Background Patients with cancer often endure substantial symptoms and treatment toxicities leading to high healthcare utilization, including hospitalizations and emergency department visits, throughout the continuum of their illness. Innovative oncology care models are needed to improve patient outcomes and reduce their healthcare utilization. Using a novel hospital at home care platform, we developed a Supportive Oncology Care at Home intervention to address the needs of patients with cancer. Methods We are conducting three trials to delineate the role of Supportive Oncology Care at Home for patients with cancer. The Supportive Oncology Care at Home intervention includes: (1) a hospital at home care model for symptom assessment and management; (2) remote monitoring of daily patient-reported symptoms, vital signs, and body weight; and (3) structured communication with the oncology team. Our first study is a randomized controlled trial to test the efficacy of Supportive Oncology Care at Home versus standard oncology care for improving healthcare utilization, cancer treatment interruptions, and patient-reported outcomes in patients with cancer receiving definitive treatment of their cancer. Participants include adult patients with gastrointestinal and head and neck cancer, as well as lymphoma, receiving definitive treatment (e.g., treatment with curative intent). The second study is a single-arm trial assessing the feasibility and acceptability of the Supportive Oncology Care at Home intervention for hospitalized patients with advanced cancer. Eligible participants include adult patients with incurable cancer who are admitted with an unplanned hospitalization. The third study is a single-arm trial assessing the feasibility and acceptability of the Supportive Oncology Care at Home intervention to enhance the end-of-life care for patients with advanced hematologic malignancies. Eligible participants include adult patients with relapsed or refractory hematologic malignancy receiving palliative therapy or supportive care alone. Discussion These studies are approved by the Dana-Farber/Harvard Cancer Center Institutional Review Board and are being conducted in accordance with the Consolidated Standards of Reporting Trials statement for non-pharmacological trials. This work has the potential to transform the paradigm of care for patients with cancer by providing them with the necessary support at home to improve their health outcomes and care delivery. Trial registrations NCT04544046, NCT04637035, NCT04690205.
Context Isolated hypogonadotropic hypogonadism (IHH) is phenotypically and genetically heterogeneous. Objective To determine the correlation between genotypic severity with pubertal and neuroendocrine phenotypes in IHH men. Design Retrospective study (1980-2020) examining olfaction (Kallmann syndrome [KS] vs. normosmic IHH [nIHH]), baseline testicular volume (absent vs. partial puberty), neuroendocrine profiling (pulsatile vs. apulsatile LH secretion), and genetic variants in 62 IHH-associated genes through exome sequencing (ES). Results In total, 242 men (KS: n = 131 [54%], nIHH: n = 111 [46%]) were included. Men with absent puberty had significantly lower gonadotropin levels (p < 0.001) and were more likely to have undetectable LH (p < 0.001). Logistic regression showed partial puberty as a significant predictor of pulsatile LH secretion (R2 = 0.71, p < 0.001, OR: 10.8 [95%CI: 3.6, 38.6]). Serum LH of 2.10 IU/L had a 95% true positive rate for predicting LH pulsatility. Genetic analyses in 204/242 IHH men with ES data available revealed 36/204 (18%) men carried protein truncating variants (PTVs) in 12 IHH genes. Men with absent puberty and apulsatile LH were enriched for oligogenic PTVs (p < 0.001), with variants in ANOS1 being the predominant PTV in this genotype-phenotype association. Men with absent puberty were enriched for ANOS1 PTVs compared to partial puberty counterparts (p = 0.002). PTVs in other IHH genes imparted more variable reproductive phenotypic severity. Conclusions Partial puberty and LH ≥ 2.10 IU/L are proxies for pulsatile LH secretion. ANOS1 PTVs confer severe reproductive phenotypes. Variable phenotypic severity in the face of severe genetic variants in other IHH genes point to significant neuroendocrine plasticity of the HPG axis in IHH men.
295 Background: Patients with advanced cancer often experience frequent and prolonged hospitalizations, and the transition from hospital to home represents a critical period for these individuals, as they prefer to maximize time at home and avoid readmissions. We sought to demonstrate the feasibility and acceptability of a Supportive Oncology Care at Home intervention to address the post-discharge needs of recently hospitalized patients with advanced cancer. Methods: We conducted a single-arm pilot trial at Massachusetts General Hospital (MGH). We enrolled English-speaking adults with advanced solid tumors experiencing their second or later unplanned hospitalization, who were being discharged home without hospice services and residing within a 50 mile radius of MGH. The three-week intervention consisted of: 1) hospital in the home care model for proactive symptom assessment and management, including clinician visits to assess patients, draw labs, administer intravenous medications and hydration, and ensure optimal symptom management; 2) remote monitoring of daily patient-reported symptoms, vital signs, and body weight; and 3) structured communication with the oncology team. The primary endpoint of the study was feasibility, defined as ≥60% of approached and eligible patients enrolling and ≥60% of participants completing daily symptom assessments. After intervention completion, patients rated the helpfulness and convenience of the intervention and symptom monitoring technology. Results: From 12/2021-6/2022, we enrolled 40 out of 66 approached patients (60.6% enrollment rate). Enrolled patients (median age = 58.5 years, 50% female, 75% white, 68% married, 50% gastrointestinal cancers) completed 93.8% of daily symptom assessments. 12 patients (30%) did not complete the intervention due to withdrawal (5), hospice transfer (4), or death (3). Among enrolled patients, 20.0% were enrolled in hospice and 15.4% died at 30 days after hospital discharge. In exit interviews, 100% and 75% rated the intervention and symptom monitoring as helpful, respectively. 83% of patients found the in-home monitoring technology convenient. Conclusions: We found that a three-week Supportive Oncology Care at Home intervention is a feasible approach to providing post-discharge care for high acuity, seriously ill hospitalized patients with advanced cancer. These patients also found the intervention highly acceptable. Future studies will test the efficacy of the intervention for reducing hospital readmissions, improving symptom management and quality of life, and increasing days spent at home near the end of life. Clinical trial information: NCT04637035.
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