BMC Palliative Care最新文献

Background: Breakthrough cancer pain (BTcP) has a negative impact on patients' quality of life, general activities, and is related to worse clinical outcomes. Fentanyl inhalant is a hand-held combination drug-device delivery system providing rapid, multi-dose (25μg/dose) administration of fentanyl via inhalation of a thermally generated aerosol. This multicenter, randomized, placebo-controlled, multiple-crossover, double-blind study evaluated the efficacy, safety, and tolerability of fentanyl inhalant in treating BTcP in opioid-tolerant patients.

Methods: The trial was conducted in opioid-tolerant cancer patients with 1 ~ 4 BTcP outbursts per day. Each patient was treated and observed for 6 episodes of BTcP (4 with fentanyl inhalant, 2 with placebo). During each episode of targeted BTcP, patients were allowed up to six inhalations, with an interval of at least 4 min between doses. Primary outcome was the time-weighted sum of PID (pain intensity difference) scores at 30 min (SPID30).

Results: A total of 335 BTcP episodes in 59 patients were treated. The mean SPID30 was -97.4 ± 48.43 for fentanyl inhalant-treated episodes, and -64.6 ± 40.25 for placebo-treated episodes (p < 0.001). Significant differences in PID for episodes treated with fentanyl inhalant versus placebo was seen as early as 4 min and maintained for up to 60 min. The percentage of episodes reported PI (pain intensity) scores ≤ 3, a ≥ 33% or ≥ 50% reduction in PI scores at 30 min, PR30 (pain relief scores at 30 min) and SPID60 favored fentanyl inhalant over placebo. Only 4.4% of BTcP episodes required rescue medication in fentanyl inhalant group. Most AEs were of mild or moderate severity and typical of opioid drugs.

Conclusion: Treatment with fentanyl inhalant was shown to be a promising therapeutic option for BTcP, with significant pain relief starting very soon after dosing. Confirmation of effectiveness requires a larger phase III trial.

Trial registration: ClinicalTrials.gov: NCT05531422 registered on 6 September 2022 after major amendment, NCT04713189 registered on 14 January 2021.

Background: Emerging randomized data, mostly from phase II trials, have suggested that patients with oligometastatic cancers may benefit from ablative treatments such as stereotactic ablative radiotherapy (SABR). However, phase III data testing this paradigm are lacking, and many studies have examined SABR in the setting of metachronous oligometastatic disease. The goal of the SABR-SYNC trial is to assess the effect of SABR in patients with oligometastatic cancers and a synchronous primary tumor.

Methods: One hundred and eighty patients will be randomized in a 1:2 ratio between standard of care (SOC) palliative-intent treatments vs. SOC + ablative therapy (SABR preferred) to all sites of known disease. Randomization will be stratified based on histology and number of metastases at enrollment. SABR may be delivered in 1-, 3- and 5-fraction regimens, with recommended doses of 20 Gy, 30 Gy, and 35 Gy, respectively. Non-SABR local modalities (e.g. surgery, thermal ablation, conventional radiation) may be used for treatment of the primary or metastases at the discretion of the treating physicians, if those modalities are clinically preferred. The primary endpoint is overall survival, and secondary endpoints include progression-free survival, time to development of new metastatic lesions, time to initiation of next systemic therapy, quality of life, and toxicity. Translational endpoints include assessment of circulating tumor DNA and immunological predictors of outcomes.

Discussion: SABR-SYNC will provide phase III data to assess the impact of SABR on overall survival in a population of patients with synchronous oligometastases. The translational component will attempt to identify novel prognostic and predictive biomarkers to aid in clinical decision making.

Trial registration: Clinicaltrials.gov NCT05717166 (registration date: Feb. 8, 2023).

Background: Deprescribing has been defined as the planned process of reducing or stopping medications that may no longer be beneficial or are causing harm, with the goal of reducing medication burden while improving patient quality of life. At present, little is known about the specific challenges of decision-making to support deprescribing for patients who are accessing palliative care. By exploring the perspectives of healthcare professionals, this qualitative study aimed to address this gap, and explore the challenges of, and potential solutions to, making decisions about deprescribing in a palliative care context.

