ-5D scores. Results: Hundred patients were included with an average age of 67,2 years. Acceptability was good with a fill rate of over 90%. For a-priori defined risk groups by SCC with alert or not, ESAS symptom score and QOL differed significantly (p < 0,05) between groups. We observed higher ESAS symptom scores in the alert group [nutritional alert: appetite: 4 (Standard Deviation SD 2,4) vs 0 (SD 1,6), p < 0,001; physical alert: fatigue: 4 (SD 1,7) vs 2 (SD 2,2) p < 0,001; psychological alert: depressed: 3,5 (SD 2,7) vs 0 (SD 1,5), p < 0,001; anxiety: 4 (SD 2,9) vs 0 (SD 1,5), p < 0,001; unwell-being: 4,5 (SD 2,7) vs. 0 (SD 1,5), p < 0,001]. Moreover, the QOL was poorer in each domain of EQ-5D in the alert group. [Social alert, self-care: 9,3% vs 0%, p = 0,02; usual activities: 25% vs 5,4%, p = 0,005. Physical alert, usual activities: 21,3% vs 2,6%, p = 0,008; mobility 29,5% vs 2,6%, p = 0,01. Pain alert, pain: 81,8% vs 11,9%, p < 0,001. Psychological alert, psychological: 56,3% vs 11,9%, p < 0,001]. Conclusions: The SCC seems to be a reliable instrument to detect cancer patients’ supportive care needs.

Palliative care improves quality of life (QoL) in advanced illnesses, but data in end-stage liver disease (ESLD) are limited. It is unknown whether palliative care delivered by hepatologists is effective when compared with palliative care specialists. To compare the effectiveness of palliative care delivered by trained hepatologists with the care delivered by conventional palliative care specialists in improving QoL at 3 months. This comparative effectiveness cluster randomized trial for US patients treated for ESLD in 19 US medical centers compared a palliative care intervention delivered by palliative care-trained hepatologists (hepatologist group; 11 centers) with palliative care specialists (consultative group; 8 centers). Eligible patients were US adults with either decompensated cirrhosis or hepatocellular cancer who had a life expectancy of at least 6 months, had not received or scheduled liver transplantation, or had not received palliative care in the prior 3 months. Hepatologists in hepatologist group alone received primary palliative care training. Data collection occurred from January 2019 through June 2025; analysis was conducted from July to September 2025. Participants received 4 palliative care visits over 3 months delivered by either palliative care-trained hepatologists or palliative care specialists, using a structured palliative care checklist. Superiority or a priori noninferiority of the effect of palliative care delivered by hepatologists vs palliative care specialists on change in QoL at 3 months, measured by the Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) total score (higher scores indicating better QoL). Secondary outcomes included change in symptom burden, distress, depression, satisfaction from baseline to 3 months, and mortality. A total of 935 patients were enrolled (mean [SD] age, 63.0 [10.3] years; 275 female [29%]; 130 Hispanic ethnicity [14%]; 144 Black [15%], 736 White [79%]). From baseline to 3 months, QoL improved in both groups (adjusted mean: hepatologist, 8.01 [95% CI, 5.38 to 10.65]; consultative, 7.02 [95% CI, 4.34 to 9.71]; both P < .001). Although superiority was not found in change in QoL, prespecified noninferiority analysis showed that the improvement in the hepatologist group was noninferior to the consultative group (adjusted mean difference, 0.98 [95% CI, -2.86 to 4.83]; P = .01). Symptom burden (adjusted mean difference, -7.52 [95% CI, -9.89 to -5.15] vs -5.31 [95% CI, -7.60 to -3.03]) and depression (adjusted mean difference, -1.18 [95% CI, -1.78 to -0.57] vs -0.90 [95% CI, -1.49 to -0.31]) improved in both groups, without significant between-group differences. Patient satisfaction improved more in the hepatologist group compared with the palliative care group (adjusted mean difference, 3.37 [95% CI, 2.24 to 4.49] vs 0.91 [95% CI, -0.15 to 1.96]; P = .002). Mortality at 3 months was similar in both groups. This cluster trial found that palliative care delivered by trained hepatologists was comparable with palliative care delivered by palliative care specialists in improving QoL in patients with ESLD and was associated with greater improvement in patient satisfaction, demonstrating the effectiveness among enrolled patients. ClinicalTrials.Gov Identifier: NCT03540771.

