Supportive Care In Oncology Research Articles

Assessing a Training Program for Integrative Medicine Practitioners in the Treatment of Acute Stress Disorder.

The study examined a training program for integrative medicine (IM) providers, teaching clinical skills for treating acute stress disorder (ASD). A 10-h online training program, designed by IM and mental health professionals, was attended by a group of 32 IM providers working in supportive and palliative oncology care. Pre- and post-course questionnaires assessed self-perceived levels of IM and mental health ASD-related skills (from 1, very low; to 7, very high). Most participants (25; 78%) completed pre- and post-study questionnaires, which showed an increase in post-course scores for the expectation that IM could reduce ASD-related pain (p=0.004). Scores for self-assessed skill levels increased for treating gastro-intestinal symptoms and appetite (p=0.039) and for dyspnea (p=0.048). A borderline increase for arousal was observed (p=0.063), with no increase with other arousal symptom cluster symptoms. The ASD-focused training program for IM practitioners was associated with an increase in self-perceived levels for related clinical skills quality of life-related concerns, primarily pain, appetite and dyspnea. Further research is needed to better understand the implications of the findings, and to explore the implementation of the learned skills in clinical practice.

In focus: Engaging Black and African American women in oncology supportive care interventions.

54 Background: For individuals navigating cancer, unaddressed psychosocial needs can adversely impact quality of life, treatment adherence, and healthcare expenditures. It is recognized that African American cancer survivors are more likely to experience distress, yet they are underrepresented in studies that evaluate interventions. Mind Over Matter (MOM) is a five-week psychoeducational program aimed at bolstering emotional coping skills. A previous study among predominantly White female-identifying breast cancer survivors revealed improvements from pre to post-MOM for anxiety, depression, and physical symptom severity and interference; no data exists for women who identify as Black and/or African American. This presentation will illustrate the strategies and processes implemented to recruit, consent, and retain Black and African American cancer survivors to test the feasibility and acceptability of MOM. Methods: In forming the research team, the diversity in institutions, experience, racial and cultural identities, and professional perspectives were prioritized. As a result of this process, team members were social workers and psychologists, one was at an HBCU institution, and another was a patient advocate from the Black community who was hired and trained enabling full participation in the research process. To improve access all aspects of the study were available online and the intervention was offered virtually in the evening to support participants' availability. Efforts were made to build relationships with non-profit organizations, then disseminating the study through emails, healthcare systems, and social media. Results: During the 3-month recruitment period, 79 individuals expressed interest in the study via email and the study website. Of these, 40 participants (50.6%) enrolled in the study, surpassing the goal of 27. Half of the enrolled survivors learned about the study through community, medical, and academic organizations, while 20% and 10% were referred via the home health system and social media, respectively. 17.5% were referred from unspecified sources. Conclusions: Through robust team development, strategic community partnerships, using a study design that addressed common barriers (e.g., program hours and delivery method, tech orientation, incentives) and a high touch approach, this study successfully enrolled half of the Black and African American female-identified cancer survivors who expressed interest in this mixed-methods study. Clinical trial information: NCT06168825 .

A descriptive study of the connections between social risk and healthcare utilization with supportive oncology care

Objective This study utilized social risk data in the electronic heath record collected as part of routine clinical practice and examined relationships with supportive oncology care contacts and healthcare utilization. Methods A total of 2,807 cancer patients were screened for four social determinants of health (SDOH) domains (financial resource strain, housing instability, food insecurity, and transportation need) and categorized to low or high risk SDOH groups. The number of patient contacts with supportive oncology was compared amongst the groups. The data were analyzed for demographic and outcome differences including emergency department visits, inpatient admissions, and appointment adherence. Results Heightened social risk was associated with more total contacts with supportive oncology care. Patients with high SDOH risk had more contacts across all outcomes examined including emergency department visits (M = 13), inpatient admissions (M = 14), and missed appointments (M = 11). Conclusions Patients with both greater social risks and acute care utilization are associated with more psychosocial interventions in supportive oncology follow-up. These findings highlight the need for comprehensive action to respond to social risk factors identified in SDOH screening.

Survey of international pediatric nutritional supportive care practices: a report from the Pediatric Study Group of the Multinational Association of Supportive Care in Cancer (MASCC)

PurposeMalnutrition is common in children with cancer. While multiple validated malnutrition screens exist, there is no universal, standardized approach to screen or diagnose malnutrition. The Multinational Association of Supportive Care in Cancer (MASCC) Pediatric Study Group is focused on oncologic supportive care for children and young adults. This subgroup designed and administered a pilot study to characterize global malnutrition screening, diagnosis, and treatment practices for pediatric patients with cancer after identifying variations in malnutrition practice patterns within its members.MethodsA novel, exploratory survey was iteratively developed and distributed in early 2020 to 45 MASCC Pediatric Study Group members. The survey included multiple questions with standard patient presentations and nutritional scenarios, and the respondents selected the answer that best reflected the care patients would receive at their institution.ResultsA validated screening tool to assess for malnutrition was routinely used by 15 of 26 respondents (58%). No single validated screen was used by more than 24% of responders, and 11 of 26 (42%) reported not having a standard malnutrition treatment screen. When the same patient was presented with the survey using different malnutrition indicators, patient care plans varied greatly. This was particularly true for z-scores compared to weight percentiles.ConclusionsDevelopment of consensus recommendations for screening practices, preferred malnutrition indicators, and treatment guidelines could help reduce the underdiagnosis of malnutrition and subsequent variation in its management and ought to be a focus of the global pediatric cancer supportive care community.

