BACKGROUND:Research suggests that burnout and work-related quality of life are concerns for pediatric oncology professionals, with limited supportive resources. This study aimed to address this resource gap through an intervention promoting hope and targeting burnout and quality of life in this group. METHODS:A single-arm pilot study of the intervention was conducted at Rady Children's Hospital San Diego. The intervention was delivered as a single-session workshop, followed by reinforcement through a mobile application. Feasibility was assessed through recruitment and retention metrics, application usage data, and informal participant acceptability feedback. Exploratory efficacy analyses were conducted on measures of hope and perceived control (intervention mechanisms), occupational burnout and professional quality of life (primary outcomes), and empathy (secondary outcome) at baseline and 1, 4, and 12 weeks post-intervention. RESULTS:Twenty participants were consented and 18 participated, with 13 (72%) completing 12-week surveys. A total of 15 participants (83%) opted to receive daily push notifications, but only 3 (20%) engaged in daily booster questions. Positive feedback suggested acceptability. Exploratory findings suggested changes in emotional exhaustion (baseline to 1 week, P = .02; baseline to 4 weeks, P = .01), a sub-construct of burnout, and secondary traumatic stress (baseline to 4 weeks, P = .01; baseline to 12-week scores, P = .01), a sub-construct of professional quality of life. CONCLUSIONS:The Hopetimize intervention was feasible for pediatric oncology health-care professionals, although daily application usage was limited. Exploratory findings suggested that a randomized controlled trial would be beneficial to delineate intervention effects on the proposed mechanisms and outcomes.
BACKGROUND:The European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS) is a validated tool for assessing the clinical benefit of systemic cancer therapies. However, application of the scale to radiotherapy (RT) remains limited. As part of an ongoing initiative to adapt the scale for RT, we applied Form 1a of ESMO-MCBS v2.0 to studies cited in the American Society for Radiation Oncology (ASTRO) guideline for Human Papillomavirus (HPV)-positive oropharyngeal cancer (OPC) to assess feasibility and identify shortcomings. METHODS:We screened 73 studies cited in the ASTRO OPC guideline. Eligible studies included randomized controlled trials and meta-analyses. Two radiation oncologists scored studies using ESMO-MCBS v2.0 Form 1a; consensus grading was reached through group review. Scoring outcomes and reasons for non-scoreability were analyzed to identify systematic limitations. RESULTS:Of 73 studies, 33 met eligibility with a total of 37 comparisons noted. Eleven comparisons were scorable. Six scored Grade A (notably for survival benefit from chemoradiation or altered fractionation), and five scored Grade B (toxicity or cost reduction). Twenty-six comparisons were non-scoreable. Four demonstrated benefit in locoregional survival. Six post-hoc subgroup analyses yielded clinically impactful findings. The remaining 16 comparisons showed no evidence of benefit. These results highlight key ESMO-MCBS limitations: lack of credit for improved local control, non-inferiority designs improving convenience/toxicity, and practice-changing post-hoc subgroup analyses. CONCLUSION:While ESMO-MCBS v2.0 performed reasonably in OPC RT trials, several limitations restrict its utility in radiotherapy. This study identifies actionable gaps that should be addressed in developing a validated RT-specific version.
Value frameworks (VFs) guide clinical and policy decisions in oncology by capturing therapeutic benefit, toxicity, and cost. Most VFs evaluate novel systemic therapies. Local treatment modalities have additional meaningful endpoints such as organ preservation, organ functional outcomes, hospitalization rates, and local tumor control. Therefore, VFs calibrated based on drug treatments may undervalue locoregional therapies. This topic discussion organizes contemporary VFs into quantitative, qualitative, and hybrid categories while examining their respective limitations for locoregional interventions. We also highlight the challenge of comparing value across treatment modalities and review emerging developments.
