Journal of palliative medicine
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Randomized Controlled Trial
A Palliative Care Intervention for Patients on Phase 1 Studies.
Background: Phase 1 clinical trials remain vital for oncology care. Patients on these trials require supportive care for quality-of-life (QOL) concerns. Objective: To test a Palliative Care Intervention (PCI) for patients with solid tumors enrolled in Phase I therapeutic trials with a priori hypothesis that psychological distress, QOL, satisfaction, symptoms, and resource utilization would be improved in the PCI group. ⋯ Conclusions: A nurse-delivered PCI can improve some QOL outcomes and distress for patients participating in Phase 1 trials. Greater integration of PC is needed to provide quality care to these patients and to support transitions from treatment to supportive care, especially at the end of life. ClinicalTrials.gov Identifier: NCT01612598.
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Randomized Controlled Trial
Randomized Clinical Trial of a Legacy Intervention for Quality of Life in Children with Advanced Cancer.
Background: Legacy-making (actions/behaviors aimed at being remembered) may be a significant component for quality of life (QOL) during advanced illness and end of life. Although legacy interventions have been tested in adults, the impact of legacy activities on QOL for children has yet to be clearly defined. Objective: This study examined the impact of our newly developed web-based legacy intervention on dimensions of QOL among children (7-17 years old) with advanced cancer. ⋯ Overall, this is a null study that warrants discussion on possible reasons for limited findings. Future legacy intervention research is needed using qualitative and quantitative methods, as well as child and parent reports, to determine how such services may improve dimensions of QOL for pediatric palliative care populations. ClinicalTrials.gov number NCT04059393.
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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
The Development of the Australian National Palliative Care Clinical Studies Collaborative "Integrating Qualitative Research into Clinical Trials Framework".
Qualitative methodologies have multiple contributions to health research, including improving baseline understanding in new areas of enquiry; questioning existing assumptions; understanding viewpoints of specific subgroups; and offering complex, contextual information. While the role of qualitative research within mixed methods approaches is well documented, the contribution to clinical trial design and conduct is less well recognized. ⋯ This practical framework provides real-world examples, including sample qualitative questions, to consider at each phase of controlled clinical trial development. As the number of randomized clinical trials in palliative care increases, a readily accessible approach to integrating qualitative research into clinical trial design and conduct is needed so that its full potential for improving study recruitment, conduct, outcomes, interpretation, and implementation may be realized.
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Randomized Controlled Trial
Evaluation of a Novel Educational Intervention to Improve Conversations About Implantable Cardioverter-Defibrillators Management in Patients with Advanced Heart Failure.
Background: Implantable cardioverter-defibrillators (ICDs) reduce the incidence of sudden cardiac death for high-risk patients with heart failure (HF), but shocks from these devices can also cause pain and anxiety at the end of life. Although professional society recommendations encourage proactive discussions about ICD deactivation, clinicians lack training in conducting these conversations, and they occur infrequently. Methods: As part of a six-center randomized controlled trial, we evaluated the educational component of a multicomponent intervention shown to increase conversations about ICD deactivation by clinicians who care for a subset of patients with advanced HF. ⋯ Preworkshop scores showed high baseline levels of confidence (4.36, standard deviation [SD] = 0.70) and skill (4.08, SD = 0.72), whereas comparisons of pre- and postworkshop scores showed nonsignificant decreases in confidence (-1.16, p = 0.252) and skill (-0.20, p = 0.843) after the training session. Conclusions: Our findings showed no significant changes in self-assessment ratings immediately after the educational intervention. However, our data did demonstrate that HF clinicians had high baseline self-perceptions of their skills in advance care planning conversations and appear to be well-primed for further professional development to improve communication in the setting of advanced HF.