An economic evaluation of an early palliative care intervention among patients with advanced cancer.

BACKGROUND: Early integration of palliative care into oncology care has shown positive effects on patient symptoms and quality of life. It may also reduce health care costs. However given the heterogeneity of settings and interventions and the lack of information on the minimally effective dose for influencing care utilisation and costs, it remains uncertain whether early palliative care reduces costs. OBJECTIVES: We sought to determine whether an early palliative care intervention integrated in usual oncology care in a Swiss hospital setting reduced utilisation and costs of health care in the last month of life when compared with usual oncology care alone. METHODS: We performed a cost-consequences analysis alongside a multicentre trial. We extracted costs from administrative health insurance data and health care utilisation from family caregiver surveys to compare two study arms: usual oncology care and usual oncology care plus the palliative care intervention. The intervention consisted of a single-structured, multiprofessional conversation with the patient about symptoms, end-of-life decisions, network building and support for carers (SENS). The early palliative care intervention was performed within 16 weeks of the diagnosis of a tumour stage not amenable or responsive to curative treatment. RESULTS: We included 58 participants with advanced cancer in our economic evaluation study. Median overall health care costs in the last month of life were 7892 Swiss Francs (CHF) (interquartile range: CHF 5637-13,489) in the intervention arm and CHF 8492 [CHF 5411-12,012] in the control arm. The average total intervention treatment cost CHF 380 per patient. Integrating an early palliative care intervention into usual oncology care showed no significant difference in health care utilisation or overall health care costs between intervention and control arms (p = 0.98). CONCLUSION: Although early palliative care is often presented as a cost-reducing care service, we could not show a significant effect of the SENS intervention on health care utilisation and costs in the last month of life. However, it may be that the intervention was not intensive enough, the timeframe too short or the study population too small for measurable effects. Patients appreciated the intervention. Single-structured early palliative care interventions are easy to implement in clinical practice and present low treatment costs. Further research about the economic impact of early palliative care should focus on extracting large, detailed cost databases showing potential shifts in cost and cost-effectiveness. CLINICAL TRIALS: gov Identifier: NCT01983956.

Single early palliative care intervention added to usual oncology care for patients with advanced cancer: A randomized controlled trial (SENS Trial).

BACKGROUND: International oncology societies recommend early palliative care. Specific models to integrate early palliative care efficiently into clinical practice are debated. The authors designed a study to look at the quantitative and qualitative outcomes of an early palliative care intervention in oncological care to decrease stress and improve quality of life. AIMS: To compare a single structured early palliative care intervention added to a usual oncology care in terms of distress and health-related quality of life at baseline compared to 6 months after enrollment. DESIGN: This multicenter randomized controlled trial (NCT01983956) enrolled adult patients with advanced cancer. Participants were either randomly assigned to usual oncology care alone or usual care plus a structured early palliative care intervention. SETTING/PARTICIPANTS: One hundred fifty adult patients with a variety of advanced cancer diagnoses were randomized. Seventy-four participants were in the intervention and 76 participants in the control group. The primary outcome was the change in patient distress assessed by the National Comprehensive Cancer Network distress thermometer at 6 months. Health-related quality of life, the secondary outcome, was assessed by the Functional Assessment of Cancer Therapy-General Questionnaire. RESULTS: The results showed no significant effect of the early palliative care intervention neither on patient distress nor on health-related quality of life. CONCLUSION: The addition of an early intervention to usual care for patients with advanced cancer did not improve distress or quality of life. Thus, patients may need more intensive early palliative care with continuous professional support to identify and address their palliative needs early.

Early palliative care integration trial: consultation content and interaction dynamics.