1901P State of supportive care in oncology 2024: Tumor types, industry support, endpoints, and trial locations

1901P State of supportive care in oncology 2024: Tumor types, industry support, endpoints, and trial locations

Medical marijuana in the treatment of cancer-associated symptoms.

Previous cancer studies have indicated that medical marijuana addresses a significant unmet need, namely chronic pain treatment and conferring oncology supportive care. However, the clinical research evaluating medical marijuana is preliminary and requires further consideration. We conducted a PubMed search primarily comprising retrospective and prospective studies, systematic reviews, and randomized clinical trials (RCTs) from approximately 2020-2023. The search included specific terms that incorporated medical marijuana, cancer treatment, cancer-related symptoms, pain management, and side effects. A total of 40 studies were included in the review, many of which were either of acceptable or good quality. Select investigations indicated that medical marijuana was associated with decreased overall pain levels and improvements in nausea and vomiting. Alternatively, the results from RCTs have found that the benefits from a placebo were equivalent to medical marijuana in both the treatment of cancer-related pain and providing an opioid-sparing effect. Despite the potential cancer-related benefits derived from medical marijuana, the study design and results for many of the investigations on which the evidence is based, were neither uniform nor conducted via RCTs; hence, the efficacy and appropriateness of medical marijuana in treating cancer-related conditions remain indeterminate.

Determinants and Factors of Physical Activity After Oncology Treatments (DEFACTO) in Metropolitan France: Protocol of a Mixed Methods Study and Intervention.

While the scientific community widely recognizes the benefits of physical activity (PA) in oncology supportive care, cancer survivors who have undergone chemo- or radio-immunotherapy treatments struggle to meet PA recommendations. This underscores the importance of identifying factors influencing active lifestyle adoption and maintenance and proposing a multilevel model (micro-, meso-, and macrolevel) to better understand facilitators and barriers. Currently, no socioecological model explains an active lifestyle in the posttreatment phase of breast, colorectal, prostate, and lung cancers. The objective is to identify factors influencing an active lifestyle in cancer survivorship and assess the feasibility of an individualized program targeting an active lifestyle. The objectives will be addressed in 3 stages. Stage 1 aims to elucidate factors associated with the active lifestyle of cancer survivors. Stage 2 involves developing an explanatory model based on previously identified factors to create a tailored health education program for an active lifestyle after oncology treatments. Stage 3 aims to evaluate the feasibility and potential effects of this personalized health education program after its national implementation. First, the exploration of factors influencing PA (stage 1) will be based on a mixed methods approach, using an explanatory sequential design and multilevel analysis. The quantitative phase involves completing a questionnaire from a socioecological perspective. Subsequently, a subset of respondents will engage in semistructured interviews to aid in interpreting the quantitative results. This phase aims to construct a model of the factors influencing an active lifestyle and develop an individualized 12-week program based on our earlier findings (stage 2). In stage 3, we will implement our multicenter, multimodal program for 150 physically inactive and sedentary cancer survivors across metropolitan France. Program feasibility will be evaluated. Measured PA level by connected device and multidimensional variables such as declared PA and sedentary behaviors, PA readiness, motivation, PA preferences, PA knowledge and skills, and barriers and facilitators will be assessed before and during the program and 52 weeks afterward. The institutional review board approved the mixed methods study (phase 1) in April 2020, and the intervention (phase 3) was approved in March 2022. Recruitment and data collection commenced in April 2022, with intervention implementation concluded in May 2023. Data collection and full analysis are expected to be finalized by July 2024. The Determinants and Factors of Physical Activity After Oncology Treatments (DEFACTO) study seeks to enhance our understanding, within our socioecological model, of factors influencing an active lifestyle among cancer survivors and to assess whether a tailored intervention based on this model can support an active lifestyle. ClinicalTrials.gov NCT05354882; https://www.clinicaltrials.gov/study/NCT05354882. DERR1-10.2196/52274.

Social Needs Risk and Patient Outcomes with Supportive Oncology Care

Social Needs Risk and Patient Outcomes with Supportive Oncology Care

The impact of outpatient supportive oncology on cancer care cost and utilization.

