Journal of palliative medicine
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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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Randomized Controlled Trial
Four Conversations: A Randomized Controlled Trial of an Online, Personalized Coping, and Decision Aid for Metastatic Breast Cancer Patients.
Background: Anticipating and making health care decisions about appropriate or preferred treatment around end-of-life care are intellectually challenging and emotionally distressing for metastatic breast cancer (MBC) patients, new interventions are needed. Objective: This study examined the effect of Four Conversations, an online and personalized coping and decision aid curriculum, on the completion of advance care directives and shared decision making among patients and their loved ones, clinicians, and spirit. Design: Participants were randomized 1:1 to Four Conversations or wait-listed usual care conditions. ⋯ Conclusions: These results suggest that Four Conversations facilitated the completion of advance care directives. Given that reductions in decisional conflict scores between the treatment and control arms were not significant, we cannot conclude that program use was associated with improved decisional conflict among MBC survivors. Online programs can be a feasible and effective alternative to in-person support.
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Randomized Controlled Trial
Advance Care Planning to Improve End-of-Life Decision-Making Consistency between Older People and Their Surrogates in Taiwan.
Background: Surrogates often do not accurately predict older people's preferences about end-of-life (EOL) care. Few studies have examined the impact of advance care planning (ACP) on EOL decision-making consistency between older people and their surrogates, and these studies have yielded conflicting results. Objectives: To evaluate the effectiveness of ACP in improving EOL decision-making consistency between older people and their surrogates. Design: The intervention in this pre-post quasi-experimental design included an informative video, a brochure about ACP, and a guided discussion about EOL wishes. Setting: Two geriatric wards in a medical center in northern Taiwan. Subjects: One hundred eight participants, as 54 pairs of older people and their surrogates, were randomly assigned to either the experimental or control group. The experimental group received an intervention, while the control group received usual care. Measurements: Life-Support Preferences Questionnaire. Results: The intervention did not improve decision-making consistency between older people and their surrogates. ⋯ This study also found that some older people had difficulty concentrating on the educational brochure or understanding the related terms. Conclusions: Preparation for ACP discussion is needed for older people and their surrogates. Longer-term effects of ACP should be monitored because ACP interventions may have enhanced empathy between older people and their surrogates. Additionally, a culturally sensitive illustrated questionnaire that explains life-support preferences and ACP topics may improve communication between older people and their surrogates.
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Randomized Controlled Trial
Feasibility of Implementing a Palliative Care Intervention for People with Heart Failure: Learnings from a Pilot Randomized Clinical Trial.
Background: People with heart failure (HF) have high morbidity and mortality and may benefit from palliative care (PC). Objective: To pilot a randomized, clinical trial of a PC intervention for people with HF. Design: Participants were randomized to usual care (UC) or intervention (UC plus specialty PC) between January 2012 and December 2013. The initial PC consultation was conducted in-hospital, with six additional contacts from the PC team over six months. Setting/Subjects: The study was undertaken in a large, urban, academic medical center with patients (n = 30) with New York Heart Association HF Class II-IV. Measurements: Patients completed a survey at baseline, three and six months, assessing pain, dyspnea, depression, and quality of life (QoL). Results: Although there were significant improvements in mean scores from baseline to six months for pain (4.3 vs. 2.4, p = 0.05), dyspnea (3.9 vs. 2.2, p = 0.03), and QoL (59.2 vs. 42.7, p = 0.001), there were no differences between study groups over time. ⋯ Given the trajectory of HF, studies may need to recruit outpatients and follow patients for a longer period to fully evaluate the impact of PC interventions. Clinical trials Identifier: NCT01461681.
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Randomized Controlled Trial
Short-Term Effects of 10% Lidocaine Ointment on Allodynia in Cancer Pain: A Randomized, Double-Blind, Placebo-Controlled, Crossover Study.
Background: There is currently no established therapy for allodynia, which is a type of neuropathic pain. However, high concentrations of topical anesthetics can anesthetize the skin and increase the sensory threshold to tactile stimulation. Objective: We aimed to evaluate the short-term effects and safety of 10% lidocaine ointment for treating allodynia in cancer pain. Design: This was a randomized double-blind crossover study comparing the efficacies of 10% lidocaine ointment and placebo ointment for the treatment of static allodynia and spontaneous pain within 24 hours after ointment application, using a numerical rating scale (NRS). Setting/Subjects: The subjects were 25 cancer patients with current pain rating of ≥4 on NRS of static allodynia in cancer pain. Results: The NRS scores for static allodynia were significantly lower in the lidocaine group than in the placebo group at two to eight hours after initial ointment application. ⋯ There was no interaction between time and group in terms of NRS values for spontaneous pain (p = 0.835), but a significant main effect of group was found, with NRS scores being significantly lower in the lidocaine group than in the placebo group (p = 0.027). There were no adverse events associated with lidocaine use. Conclusions: Lidocaine ointment 10% can alleviate allodynia for two to eight hours after application.