Video and In-Person Palliative Care Delivery Challenges before and during the COVID-19 Pandemic.

CONTEXT: Palliative care (PC) clinicians faced many challenges delivering outpatient care during the coronavirus-19 (COVID-19) pandemic. OBJECTIVES: We described trends for in-person and video visit PC delivery challenges before and during the COVID-19 pandemic in the U.S. METHODS: We performed a secondary data analysis of patient characteristics and PC clinician surveys from a multisite randomized controlled trial at 20 academic cancer centers. Patients newly diagnosed with advanced lung cancer (N = 653) were randomly assigned to receive either early in-person or telehealth PC and had at least monthly PC clinician visits. PC clinicians completed surveys documenting PC delivery challenges after each encounter. We categorized patients into 3 subgroups according to their PC visit dates relative to the onset of the COVID-19 pandemic in the U.S.-pre-COVID-19 (all visits before March 1, 2020), pre/post-COVID-19 (≥1 visit before and after March 1, 2020), and post-COVID-19 (all visits after March 1, 2020). We performed Pearson's chi-squared, Fisher's exact, and Kruskal-Wallis tests to examine associations. RESULTS: We analyzed 2329 surveys for video visits and 2176 surveys for in-person visits. For video visits, the pre-COVID-19 subgroup (25.8% [46/178]) had the most technical difficulties followed by the pre/post-COVID-19 subgroup (17.2% [307/1784]) and then the post-COVID-19 subgroup (11.4% [42/367]) (P = 0.0001). For in-person visits, challenges related to absent patients' family members occurred most often in the post-COVID-19 subgroup (6.2% [16/259]) followed by the pre/post-COVID-19 subgroup (3.6% [50/1374]) and then the pre-COVID-19 subgroup (2.2% [12/543]) (P = 0.02). CONCLUSION: Technical difficulties related to PC video visits improved, whereas in-person visit challenges related to absent patients' family members worsened during the pandemic.

Health-Related Quality of Life and Depression Symptoms in a Cross Section of Patients with Advanced Lung Cancer before and during the COVID-19 Pandemic.

Background: Adults with advanced lung cancer experience reduced health-related quality of life (HRQOL) and psychological symptoms at diagnosis. Objective: This study aimed to evaluate whether the COVID-19 pandemic worsened HRQOL among patients recently diagnosed with cancer. Design: We analyzed baseline data from two randomized controlled trials of early palliative care to compare HRQOL and depression symptoms among those enrolled during the pandemic (January 2020 to January 2021) versus prepandemic (March 2018 to January 2019). Setting/Subjects: This cohort included patients recently diagnosed with advanced lung cancer in two multisite studies. Measurements: We used analysis of covariance to calculate adjusted mean differences between groups with the timeframe as an independent variable and HRQOL (using the Functional Assessment of Cancer Therapy-General) and depression symptoms (using the Patient Health Questionnaire-9) as dependent variables, adjusting for age, gender, relationship status, performance status, symptoms, and time since diagnosis. We tested for an interaction between the COVID-19 timeframe and relationship status. Results: Neither HRQOL (adjusted mean difference -1.78; p = 0.137) nor depression symptoms (0.06; p = 0.889) differed between patients enrolled pre-COVID-19 (n = 665) relative to those enrolled during COVID-19 (n = 191) in adjusted analyses. Relationship status moderated the effect of the COVID-19 timeframe on HRQOL; unmarried patients experienced worse HRQOL during COVID-19 (adjusted mean difference: -5.25; p = 0.011). Conclusions: The COVID-19 pandemic did not further reduce HRQOL or increase depression symptoms among patients recently diagnosed with lung cancer, but did worsen HRQOL for unmarried patients in moderation analysis. Psychosocial evaluation and supportive care are important for all patients, particularly those with limited social support. Clinical trial registration numbers: NCT03337399 and NCT03375489.

Study protocol for a randomised trial evaluating the non-inferiority of stepped palliative care versus early integrated palliative care for patients with advanced lung cancer.

INTRODUCTION: Integrating palliative care (PC) early in the illness course for patients with serious cancers improves their outcomes and is recommended by national organisations such as the American Society of Clinical Oncology. However, monthly visits with PC clinicians from the time of diagnosis can be challenging to implement due to the lack of specialty-trained PC clinicians and resources. Therefore, we developed a stepped care model to triage PC service based on patients' needs. METHODS AND ANALYSIS: We are conducting a non-blinded, randomised trial to evaluate the non-inferiority of a stepped PC model compared with an early integrated PC model for improving patients' quality of life (QOL) at 24 weeks (primary outcome). Patients assigned to early integrated PC meet with PC every 4 weeks throughout their illness. Patients assigned to stepped PC have PC visits only at clinically significant points in their illness (eg, cancer progression) unless their QOL decreases, at which time they are 'stepped up' and meet with PC every 4 weeks throughout the remainder of their illness. Secondary aims include assessing whether stepped PC is non-inferior to early integrated PC regarding patient-clinician communication about end of life care and length of stay on hospice as well as comparing resource utilisation. Patients are recruited from the Massachusetts General Hospital Cancer Center, Boston, Massachusetts; Duke Cancer Center, Durham, North Carolina and University of Pennsylvania Abramson Cancer Center, Philadelphia, Pennsylvania. The target sample size is 510 patients. ETHICS AND DISSEMINATION: The study is funded by the National Cancer Institute, approved by the Dana-Farber/Harvard Cancer Center Institutional Review Board and will be reported in accordance with the Consolidated Standards of Reporting Trials statement. We will disseminate results through professional society meetings, peer-reviewed publications and presentations to patient organisations. TRIAL REGISTRATION NUMBER: NCT03337399.