Supportive oncology (SO) care reduces symptom severity, admissions, and costs in patients with advanced cancer. This study examines the impact of SO care on utilization and costs. Retrospective analysis of utilization and costs comparing patients enrolled in SO versus three comparison cohorts who did not receive SO. Using claims, the authors estimated differences in health care utilization and cost between the treatment group and comparison cohorts. The treatment group consisting of patients treated for cancer at an National Cancer Institute-designated cancer center who received SO between January 2018 and December 2019 were compared to an asynchronous cohort that received cancer care before January 2018 (n=60), a contemporaneous cohort with palliative care receiving SO care from other providers in the Southeastern Pennsylvania region during the program period (n=86), and a contemporaneous cohort without palliative care consisting of patients at other cancer centers who were eligible for but did not receive SO care (n=393). At 30, 60, and 90 days post-enrollment into SO, the treatment group had between 27% and 70% fewer inpatient admissions and between 16% and 54% fewer emergency department visits (p<.05) compared to non-SO cohorts. At 90 days following enrollment in SO care, total medical costs were between 4.4% and 24.5% lower for the treatment group across all comparisons (p<.05). SO is associated with reduced admissions, emergency department visits, and total costs in advanced cancer patients. Developing innovative reimbursement models could be a cost-effective approach to improve care of patients with advanced cancer.

A new comprehensive and stratified concept for supportive care in cancer patients.

Supportive care in oncology has evolved alongside effective anticancer treatments since the 1960s, beginning with the advent of chemotherapy for acute leukemia. It was initially focused on managing treatment-induced complications, and expanded to address broader aspects of patient well being; the scope of supportive care needs to be periodically re-assessed. Early palliative care interventions, and more recently advance care planning emerged as vital components, improving patient outcomes and quality of life. Despite barriers, such as prognostic uncertainty, these approaches have demonstrated significant benefits for patients with advanced disease. Additionally, the management of cancer survivors requires ongoing medical surveillance and psycho-social support. In the last years, integrative medicine has also emerged as a complementary approach to address survivors' holistic needs. A proposed stratified model of supportive care emphasizes interventions based on patients' prognosis, with interdisciplinary collaboration ensuring comprehensive care across all stages of the cancer journey. This model provides a framework for the development of integrated supportive care units.

The potential and importance of exercise therapy in pediatric oncology – The PrepAIR study

Introduction Modern therapy has improved survival for children with cancer. However, treatment takes its toll. Children experience delays in motor development milestones such as walking, running, jumping or climbing, diminishing children’s quality of life and affecting their social reintegration. One side-effect of chemotherapy and crucial cause of the many dysfunctions is a peripheral neuropathy (CIPN). Depending on the neurotoxic agent, 52%-100% of children are affected (Kandula et al. 2016). It causes severe symptoms such as loss of sensation, numbness, pain, absent reflexes as well as loss of balance control. It is also of high clinical relevance as it affects medical therapy. Additionally, recovery is poor and there are currently no treatment options (Loprinzi et al. 2020). Previous research has shown (Streckmann et al. 2022) promising results: Specific exercises can reduce symptoms of CIPN and improve patients’ quality of life. In our most recent study in adults, we were also able to prevent the onset of CIPN with clinical impact. We hypothesize that CIPN could be the root of many problems children experience during therapy. Our aim is to maintain relevant sensory and motor functions in children in order for them to receive their planned medical therapy and become fitter and socially better integrated survivors. Methods We are therefore currently running a large, prospective, multicenter, randomized controlled trial (Basel, Bern, Aarau, St. Gallen, Freiburg (D) and Berlin (D)), randomizing N = 131 children planned to receive a neurotoxic chemotherapy into an intervention group or a treatment as usual group and accompanying them throughout their oncological therapy. After therapy the control group will also be shown the training. Primary endpoint is the incidence of CIPN, secondary endpoints are postural control, dorsiflexion function, knee extension strength, lower limb power, walk to run transition time, CIPN-related pain, participation of exercise-related leisure activities, children’s’ physical self-concept and quality of life. Discussion/Conclusion We hypothesize that less children in the intervention group will develop symptoms of CIPN and will be able to maintain relevant motor and sensory functions which will enable them to receive their planned medical therapy but also to stay on the age-appropriate motor development level, improve their quality life and enhance social reintegration after therapy. This would show that specific exercise therapy is more than just a lifestyle intervention, it could be a therapy option without further side- effects, changing supportive care in oncology. This study will therefore contribute to our endeavors to implement exercise therapy in pediatric oncology long-term empowering patients to return to an active lifestyle and additionally reduce the risk of long-term secondary diseases.

