BACKGROUND: As the global population ages, palliative care is ever more essential to provide care for patients with incurable chronic conditions. However, in many countries, doctors are not prepared to care for dying patients. Palliative care education should be an urgent concern for all medical schools all around the world, including Latin America and Brazil. Advances in palliative care education require robust assessment tools for constant evaluation and improvement of educational programmes. Bandura's social cognitive theory proposes that active learning processes are mediated by self-efficacy and associated outcome expectancies, both crucial elements of developing new behaviour. The Self-Efficacy in Palliative Care (SEPC) and Thanatophobia Scales were developed using Bandura's theory to assess the outcomes of palliative care training.
OBJECTIVES: We aimed to translate and validate these scales for Brazilian Portuguese to generate data on how well doctors are being prepared to meet the needs of their patients.
DESIGN: Cross-sectional study.
SETTING: One Brazilian medical school.
PARTICIPANTS: Third-year medical students.
METHODS: The authors translated the scales following the European Organisation for Research and Treatment of Cancer's recommendations and examined their psychometric properties using data collected from a sample of 111 students in a Brazilian medical school in 2017.
RESULTS: The Brazilian versions of SEPC and Thanatophobia Scales showed good psychometric properties, including confirmatory factor analysis, replicating the original factors (factor range: 0.51-0.90), and acceptable values of reliability (Cronbach's alpha: 0.82-0.97 and composite reliability: 0.82-0.96). Additionally, the Brazilian versions of the scales showed concurrent validity, demonstrated through a significant negative correlation.
CONCLUSIONS: The Brazilian version of the scales may be used to assess the impact of current undergraduate training and identify areas for improvement within palliative care educational programmes. The data generated allow Brazilian researchers to join international conversations on this topic and educators to develop tailored pedagogical approaches.
Purpose: To determine the efficacy of specifically targeted interventions in palliative care, sequential use of the Demoralization Scale (DS) could be a useful approach. This study’s main objective was to evaluate the weekly use of the DS for palliative care inpatients. Secondary objectives were the analysis of the DS, self-perceived strain, and personal benefits of the assessment.
Methods: Patients admitted to 3 palliative care units (PCUs) were tested for eligibility and asked to complete the DS weekly. Self-perceived strain was rated on a numeric scale (0–10). Open questions about strain and helpfulness of the survey were asked.
Results: Over 10 months, 568 patients were admitted to the PCUs; 193 patients were eligible. A total of 120 patients participated once, of whom only 41 (34.1%) participated at least twice. The mean self-perceived strain caused by the assessment was 1.53 at T1 (N = 117, SD = 2.27, max = 8).
Conclusions: While the single use of the DS in PCUs seems justified in view of the possibility to detect severe demoralization with overall low to moderate strain and self-perceived helpfulness for patients, the feasibility of the sequential use of the DS has to be regarded critically. Our study undermines the complexity of assessing changes in self-reported psychological phenomena with end-of-life patients at a PCU. The most limiting factors for participating twice were that patients were either discharged from hospital or declined further participation.
Background: Frailty is a natural consequence of the aging process. With the increasing aging population in Mainland China, the quality of life and end-of-life care for frail older people need to be taken into consideration. Advance Care Planning has also been used worldwide in long-term facilities, hospitals and communities to improve the quality of end-of-life care, increase patient and family satisfaction, and reduce healthcare costs and hospital admissions in Western countries. However, it has not been practiced in China.
Research objective: This study aimed to evaluate the effectiveness of a modified Advance Care Planning intervention in certainty of end-of-life care, preferences for end-of-life care, quality of life concerns, and healthcare utilization among frail older people.
Research design: This study used a quasi-experimental design, with a single-blind, control group, pretest and repeated posttest approach.
Participants and research context: A convenience sample of 74 participates met the eligibility criteria in each nursing home. A total of 148 frail older people were recruited in two nursing homes in Zhejiang Province, China.
