Regulations on palliative sedation: an international survey across eight European countries.

BACKGROUND: Palliative sedation is a commonly accepted medical practice. This study aims to clarify how palliative sedation is regulated in various countries and whether this may impact its practice. METHODS: An online survey requesting regulations on palliative sedation was conducted in Belgium, Germany, Hungary, Italy, The Netherlands, Spain, Romania and the UK. Purposive sampling strategy was used to identify clinicians from different medical fields and legal experts for each country. Regulations were analyzed using the principles of the European Association for Palliative Care Framework on palliative sedation. Country reports describing how palliative sedation is regulated were elaborated. RESULTS: One hundred and thirty-nine out of 223 (62%) participants identified 31 laws and other regulations affecting palliative sedation. In Spain, 12 regional laws recognize palliative sedation as a right of the patient at the end of life when there are refractory symptoms. In Italy, the law of informed consent and advance directives specifically recognizes the doctor can use deep sedation when there are refractory symptoms. There are also general medical laws that, while not explicitly referring to palliative sedation, regulate sedation-related principles: the obligation of doctors to honour advance directives, informed consent, the decision-making process and the obligation to document the whole process. In Germany, the Netherlands and the UK, palliative sedation is also regulated through professional guidelines that are binding as good practice with legal significance. CONCLUSIONS: Palliative sedation is considered in the general law of medical practice, in laws regarding the patient's autonomy, and through professional guidelines.

Monitoring the clinical practice of palliative sedation (PALSED) in patients with advanced cancer: an international, multicentre, non-experimental prospective observational study protocol.

BACKGROUND: Palliative sedation involves the intentional lowering of consciousness at the end of life. It can be initiated to relieve a patient's burden caused by refractory symptoms at the end of life. The impact of palliative sedation needs to be clinically monitored to adjust the proper dose and regimen of sedative medication to ensure that patients are at ease and comfortable at the end of their lives. Although there is consensus among health care professionals and within guidelines that efficacy of palliative sedation needs to be closely monitored, there is no agreement about how, when, and by whom, this monitoring should be performed. The aim of this study is to evaluate the effects of palliative sedation by measuring the discomfort levels and sedation/agitation levels of the patients at regular timepoints. In addition, the clinical trajectories of those patients receiving palliative sedation will be monitored and recorded. METHODS: The study is an international prospective non-experimental observational multicentre study. Patients are recruited from in-patient palliative care settings in Belgium, Germany, Italy, Spain and the Netherlands. Adult patients with advanced cancer are monitored by using proxy observations of discomfort (DS-DAT) and depth of sedation/agitation levels (RASS-PAL) during palliative sedation. After the palliative sedation period, the care for the specific participant case is evaluated by one of the attending health care professionals and one relative via a questionnaire. DISCUSSION: This study will be the first international prospective multicenter study evaluating the clinical practice of palliative sedation including observations of discomfort levels and levels of sedation. It will provide valuable information about the practice of palliative sedation in European countries in terminally ill cancer patients. Results from this study will facilitate the formulation of recommendations for clinical practice on how to improve monitoring and comfort in patients receiving palliative sedation. TRIAL REGISTRATION: This study is registered at Clinicaltrials.gov since January 22, 2021, registration number: NCT04719702.

Methadone as First-line Opioid for the Management of Cancer Pain.

AIM: The aim of this study was to assess the efficacy and adverse effects of methadone when used as first-line therapy in patients that are either receiving low doses of opioids or none. METHODS: Patients with advanced cancer were prospectively assessed. Opioid-naive patients (L-group) were started with methadone at 6 mg/day. Patients receiving weak or other opioids in doses of <60 mg/day of OME (H-group) were started with methadone at 9 mg/day. Methadone doses were changed according to the clinical needs to obtain the most favorable balance between analgesia and adverse effects. Edmonton Symptom Asssement Score (ESAS), Memorial Delirium Assessment Score (MDAS), doses of methadone, and the use of adjuvant drugs were recorded before starting the study treatment (T0), 1 week after (T7), 2 weeks after (T14), 1 month after (T30), and 2 months after (T60). Methadone escalation index percent (MEI%) and in mg (MEImg) were calculated at T30 and T60. RESULTS: Eighty-two patients were assessed. In both groups H and L, there were significant changes in pain and symptom intensity at the different times during the study. Adverse effects as causes of drop-out were minimal. Mean MEImg was 0.09 (SD 0.28) and 0.02 (SD 0.07) at T30 and T60, respectively. MEI% was 1.01 (SD 3.08) and 0.27 (SD 0.86) at T30 and T60, respectively. CONCLUSION: Methadone used as a first-line opioid therapy provided good analgesia with limited adverse effects and a minimal opioid-induced tolerance.

