A point-of-care pilot randomized intervention to connect patients with cancer-induced financial toxicity to telehealth financial counseling.

PURPOSE: Elevated costs of cancer treatment can result in economic and psychological "financial toxicity" distress. This pilot study assessed the feasibility of a point-of-care intervention to connect adult patients with cancer-induced financial toxicity to telehealth-delivered financial counseling. METHODS: We conducted a three-armed parallel randomized pilot study, allocating newly referred patients with cancer and financial toxicity to individual, group accredited telehealth financial counseling, or usual care with educational material (1:1:1). We assessed the feasibility of recruitment, randomization, retention, baseline and post-intervention COmprehensive Score for Financial Toxicity (COST), and Telehealth Usability Questionnaire (TUQ) scores. RESULTS: Of 382 patients screened, 121 were eligible and enrolled. 58 (48%) completed the intervention (9 individual, 9 group counseling, 40 educational booklet). 29 completed follow-up surveys: 45% female, 17% African American, 79% white, 7% Hispanic, 55% 45-64 years old, 31% over 64, 34% lived in rural areas, 24% had cancer stage I, 21% II, 7% III, 31% IV. Baseline characteristics were balanced across arms, retention status, surveys completion. Mean (SD) COST was 12.4 (6.1) at baseline and 16.0 (8.4) post-intervention. Mean (SD) COST score differences were 6.3 (11.6) after individual counseling, 5.8 (8.5) after group counseling, and 2.5 (6.4) after usual care. Mean TUQ score among nine counseling participants was 5.5 (0.9) over 7.0. Non-parametric comparisons were not statistically meaningful. CONCLUSION: Recruitment and randomization were feasible, while study retention presented challenges. Nine participants reported good usability and satisfaction with telehealth counseling. Larger-scale trials focused on improving participation, retention, and impact of financial counseling among patients with cancer are justified.

Phase II Study of Olaparib and Temozolomide for Advanced Uterine Leiomyosarcoma (NCI Protocol 10250).

PURPOSE: Uterine leiomyosarcoma (uLMS) is an aggressive subtype of soft-tissue sarcoma with frequent metastatic relapse after curative surgery. Chemotherapy provides limited benefit for advanced disease. Multiomics profiling studies have identified homologous recombination deficiency in uLMS. In preclinical studies where olaparib and temozolomide provided modest activity, the combination was highly effective for inhibiting uLMS tumor growth. PATIENTS AND METHODS: NCI Protocol 10250 is a single-arm, open-label, multicenter, phase II study evaluating olaparib and temozolomide in advanced uLMS. Patients with progression on ≥1 prior line received temozolomide 75 mg/m2 orally once daily with olaparib 200 mg orally twice a day both on days 1-7 in 21-day cycles. The primary end point was the best objective response rate (ORR) within 6 months. A one-stage binomial design was used. If ≥5 of 22 responded, the treatment would be considered promising (93% power; α = .06). All patients underwent paired biopsies that were evaluated with whole-exome sequencing (WES)/RNAseq and a RAD51 foci formation assay. RESULTS: Twenty-two patients were evaluable. The median age was 55 years, and 59% had received three or more prior lines. Best ORR within 6 months was 23% (5 of 22). The overall ORR was 27% (6 of 22). The median progression-free survival (mPFS) was 6.9 months (95% CI, 5.4 months to not estimable). Hematologic toxicity was common (grade 3/4 neutropenia: 75%; thrombocytopenia: 32%) but manageable with dose modification. Five of 16 (31%) of tumors contained a deleterious homologous recombination gene alteration by WES, and 9 of 18 (50%) were homologous recombination-deficient by the RAD51 assay. In an exploratory analysis, mPFS was prolonged for patients with homologous recombination-deficient versus homologous recombination-proficient tumors (11.2 v 5.4 months, P = .05) by RAD51. CONCLUSION: Olaparib and temozolomide met the prespecified primary end point and provided meaningful clinical benefit in patients with advanced, pretreated uLMS.

Frequency, barriers, outcomes, and consequences of reporting sexual harassment in clinical oncology.