Ethical considerations: The study received ethical approval from the Clinical Research Ethics Committee, the Faculty of Medicine, and The Chinese University of Hong Kong, CREC Ref. No: 2016.059.
Findings: The results indicated the Advance Care Planning programme was effective at increasing autonomy in decision making on end-of-life care issues, decreasing decision-making conflicts over end-of-life care issues, and increasing their expression about end-of-life care.
Discussion: This study promoted the participants’ autonomy and broke through the inherent custom of avoiding talking about death in China.
Conclusion: The modified Advance Care Planning intervention is effective and recommended to support the frail older people in their end-of-life care decision in Chinese society.
Introduction : En France, la méthadone est autorisée uniquement comme traitement de substitution. Elle peut être utilisée pour les douleurs liées au cancer. Le but de cette étude est d’évaluer l’efficacité et les effets secondaires de la méthadone dans cette indication.
Méthode : Il s’agit d’une étude rétrospective de janvier 2010 à février 2011, incluant tous les patients recevant de la méthadone pour la première fois. Le soulagement était considéré comme obtenu si l’intensité de la douleur était inférieure ou égale à 3/10 sur l’échelle d’évaluation numérique (EN) ou inférieure ou égale à 30/100 sur une échelle visuelle analogique (Eva), à j7 et j28. Les effets secondaires et leur persistance ont été explorés pendant l’instauration, à j7 et j28.
Résultats : Vingt-deux patients ont été inclus. Vingt patients ont été évalués au 7e jour, dix-huit patients à 28e. À j7, seize patients (80 %) étaient soulagés et onze (61 %) au 28e jour. Peu de patients ont présenté des effets indésirables : 8 patients (40 %) à j7 et 3 (16,7 %) à j28.
Conclusion : La méthadone est un traitement utile contre la douleur cancéreuse, en particulier pour la douleur cancéreuse rebelle et complexe.
BACKGROUND: Bereavement support is a key component of palliative care, with different types of support recommended according to need. Previous reviews have typically focused on specialised interventions and have not considered more generic forms of support, drawing on different research methodologies.
AIM: To review the quantitative and qualitative evidence on the effectiveness and impact of interventions and services providing support for adults bereaved through advanced illness.
DESIGN: A mixed-methods systematic review was conducted, with narrative synthesis of quantitative results and thematic synthesis of qualitative results. The review protocol is published in PROSPERO ( www.crd.york.ac.uk/prospero , CRD42016043530).
DATA SOURCES: The databases MEDLINE, Embase, PsycINFO, CINAHL and Social Policy and Practice were searched from 1990 to March 2019. Studies were included which reported evaluation results of bereavement interventions, following screening by two independent researchers. Study quality was assessed using GATE checklists.
RESULTS: A total of 31 studies were included, reporting on bereavement support groups, psychological and counselling interventions and a mix of other forms of support. Improvements in study outcomes were commonly reported, but the quality of the quantitative evidence was generally poor or mixed. Three main impacts were identified in the qualitative evidence, which also varied in quality: 'loss and grief resolution', 'sense of mastery and moving ahead' and 'social support'.
CONCLUSION: Conclusions on effectiveness are limited by small sample sizes and heterogeneity in study populations, models of care and outcomes. The qualitative evidence suggests several cross-cutting benefits and helps explain the impact mechanisms and contextual factors that are integral to the support.
Background: o randomized controlled trials (RCT) have yet identified the optimal palliative radiotherapy scheme in patients with incurable head and neck squamous cell carcinoma (HNSCC). We conducted RCT to compare two radiation schemes in terms of efficacy, toxicity and quality-of-life (QoL).
Materials and methods: Patients with locally-advanced HNSCC who were ineligible for radical treatment and those with limited metastatic disease were randomly assigned in 1:1 ratio to arm 1 (36 Gy in 6 fractions, twice a week) or arm 2 (50 Gy in 16 fractions, four times a week).