Conversion ratios for opioid switching: a pragmatic study.

BACKGROUND: The final conversion ratios among opioids used for successful switching are unknown. The aim of this study was to determine the initial and final conversion ratios used for a successful opioid switching in cancer patients, and eventual associated factors. METHODS: Ninety-five patients who were successfully switched were evaluated. The following data were collected: age, gender, Karnofsky performance score, primary cancer, cognitive function, the presence of neuropathic, and incident pain. Opioids, route of administration, and their doses expressed in oral morphine equivalents used before OS were recorded as well as opioids use for starting opioid switching, and at time of stabilization. Physical and psychological symptoms were routinely evaluated by Edmonton Symptom Assessment Scale. RESULTS: No statistical changes were observed between the initial conversion ratios and those achieved at time of stabilization for all the sequences of opioid switching. When considering patients switched to methadone, there was no association between factors taken into considerations. CONCLUSION: Opioid switching is a highly effective and safe technique, improving analgesia and reducing the opioid-related symptom burden. The final conversion ratios were not different from those used for starting opioid switching. Patients receiving higher doses of opioids should be carefully monitored for individual and unexpected responses in an experienced palliative care unit, particularly those switched to methadone. Future studies should provide data regarding the profile of patients with difficult pain to be hospitalized.

Financial distress and its impact on symptom expression in advanced cancer patients.

AIM: To assess financial distress (FD) and its impact on symptom expression and other quality of life issues PATIENTS AND METHODS: Advanced cancer patients admitted to inpatient and outpatient clinics were selected. Standard epidemiological data including age, gender, primary cancer diagnosis, and Karnofsky level were recorded. Data regarding marital status, number of cohabitants, religious belief, educational level, and family income (< 1000, 1000-3.000, > 3000 euros), as well as extra costs not covered by health care system, were collected. Symptom burden including FD was measured by Edmonton Symptom Assessment Scale (ESAS), FACT-G (Functional Assessment of Cancer Therapy-General), and HADS (Hospital Anxiety Depression scale) were measured. RESULTS: Two hundred thirty-six patients were evaluated. The mean FD was 3.55 (SD 3.1). One hundred patients (42%) had a FD of ≥ 4. There was an inverse correlation between FD and income (P = 0.032). Most patients incurred in extra-costs, the most frequent being for drugs (n, 114). FD was inversely associated with age (P = 0.024), marital status (divorced or separated, P = 0.005), ESAS anxiety (P = 0.006), total ESAS (P = 0.019), physical well-being (P = 0.033), poor social family well-being (P = 0.004), emotional well-being (P = 0.045), poor functional well-being (P = 0.019), HADS-A (P = 0.003), and global HADS (P = 0.034). Family income was inversely related to age (P = 0.023), education level (P < 0.0005), less number of hospital admissions in the last month (P = 0.020), physical well-being (P = 0.039), social/family well-being (P = 0.020), and total well-being (P = 0.001). CONCLUSION: FD is very common in advanced cancer patients. FD was associated with anxiety, depression, and poor quality of life. The screening of FD may allow to develop effective interventions of social support.

The lower the expectations in controlling the symptoms of advanced cancer patients, the better the clinical response.