From existential uncertainty to a new mindset promoting recovery: Exploring the development of uncertainty experience in women with vulvar neoplasia – A qualitative longitudinal study

BackgroundWomen with vulvar neoplasia continue to experience uncertainty up to six months post-surgery. Uncertainty in illness is considered a significant psychosocial stressor, that negatively influences symptom distress, self-management strategies and quality of life. According to the Reconceptualized Uncertainty in Illness Theory, the appraisal of uncertainty changes positively over time in chronic illness. We aimed at exploring whether and how the experience of uncertainty develops in women with vulvar neoplasia.MethodsWe selected a purposive sample of seven women diagnosed with vulvar neoplasia in four Swiss and one Austrian women’s clinic. By means of a qualitative longitudinal study, we conducted 30 individual interviews at five points of time during one year after diagnosis. We applied Saldaña’s analytical questions for longitudinal qualitative research.ResultsFirst, participants experienced uncertainty as an existential threat, then an inherent part of their illness, and finally a certainty. Women initially associated the existential threat with a high risk for suffering from severe health deteriorations. Participants that could reduce their individually assessed risk by adopting health promoting behaviors, accepted the remaining uncertainty. From now on they reframed uncertainty into a certainty. This new mindset was based on a belief of promoting recovery and reducing the risk of recurrence.ConclusionsThe long-lasting and oscillating nature of uncertainty should receive attention in supportive oncology care. Uncertainty concerning existential issues is of special importance since it can inhibit a positive development of uncertainty experience.

Supportive oncology care: a resource unequally mobilized to cope with cancer

Supportive oncology care: a resource unequally mobilized to cope with cancer

Health Care Resource Utilization (HCRU) and Cost of Management of Cytokine Release Syndrome (CRS) and Neurological Events (NEs) in Patients with R/R Follicular Lymphoma (FL) Receiving Lisocabtagene Maraleucel (liso-cel) in the TRANSCEND FL Study

Background: Adverse events (AEs) such as CRS and NEs of varying severity have been associated with CAR T cell therapies, including liso-cel, an autologous, CD19-directed, 4-1BB CAR T cell product administered at equal target doses of CD8 + and CD4 + CAR + T cells. Liso-cel has previously demonstrated clinically meaningful responses in patients with R/R FL in the phase 2 TRANSCEND FL study (NCT04245839). In addition, previous research among patients with large B-cell lymphoma has suggested an acceptable safety profile with few grade ≥ 3 CRS/NEs, and safety data from TRANSCEND FL are in line with this larger dataset. However, there is limited to no research published on estimates of HCRU and costs related to the management of CRS/NEs among liso-cel-treated patients with FL. This analysis evaluated HCRU and estimated costs of managing CRS/NEs by grade and concurrency for patients with R/R FL who received liso-cel treatment in the TRANSCEND FL study. Methods: Retrospective analyses were conducted for liso-cel-treated patients with R/R FL (second line or later) who experienced CRS/NEs within 90 days after infusion using patient-level HCRU data from the TRANSCEND FL study databases. HCRU captured included facility (standard inpatient [IP] and ICU hospitalizations), length of stay (LOS), diagnostics (eg, laboratory and imaging), procedures (eg, dialysis and mechanical ventilation), and medications (eg, oncology supportive care, prophylactics, and other AE management). Costs of managing CRS/NEs were estimated using a microcosting methodology in which 1) HCRU from the time of AE onset through resolution was identified and 2) the most recently available unit costs sourced from public databases or literature (US Centers for Medicare and Medicaid Services, Healthcare Cost and Utilization Project, and IBM ® Micromedex ® RED BOOK ®) were applied to each HCRU and adjusted to 2023 US dollars using the Consumer Price Index. Analyses were stratified by AE grade and concurrency of events (CRS or NEs only, nonconcurrent CRS and NEs, and concurrent CRS and NEs). Patients with nonconcurrent and concurrent CRS/NEs were categorized by the highest-grade event experienced. Results: CRS only occurred in 59/130 (45%) patients, NEs only occurred in 4/130 (3%), and CRS and/or NEs occurred in 79/130 (61%). Of the 79 patients who experienced CRS and/or NEs, 75 (95%) were grade ≤ 2 and 4 (5%) were grade 3; no grade 4 or 5 CRS/NEs were observed. Most CRS/NEs were experienced as a single event (63/79 [80%]). Patients who experienced CRS and/or NEs had a median (range) age of 60 (23‒78) years and were predominantly male (51/79 [65%]). Estimated median management costs ranged from $20,306 (grade 1 CRS only) to $50,400 (grade 3 CRS or NEs; Figure). The largest contributor to median management costs across CRS/NE categories was facility HCRU. Key HCRU and total LOS (standard IP hospitalization and ICU stay days among hospitalized patients) are shown in the Table. Almost all patients (78/79 [99%]) had a standard IP hospitalization, and only 1 patient (1%) with a grade 3 CRS only event was admitted to the ICU. Median (range) total LOS for IP/ICU admission was 1.5 days longer among patients with grade 3 versus grade ≤ 2 CRS and/or NEs (5.5 [3‒8] days vs 4 [1‒14] days). Although there were very few grade 3 events (n = 4) to assess, patients with grade 3 versus grade ≤ 2 CRS and/or NEs also had higher rates of utilization for some medications (eg, tocilizumab: 3/4 [75%] vs 28/75 [37%]; corticosteroids: 4/4 [100%] vs 19/75 [25%]). Conclusions: While most patients with R/R FL treated with liso-cel in the TRANSCEND FL study experienced treatment-emergent CRS and/or NEs, they were almost all of low severity (grade ≤ 2) and experienced as single events. Management costs for CRS/NEs, primarily related to facility HCRU, increased with greater AE severity and concurrency. The additional median cost for a patient with grade 3 versus grade ≤ 2 CRS or NEs was $22,586, representing an 88% increase in cost; however, this finding must be considered in the context of the small number of overall grade 3 events (n = 4) and ICU admissions (n = 1). CAR T cell therapies with few associated higher severity AEs provide a potential option to optimize resource use and costs for the management of CRS/NEs in patients with FL.