Sexual harassment is increasingly recognized as widely prevalent in medicine. Broad efforts at the organizational and society level are working to address this inequity, but many of these efforts rely on reporting to eradicate problematic behaviors and shift culture. We examined, among oncologists experiencing sexual harassment, the frequency of reporting, as well as barriers, outcomes, and consequences of reporting. Among 271 survey respondents, 217 reported sexual harassment from peers or superiors or from patients or families. Most harassed oncologists (n = 148, 68%) did not report the event to authority because of concerns about future negative consequences for themselves. Among the minority who reported harassment (n = 31, 14%), 52% felt their concerns were not taken seriously and 55% reported no action was taken as a result of their report. Furthermore, 52% experienced retaliatory behavior. Addressing these findings may help to inform the change necessary to create an antiharassment culture in oncology.

Incidence, Nature, and Consequences of Oncologists' Experiences With Sexual Harassment.

PURPOSE: The incidence and impact of workplace sexual harassment (SH) of oncologists requires rigorous characterization. METHODS: Oncologists identified by ASCO's Research Survey Pool and social media outreach completed validated measures of SH (encompassing gender harassment, unwanted sexual attention, and sexual coercion) and four outcomes (mental health, job satisfaction, turnover intentions, and sense of workplace safety) over the previous year. Multivariable regression models assess the impact of SH on the four outcomes. RESULTS: Of 271 cisgender respondents (153 women and 118 men), 189 (70%) experienced SH in the past year alone by peers and/or superiors (80% of women v 56% of men, P < .0001). Specifically, 186 (69%) experienced gender harassment (79% of women, 55% of men, P < .0001), 45 (17%) unwanted sexual attention (22% of women, 9% of men, P = .005), and 7 (3%) sexual coercion (3% of women, 2% of men, P = .42). SH by patients and/or families in the past year was experienced by 143 (53% overall: 67% of women, 35% of men, P < .0001). Specifically, 141 (52%) experienced gender harassment (66% of women, 34% of men, P < .0001), 15 (6%) unwanted sexual attention (5% of women, 6% of men, P = .80), and 3 (1%) sexual coercion (1% of women, 1% of men, P = .72). Multivariable analysis showed that past-year SH by peers and/or superiors was significantly associated with decreased mental health (ß = -0.45, P = .004), sense of workplace safety (ß = -0.98, P < .001), and job satisfaction (ß = -0.69, P = .001), along with increased turnover intentions (ß = 0.93, P < .0001). Past-year SH by patients and/or families was significantly associated with decreased mental health (ß = -0.41, P = .002), sense of workplace safety (ß = -0.42, P = .014), and increased turnover intentions (ß = 0.58, P = .0004). There were no significant interactions between the respondents' gender and the SH scores in any of the four outcome models, signifying no difference in impact between men and women oncologists. CONCLUSION: This study using validated measures of SH to systematically characterize oncologists' workplace experience demonstrates substantial incidence of SH in the previous one year alone and its impact on men and women oncologists, informing the need for and design of effective protective and preventive measures.

Caring for Colleagues and Loved Ones With Cancer.

Throughout the arc of a career in medicine, physicians are universally faced with the difficult decision of when to provide care for a colleague and when to refer to another physician. Gauging the magnitude of your relationship, both professionally and personally, and then weighing how to add the roles of physician and patient to your preexisting relationship is complex. We review and discuss care of family and colleagues, address ethical boundaries both firm and flexible, and explore the emotional weight of those relationships.

Infusion Room-Based Transition to Practice Model for Teaching Cancer Systemic Therapy Management.

PURPOSE: Oncology training requirements mandate that fellows demonstrate competence in delivery of cancer therapeutics, understand clinical indications for treatment, and manage toxicities by completion of training. An academic training environment may hinder fellows' engagement in prescribing, monitoring, and adjusting cancer therapy; thus, trainees may complete their fellowship with limited experience in developing such critical skills. To provide hands-on experience in cancer systemic therapy management, we created a novel infusion room-based rotation in the final year of training; here we report the structure, logistics, and evaluation of this innovative program. METHODS: In 2004, The University of Florida Hematology Oncology Fellowship Program created an outpatient infusion room rotation called Transition to Practice (TTP). We surveyed 20 graduates of the program to assess the ability of the rotation to teach skills necessary for systemic therapy management and identify which fellowship rotations had an impact on their readiness to practice independently. RESULTS: Nineteen graduates completed the survey. TTP was rated highest for promoting independence in making decisions related to therapy and adjustment to the treatment plan. It was less valuable in teaching the financial aspects of cancer therapy encounters. The Veterans Affairs Medical Center continuity clinic and the TTP rotation were highly regarded for preparing graduates to practice oncology independently. CONCLUSION: We consider the TTP model an effective learning environment for oncology trainees to develop the essential skill set for managing cancer systemic therapy on the basis of this single-institution analysis of recent graduates. This model could be applied to training other oncology professionals, such as advanced practice providers, who are new to the field.