10052 Background: Patients (pts) diagnosed with hematologic malignancies during adolescence &amp; young adulthood (AYA) are a uniquely challenging population who are understood to have robust supportive care needs. Here, we describe their symptom burdens and the feasibility of integrating palliative care into an outpatient, multi-disciplinary AYA leukemia clinic at an academic medical center. Methods: Palliative care was introduced into the AYA clinic in 8/2020 to provide symptom-focused care. Pre-existing clinic services included psychologists, pharmacists, and social workers. All established pts receiving routine follow up were referred by the oncology team to the Supportive Care team, which provided same-day palliative care consultation in the same clinic space with a telehealth option and as needed follow-up. To describe baseline symptom burdens, a random cross-sectional sample of pts completed a multi-domain symptom assessment (SA) using validated self-report instruments including physical (Edmonton Symptom Assessment Scale [ESAS]); emotional (Brief Symptom Inventory-18 [BSI-18]); financial (FACIT-COST); cognitive (Childhood Cancer Survivor Study – Neurocognitive Questionnaire); spiritual (FACIT -Spiritual Well-being Scale); and quality of life (QOL) (FACT-General) measures. All pts have a diagnosis of acute or chronic leukemia and were on active treatment or in survivorship. Results: Over 6 months, 30 pts (median age 29 years at assessment, range 18-45 years) received symptom-focused palliative care over 16 combined clinics with 81 total encounters averaging 5 pts (range 1-8) per clinic. 47% were female. No pts declined palliative care. Pts received on average 2.7 follow up visits (range 1-6), with 50% of encounters resulting in adjustments to medical management. Common issues addressed included pain, muscle cramps, neuropathy, anxiety, insomnia, depression, nausea, and non-pharmacological symptom control remedies. Of 46 pts, 31 (67%) completed the SA (median age 30 years at assessment, range 18-43 years); 48% were female; 84% were on treatment. 100% of pts reported fatigue, and 48% reported &gt; = 1 severe symptom (range 0-7) based on the ESAS with “poor feeling of well-being” as the most common (23%). 45% met criteria for BSI-18 emotional distress, and 45% reported some neurocognitive impairment. Emotional distress (p &lt; 0.01), financial toxicity (p = 0.03), low spiritual well-being (p &lt; 0.01), and presence of pain, nausea, or depression (p &lt; 0.05) were all associated with lower QOL. Conclusions: AYA pts with leukemia undergoing treatment and in survivorship experience high symptom burden with poor QOL. It is feasible to both assess symptom burden and provide early palliative care focused on symptom management in an outpatient, multi-disciplinary clinic setting.

Objective:A common disorder requiring symptom palliation in palliative and end-of-life care is cancer. Cancer pain is recognized as a global health burden. This paper sought to systematically examine the extent to which there is an adequate scientific research base on cancer pain and its reporting characteristics in the palliative care journal literature.Materials and Methods:Search conducted in MEDLINE and CINAHL sought to locate all studies published in 19 palliative/ hospice/ supportive/ end-of-life care journals from 2009 to 2010. The journals included were: American Journal of Hospice and Palliative Care, BMC Palliative Care, Current Opinion in Supportive and Palliative Care, End of Life Care Journal, European Journal of Palliative Care, Hospice Management Advisor, Indian Journal of Palliative Care, International Journal of Palliative Nursing, Internet Journal of Pain Symptom Control and Palliative Care, Journal of Pain and Palliative Care Pharmacotherapy, Journal of Palliative Care, Journal of Palliative Medicine, Journal of Social Work in End-of-life and Palliative Care, Journal of Supportive Oncology, Palliative Medicine, Palliative and Supportive Care, and Supportive Care in Cancer. Journal contents were searched to identify studies that included cancer pain in abstract.Results:During the years 2009 and 2010, of the selected 1,569 articles published in the journals reviewed, only 5.86% (92 articles) were on cancer pain.Conclusion:While researchers in the field of palliative care have studied cancer pain, the total percentage for studies is still a low 5.86%. To move the field of palliative care forward so that appropriate guidelines for cancer pain management can be developed, it is critical that more research be reported upon which to base cancer pain therapy in an evidence-based palliative care model.

Objective To obtain feedback from parents of children who died from cancer about their understanding of palliative care, their experiences of palliative and supportive care received during their child's illness, and their palliative and supportive care needs. Design A qualitative study with semi-structured interviews. Participants: 24 parents from Perth (n = 10), Melbourne (n = 5), Brisbane (n = 5) and Sydney (n = 4). Setting: Five Australian tertiary paediatric oncology centres. Results Parents whose children died from cancer live within a context of chronic uncertainty and apprehension. Parents construed palliative care negatively as an independent process at the end of their children's lives rather than as a component of a wider and continuous process where children and their families are offered both curative and palliative care throughout the cancer trajectory. The concept of palliative care was perceived to be misunderstood by key health professionals involved in the care of the child and family. The importance and therapeutic value of authentic and honest relationships between health professionals and parents, and between health professionals and children were highlighted as a critical aspect of care. Also highlighted was the need to include children and adolescents in decision making, and for the delivery of compassionate end-of-life care that is sensitive to the developmental needs of the children, their parents and siblings. Conclusions There is a need for health professionals to better understand the concept of palliative care, and factors that contribute to honest, open, authentic and therapeutic relationships of those concerned in the care of the dying child. This will facilitate a better understanding by both parents and their children with cancer, and acceptance of the integration of palliative and supportive care in routine cancer care. Palliative Medicine 2008; 22 : 59—69

Editorial introductions.

Editorial introductions.