Journal of palliative medicine
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Multicenter Study Observational Study
Low-Dose Trazodone for Delirium in Patients with Cancer Who Received Specialist Palliative Care: A Multicenter Prospective Study.
Background: Clinical usefulness of trazodone for delirium in patients receiving palliative care is unclear. Objectives: To examine the safety and effectiveness of trazodone for delirium. Design: A secondary analysis of a multicenter prospective observational study. ⋯ After three-day observation, the DRS total score (11.6 ± 5.3 to 8.7 ± 6.5 [difference -2.9, 95% confidence interval -5.3 to -0.5, p = 0.02]); sleep-wake cycle disturbance (p = 0.047), lability of affect (p < 0.001), and motor agitation subscales (p < 0.001) were significantly decreased. The most frequent adverse event was somnolence (n = 9). Conclusions: Low-dose trazodone treatment was generally safe and may be effective in reducing delirium severity.
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Randomized Controlled Trial Multicenter Study
Switching Ratio from Parenteral to Oral Methadone 1:1.2 Is Safer Compared with Ratio 1:2 in Patients with Controlled Cancer Pain: A Multicenter Randomized-Controlled Trial (RATIOMTD-010810).
Background: The most commonly used switching ratio from parenteral to oral methadone is 1:2. Methadone is highly bioavailable and a lower ratio might result in similar analgesia with less toxicity. Objective: To compare success and side effects with two ratios from parenteral to oral methadone: 1:2 versus 1:1.2 in hospitalized patients with cancer pain. ⋯ Conclusion: Ratio 1:1.2 when changing from parenteral to oral methadone resulted in lower toxicity and no difference in analgesia. More conservative dose adjustment during methadone route change should be considered. European Clinical Trials Register (EudraCT No. 2010-024092-39).
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Randomized Controlled Trial Multicenter Study
Multisite, Randomized Trial of Early Integrated Palliative and Oncology Care in Patients with Advanced Lung and Gastrointestinal Cancer: Alliance A221303.
Background: We conducted a multicenter, randomized trial of early integrated palliative and oncology care in patients with advanced cancer to confirm the benefits of early palliative care (PC) seen in prior single-center studies. Methods: We randomly assigned patients with newly diagnosed incurable cancer to early integrated palliative and oncology care (n = 195) or usual oncology care (n = 196) at sites through the Alliance for Clinical Trials in Oncology. Patients assigned to the intervention were expected to meet with a PC clinician at least monthly until death, whereas usual care patients consulted PC on request. ⋯ Intervention patients reported a mean 3.35 (standard deviation [SD] = 14.7) increase in FACT-G scores from baseline to week 12 compared with usual care patients who reported a 0.12 (SD = 12.7) increase from baseline (p = 0.10). Conclusion: This study highlights the difficulties of conducting multicenter trials of supportive care interventions in patients with advanced cancer. Clinical Trials Registration: NCT02349412.
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Multicenter Study
A Multicenter Cohort Study to Explore Differentiating Factors between Tumor Fever and Infection among Advanced Cancer Patients.
Background : Tumor fever and infection are common febrile etiologies among advanced cancer patients. To date, only few studies have been conducted to differentiate between tumor fever and infections. Objective: This study aimed to identify discriminating factors that provide rapid results and are feasible and minimally invasive for discriminating between tumor fever and infection in advanced cancer patients. Methods : This is a retrospective cohort study. Advanced cancer patients with clinically diagnosed tumor fever or infection, who received medical treatment from palliative care specialists in 10 nationwide Japanese hospitals, were consecutively identified during August 2012 and November 2014. ⋯ Their mean age was 68.8 years, 68 (64.8%) were men, and the median palliative performance status (PPS) was 50. Statistically significant factors predicting tumor fever by logistic regression analysis were as follows: deterioration of PPS (odds ratio, 0.078), shaking chills during fever (0.067), and change from baseline data of neutrophil/lymphocyte ratio of ≥5 (0.14). Conclusions : Shaking chills during fever, and changes from baseline of performance status and white blood cell differentiation can be useful to differentiate between tumor fever and infection among advanced cancer patients. Further confirmatory studies are needed.
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Randomized Controlled Trial Multicenter Study Comparative Study
A Multicenter, Randomized Controlled Trial of Perioperative Palliative Care Surrounding Cancer Surgery for Patients and Their Family Members (PERIOP-PC).
Background: Despite positive outcomes associated with specialist palliative care (PC) in diverse medical populations, little research has investigated specialist PC in surgical ones. Although cancer surgery is predominantly safe, operations can be extensive and unpredictable perioperative morbidity and mortality persist, particularly for patients with upper gastrointestinal (GI) cancers. Objectives and Hypotheses: Our objective is to complete a multicenter, randomized controlled trial comparing surgeon-PC co-management with surgeon-alone management among patients pursuing curative-intent surgery for upper GI cancers. ⋯ Caregiver: quality of life, caregiver burden, spiritual distress, and prognostic awareness. Intent-to-treat analysis will be used. Ethics and Dissemination: This study has been approved by the institutional review boards of all study sites and is registered on clinicaltrials.gov (NCT03611309, First received: August 2, 2018).