Perspectives on death and dying: a study of resident comfort with End-of-life care.

BACKGROUND: Despite the benefits to early palliative care in the treatment of terminal illness, barriers to timely hospice referrals exist. Physicians who are more comfortable having end-of-life (EOL) conversations are more likely to refer to hospice. However, very little is known about what factors influence comfort with EOL care. METHODS: An anonymous survey was sent to all the residents and fellows at a single institution. Self-reported education, experience and comfort with EOL care was assessed. Using multivariate logistic regression analysis, variables that influenced comfort with EOL conversations were analyzed. RESULTS: Most residents (88.1%) reported little to no classroom training on EOL care during residency. EOL conversations during residency were frequent (50.6% reported > 10) and mostly unsupervised (61.9%). In contrast, EOL conversations during medical school were infrequent (3.7% reported >10) and mostly supervised (78.6%). Most (54.3%) reported little to no classroom training on EOL care during medical school. Physicians that reported receiving education on EOL conversations during residency and those who had frequent EOL conversations during residency had significantly higher comfort levels having EOL conversations (p = 0.017 and p = 0.003, respectively). Likewise, residents that felt adequately prepared to have EOL conversations when graduating from medical school were more likely to feel comfortable (p = 0.030). CONCLUSIONS: Most residents had inadequate education in EOL conversation skills during medical school and residency. Despite the lack of training, EOL conversations during residency are common and often unsupervised. Those who reported more classroom training during residency on EOL skills had greater comfort with EOL conversations. Training programs should provide palliative care education to all physicians during residency and fellowship, especially for those specialties that are most likely to encounter patients with advanced terminal disease.

Managing cetuximab hypersensitivity-infusion reactions: incidence, risk factors, prevention, and retreatment.

Cetuximab is an anti-epidermal growth factor receptor (EGFR) monoclonal antibody approved by the US Food and Drug Administration for the treatment of colorectal (CRC) and head and neck (H&N) cancers. Hypersensitivity-infusion reactions (HIRs) confer moderate morbidity and potential mortality. HIRs have a wide geographic incidence with few identifiable risk factors. Limited data regarding risk-reduction interventions for HIR or post-HIR retreatment are available. All patients treated with cetuximab at a single Veterans Affairs facility were monitored for development of HIRs, with baseline clinical, demographic, and supportive care data recorded. All received standard premedication based on cohort assignment. A total of 51 consecutive patients (30 CRC; 21 H&N) received at least one dose of cetuximab. Grades II-IV HIRs occurred in 14 patients (27%; 6 grade II, 6 grade Ill, 2 grade IV). There was no grade V HIR. All HIRs occurred during the first infusion. There were no differences between age, race, diagnosis, stage, concurrent chemotherapy, or radiotherapy with cetuximab, allergy history, or military service era of patients developing HIRs versus those who did not.There were no identifiable risk factors that predicted the severity of HIR. Neither premedication modifications (P = 0.34) nor bronchodilator use (P= 0.12) impacted the incidence or severity of HIR. A cetuximab test dose successfully elicited an HIR and resulted in an 87% cost savings. None of five patients receiving subsequent retreatment with anti-EGFR MoAb had recurrence of an HIR. An HIR during cetuximab infusion can be a serious and underestimated toxicity. The relatively high incidence reported here is consistent with that previously identified in the Southeastern United States. No clinical, demographic, or historic variables reliably predicted HIR in our population. Use of a test dose to elicit a HIR appears to be feasible and cost-effective. Use of panitumumab after a cetuximab HIR in select patients with CRC appears to be feasible and safe.