Revised European Association for Palliative Care (EAPC) recommended framework on palliative sedation: An international Delphi study.

BACKGROUND: The European Association for Palliative Care (EAPC) acknowledges palliative sedation as an important, broadly accepted intervention for patients with life-limiting disease experiencing refractory symptoms. The EAPC therefore developed 2009 a framework on palliative sedation. A revision was needed due to new evidence from literature, ongoing debate and criticism of methodology, terminology and applicability. AIM: To provide evidence- and consensus-based guidance on palliative sedation for healthcare professionals involved in end-of-life care, for medical associations and health policy decision-makers. DESIGN: Revision between June 2020 and September 2022 of the 2009 framework using a literature update and a Delphi procedure. SETTING: European. PARTICIPANTS: International experts on palliative sedation (identified through literature search and nomination by national palliative care associations) and a European patient organisation. RESULTS: A framework with 42 statements for which high or very high level of consensus was reached. Terminology is defined more precisely with the terms suffering used to encompass distressing physical and psychological symptoms as well as existential suffering and refractory to describe the untreatable (healthcare professionals) and intolerable (patient) nature of the suffering. The principle of proportionality is introduced in the definition of palliative sedation. No specific period of remaining life expectancy is defined, based on the principles of refractoriness of suffering, proportionality and independent decision-making for hydration. Patient autonomy is emphasised. A stepwise pharmacological approach and a guidance on hydration decision-making are provided. CONCLUSIONS: This is the first framework on palliative sedation using a strict consensus methodology. It should serve as comprehensive and soundly developed information for healthcare professionals.

Report on palliative sedation medication usage: a survey of palliative care experts in Eight European countries.

BACKGROUND: The practice of palliative sedation continues to raise ethical questions among people, which in turn leads to its varied acceptance and practice across regions. As part of the Palliative Sedation European Union (EU) project, the aim of the present study was to determine the perceptions of palliative care experts regarding the practice of palliative sedation in eight European countries (The Netherlands, Belgium, Germany, UK, Italy, Spain, Hungary, and Romania). METHODS: A specifically designed survey, including questions on the most frequently used medications for palliative sedation, their availability per countries and settings, and the barriers and facilitators to the appropriate practice of palliative sedation was sent to expert clinicians involved and knowledgeable in palliative care in the indicated countries. A purposive sampling strategy was used to select at least 18 participating clinicians per consortium country. Descriptive statistical analysis was conducted on the survey data. RESULTS: Of the 208 expert clinicians invited to participate, 124 participants completed the survey. Midazolam was perceived to be the most frequently used benzodiazepine in all eight countries. 86% and 89% of expert clinicians in Germany and Italy, respectively, perceived midazolam was used "almost always", while in Hungary and Romania only about 50% or less of the respondents perceived this. Levomepromazine was the neuroleptic most frequently perceived to be used for palliative sedation in the Netherlands, Spain, Germany, and the United Kingdom. Between 38- 86% of all eight countries´ expert clinicians believed that opioid medications were "almost always" used during palliative sedation. The perceived use of IV hydration and artificial nutrition "almost always" was generally low, while the country where both IV hydration and artificial nutrition were considered to be "very often" given by a third of the expert clinicians, was in Hungary, with 36% and 27%, respectively. CONCLUSIONS: Our study provides insight about the differences in the perceived practice of medication during palliative sedation between eight European countries. In countries where palliative care services have been established longer perceptions regarding medication use during palliative sedation were more in line with the recommended European guidelines than in Central and Eastern European countries like Romania and Hungary.

Opioid-induced Neurotoxicity in Patients with Cancer Pain.

OPINION STATEMENT: Opioid-induced neurotoxicity (OINT) is a neuropsychiatric syndrome observed with opioid therapy. The mechanism of OINT is thought to be multifactorial, and many risk factors may facilitate its development. If symptoms of OINT are seen, the prescriber should consider hydration, discontinuation of the offending opioid drug, or switching of opioid medication, or the use of some adjuvants. Multiple factors like inter- and intraindividual differences in opioid pharmacology may influence the accuracy of dose calculations for opioid switching. Experience and clinical judgment in a specialistic palliative care setting should be used and individual patient characteristics considered when applying any conversion table.

A better interpretation of data regarding the opioid switching to methadone.

In a recent study methadone has been reported more effective witha 3-day switch (3DS) was more effective than the stop and go strategy (SAG). Many shorcomings, however, are of concerns. The poor selection fo patients with low level of pain intensity, the incomprehensibile choice of of SAG or 3DS, and considerations reported in a previous controlled study with evident methodological limits, make their conclusion inaccurate. Controlled studies are fundamental in research. However, a pragmatic approach reflecting daily practice should be carefully taken into consideration. A more flexible use of SAG strategy and strict clinical observation to change doses according to the clinical response may provide the optimal treatment in patients receiving high doses of opioids.

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.

Constipation in Cancer Patients - an Update of Clinical Evidence.