Methods: Semi-structured interviews were conducted with healthcare professionals in-person or via video call, between August 2022 - January 2023. Perspectives on approaches to deprescribing in palliative care; when and how they might deprescribe; and the role of carers and family members within this process were discussed. Interviews were audio-recorded and transcribed verbatim. Reflexive thematic analysis enabled the development of themes. QSR NVivo (Version 12) facilitated data management. Ethical approval was obtained from the NHS Health Research Authority (ref 305394).

Results: Twenty healthcare professionals were interviewed, including: medical consultants, nurses, specialist pharmacists, and general practitioners (GPs). Participants described the importance of deprescribing decision-making, and that it should be a considered, proactive, and planned process. Three themes were developed from the data, which centred on: (1) professional attitudes, competency and responsibility towards deprescribing; (2) changing the culture of deprescribing; and (3) involving the patient and family/caregivers in deprescribing decision-making.

Conclusions: This study sought to explore the perspectives of healthcare professionals with responsibility for making deprescribing decisions with people accessing palliative care services. A range of healthcare professionals identified the importance of supporting decision-making in deprescribing, so it becomes a proactive process within a patient's care journey, rather than a reactive consequence. Future work should explore how healthcare professionals, patients and their family can be supported in the shared decision-making processes of deprescribing.

Trial registration: Ethical approval was obtained from the NHS Health Research Authority (ref 305394).

Background: Pediatric palliative care (PPC) patients are at an elevated risk of malnutrition. Nutritional inadequacy can also cause micronutrient deficiencies. These factors can lead to weight loss, stunted growth, and poor quality of life. Despite the prevalence of these issues, limited research exists in the micronutrient status of PPC patients. The purpose of this study was to determine the vitamin B12 and D, iron, ferritin, folate, calcium, phosphorus, and magnesium levels of PPC patients to contribute to a better understanding of their micronutrient needs as well as the appropriate management of diet and treatment approaches.

Methods: This was a single-center observational cross-sectional retrospective study. This study evaluated the levels of vitamin B12, 25-hydroxyvitamin D, iron, ferritin, folate, calcium, phosphorus, and magnesium in PPC patients. The patients were classified according to the Chronic Complex Conditions (CCC) v2 and then compared.

Results: A total of 3,144 micronutrient data points were collected from 822 hospitalizations of 364 patients. At least one micronutrient deficiency was identified in 96.9% of the patients. The most prevalent deficiencies were observed for iron, calcium, and phosphate. In addition, 25-hydroxyvitamin D deficiency was observed in one-third of patients. Calcium, magnesium, phosphorus, folate, and 25-hydroxyvitamin D were negatively correlated with age.

Conclusion: The results of this study indicate that micronutrient deficiencies are highly prevalent in PPC patients. These findings have the potential to contribute to improvements in the nutritional and therapeutic management of patients.

Background: While home is frequently expressed as the favorite place of death (PoD) among terminally ill cancer patients, various factors affect the fulfillment of this wish. The determinants of the PoD of cancer patients in countries without healthcare system-integrated palliative and supportive care have not been studied before. This study aimed at identifying the predictors of the PoD of patients who suffer from advanced cancer by developing a reliable predictive model among who received home-based palliative care in Iran as a representative of the countries with isolated provision of palliative care services.

Methods: In a cross-sectional study, electronic records of 4083 advanced cancer patients enrolled in the Iranian Cancer Control Center (MACSA) palliative homecare program, who died between February 2018 and February 2020 were retrieved. Multivariable binary logistic regression analysis as well as subgroup analyses (location, sex, marital status, and tumor topography) was performed to identify the predictors of PoD.

Results: Of the 2398 cases included (mean age (SD) = 64.17 (14.45) year, 1269 (%52.9) male), 1216 (50.7%) patients died at home. Older age, presence and intensity of medical homecare in the last two weeks and registration in the Tehran site of the program were associated with dying at home (P < 0.05). Gynecological or hematological cancers, presence and intensity of the calls received from the remote palliative care unit in the last two weeks were predictors of death at the hospital (p < 0.05). The model was internally and externally validated (AUC = 0.723 (95% CI = 0.702-0.745; P < 0.001) and AUC = 0.697 (95% CI = 0.631-0.763; P < 0.001) respectively).

Conclusion: Our model highlights the demographic, illness-related and environmental determinants of the PoD in communities with patchy provision of palliative care. It also urges policymakers and service providers to identify and take the local determinant of the place of death into account to match the goals of palliative and supportive services with the patient preferences.