AIM: The aim of this study was to compare patients' global impression (PGI) and the achievement of personalised symptom goal response (PSGR), after a comprehensive palliative care treatment in advanced cancer patients having high (HPSG) and low symptom goals (LPSG). PATIENTS AND METHODS: Advanced cancer patients admitted to palliative care units rated symptoms intensity by the Edmonton Symptom Assessment Score (ESAS) at admission and then after one week of comprehensive palliative care treatment. For each symptom, patients were divided into two groups, according to their patient symptom goal (PSG): ≥4 (HPSG), and 0-2 (LPSG). PGI and PSGR were evaluated after one week of palliative care. The Memorial Delirium Assessment Scale (MDAS) was assessed at admission. RESULTS: After one week of palliative care, changes in ESAS items were significantly larger in the HPSG group. HPSG patients had a better PGI and reached their target more frequently than LPSG patients for pain, weakness, and poor well-being. LPSG patients were more likely to obtain their target for appetite and insomnia. HPSG patients were more likely to have a lower Karnofsky, a lower educational level, older age, or higher MDAS values for the different ESAS items. CONCLUSION: Advanced cancer patients with low expectations (HPSG) were more likely to achieve their PSGR after a comprehensive palliative care treatment, reporting also a better PGI for some leading symptoms such as pain, weakness, and poor well-being. More fragile patients seem to have lower expectations and to be more likely to be satisfied.

Barriers and Adherence to Pain Management in Advanced Cancer Patients.

AIM: To assess patients' barriers to pain management and analgesic medication adherence in patients with advanced cancer. METHODS: This was a prospective cross-sectional study in patients with advanced cancer receiving chronic opioid therapy. Age, gender, cancer diagnosis, Karnofsky level, and educational status were recorded. The Brief Pain Inventory (BPI), Edmonton Symptom Assessment Scale (ESAS), Memorial Delirium Assessment Scale (MDAS), Barriers Questionnaire II (BQ-II), Medication Adherence Rating Scale (MARS), and Hospital Anxiety and Depression Scale (HADS) were the measurement instruments used. RESULTS: One-hundred-thirteen patients were analyzed. The mean age was 68 (±13) years, and 59 (52%) were male. The mean Karnofsky status was 51.4 (standard deviation [SD] 11.5). The mean score for BQ-II items was 1.77 (SD 0.7). The BQ-II score was independently related to the HADS-Depression score (P = 0.033) and the total HADS score (P = 0.049). Negative side-effects and attitudes toward psychotropic medication globally prevailed among MARS items. These items were independently associated with gender (P = 0.030), pain (P = 0.003), and depression (P = 0.047). CONCLUSION: Barriers to pain management were mild. Psychological factors such as depression were the main factor associated with barriers. Poor adherence to analgesic medication was mostly manifested as negative side-effects and attitudes toward psychotropic medication, was more frequent observed in females, and was associated with the ESAS items pain and depression.

Association between alcoholism and symptom expression, patient symptom goals, and clinical response in advanced cancer patients.

AIM: The aim of this study was to determine the influence of alcoholism on symptom expression, personalized symptom goal (PSG) and patient goal response (PGR), and patient global impression (PGI) in advanced cancer patients. METHODS: This was a secondary analysis of an international multicenter study. Advanced cancer patients who had a history of alcohol dependence positive, according to CAGE (cut down, annoy, guilt, eye-opener), were selected. Thirty patients (3.45%) were CAGE-positive. This sample was matched with 30 patients with similar characteristics who were CAGE-negative. Patients rated symptom intensity by using the Edmonton Symptom Assessment Score (ESAS) at admission (T0) and then after 1 week. For each symptom, patients reported their PSG. After a week of comprehensive palliative care, PSG was measured again (T7), as well as the achievement of PGR, and PGI. Minimal clinically important difference (MCID) was calculated by PGI of improvement or deterioration at T7 (bit better or a little worse, respectively). RESULTS: A significant decrease in intensity was found for most symptoms in both groups. In CAGE-negative and CAGE-positive patients, most patients had a PSG of ≤ 3 for all ESAS items as a target at T0. All PSG targets did not changed significantly after 1 week of palliative care in both groups. Although CAGE-positive basically had unfavorable PGI and PGR, a statistical significance was achieved only for appetite (P = 0.037; ANOVA test). In CAGE-negative patients, Karnofsky was the only factor independently associated with PGI for pain and dyspnea. Factors independently associated with PGI for nausea were symptom intensity at T0 and home situation. In CAGE-positive patients, Karnofsky was independently associated with PGI for pain, nausea, and well-being. Symptom intensity at T0 was independently associated with PGI for weakness. CONCLUSION: CAGE-positive advanced cancer patients favorably responded to a palliative care intervention. No greater differences have been found in comparison with CAGE-negative patients for PSG, PGR, and PGI, except for appetite. Further studies with large number of patients could confirm some trends observed in this study.