Results: The trial was discontinued early because of slow accrual (34 patients enrolled). Objective response rates were 38.9% and 57.1% for arm 1 and 2 respectively (p = 0.476). The median time to loco-regional progression was not reached. The loco-regional control rates at 1 year was 57.4% and 69.3% in arm 1 and 2 (p = 0.450, HR = 0.56, 95%CI 0.12–2.58). One-year overall survival was 33.3% and 57.1%, with medians of 35.4 and 59.5 weeks, respectively (p = 0.215, HR = 0.55, 95%CI 0.21–1.43). Acute grade =3 toxicity was lower in arm 1 (16.7% versus 57.1%, p = 0.027), with the largest difference in grade 3 mucositis (5.6% versus 42.9%, p = 0.027). However, no significant deterioration in any of the patient-reported QoL-scales was found.
Conclusion: No solid conclusion could be made on this incomplete study which is closed early. Long-course radiotherapy did not show significantly better oncologic outcomes, but was associated with more acute grade 3 mucositis. No meaningful differences in QoL-scores were found. Therefore, the shorter schedule might be carefully advocated. However, this recommendation should be interpreted with great caution because of the inadequate statistical power.
BACKGROUND: End of life care is often inadequate for people with dementia. Advanced care planning (ACP) has the potential to improve outcomes for people with dementia. The aim of this review is to establish the strength of the evidence and provide decision makers with a clear understanding of what is known about ACP for people living with dementia.
DESIGN: Evidence synthesis including systematic reviews and primary studies. PROSPERO registration: CRD42018107718.
DATA SOURCES: PubMed, CINAHL Plus, SCOPUS, Social Care Online and Cochrane Library were searched (July 2018). No year limit applied. To be included, reviews had to evaluate effectiveness of ACP for people with dementia or report on views and experiences of ACP from the perspective of people with dementia, carers, or health and care professionals. Additional searches (September 2018) were conducted to identify recent primary studies not included in the reviews.
REVIEW METHODS: Data extraction was undertaken by one reviewer and checked by a second. Methodological quality was assessed using AMSTAR-2 and Joanna Briggs Institute instruments by two authors independently. Outcomes were categorized and tabulated to assess effectiveness. Qualitative data was analysed using thematic synthesis.
RESULTS: Nineteen reviews (163 unique studies) and 11 primary articles with a range of advance care planning definitions and of variable quality were included. Advance care planning was associated with decreased hospitalizations, increased concordance between care received and prior wishes and increased completion of advance care planning documents but quality of primary research was variable. Views of ACP for people with dementia can be clustered around six themes; 1) timing and tailoring, 2) willingness to engage, 3) roles and responsibilities of healthcare professionals, 4) relationships, 5) training and 6) resources needed. Diminishing decision-making capacity over time is a key overarching feature.
CONCLUSIONS: Advance care planning is acceptable for people with dementia and their carers and is associated with improved outcomes. Guidelines on which outcomes and which definition to use are necessary, as is research to test different approaches to ACP. Education on topics related to diminishing decision-making capacity is key to optimize advance care planning for people with dementia and their carers.
Background: Nurses are involved in providing end-of-life care for end stage individuals and their self-efficacy is one of the key factors bearing on such care. The purpose of this study was to determine the effect of palliative care on perceived self-efficacy of the nurses.
Methods: this is a quasi-experimental study with pretest-posttest design. Sampling was randomized and included 40 individuals. The intervention consisted of palliative care training for four sessions, each lasting 45 min. Data were collected using demographic and perceived self-efficacy questionnaires completed before and after the intervention. Data were then analyzed by SPSS 16 software using descriptive and inferential statistics.
Results: The mean age of the participants was 38.6 and their work experience was 14.25 years. The majority of the participants were female (85%) and had a bachelor level of education (92.5%). The findings showed that “perceived self-efficacy”, “psychosocial support” and “symptom management” improved significantly after intervention (p < 0.05).