Cytokine Release Syndrome and Neurological Event Management Resource Use and Costs Among Patients with Relapsed or Refractory Large B-Cell Lymphoma Who Received Second-Line Lisocabtagene Maraleucel Treatment in TRANSFORM and PILOT

Background:CAR T cell therapies are associated with cytokine release syndrome (CRS) and neurological events (NEs). Lisocabtagene maraleucel (liso-cel) is an autologous, CD19-directed, 4-1BB CAR T cell product administered at equal target doses of CD8 + and CD4 + CAR + T cells. There is limited published research on AE management-related health care resource utilization (HCRU) and costs in the second-line (2L) setting. The objective of this study was toestimate HCRU and costs for managing CRS and/or NEs after liso-cel administration among patients with R/R large B-cell lymphoma (LBCL) treated with liso-cel as 2L therapy in the TRANSFORM (NCT03575351) and PILOT (NCT03483103) studies. Methods: A microcosting methodology was used to assess CRS and/or NE management-related HCRU identified from pooled TRANSFORM and PILOT case report forms and to estimate associated costs among patients who experienced CRS or NEs after liso-cel administration. CRS or NEs were only included if the AE initiated within 90 days after the patient received liso-cel. HCRU categories captured the following: facility (eg, standard inpatient hospitalizations and ICU admissions and length of stay [LOS]), procedures (eg, dialysis and mechanical ventilation), diagnostics (eg, laboratory, imaging, and biopsy), and medications (eg, oncology supportive care, prophylactics, and other AE management). In the nonconcurrent and concurrent CRS/NE categories, events were classified per the highest grade event. HCRU by grade, per the study's management guidelines, were identified from onset of the AE through resolution. Lee criteria were used to determine CRS event grades (Lee DW, et al. Blood 2014), while the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03, was used to determine NE grades. Unit costs from publicly available data sources (United States [US] Centers for Medicare &amp; Medicaid Services, Healthcare Cost and Utilization Project, and IBM ® Micromedex ® RED BOOK ®) or published literature were applied to each HCRU after being adjusted to 2021 US dollars using the Consumer Price Index as needed. Analyses were stratified by grade and concurrency. Results: Among 150 patients treated with liso-cel, 92 (61%) experienced CRS and/or NEs, which were mostly grade ≤ 2 events (n = 76 [83%]). Most patients experienced CRS only (n = 34 [37%]) or NE only (n = 24 [26%]) that ranged in total median cost of $675 for grade 2 NE only to $35,181 for grade 2 CRS only (Figure). In the remaining patients, most experienced AEs concurrently (22/34 [65%]) vs nonconcurrent (12/34 [35%]) with total median costs ranging from $5018 for nonconcurrent grade ≤ 2 CRS/NE to $33,918 for concurrent grade ≥ 3 CRS/NE. Median total cost for grade ≥ 3 CRS/NE was equal to $24,219 versus $5312 for grade ≤ 2, reflecting an additional $18,907 or 356% increase in cost of grade ≥ 3 compared with grade ≤ 2. Facility and medications were the major contributors to CRS/NE management costs. Only 20% (18/92) of patients were hospitalized and 2% (2/92) of patients admitted to the ICU, with proportions higher among grade ≥ 3 CRS/NE than grade ≤ 2 (standard inpatient hospitalization: 6/16 [38%] vs 12/76 [16%]; ICU: 2/16 [13%] vs 0/76 [0%]; Table). Patients with grade ≥ 3 CRS/NE had a median total 4.5 days longer LOS than grade ≤ 2 (median [range], 9.5 [2-19] vs 5 [2-15], respectively). Some medication usage was also higher among patients with grade ≥ 3 CRS/NE compared with grade ≤ 2 (tocilizumab: 10/16 [63%] vs 26/76 [34%]; corticosteroids: 15/16 [94%] vs 39/76 [51%]; vasopressors: 1/16 [6%] vs 2/76 [3%]). No dialysis or mechanical ventilation was recorded for patients experiencing CRS/NE. Conclusions: Over half of patients with R/R LBCL experienced any-grade CRS and/or NEs after liso-cel administration in TRANSFORM and PILOT, and the majority of these (83%) were low grade. Resource use and costs for management of AEs among patients with less severe CRS/NEs were relatively minimal compared with patients who had more severe CRS/NEs (with the exception of a few outliers). In general, HCRU and costs increased with greater severity. These results are largely consistent to those for third-line-treated patients (Abramson JS, et al. Blood Adv 2021). Additionally, results presented here further support that CAR T cell therapies with low rates of CRS/NEs (and few events are of higher severity) have the potential to minimize AE management-related HCRU and costs among patients with LBCL.