Personalized goal for insomnia and clinical response in advanced cancer patients.

AIM: The aim of this study was to assess the Personalized Insomnia Intensity Goal (PIIG), the achievement of Personalized Goal Response (PGR), and Patient Global Impression (PGI) after a comprehensive symptom management. PATIENTS AND METHODS: Advanced cancer patients admitted to palliative care units rated pain and symptoms intensity and their PIIG by using the Edmonton Symptom Assessment Score (ESAS) (T0). In patients with significant levels of insomnia, the achievement of target expected (PIIG) was measured (patient goal response, PIGR), as well the patient global impression (PGI), by the minimal clinically important difference (MCID), after a comprehensive symptom management (T7). RESULTS: Three hundred ninety-seven patients with a level of insomnia of ≥ 3 on ESAS were analyzed in this study. The mean values of PIIG at T0 and T7 were 1.2 (SD 1.5) and 0.9 (SD 1.4), respectively. Most patients (n = 406, 89.8%) indicated a PIIG of ≤ 3 as a target at T0. Such target was significantly lower at T7 (p = < 0.0005). PGI, expressed as MCID, was perceived with a mean decrease in insomnia intensity of - 2.3. In a minority of patients (n = 26; 5.8%) insomnia worsened, with a MCID of 0.50 (SD 2.8). Higher insomnia intensity at T0 and lower insomnia intensity at T7 were independently related to PGI. PIGR was achieved in 87.9% of patients. PIGR was associated with PIIG at T0, and inversely associated to insomnia intensity at T0 and T7, and PIIG at T7. CONCLUSION: PGIR and PGI seem to be relevant for evaluating the effects of a comprehensive management of insomnia, suggesting therapeutic decisions according to PIIG. Some factors influencing the individual target and clinical response have been detected.

Personalized Pain Goals and Responses in Advanced Cancer Patients.

OBJECTIVE: To assess the personalized pain intensity goal (PPIG), the achievement of a personalized pain goal response (PPGR), and patients' global impression (PGI) in advanced cancer patients after a comprehensive pain and symptom management. DESIGN: Prospective, longitudinal. SETTING: Acute pain relief and palliative/supportive care. SUBJECTS: 689 advanced cancer patients. METHODS: Measurement of Edmonton Symptom Assessment Score (ESAS) and personalized pain intensity goal (PPIG) at admission (T0). After a week (T7) personalized pain goal response (PPGR) and patients' global impression (PGI) were evaluated. RESULTS: The mean PPIG was 1.33 (SD 1.59). A mean decrease in pain intensity of - 2.09 was required on PPIG to perceive a minimal clinically important difference (MCID). A better improvement corresponded to a mean change of - 3.41 points, while a much better improvement corresponded to a mean of - 4.59 points. Patients perceived a MCID (little worse) with a mean increase in pain intensity of 0.25, and a worse with a mean increase of 2.33 points. Higher pain intensity at T0 and lower pain intensity at T7 were independently related to PGI. 207 (30.0%) patients achieved PPGR. PPGR was associated with higher PPIG at T0 and T7, and inversely associated to pain intensity at T0 and T7, and Karnofsky level. Patients with high pain intensity at T0 achieved a favorable PGI, even when PPIG was not achieved by PPGR. CONCLUSION: PPIG, PPGR and PGI seem to be relevant for evaluating the effects of a comprehensive management of pain, assisting decision-making process according to patients' expectations. Some factors may be implicated in determining the individual target and the clinical response.

Symptom Expression in Patients with Advanced Cancer Admitted to an Acute Supportive/Palliative Care Unit With and Without Delirium.