Conclusion: Based on the results, palliative care education has the potential to increase nurses’ perceived self-efficacy. Since all members of the health care team Including nurses play an important role in providing palliative care, nursing managers can take an effective step to maximize the capacity of nurses by planning and supporting training in this regard.
BACKGROUND: Patients with advanced cancer, receiving at-home palliative care, are subject to numerous symptoms that are changeable and often require attention, a stressful situation that also impacts on the family caregiver. It has been suggested that music therapy may benefit both the patient and the caregiver. We propose a study to analyse the efficacy and cost utility of a music intervention programme, applied as complementary therapy, for cancer patients in palliative care and for their at-home caregivers, compared to usual treatment.
METHOD: A randomised, double-blind, multicentre clinical trial will be performed in cancer patients in at-home palliative care and their family caregivers. The study population will include two samples of 40 patients and two samples of 41 caregivers. Participants will be randomly assigned either to the intervention group or to the control group. The intervention group will receive a seven-day programme including music sessions, while the control group will receive seven sessions of (spoken word) therapeutic education. In this study, the primary outcome measure is the assessment of patients' symptoms, according to the Edmonton Symptom Assessment System, and of the overload experienced by family caregivers, measured by the Caregiver Strain Index. The secondary outcomes considered will be the participants' health-related quality of life, their satisfaction with the intervention, and an economic valuation.
DISCUSSION: This study is expected to enhance our understanding of the efficacy and cost-utility of music therapy for cancer patients in palliative care and for their family caregivers. The results of this project are expected to be applicable and transferrable to usual clinical practice for patients in home palliative care and for their caregivers. The approach described can be incorporated as an additional therapeutic resource within comprehensive palliative care. To our knowledge, no previous high quality studies, based on a double-blind clinical trial, have been undertaken to evaluate the cost-effectiveness of music therapy. The cost-effectiveness of the project will provide information to support decision making, thereby improving the management of health resources and their use within the health system.
IMPORTANCE: Underutilization of hospice occupational therapy may be attributable to a lack of evidence on efficacy.
OBJECTIVE: To conduct a scoping review of occupational therapy outcome studies to ascertain how efficacy is captured in the literature.
DATA SOURCES: PubMed, CINAHL, MEDLINE, Scopus, Directory of Open Access Journals, Web of Science, OT Search, and Google Scholar.
STUDY SELECTION AND DATA COLLECTION: Search terms: hospice, palliative care, occupational therapy, rehabilitation, outcome measure, and assessment. Inclusion criteria: research studies in English, centered on adult hospice care, published between January 1997 and September 2017, and investigated occupational therapy efficacy with an outcome measure. Exclusion criteria: systematic reviews, participants not at terminal disease end stages, or intervention program reviews lacking differentiated occupational therapy outcomes.
FINDINGS: Seven articles met the inclusion criteria. Findings include frequent use of noncontrolled, quasi-experimental, prospective research designs; a focus on occupational performance; and no generally accepted hospice occupational therapy outcome measure.
CONCLUSION AND RELEVANCE: Outcome measures of participation in end-of-life occupations and environmental influences on occupational engagement are needed to effectively support occupational therapy practice and research with people who are terminally ill.
WHAT THIS ARTICLE ADDS: Occupational therapy in end-of-life care is growing in complexity yet remains low in utilization. This review adds insights into current practice and future research foci for the profession.
PURPOSE: Single-port laparoscopic techniques can be optimized with confined incisions. This approach has an intraoperative advantage of excellent visualization of the correct intestinal segment for exteriorization, along with direct visual control of the extraction to avoid twisting. However, only a few studies have verified the efficacy of the technique. Thus, this study assessed the results of single-port laparoscopic stoma creation for fecal diversion, specifically focusing on feasibility, safety, and efficacy.
METHODS: Patients who underwent single-incision enterostomy performed by a single surgeon were included. Data on demographics, indications for and chosen procedure, and operation results were retrospectively collected and analyzed.