Importance:Financial toxicity significantly affects individuals with cancer, impacting not only treatment adherence and outcomes but also psychological dimensions such as satisfaction with life (SWL). Identifying mediators of psychological outcomes of financial toxicity, including hopefulness and social support, is critical for informing interventions to mitigate financial toxicity burdens. Objective:To examine the association of financial toxicity with hopefulness, social support, and SWL in patients with cancer, and to test the roles of hopefulness and social support in the association between financial toxicity and SWL. Design, Setting, and Participants:This cross-sectional analysis assessed baseline patient-reported financial toxicity from participants of the prospective, multisite Economic Strain and Resilience in Cancer-II (ENRICh-II) study who enrolled from August 2020 to December 2022. Included patients were adults receiving ambulatory cancer care for various malignant neoplasm types diagnosed in the year prior from academic, community-based, and federally qualified health centers across 6 oncology clinics. Data were primarily analyzed between January and June 2024. Exposure:Financial toxicity was assessed using the ENRICh instrument, which measures global financial toxicity burden and financial toxicity-related material, coping, and psychological distress burden subdomain scores. Main Outcomes and Measures:The Satisfaction with Life Scale measured life satisfaction. Hypothesized mediators were measured using the State Hope Scale and Medical Outcomes Study Social Support Survey. A bootstrapping approach to multiple mediation was applied, controlling for demographic and clinical covariates. Results:A total of 519 participants were surveyed (mean [SD] age, 52.0 [15.2] years; 349 female [67.2%]; 49 Black [9.4%], 137 Hispanic [26.4%], 278 White [53.6%]). The most common cancers included breast (202 [38.9%]); colon, rectum, and anal (111 [21.4%]); biliary, liver, pancreatic, and stomach (65 [12.5%]); and leukemia, lymphoma, and other hematologic malignant neoplasms (53 [10.2%]). Higher financial toxicity was significantly associated with lower SWL (r = -0.34, P < .001). Hopefulness and social support each partially mediated this association (social support, -0.03 [95% CI, -0.06 to -0.01]; hope, -0.08, [95% CI, -0.12 to -0.03]). The combined multiple mediation path was significant (-0.02 [95% CI, -0.04 to -0.01]). These associations also existed for the material, coping, and psychological distress financial toxicity domains. Conclusions and Relevance:In this multisite, cross-sectional study, greater financial toxicity burden was associated with lower life satisfaction; individuals' hopefulness and perceived social support levels-representing dimensions of psychosocial resilience-statistically mediated this association. These results support an approach that would embed strategies to strengthen psychosocial resilience factors, in combination with current financial assistance, to help mitigate the downstream impacts of cancer-related financial toxicity.
PURPOSE:The European Society of Medical Oncology (ESMO) magnitude of clinical benefit scale (MCBS) version 1.1 is an evaluation scale that was developed to evaluate the MCBS reported in clinical research studies of cancer treatments. The American Society for Radiation Oncology (ASTRO) and the European Society for Radiotherapy and Oncology (ESTRO) created joint guidelines for the use of local therapy in the management of extracranial oligometastatic non-small cell lung cancer (NSCLC). We applied the ESMO-MCBS v.1.1 to evaluate the clinical benefit reported in studies that informed the ASTRO/ESTRO guidelines. METHODS AND MATERIALS:We applied the ESMO-MCBS v1.1 to the 23 studies identified by the ASTRO/ESTRO taskforce. As well, we evaluated the recently published Consolidative Use of Radiotherapy to Block Oligoprogression study and Stereotactic Radiotherapy for Oligo-Progressive Metastatic Cancer Trial, for a total of 25 studies evaluated. All evaluated studies were graded by at least 3 of the authors. Any discrepancies were subsequently reviewed by the scoring authors. RESULTS:The addition of stereotactic body radiation therapy to all sites of oligometastatic disease in combination with standard-of-care chemotherapy was associated with substantial improvements in survival. These studies resulted in a score of 4 using form 2a (noncurative treatment with overall survival from standard therapy between 12 and 24 months). Of the 10 prospective single-arm studies, 9 received a score of 3 using form 3, due to progression-free survival exceeding 6 months. No studies received a score of 5 (highest clinical benefit). CONCLUSIONS:The use of local radiation in the treatment of extracranial oligometastatic NSCLC is associated with a substantial clinical benefit, according to the ESMO-MCBS v1.1. Radiation therapy was comparable to established and groundbreaking targeted therapies such as pembrolizumab in combination with pemetrexed for epidermal growth factor receptor and anaplastic lymphoma kinase-negative NSCLC, and osimertinib for epidermal growth factor receptor-mutated NSCLC. MCBS would be even higher if quality-of-life improvements are found in future trials.
PURPOSE:The study aimed to compare the effects of technological versus interpersonal psychoeducational interventions in reducing treatment-related anxiety in breast cancer patients undergoing radiation therapy. METHODS AND MATERIALS:This prospective randomized controlled trial enrolled 241 patients with breast cancer, randomly assigning them into 3 arms: video education (n = 51), medical physicist consultation (n = 92), and standard care (n = 98). The video education group viewed an informational video prior to simulation, whereas the physicist consultation group received personalized treatment plan explanations before their first treatment. Anxiety levels were assessed using the State-Trait Anxiety Inventory and distress thermometer at 4 time points: after initial consultation, after simulation, after first treatment, and at treatment completion. RESULTS:Baseline anxiety scores were comparable across all groups following initial consultation. Medical physicist consultation patients demonstrated significantly lower distress thermometer scores after first treatment compared with both video education (P < .0043) and standard care groups (P < .0051). Although video education and standard care groups showed significant anxiety reduction between first and last treatments through habituation, the medical physicist group maintained consistently lower anxiety levels throughout treatment, suggesting earlier anxiety resolution through interpersonal intervention. CONCLUSIONS:Direct patient education by medical physicists resulted in more rapid anxiety reduction compared with video-based education or standard care. The effectiveness of interpersonal intervention preceded the natural anxiety reduction observed through habituation in other groups. These findings support the integration of medical physicists into direct patient care and demonstrate the superior impact of human connection over technological interventions in managing radiation therapy-related anxiety.