AIM: The aim of this study was to investigate the relationship between delirium and symptom expression in patients with advanced cancer admitted to an acute supportive/palliative care unit (ASPCU). METHODS: A consecutive sample of patients with advanced cancer who were admitted to an ASPCU was prospectively assessed for a period of 10 months. The Edmonton Symptom Assessment Scale (ESAS) and the MDAS (Memorial Delirium Assessment Scale) were measured at admission (T0) and after 7 days of palliative care (T7). RESULTS: Two hundred forty-six patients had complete data regarding MDAS measurements, at either T0 and T7. Of these, 75 (30.5%) and 63 patients (25.6%) had delirium at T0 and after a week of palliative care (T7), with a decrease in the frequency of delirium of 4.9% (from 30.5% to 25.6%); that means that 16% of patients with delirium improved their cognitive status after initiation of palliative care. Intensities of pain, depression, poor well-being, and global ESAS were significantly higher in patients with delirium. Patients who did not have delirium at T0 but developed delirium during admission after 1 week of palliative care had a higher level of symptom expression for pain, weakness, nausea, anxiety, dyspnea, appetite, and consequently global ESAS. Patients who did not develop delirium at any time had a relevant decrease in intensity of all ESAS items after 1 week of palliative care. The decrease of symptom intensity was significant for pain, insomnia, appetite, poor well-being, and global ESAS in patients with delirium either at T0 and T7, although these differences were less relevant than those observed in patients without delirium. In patients with delirium at T0 who improved their cognitive function at T7 (no delirium), significant changes were found in most ESAS items. CONCLUSION: Symptom expression is amplified in patients with delirium, whereas patients without delirium may be more responsive to palliative treatments with a significant decrease in intensity of ESAS items. IMPLICATIONS FOR PRACTICE: Symptom expression is amplified in patients with cancer who have delirium, whereas patients without delirium may be more responsive to palliative treatments with a significant decrease in symptom intensity.

Personalized Symptom Goals and Patient Global Impression on Clinical Changes in Advanced Cancer Patients.

BACKGROUND: The aim of this study was to assess the patients' global impression (PGI) after symptom management, as well as the achievement of personalized symptom goals (PSG). The secondary outcome was to assess related factors. SUBJECTS, MATERIALS, AND METHODS: Advanced cancer patients admitted to palliative care units rated symptom intensity by using the Edmonton Symptom Assessment Score (ESAS) at admission and then after 1 week. For each symptom, patient-reported PGI and PSG, as well as the rate of PSG response, were evaluated. RESULTS: Eight hundred seventy-six patients were taken into consideration for this study. A mean of 1.71-2.16 points was necessary to perceive a bit better improvement of symptom intensity. Most patients had a PSG of ≤3. A statistically significant number of patients achieved their PSG after starting palliative care. Patients with high intensity of ESAS items at admission achieved a more favorable PGI response. In the multivariate analysis, symptom intensity and PSG were the most frequent factors independently associated to a best PGI, whereas high levels of Karnofsky had a lower odd ratio. CONCLUSION: PSG and PGI seem to be relevant for patients' assessment and decision-making process, translating in terms of therapeutic intervention. Some factors may be implicated in determining the individual target and clinical response. IMPLICATIONS FOR PRACTICE: Personalized symptom goals and global impression of change are relevant for patients' assessment and decision-making process, translating in terms of therapeutic intervention. Some factors may be implicated in determining the individual target and clinical response.

Symptom hyper-expression in advanced cancer patients with anxiety and depression admitted to an acute supportive/palliative care unit.

PURPOSE: The aim of this study was to compare symptom expression in advanced cancer patients with depression and anxiety and in patients with no such symptoms. METHODS: Secondary analysis of a previous study assessing the role of an acute palliative supportive care unit (APSCU) in a comprehensive cancer center. Patients completed the Edmonton Symptom Assessment System (ESAS) at admission (T0) and 7 days after or at discharge (T7). RESULTS: Three hundred-fourteen consecutive cancer patients admitted to the APSCU were surveyed. Eighty-six and 66 patients improved their level of depression and anxiety, respectively (passing from ≥ 4 to 0-3, from T0 to T7), after that palliative care intervention resulted in a significant improvement of the other symptoms. Changes were statistically significant for both symptoms (P < 0.0005). Patients admitted for uncontrolled pain were more likely to be anxious, while patients admitted for other symptoms or end-of-life care were more likely to be depressed. The presence of anxiety and depression (≥ 4/10 on ESAS) was significantly associated with a higher level of symptom expression at admission and at T7 (P < 0.0005). In patients presenting both psychological symptoms, symptom expression was significantly more relevant in comparison with patients not reporting moderate-severe psychological symptoms. Pain and depression were independently associated with anxiety at T0. Variables independently associated with depression at T0 were drowsiness, appetite, and anxiety. CONCLUSIONS: Psychological symptoms of ESAS concur to hyper-express some symptoms and make symptom control more difficult. A clear association between anxiety and depression exists.