RESULTS: Between April 2015 and January 2018, a total of 13 patients (8 males, 5 females) with a mean age of 57.7 years (range, 41-83 years) underwent single-port ileostomy creation. The most common reason for diversion was palliative ileostomy for colon obstruction or fistula from peritoneal malignancy (n = 12), followed by colonic fistula with necrotizing pancreatitis (n = 1). There were no cases of conversion to open or multiport laparoscopic surgery. The mean operative time was 54 minutes (range, 37-118 minutes), and the median length of hospital stay was 8 days (range, 2-211 days). A postoperative complication, aspiration pneumonia, was documented in 1 patient and treated conservatively. The mean duration of bowel movement was 0.7 days (range, 0-4 days). All stomas had good function, and there was no 30-day mortality.
CONCLUSION: Single-port laparoscopic ileostomy in patients with a palliative setting could be a safe and feasible option for fecal diversion.
OPINION STATEMENT: As palliative care (PC) continues its rapid growth, an emerging body of evidence is demonstrating that its approach of interdisciplinary supportive care benefits many patient populations, including in the oncology setting. As studies and data proliferate, however, questions persist about who, what, why, when, and how PC as well as the ideal time for a PC consult and length of involvement. When comparing outcomes from chemotherapy trials, it is important to consider the dosing regimens used in the various studies. In the same way, it is important to account for the "dose" of the PC interventions utilized across studies, and apples to apples comparisons are needed in order to draw accurate conclusions about PC's benefits. Studies which include a true interdisciplinary PC intervention consistently show improvements in patient quality of life, as well as cost savings, with further study needed for other outcomes. These benefits cannot be extrapolated to care which may be labeled "palliative care," but which does not meet the standard of true interdisciplinary PC. The ultimate question is: Does PC indeed improve outcomes?
BACKGROUND: In the absence of randomized controlled trials, real-world evidence may aid practitioners in optimizing the selection of therapy for patients with cancer. The study's aim was to determine real-word use, as well as compare effectiveness, of single-agent and combination chemotherapy as palliative treatment for female patients with metastatic breast cancer (mBC).
MATERIALS AND METHODS: Using administrative claims data from the Symphony Health's Integrated Oncology Dataverse, female patients with mBC treated with at least one chemotherapy-only treatment (COT) between January 1, 2013, and December 31, 2017 were selected. The frequency of use of single-agent versus combination chemotherapy overall and by line of therapy (LOT) was calculated whereas effectiveness was measured using time to next treatment (TNT).
RESULTS: A total of 12,381 patients with mBC were identified, and 3,777 (31%) received at least one line of COT. Of the 5,586 observed LOTs among the 3,777 patients, 66.5% were single-agent and 33.5% combination chemotherapy. Combination chemotherapy was most frequently used in first-line (45%) and least frequently in fifth-line (16%). Across all LOTs, median TNT was significantly longer for single-agent versus combination chemotherapy (5.3 months vs. 4.1 months, p < .0001). Comparison of median TNT by LOT showed significance in third-line and greater but not in first-line or second-line. Among single agents, the median TNT for patients receiving capecitabine was longest in comparison to all other single agents.
CONCLUSIONS: The frequency of combination COT use, particularly in first-line, warrants further research given published guideline recommendations. The observed TNT difference favoring single-agent treatment in later lines supports guideline recommendations. Variance between single-agent preference and observed TNT was noteworthy.
IMPLICATIONS FOR PRACTICE: Although published data from evidence- and consensus-based guidelines recommend single-agent over combination chemotherapy, the extensive list of agents available for use and a gap in the comparative effectiveness research of these agents have resulted in significant variances in patterns of care. The aim of this study was to assess real-world treatment patterns and their effectiveness during palliative therapy of metastatic breast cancer. The objective was to understand when and how chemotherapy-only treatment is used in metastatic breast cancer and whether comparative effectiveness analysis supports the observed patterns of care.