Healthcare Resource Utilization and Economic Burden of Cytokine Release Syndrome and Neurotoxicity in Patients with Relapsed and Refractory Multiple Myeloma (RRMM) Receiving Idecabtagene Vicleucel in Earlier-Line Settings in the KarMMa-3 Clinical Trial

Introduction: Adverse events (AE), such as cytokine release syndrome (CRS) and neurological toxicity (NT), have been associated with chimeric antigen receptor (CAR) T cell therapies. Idecabtagene vicleucel (ide-cel, bb2121), a B-cell maturation antigen-directed CAR T cell therapy, demonstrated deep and durable responses in triple-class exposed (TCE) patients (pts) with RRMM in the pivotal, single-arm, open-label phase 2 KarMMa (3 prior lines of therapy [LOTs]; NCT03361748) (Munshi NC, et al. NEJM 2021;384:705-716) and superior progression-free survival with ide-cel vs standard regimens in the phase 3 KarMMa-3 trial (2-4 prior LOTS; NCT03651128) (Rodríguez-Otero P, et al. NEJM 2023;388:1002-1014). Healthcare resource utilization (HCRU) and costs associated with CRS/NT management were estimated previously for pts receiving ide-cel in the KarMMa trial (McGarvey N, et al. Value Health 2023;26:S89) and suggested low rates of severe (grade ≥ 3) CRS/NT following ide-cel infusion and higher HCRU and costs with increasing AE severity. To further assess resource and economic burden associated with care of treatment-emergent AEs, this analysis evaluated HCRU and estimated cost of CRS/NT management among pts treated with ide-cel in earlier-line settings in the KarMMa-3 study. Methods: In this retrospective study, case report forms from the KarMMa-3 clinical trial database among pts experiencing a CRS and/or NT event that initiated within 90 days post ide-cel infusion were assessed. Pt-level HCRU data, including hospitalizations and length of hospital stay (LOS) (standard inpatient [IP], intensive care unit [ICU] days), diagnostics (eg, lab work, imaging), procedures (eg, dialysis, intubation), and medications (eg, oncology supportive care, prophylactics, other AE management) were identified from CRS/NT onset through resolution. AE management costs were estimated using a micro-costing methodology in which unit costs sourced from public databases or literature (eg, United States Centers for Medicare and Medicaid Services, Healthcare Cost and Utilization Project, IBM ® Micromedex ® RED BOOK ®) were adjusted to 2022 US dollars (USD) using the Consumer Price Index and applied to each HCRU identified. Results: Of 225 pts treated with ide-cel in the KarMMa-3 trial, 203 (90.2%) experienced any grade CRS and/or NT event. Pts experiencing a CRS/NT event had a mean (standard deviation [SD]) age of 61.9 (8.9) years and most were male (123/203 [60.6%]), White (138/203 [68.0%]), and non-Hispanic or Latino (138/203 [68.0%]). The majority (187/203 [92.1%]) of pts experienced less severe CRS/NT events (grade ≤ 2), which resolved quicker and relatively few pts (16/203 [7.9%]) had a more severe (grade ≥ 3) event, which took longer to resolve. Among pts who received ide-cel, the estimated median cost of AE management ranged from USD 17,124 (CRS only grade 1) to USD 181,552 (nonconcurrent CRS or NT grade ≥ 3) (Figure 1). Additional median costs for a pt with a grade ≥ 3 CRS/NT event was USD 31,045 higher than a grade ≤ 2 CRS/NT event. Across AE categories, the main contributors to CRS/NT management were facility costs, namely standard IP hospitalizations and ICU stays. Almost all pts (202/203 [99.5%]) had a standard IP hospitalization; 3.9% (8/203) had an ICU stay (Table 1). The trial protocol required a stay of ≥ 15 days post infusion unless admitted to the ICU; some hospitalization days recorded during the AE overlapped with the protocol-required stay. ICU admissions were more common among pts with CRS/NT grade ≥ 3 (7/16 [43.8%]) than those with grade ≤ 2 (1/187 [0.5%]). Median (range) total LOS was 10 days longer among pts with grade ≥ 3 (14.5 [2-84] days) than those with grade ≤ 2 (4 [1-34] days) CRS/NT. Pts with grade ≥ 3 CRS/NT had higher rates of HCRU than those with grade ≤ 2 for several interventions, such as medications (eg, tocilizumab + corticosteroids: 13/16 [81.3%] vs 63/187 [33.7%]), diagnostics (eg, imaging: 14/16 [87.5%] vs 48/187 [25.7%]), and procedures (eg, dialysis:3/16 [18.8%] vs 0/187 [0%]). Conclusions: Most pts with RRMM treated with ide-cel in the KarMMa-3 trial experienced a CRS and/or NT event, however, few were of high severity (grade ≥ 3). HCRU and costs for CRS/NT increased with AE severity and management. CAR T cell therapies associated with lower-severity AEs and planned interventions to prevent higher-grade AEs may provide an opportunity to better manage HCRU and costs.