Characteristics and care pathways of advanced cancer patients in a palliative-supportive care unit and an oncological ward.

BACKGROUND: A supportive palliative care unit (SPCU) may have a positive impact on patients' care. The aim of this study was to compare the pattern of patients admitted to a specialized SPCU and to a traditional oncologic ward (OW) in a consecutive sample of advanced cancer patients. METHODS: Data on patients demographics, reasons for and kind of admission, care-giver, anticancer treatments, being on/off treatment or uncertain, origin setting, who proposed hospital admission, the use of opioids, and hospitalization were gathered. The same parameters were recorded at discharge. A follow-up was performed by phone 1 month after discharge. RESULTS: Two-hundred patients were surveyed. Awareness of disease was more complete in OW patients (P = 0.001). Uncontrolled pain and symptoms were the prevalent reasons for admission to SPCU (P < 0.0005). Toxicity from chemotherapy was more frequently reported by OW patients (P = 0.001). SPCU patients received higher doses of opioids (P = 0.004). More SPCU patients were referred from home and were discharged home (P < 0.0005 and P = 0.018, respectively). Emergency admissions were more frequently reported in OW patients (P < 0.0005). One month after, more SPCU patients were at home and were still on active treatment (P = 0.002, and P = 0.05, respectively). More OW patients died within 1 month (P = 0.001). CONCLUSION: SPCU allows a better planning admission to hospital and a better care trajectory in advanced cancer patients in comparison to a busy OW, where unselected emergencies more frequently occur.

The effects of alcoholism and smoking on advanced cancer patients admitted to an acute supportive/palliative care unit.

AIM: The aim of this prospective study was to determine the characteristics and symptom burden of advanced cancer patients with alcoholism problems and smoking, who were referred to an acute palliative/supportive care unit (ASPCU) of a comprehensive cancer center. METHODS: Patients' characteristics, indications for admission, kind of admission, awareness of prognosis, and anticancer treatments were recorded. The Edmonton Symptom Assessment Scale (ESAS) was used to assess physical and psychological symptoms, and the CAGE questionnaire for the diagnosis of alcoholism. Patients were also divided in three groups: persistent smokers (PS), former smokers (FS), and non-smokers (NS). The Memorial Delirium Assessment Scale (MDAS) was used to assess the cognitive status of patients. Analgesic drugs and their doses at admission and discharge were recorded, as well opioid escalation index during hospital stay. RESULTS: Three hundred fourteen consecutive cancer patients were surveyed. Forty-seven (14.9%), 143 (45.5%), and 124 (39.5%) subjects were PS-patients, FS-patients, and NS-patients, respectively. Sixteen patients were CAGE-positive. Females were more frequently NS, while males were more frequently FS (p = 0.0005). Statistical differences were also observed in disease awareness among the categories of smoking (p = 0.048). No statistical differences were found in ESAS items, except for drowsiness at T0 in NS-patients. Differences were found in OME and OEI, although the large variability of data did not determined a statistical difference. Higher values of nausea (at T0, p = 0.0005), dyspnea (at T0 and TX, p = 0.08 and 0.023, respectively), and well-being (at TX p = 0.003) were reported in CAGE-positive patients. No correlation was found between CAGE-positive patients and smokers. CONCLUSION: Although smoking and alcoholism have obvious implications in advanced cancer patients, data remain controversial, as present data did provide limited data to confirm risk factors for advanced cancer patients. Clinical response was not strongly influenced by these risk factors.

Characteristics of advanced cancer patients who were readmitted to an acute palliative/supportive care unit.