Purpose: The attack by Hamas on Israeli civilians (October 7, 2023) triggered the ongoing war, which could be detrimental to cancer care in general and radiation therapy (RT) in particular. To assure continuity of care within the Radiation Oncology Department of Samson Assuta Ashdod University Hospital (SAAUH), which borders on Gaza, patient-centric measures were redoubled by our institution. This study describes the impact of these measures on patients' perception and their willingness to continue RT, despite fear of war. Methods and Materials: A survey questionnaire was designed to detect changes in attitude and treatment adherence during war. It was offered to the patients undergoing RT at SAAUH. A Pearson correlation between the items relating to desire to continue the therapy was calculated. Smallest space analysis was conducted to illustrate the association between the variables. Results: Forty-seven patients enrolled in this study reported a significantly lower feeling of personal safety during wartime in comparison with the confidence in the professionalism of the staff (paired samples t test, t(43) = 4.61; P < .001). Simultaneously, patients perceived that the impact of the national situation on their health was very low (mean of 1.59 on a scale of 1-6). Both the Pearson correlation test and smallest space analysis revealed that the desire to continue treatment in general and to continue treatment at the same department were significantly related to trust in the staff's professionalism. Conclusions: Fear of war can pose a major pitfall in providing daily RT care. This obstacle may be potentially overridden by creating deep, trusting relationships between the patients and the medical staff. (c) 2024 The Authors. Published by Elsevier Inc. on behalf of American Society for Radiation Oncology. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
Introduction: Although the concept of hope is highly relevant for cancer patients, little is known about its association with cancer-relevant biomarkers. Here we examined how hope was related to diurnal cortisol and interleukin-6 (IL-6), a pro-inflammatory cytokine previously associated with tumor biology and survival in ovarian cancer. Secondly, we examined whether hope and hopelessness are distinctly associated with these biomarkers.Method: Participants were 292 high-grade ovarian cancer patients who completed surveys and provided saliva samples 4x/daily for 3 days pre-surgery to assess diurnal cortisol. Blood (pre-surgery) and ascites were assessed for IL-6. Hope and hopelessness were assessed using standardized survey items from established scales (Center for Epidemiological Studies Depression Scale; Profile of Mood States, Functional Assessment of Cancer Therapy). Two hopeless items were z-scored and combined into a composite for analysis. Regression models related these variables to nocturnal cortisol, cortisol slope, plasma and ascites IL-6, adjusting for cancer stage, BMI, age, and depression.Results: Greater hope was significantly related to a steeper cortisol slope, beta = -0.193, p = 0.046, and lower night cortisol, beta = -0.227, p = 0.018, plasma IL-6, beta = -0.142, p = 0.033, and ascites IL-6, beta = -0.290, p = 0.002. Secondary analyses including both hope and hopelessness showed similar patterns, with distinct relationships of hope with significantly lower nocturnal cortisol beta = -0.233, p = 0.017 and ascites IL-6, beta = -0.282, p = 0.003, and between hopelessness and a flatter cortisol slope, beta = 0.211, p = 0.031.Conclusions: These data suggest a biological signature of hope associated with less inflammation and more normalized diurnal cortisol in ovarian cancer. These findings have potential clinical utility but need replication with more diverse samples and validated assessments of hope.