Estimation of Postinfusion Resource Use and Total Costs of Care for Patients with R/R Follicular Lymphoma (FL) Receiving Lisocabtagene Maraleucel (liso-cel) in the TRANSCEND FL Study

Background: Liso-cel, an autologous, CD19-directed, 4-1BB CAR T cell product administered at equal target doses of CD8 + and CD4 + CAR + T cells, has previously demonstrated clinically meaningful responses in patients with R/R FL in the global phase 2 TRANSCEND FL study (NCT04245839). Limited evidence is published on estimates of health care resource utilization (HCRU) and cost of postinfusion care among patients with large B-cell lymphoma (LBCL) treated with liso-cel (Palomba ML, et al. Leuk Lymphoma 2021), and no evidence is currently available for patients with R/R FL. This analysis evaluated postinfusion HCRU and estimated cost of care across a 6-month period among patients treated with liso-cel in the TRANSCEND FL study. Methods: In this retrospective analysis, patient-level HCRU data from the TRANSCEND FL study database, including hospitalizations and length of hospital stay (LOS) for the entire hospitalization period postinfusion (standard inpatient [IP] and ICU days), diagnostics (eg, laboratory work and imaging), procedures (eg, dialysis and intubation), and medications (eg, oncology supportive care, prophylactics, and other AE management), were analyzed from the day of liso-cel infusion through 6 months of follow-up. Postinfusion costs (not including the cost of liso-cel) were estimated using a microcosting methodology in which HCRU in the 6-month period was identified and unit costs sourced from public databases or literature (adjusted to 2023 US dollars [USD] using the Consumer Price Index) were applied to each HCRU. Facility costs were sourced from the Healthcare Cost and Utilization Project National Inpatient Sample (2020) databases (Dasta JF, et al. Crit Care Med 2005), and the US Centers for Medicare and Medicaid Services (CMS) Hospital Outpatient Prospective Payment System (OPPS; 2023). Diagnostic and procedure costs were obtained from the CMS OPPS (2023), clinical laboratory fee schedule (2023), physician fee schedule (2023), durable medical fee schedule (2023), and Dasta 2005. Medication cost data were obtained from IBM ® Micromedex ® RED BOOK ® (2023) using wholesale acquisition cost and were uniformly applied across sites of care. Average total cost by month after liso-cel infusion was calculated among patients with ongoing status in that month. Patients censored due to data cutoff were excluded. Results: A total of 130 patients were treated with liso-cel in the TRANSCEND FL study, primarily in the fourth-line setting (45.4%). These patients had a median (range) age of 60 (23‒80) years and were predominantly male (83/130 [63.8%]) and White (69/130 [53.1%]); 45 (34.6%) had unknown race. Among patients who received liso-cel infusions, the estimated mean 6-month postinfusion total cost of care was $89,516 (Figure 1). Most 6-month costs ($77,088 [86.1%]) were incurred in Month 1 after infusion and were primarily driven by facility costs ($66,683 [74.5%]), namely standard IP hospitalization and ICU stays. HCRU and LOS (including standard IP hospitalization and ICU days) are shown in Table 1. Almost all patients were hospitalized in the standard IP setting (128/130 [98.5%]). Few patients were admitted to the ICU (4/130 [3.1%]), and 3/130 (2.3%) had an emergency department visit. Median (range) hospitalization time was 14 (3‒45) days for standard IP and 5 (3‒7) days for ICU stays. Some patients received corticosteroids (30/130 [23.1%]) or tocilizumab (31/130 [23.8%]), and few required intravenous immunoglobulin (11/130 [8.5%]), vasopressors (4/130 [3.1%]), lumbar puncture (2/130 [1.5%]), or mechanical ventilation (1/130 [0.8%]). No patients received dialysis. Conclusions: The majority of costs in the 6-month period after liso-cel infusion among patients with R/R FL in the TRANSCEND FL study were incurred in Month 1 and were facility related (IP and ICU hospitalizations and LOS). These findings, consistent with those previously reported for patients with LBCL treated with liso-cel, support that a single infusion of liso-cel is associated with significantly less HCRU and costs after the initial treatment period in the first month.