OBJECTIVES: The aim of this study was to assess the characteristics of patients readmitted to an acute supportive/palliative care unit (ASPCU), the reasons for readmission, and the outcome after receiving specialistic assessment and treatment. METHODS: A consecutive sample of patients was assessed for a period of 10 months. Epidemiological characteristics, including age, gender, Karnofsky level, diagnosis, caregivers, education, disease awareness, kind of admission, and anticancer treatment in the previous 30 days, were recorded, as well as hospital stay, death, and discharge at home. The principal reasons for admission were recorded. Symptom intensity and opioid doses, expressed as oral morphine equivalents, were also measured. RESULTS: In the study period, 79 (25.2%) readmissions were recorded. Thirty-seven (46.8%) readmissions occurred within 30 days after discharge. Pain was more frequently reported as indication for admission at the first and the second readmission in comparison with the first admission. The burden of symptoms was significantly higher in patients with a readmission in comparison with patients at the first admission. Opioid doses, expressed as oral morphine equivalents, were significantly different between the first admission and readmissions. In both patients at the first admission or readmission, a significant decrease in symptom intensity has been reported at discharge. CONCLUSION: About 25% of patients discharged from an ASCPU are expected to be readmitted for reemerging of clinical problems. Re-exacerbation of pain seems to be the most frequent reason. A further clinical reassessment and treatment were equally effective in controlling the symptom burden of these patients at any readmission.

Sleep disturbances in advanced cancer patients admitted to a supportive/palliative care unit.

The aim of this study was to assess the prevalence of sleep disturbances and possible correlations with associated factors in a sample of patients admitted to an acute palliative/supportive care unit.A consecutive sample of patients with advanced cancer was prospectively assessed for a period of 6 months. Epidemiological and clinical data, treatments received in the last month, Karnofsky status, Edmonton Symptom Assessment System (ESAS), and concomitant medical treatment were also recorded. Patients were administered the Athens Insomnia Scale (AIS) and the Hospital Anxiety and depression scale (HADS).Two hundred nineteen patients met the inclusion criteria. The mean age was 65.4 years (SD 12.4), and 111 patients were males. The mean Karnofsky status was 46.6 (SD = 12). All patients had consistent sleep disturbances (AIS ≥6), with a large number of patients having intense-maximum sleep disturbances. No relationships of AIS with gender, age, primary diagnosis, socio-educational factors, and anticancer treatments were found. AIS score was significantly associated with Karnofsky; intensities of pain, asthenia, anorexia, anxiety, depression, drowsiness, and well-being; and the use of corticosteroids and benzodiazepines. There was a positive correlation of HADS anxiety and HADS depression with sleep disturbances (p = 0.000). In the multivariate analysis, AIS increased only with the level of anxiety and depression assessed by HADS.Sleep disturbances were ubiquitous in advanced cancer patients admitted to a supportive/palliative care unit and were strongly correlated with psychological distress. Assessment of sleep disorders is mandatory in this population for the obvious interference with quality of life.

The use of low doses of a sublingual fentanyl formulation for breakthrough pain in patients receiving low doses of opioids.

OBJECTIVE: The aim of this study was to prospectively assess the efficacy and safety of low doses of sublingual fentanyl (SLF) for the treatment of breakthrough pain (BTP) in cancer patients in patients who were receiving low opioid doses for background analgesia. METHODS: A sample of cancer patients presenting BTP episodes and receiving stable low doses of opioids for background pain (less than 60 mg of oral morphine equivalents) was selected to assess the efficacy and safety of low doses of SLF (67 µg). For each patient, data from four consecutive episodes were collected. For each episode, changes in pain intensity and adverse effects when pain got severe (T0), and 5, 10, and 15 min after SLF administration (T5-T30) were recorded. The occurrence of serious effects occurring within 2 h of SLF administration were also considered. RESULTS: Fifty-one patients were recruited for the study. The mean age was 66.8 (SD 12.9). A mean of 3.3 episodes/patient were recorded. Four patients did not have episodes of BTP. 147 episodes were evaluated. Six episodes (4.1 %) required a rescue medication at T30. Pain intensity significantly decreased at T5, T10, T15 and T30 (p < 0.0005 in all cases). A high percentage of patients had a pain reduction of more than 33 and 50 % at T5, T10, T15 and T30. Adverse effects were mild and generally already present, due to basal opioid treatment or disease. No serious adverse effects were observed for the subsequent 2 h. CONCLUSION: This study suggests that SLF given in low doses in patients receiving lower doses of opioids for background analgesia is safe and effective in clinical practice.