Background: The European Society of Medical Oncology (ESMO) has suggested using the ESMO-Magnitude of Clinical Benefit Scale (MCBS) to grade the magnitude of clinical benefit of cancer therapies. This approach has not been applied to radiation therapy (RT) yet. We applied the ESMO-MCBS to experiences describing the use of RT to assess (1) the 'scoreability' of the data, (2) evaluate the reasonableness of the grades for clinical benefit and (3) identify potential shortcomings in the current version of the ESMO-MCBS in its applicability to RT.Materials and methods: We applied the ESMO-MCBS v1.1 to a selection of studies in radiotherapy that had been identified as references in the development of American Society for Radiation Oncology (ASTRO) evidence-based guidelines on whole breast radiation. Of the 112 cited references, we identified a subset of 16 studies that are amenable to grading using the ESMO-MCBS. Results: Of the 16 studies reviewed, 3/16 were scoreable with the ESMO tool. Six of 16 studies could not be scored because of shortcomings in the ESMO-MCBS v1.1: (1) in 'non-inferiority studies', there is no credit for improved patient convenience, reduced patient burden or improved cosmesis; (2) in 'superiority studies' evaluating local control as a primary endpoint, there is no credit for the clinical benefit such as reduced need for further interventions. In 7/16 studies, methodological deficiencies in the conduct and reporting were identified.Conclusions: This study represents a first step in determining the utility of the ESMO-MCBS in the evaluation of clinical benefit in radiotherapy. Important shortcomings were identified that would need to be addressed in developing a version of the ESMO-MCBS that can be robustly applied to radiotherapy treatments. Optimization of the ESMO-MCBS instrument will proceed to enable assessment of value in radiotherapy.
Purpose: The aim of this study was to evaluate a formulation of pegylated liposomal mitomycin C lipidic prodrug (PL-MLP) in patients concomitantly undergoing external beam radiation therapy (RT). Methods and Materials: Patients with metastatic disease or inoperable primary solid tumors requiring RT for disease control or symptom relief were treated with 2 courses of PL-MLP (1.25, 1.5, or 1.8 mg/kg) at 21-day intervals, along with 10 fractions of conventional RT or 5 stereotactic body RT fractions initiated 1 to 3 days after the first PL-MLP dose and completed within 2 weeks. Treatment safety was monitored for 6 weeks, and disease status was re-evaluated at 6-week intervals thereafter. MLP levels were analyzed 1 hour and 24 hours after each PL-MLP infusion.Results: Overall, 19 patients with metastatic (18) or inoperable (1) disease received combination treatment, with 18 completing the full protocol. Most patients (16) had diagnoses of advanced gastrointestinal tract cancer. One grade 4 neutropenia event possibly related to study treatment was reported; other adverse events were mild or moderate. Of the 18 evaluable patients, 16 were free of RT target lesion progression at first re-evaluation. Median survival of the entire patient population was 63.3 weeks. Serum MLP level correlated with dose increases and similar long circulating profiles were observed before and after RT.Conclusions: PL-MLP up to 1.8 mg/kg in combination with RT treatment is safe, with a high rate of tumor control. Drug clearance is not affected by radiation. PL-MLP is potentially an attractive option for chemoradiation therapy that warrants further evaluation in randomized studies in the palliative and curative settings. & COPY; 2023 Elsevier Inc. All rights reserved.
Two models of hope have predominated in the literature pertaining to cancer-Snyder's "Hope Theory" and Herth's hope model-both of which have produced brief self-report measures. Growing evidence demonstrates that hope, as operationalized in these models, is associated with a number of psychological variables in individuals with cancer, including depression, distress, coping, symptom burden, and posttraumatic growth. Emerging evidence also suggests that hope may predict probability of survival in advanced cancer. Surveys show that patients and families generally prefer healthcare communication that authentically conveys prognosis; such communication is not associated with decreased hope, but may actually foster hope. Finally, several interventions have been developed to enhance hope in people with cancer, which generally demonstrate medium effects.
Background Patients prefer medical communication including both hopefulness and realism, though health-care professional (HCPs) struggle to balance these. Providers could thus benefit from a detailed personal understanding of hope, allowing them to model and convey it to patients. Additionally, given that hope is associated with lower levels of burnout, HCPs may benefit from tools designed to enhance their own personal hopefulness. Several investigators have proposed offering HCPs interventions to augment hope. We developed an online workshop for this purpose. Methods Feasibility and acceptability of the workshop were assessed in members of the SWOG Cancer Research Network. Three measures were used: the Was-It-Worth-It scale, a survey based on the Kirkpatrick Training Evaluation Model, and a single item prompting participants to rate the degree to which they believe concepts from the workshop should be integrated into SWOG studies. Results Twenty-nine individuals signed up for the intervention, which consisted of a single 2-hour session, and 23 completed measures. Results from Was-It-Worth-It items indicate that nearly all participants found the intervention relevant, engaging, and helpful. Mean ratings for Kirkpatrick Training Evaluation Model items were high, ranging from 6.91 to 7.70 on 8-point scales. Finally, participants provided a mean rating of 4.44 on a 5-point scale to the item "To what degree do you believe it may be useful to integrate concepts from this workshop into SWOG trials/studies?" Conclusions An online workshop to enhance hopefulness is feasible and acceptable to oncology HCPs. The tool will be integrated into SWOG studies evaluating provider and patient well-being.