Supportive Care in Pediatric Oncology: Opportunities and Future Directions

The optimization of outcomes for pediatric cancer patients relies on the successful advancement of supportive care to ease the treatment burden and mitigate the long-term impacts of cancer therapy. Advancing pediatric supportive care requires research prioritization as well as the development and implementation of innovations. Like the prevailing theme throughout pediatric oncology, there is a clear need for personalized or precision approaches that are consistent, evidence-based, and guided by clinical practice guidelines. By incorporating technology and datasets, we can address questions which may not be feasible to explore in clinical trials. Now is the time to listen to patients’ voices by using patient-reported outcomes (PROs) to ensure that their contributions and experiences inform clinical care plans. Furthermore, while the extrapolation of knowledge and approaches from adult populations may suffice in the absence of pediatric-specific evidence, there is a critical need to specifically understand and implement elements of general and developmental pediatrics like growth, nutrition, development, and physical activity into care. Increased research funding for pediatric supportive care is critical to address resource availability, equity, and disparities across the globe. Our patients deserve to enjoy healthy, productive lives with optimized and enriched supportive care that spans the spectrum from diagnosis to survivorship.

Current challenges and potential solutions to the use of digital health technologies in evidence generation: a narrative review.

Digital health is a field that aims to improve patient care through the use of technology, such as telemedicine, mobile health, electronic health records, and artificial intelligence. The aim of this review is to examine the challenges and potential solutions for the implementation and evaluation of digital health technologies. Digital tools are used across the world in different settings. In Australia, the Digital Health Translation and Implementation Program (DHTI) emphasizes the importance of involving stakeholders and addressing infrastructure and training issues for healthcare workers. The WHO's Global Task Force on Digital Health for TB aims to address tuberculosis through digital health innovations. Digital tools are also used in mental health care, but their effectiveness must be evaluated during development. Oncology supportive care uses digital tools for cancer patient intervention and surveillance, but evaluating their effectiveness can be challenging. In the COVID and post-COVID era, digital health solutions must be evaluated based on their technological maturity and size of deployment, as well as the quality of data they provide. To safely and effectively use digital healthcare technology, it is essential to prioritize evaluation using complex systems and evidence-based medical frameworks. To address the challenges of digital health implementation, it is important to prioritize ethical research addressing issues of user consent and addressing socioeconomic disparities in access and effectiveness. It is also important to consider the impact of digital health on health outcomes and the cost-effectiveness of service delivery.

Using IT to Improve Outcomes for Children Living With Cancer (SyMon-SAYS): Protocol for a Single-Institution Waitlist Randomized Controlled Trial.

Children and adolescents with cancer may experience multiple disease- and treatment-related symptoms that negatively affect health-related quality of life. Routine symptom surveillance thus constitutes an important component of supportive care in pediatric oncology. The Symptom Monitoring and Systematic Assessment and Reporting System in Young Survivors (SyMon-SAYS) system will administer, score, interpret, and display the results of symptom assessments captured weekly using patient-reported outcomes presented via the electronic health record (EHR) portal between clinic visits in oncology ambulatory settings, when patients are likely to be more symptomatic. This study is testing a digital system for routine symptom surveillance that includes EHR-based reports to clinicians and alerts for severe symptoms. In this randomized trial, we are examining the effects of the SyMon-SAYS system on perceived barriers to symptom management, self-efficacy, and symptom severity. Better self-management and timely clinical intervention to address symptoms promote adherence to treatment plans, strengthen child and parent self-efficacy, improve interactions between children, parents, and their clinical providers, and optimize clinical outcomes. The SyMon-SAYS system is integrated into the EHR to streamline the presentation of symptom scores and delivery of alerts for severe symptoms to clinicians using EHR (Epic) messaging functionalities. Children (aged 8 to 17 years) complete the weekly symptom assessment and review the symptom report by logging into the patient portal (Epic MyChart). This single-institution waitlist randomized controlled trial is recruiting 200 children (aged 8-17 years) with cancer and their parents, guardians, or caregivers. Participating dyads are randomly assigned to receive the intervention over 16 weeks (Group A: 16-week SyMon-SAYS intervention; Group B: 8-week usual care and then an 8-week SyMon-SAYS intervention). Analyses will (1) evaluate the efficacy of SyMon-SAYS at week 8 and the maintenance of those effects at week 16; (2) evaluate factors associated with those efficacy outcomes, including contextual factors, adherence to the SyMon-SAYS intervention, demographic characteristics, and clinical factors; and (3) evaluate predictors of adherence to the SyMon-SAYS intervention and preference of SyMon-SAYS versus usual care. Data collection is currently in progress. We hypothesize that at 8 weeks, those receiving the SyMon-SAYS intervention will report decreased parent-perceived barriers to managing their children's symptoms, increased parent and child self-efficacy, decreased child symptom burden, and ultimately better child health-related quality of life, compared to waitlist controls. Feasibility, acceptability, and engagement from the perspectives of the children with cancer, their parents, and their clinicians will be examined using mixed methods. We anticipate that this system will facilitate prompt identification of problematic symptoms. Additionally, we hypothesize that with the availability of graphical symptom reports over time, and timely provider responses, children or parents will become better informed and take an active role in managing their symptoms, which will further improve clinical outcomes. ClinicalTrials.gov NCT04789720; https://clinicaltrials.gov/study/NCT04789720. DERR1-10.2196/50993.