Hiccup is a recognised symptom amongst the palliative care population. It can be debilitating, with significant impact on quality of life. The pathophysiology is poorly understood and the list of aetiological factors is extensive. The current treatment recommendations are based on a small body of evidence and there remains uncertainty regarding optimal management. The aim of this study was to systematically review the evidence for oral baclofen in the management of hiccups in adult palliative care patients. A search was conducted using MEDLINE, Embase, the Cochrane library and CINAHL, as well as a hand search and review of the grey literature. Relevant articles were identified using pre-defined eligibility criteria. Quality assessment was guided by the SIGN grading system, CASP, Hawker et al's checklist and Cochrane's risk of bias tool. A narrative approach was used for data synthesis. Four relevant articles were identified; one randomised controlled trial and three case series. This gave a combined total of 22 patients, all of whom benefited from the use of oral baclofen in the treatment of hiccups, with few reports of side effects. The dose ranged from 10mg once only to 20mg TDS, and the duration from 1-24 days. However, the overall quality of the evidence was low. While baclofen is an option in the management of hiccups, it is difficult to make recommendations based on the body of evidence presented in this systematic review. There is a lack of RCTs in this field and further research is warranted.
Advance care planning (ACP) enables individuals to think ahead and define their goals and preferences for future treatment and care. Such a process has been shown to have a positive impact on both the indivdual and those close to them, and is widely considered to be an integral part of best practice long-term care. Implementation in daily nursing home practice however still seems to be a challenge, and research has failed to provide recommendations on how to implement ACP successfully in the complex setting of a nursing home. Effectiveness research has therefore been recommended to go beyond "does it work?" to "how and under what circumtances does it work?".
Towards successfull advance care planning in nursing homes was written as a Joint PhD dissertation and explores how to implement advance care planning successfully in nursing homes. Through the theory-based development and evaluation of a complex intervention, using qualitative and quantitative research methods, this work aims to contribute to improving advance care planning in routine nursing home care in Flanders, Belgium.
Chronic obstructive pulmonary disease (COPD) is common chronic respiratory disorder, predominantly caused by exposure to cigarette smoke or biomass fuels, and it usually affects older adults. Dyspnea in COPD that is unresponsive to traditional management is a challenging disease complication for both the patient and the health care professional. Off-label use of opioids has been advocated as a pharmacotherapy strategy for refractory dyspnea. However, negative respiratory outcomes are a potential concern with opioids drugs, especially among individuals with COPD. In this review, randomized controlled trials evaluating opioid efficacy among individuals with COPD are reviewed and critically analyzed, and data from observational drug safety studies is also presented. In summary, the evidence in support of using opioids for refractory dyspnea in COPD is minimal and weak, and there is mounting data demonstrating that opioids are associated with increased respiratory-related morbidity and mortality in this population. Therefore, current evidence does not support the broad application of opioids for refractory dyspnea among individuals with COPD. However, there may be subsets of individuals that experience modest improvement in dyspnea with opioids, and better understanding predictors and mechanisms of such opioid responsiveness should be a focus of future research endeavours.
The aim of the present study is to validate the Self-Efficacy in Palliative Care Scale (SEPC) in Spanish nursing professionals and students, to describe their levels of self-efficacy, and to determine the influencing factors. A validation study and a cross-sectional descriptive study were carried out, with the data analysed using contrast tests and multiple linear regression; 552 nurses and 440 nursing students participated. The Spanish version consists of 23 items and has a high degree of reliability (a = 0.944). Confirmatory factor analysis revealed one additional factor (i.e., management of psychosocial and spiritual aspects) in comparison to the original scale. Contrast tests revealed that the mean SEPC score was higher in professionals than in students (p < 0.001) and that the professionals who had higher levels of self-efficacy were older (p < 0.001), had more previous training (p < 0.001), and had more experience in end-of-life care (p = 0.001). The linear analysis results confirm a significant association between age and previous training in end-of-life care. The Spanish version of the SEPC is a reliable tool for both nursing professionals and students. The level of self-efficacy of both groups is moderate and is influenced by age, experience, and training in end-of-life care.