OBJECTIVES: Evidence for the positive impact of the early integration of palliative care (EPC) continues to grow. Less is known about how EPC improves patient and family outcomes, including the content of EPC consultations. Therefore, we aimed to better understand the content of EPC consultations including areas addressed, percentage covered per area and interaction style. METHODS: As part of a trial in which EPC in addition to oncology care was compared with oncology care alone, we audio recorded 10 interventions. The palliative care team led the interventions using SENS, a conversation structure, which stands for: Symptoms, End-of-life decision-making, Network and Support. We employed two approaches to analysis: the Roter interaction analysis system (RIAS) to analyse interaction dynamics and SENS as a framework for content analysis. RESULTS: Physician-patient communication covered 91% of the interaction. According to RIAS, the consultations were evenly dominated between physicians and patients (ratio=1.04) and highly patient-centred (ratio=1.26). Content wise, rapport was the largest category covering 27% of the consultation, followed by decision-making (21%) and by symptom assessment/management (17%) including 8.1% for physical symptoms and 5.4% for psychosocial aspects. Network discussions covered 17%, and lastly, support for the family 7%. CONCLUSIONS: EPC consultations cover a variety of end-of-life topics while putting a high value in establishing rapport, developing a relationship with patients, and on providing reassurance and positive emotional talk. EPC consultations using predefined structures may guarantee that a minimum of important aspects are addressed in a way in which the relationship with the patient remains at the centre.

Feelings of Burden in Palliative Care: A Qualitative Analysis of Medical Records.

BACKGROUND: Care for palliative care patients is often provided by unpaid caregivers (eg, family members) who take care of the patient's daily needs (eg, bathing, dressing). Family members of palliative care patients are involved in numerous ways. These tasks and responsibilities can make them feel burdened and even overburdened. AIM: We specifically looked at patients' medical records to determine what is being reported about burden and overburden and who seems to be mostly affected. Burden was understood as a weight or task that is difficult to accept or carry, whereas overburden indicates that this weight or task cannot be carried anymore. METHODS: We looked at 300 medical records of palliative care patients written by health-care professionals. Written notes were analyzed using latent content analysis as it helps to analyze large amounts of textual data qualitatively and to understand the underlying concepts of what was said. RESULTS: Most (73.5%) patients had a cancer diagnosis. Mean age was 67.6 years (range, 22-98 years). Burden and overburden were identified as main categories and further divided into the following subcategories: for patients and families. According to the written notes, patients often felt burdened by their disease, financial problems, situation at home, and families' reactions to their disease. By and large, patients felt overburdened by their own disease. Families often felt burdened because of issues related to patients' medical condition, providing home care, or financial and social aspects. Families mentioned home care and the decision-making process as being overburdening. CONCLUSION: Findings in the palliative care patients' medical records are inasmuch important, as they point at the health-care staff's awareness of possible weights and tasks that might be burdensome for patients and their families. Attention should be drawn to the documentation of medical records in order to identify recurrent difficulties and to help discuss these.

A vaccine against nicotine for smoking cessation: a randomized controlled trial.

BACKGROUND: Tobacco dependence is the leading cause of preventable death and disabilities worldwide and nicotine is the main substance responsible for the addiction to tobacco. A vaccine against nicotine was tested in a 6-month randomized, double blind phase II smoking cessation study in 341 smokers with a subsequent 6-month follow-up period. METHODOLOGY/PRINCIPAL FINDINGS: 229 subjects were randomized to receive five intramuscular injections of the nicotine vaccine and 112 to receive placebo at monthly intervals. All subjects received individual behavioral smoking cessation counseling. The vaccine was safe, generally well tolerated and highly immunogenic, inducing a 100% antibody responder rate after the first injection. Point prevalence of abstinence at month 2 showed a statistically significant difference between subjects treated with Nicotine-Qbeta (47.2%) and placebo (35.1%) (P = 0.036), but continuous abstinence between months 2 and 6 was not significantly different. However, in subgroup analysis of the per-protocol population, the third of subjects with highest antibody levels showed higher continuous abstinence from month 2 until month 6 (56.6%) than placebo treated participants (31.3%) (OR 2.9; P = 0.004) while medium and low antibody levels did not increase abstinence rates. After 12 month, the difference in continuous abstinence rate between subjects on placebo and those with high antibody response was maintained (difference 20.2%, P = 0.012). CONCLUSIONS: Whereas Nicotine-Qbeta did not significantly increase continuous abstinence rates in the intention-to-treat population, subgroup analyses of the per-protocol population suggest that such a vaccination against nicotine can significantly increase continuous abstinence rates in smokers when sufficiently high antibody levels are achieved. Immunotherapy might open a new avenue to the treatment of nicotine addiction. TRIAL REGISTRATION: Swiss Medical Registry 2003DR2327; ClinicalTrials.gov NCT00369616.