HEREDITARY ENDOCRINE TUMOURS: CURRENT STATE-OF-THE-ART AND RESEARCH OPPORTUNITIES: Early thyroidectomy in multiple endocrine neoplasia: a four decade experience.

Forty years ago, physicians caring for the J-kindred, a 100+ member family with multiple endocrine neoplasia type 2A (MEN2A), hypothesized that early thyroidectomy based on measurement of the biomarker calcitonin could cure patients at risk for development of medullary thyroid carcinoma (MTC). We re-evaluated 22 family members with proven RET proto-oncogene mutations (C634G) who underwent thyroidectomy and central lymphadenectomy between 1972 and 1994 based on stimulated calcitonin abnormalities. Current disease status was evaluated by serum calcitonin measurement and neck ultrasound in 18 of the 22 prospectively screened patients. The median age of the cohort at thyroidectomy was 16.5 years (range 9-24). The median duration of follow-up at the time of examination was 40 years (range 21-43) with a median current age of 52 years (range 34-65). Fifteen of the 18 patients had no detectable serum calcitonin (<2 pg/mL). Three had detectable serum calcitonin measurements, inappropriately elevated following total thyroidectomy. None of the 16 patients imaged had an abnormal ultrasound. Survival analysis shows no MTC-related deaths in the prospectively screened patients, whereas there were many in prior generations. Early thyroidectomy based on biomarker testing has rendered 15 of 18 MEN2A patients (83%) calcitonin-free with a median follow-up period of 40 years. There have been no deaths in the prospectively screened and thyroidectomized group. We conclude that early thyroidectomy and central lymph node dissection is an effective prophylactic treatment for hereditary MTC.

Early Integrated Telehealth versus In-Person Palliative Care for Patients with Advanced Lung Cancer: A Study Protocol.

Introduction: Early palliative care (PC) integrated with oncology care improves quality of life (QOL), depression symptoms, illness understanding, and end-of-life (EOL) care for patients with advanced lung cancer. The aims of this trial are to compare the effect of delivering early integrated PC through telehealth versus in-person on patient and caregiver outcomes. We hypothesize that both modalities for delivering early PC would be equivalent for improving patient QOL, communication about EOL care preferences with their oncologist, and length of stay in hospice. Methods: For this comparative effectiveness trial, we will enroll and randomize 1250 adult patients with advanced nonsmall cell lung cancer (NSCLC), who are not being treated with curative intent, to receive either early integrated telehealth or in-person PC at 20 cancer centers throughout the United States. Patients may also invite a family caregiver to participate in the study. Patients and their caregivers in both study groups meet at least every four weeks with a PC clinician from within 12 weeks of patient diagnosis of advanced NSCLC until death. Participants complete measures of QOL, mood, and quality of communication with oncologists at baseline before randomization and at 12, 24, 36, and 48 weeks. Information on health care utilization, including length of stay in hospice, will be collected from patients' health records. To test equivalence in outcomes between study groups, we will compute analysis of covariance and mixed linear models, controlling for baseline scores and study site. Study Implementation and Stakeholder Engagement: To ensure that this comparative effectiveness trial and findings are as patient centered and meaningful as possible, we have incorporated a robust patient and stakeholder engagement plan. Our stakeholder partners include (1) patients/families, (2) PC clinicians, (3) telehealth experts and clinician users, (4) representatives from health care systems and medical insurance providers, and (5) health care policy makers and advocates. These stakeholders will inform and provide feedback about every phase of study implementation.

Medullary Thyroid Carcinoma Associated with Germline RETK666N Mutation.

BACKGROUND: Multiple endocrine neoplasia type 2 is an autosomal dominant inherited syndrome caused by activating mutations in the RET proto-oncogene. The RETK666N DNA variant was previously reported in two isolated medullary thyroid carcinoma (MTC) cases, but no family studies are available, and its oncogenic significance remains unknown. METHODS: The clinical features, genetic data, and family information of eight index MTC patients with a germline RETK666N variant were assessed. RESULTS: Four probands presented with MTC and extensive nodal metastasis, one with biopsy-confirmed distant metastasis. Two additional probands presented with localized disease. However, nodal status was not available. Of the final two probands, one had an incidental 1.5 mm MTC and C-cell hyperplasia uncovered after surgery for papillary thyroid carcinoma, and one had two foci of MTC (largest dimension 2.3 cm) detected after surgery for dysphagia. Genetic screening identified 16 additional family members carrying the K666N variant (aged 5-90 years), 11 of whom have documented evaluation for MTC. Of these, only two were found to have elevated basal serum calcitonin upon screening, and the remaining patients had calcitonin levels within the reference range. One patient who elected to have a thyroidectomy at 70 years of age was confirmed to have MTC. The other subject, 57 years old, elected surveillance. Four prophylactic thyroidectomies were performed, with one case of C-cell hyperplasia at 20 years and three cases that revealed normal pathology at ages 21, 30, and 30 years. None of the K666N DNA variant carriers had evidence of primary hyperparathyroidism or pheochromocytoma. CONCLUSIONS: From this case series, the largest such experience to date, it is concluded that the RETK666N variant is likely pathogenic and associated with low penetrance of MTC. However, the findings are insufficient to define its pathogenicity clearly and make firm recommendations for screening and treatment. Given the potential benefit associated with early detection of aberrant C-cell growth, and the noninvasive nature of genetic testing, "at risk" individuals should be screened, and if the K666N variant is identified, they should be managed using a personalized screening approach for detection of MTC.