Background: In health care, clinical effectiveness involves evaluating the degree to which clinical interventions achieve beneficial patient and caregiver outcomes.
Objective: To evaluate the clinical effectiveness of care in a specialist palliative care unit (SPCU) in Ireland, including an analysis of the temporal relationship among admission, Phase of Illness and patient and family distress.
Design/Measurements: A consecutive case series with prospectively collected admission data (n = 400). Using a casemix tool (Phase of Illness), pain, other symptoms, psychological and family distress, and performance status were documented on admission and then daily by medical staff.
Results: Three hundred forty-two (85%) patients had complete data recorded on day 1. After admission, there were linear correlations between days since admission and progressive improvements in pain (Cramer's V = 0.131, p < 0.001), other symptoms (V = 0.206, p < 0.001), psychological distress (V = 0.101, p < 0.001), and family distress (V = 0.124, p < 0.001). Forty-three percent were in an unstable phase on admission. Nearly two thirds (60.7%) of these unstable patients converted to a stable phase within 48 hours of admission. Over the first 72 hours, 70.7% of unstable patients converted to a stable phase. There was also a significant correlation between phase stabilization and pain and symptom control (p = 0.007). Stable phase over the first 4 days and first 14 days was associated with significantly higher performance status.
Conclusion: This study demonstrates the significant clinical effectiveness of SPCU admission across the different aspects of patient and family care.
Background: Treatment of delirium often includes haloperidol. Second-generation antipsychotics like olanzapine have emerged as an alternative with possibly fewer side effects. The aim of this multicenter, phase III, randomized clinical trial was to compare the efficacy and tolerability of olanzapine with haloperidol for the treatment of delirium in hospitalized patients with advanced cancer.
Materials and Methods: Eligible adult patients (=18 years) with advanced cancer and delirium (Delirium Rating Scale-Revised-98 [DRS-R-98] total score =17.75) were randomized 1:1 to receive either haloperidol or olanzapine (age-adjusted, titratable doses). Primary endpoint was delirium response rate (DRR), defined as number of patients with DRS-R-98 severity score <15.25 and =4.5 points reduction. Secondary endpoints included time to response (TTR), tolerability, and delirium-related distress.
Results: Between January 2011 and June 2016, 98 patients were included in the intention-to-treat analysis. DRR was 45% (95% confidence interval [CI], 31–59) for olanzapine and 57% (95% CI, 43–71) for haloperidol ( DRR -12%; odds ratio [OR], 0.61; 95% CI, 0.2–1.4; p = .23). Mean TTR was 4.5 days (95% CI, 3.2–5.9 days) for olanzapine and 2.8 days (95% CI, 1.9–3.7 days; p = .18) for haloperidol. Grade =3 treatmen-related adverse events occurred in 5 patients (10.2%) and 10 patients (20.4%) in the olanzapine and haloperidol arm, respectively. Distress rates were similar in both groups. The study was terminated early because of futility.
Conclusion: Delirium treatment with olanzapine in hospitalized patients with advanced cancer did not result in improvement of DRR or TTR compared with haloperidol. Clinical trial identification number. NCT01539733. Dutch Trial Register. NTR2559.
Implications for Practice: Guidelines recommend that pharmacological interventions for delirium treatment in adults with cancer should be limited to patients who have distressing delirium symptoms. It was suggested that atypical antipsychotics, such as olanzapine, outperform haloperidol in efficacy and safety. However, collective data comparing the efficacy and safety of typical versus atypical antipsychotics in patients with cancer are limited. If targeted and judicious use of antipsychotics is considered for the treatment of delirium in patients with advanced cancer, this study demonstrated that there was no statistically significant difference in response to haloperidol or olanzapine. Olanzapine showed an overall better safety profile compared with haloperidol, although this difference was not statistically significant.