Long-term efficacy and tolerability of intranasal fentanyl in the treatment of breakthrough cancer pain.

PURPOSE: The aim of the present study was to assess the long-term tolerability and efficacy of intranasal fentanyl (INFS) in opioid-tolerant patients with breakthrough cancer pain (BTP). PATIENTS AND METHODS: A 6 months, observational, prospective, cohort study design was employed to follow advanced cancer patients with BTP receiving INFS under routine clinical practice. Eligible adult cancer patients suffering from BTP had been prescribed INFS at effective doses. Data were collected at T0 and at month intervals for six months. The principal outcomes were the evaluation of possible serious adverse effects with prolonged use of INFS, the efficacy of BTP treatment with INFS, the quality of sleep, the rate of INFS discontinuation, and reasons for that. RESULTS: Seventy-five patients were surveyed. Thirty-four patients (45.3 %) had a follow-up at 3 months, and twelve patients (16 %) were followed up at 6 months. The mean opioid doses, expressed as oral morphine equivalents, ranged 111-180 mg/day, while the mean INFS doses were 87-119 µg. Adverse effects were reported in a minority of patients and were considered to be associated with opioid therapy used for background pain. The quality of sleep significantly improved during the first 3-4 months. Finally, efficacy based on a general impression regarding the efficacy of INFS was good-excellent in most patients and statistically improved in time up to the third month. CONCLUSION: The long-term use of INFS in advanced cancer patients is effective and safe. No serious adverse effects were found up to six months of assessment. The level of quality of sleep and patients' satisfaction was relatively good, considering the advanced stage of disease.

Prevalence of oral mucositis, dry mouth, and dysphagia in advanced cancer patients.

BACKGROUND: Oral symptoms can be a sign of an underlying systemic condition and have a significant impact on quality of life, nutrition, and cost of care, while these lesions are often studied in the context of cancer treatment. However, information regarding oral symptoms in advanced cancer patients is poor. The aim of this multicenter study was to determine the prevalence and the characteristics of oral symptoms in a large population of advanced cancer patients. METHODS: A consecutive sample of patients with advanced cancer for a period of 6 months was prospectively assessed for an observational study. At time of admission, the epidemiological characteristics, surgery-radiotherapy of head and neck, and oncologic treatments in the last month were recorded. The presence of mucositis, dry mouth, and dysphagia was assessed by clinical examination and patients' report and their intensity recorded. Patients were also asked whether they had limitation on nutrition of hydration due to the local condition. RESULTS: Six hundred sixty-nine patients were surveyed in the period taken into consideration. The mean age was 72.1 years (SD 12.3), and 342 patients were males. The primary tumors are listed in Table 1. The prevalence of mucositis was 22.3 %. The symptom relevantly reduced the ingestion of food or fluids and was statistically associated with the Karnofsky level and head and neck cancer. The prevalence of dry mouth was 40.4 %, with a mean intensity of 5.4 (SD 2.1). Several drugs were concomitantly given, particularly opioids (78 %), corticosteroids (75.3 %), and diuretics (70.2 %). Various and nonhomogeneous treatments were given for dry mouth, that was statistically associated with current or recent chemotherapy, and hematological tumors. The prevalence of dysphagia was 15.4 % with a mean intensity of 5.34 (SD 3). Dysphagia for liquids was observed in 52.4 % of cases. A high level of limitation for oral nutrition due to dysphagia was found, and in 53.4 % of patients, alternative routes to the oral one were used. Dysphagia was statistically associated with the Karnofsky level and head and neck cancer. A strong relationship between the three oral symptoms was found. CONCLUSION: In advanced cancer patients, a range of oral problems significantly may impact on the physical, social, and psychological well-being of advanced cancer patients to varying degrees. These symptoms should be carefully assessed early but become imperative in the palliative care setting when they produce relevant consequences that may be life-threatening other than limiting the daily activities, particularly eating and drinking.