OPINION STATEMENT: Constipation is one of the most frequent problems in cancer patients, and its etiology is multifactorial. It leads to decreased quality of life and impedes optimal pain treatment. Despite the high prevalence, constipation is frequently underdiagnosed mainly because of lack of validated diagnostic criteria or widely accepted definition of constipation in cancer patients. All cancer patients should be evaluated regularly for constipation, and concomitant causes and risk factors were assessed. Opioids are responsible for a much of the secondary constipation in cancer patients. The management of constipation in cancer patients should be multifaceted, addressing dietary and behavioral issues and optimizing pharmacological interventions. Prevention of opioid-induced constipation (OIC) is pivotal, as treatment is often unsatisfactory or inefficient. Dietary and behavioral interventions should be considered. Non-pharmacological measures include hydration and nutrition, ensuring privacy during defecation, using a commode or footstool, and the availability of a caregiver. Abdominal massage may be of value. Traditional laxatives are recommended in prevention but not in the treatment of OIC. Peripherally acting mu-opioid receptor antagonists (PAMORA) appear the first choice in the treatment and an alternative to laxatives in some recent clinical practice guidelines in preventing OIC. Naldemedine, naloxegol, and methylnaltrexone are supported by quality evidence for OIC management. Naloxone or naltrexone, taken orally in combined formulations with opioids, may be valuable in preventing or reducing OIC symptoms.

Pattern and characteristics of patients admitted to a hospice connected with an acute palliative care unit in a comprehensive cancer center.

PURPOSE: Information about inpatient hospice activity is limited. No data exist about the pattern and the characteristics of advanced cancer patients admitted to a hospice connected to an acute supportive/palliative care unit (ASPCU). METHODS: Data of hospice admissions were retrieved from the database where all data were prospectively collected. The Edmonton Symptom Assessment Scale (ESAS) and the use of analgesics and adjuvant were recorded at admission (T0), 1 week (T7), 2 weeks (T14), and the day before death (T-end). The use of palliative sedation and its indication, duration, and drugs end doses used were recorded. The number of hospice deaths, discharges, and hospice staying were recorded. RESULTS: One hundred seventy-seven patients were admitted in 13 months. There were significant differences in total ESAS at T0 (P = 0.033), total ESAS being significantly lower in patients admitted from the ASPCU than those referred from other settings. The day before death (T-end), only 48 patients could be evaluated. Patients referred by a palliative care setting were more likely to be prescribed opioids at T0 (P = 0.0007). At T-end, there was a significant increase in the use of morphine and haloperidol (P < 0.05). Seventeen percent of patients died within 48 h. Only a minority of patients could be properly assessed at T-end (25%). Palliative sedation was performed in 10.1% of patients. The mean hospice staying was 16.3 (SD 21.4) days. There were no differences in mean hospice staying between patients who died in hospice or those discharged (P = 0.873). CONCLUSION: The presence of a hospice in a comprehensive cancer center could offer a further opportunity for continuing care. Specialized palliative care may be offered to patients referred from other hospitals, home palliative care, but above all, transfer to hospice may allow a continuity of care for those patients who were initially admitted to an ASPCU for symptom control, to which anticancer therapies were withdrawn or withhold after multidisciplinary consultation. Similarly, after a proper palliative care consultation in other hospital units, patients may be referred to hospice. This process may avoid transfers to external hospices, which can prevent the continuity of care.

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.

The use of complementary alternative medicines in advanced cancer patients followed at home.

OBJECTIVES: To assess the use of complementary alternative medicines (CAM) in advanced cancer patients followed at home. METHODS: A consecutive sample of advanced cancer patients admitted to a home palliative care program was invited to participate in the study in a period of two months. Demographic characteristics, religious belief, education level, diagnosis, and socio-economic condition were recorded. Patients were asked about the use of CAM, considered to be a health-related treatment practiced outside the established health services. Information about CAM indications and those who prescribed or suggested CAM were also collected. RESULTS: Two hundred and eighty-three advanced cancer patients followed at home were surveyed. Twelve patients (4.2%) were receiving CAM. The indication and type of CAM were variable, as well as the costs. Given the low number of patients taking CAM, no further analysis was performed. CONCLUSION: A limited number of advanced cancer patients followed at home were using CAM. Further multicenter studies with a larger sample should be performed to provide information about such therapies, also including eventual benefits.

A peripheral opioid antagonist for treating urinary retention induced by opioids: A case report.

BACKGROUND: Urinary retention is a poorly studied opioid-related adverse effect. There is a paucity of data regarding the treatment of such disturbance in patients with advanced cancer receiving opioids. ACTUAL CASE: A young man, without comorbidities, was receiving 30 mg/day of oxycodone for abdominal pain due to pancreatic cancer, unsuccessfully. He also complained of severe urinary retention that developed after initiation of opioid therapy. Methadone therapy was effective on pain intensity, but bladder dysfunction persisted. POSSIBLE COURSES OF ACTION: Only anedoctal experience exists for opioid-induced urinary retention. The options included alpha-receptor blockers and flavoxate, which are symptomatic drugs, not addressed to the possible mechanism. FORMULATION OF A PLAN: The use of a peripheral opioid antagonist was planned, according to the presumed mechanism of urinary retention. Thus, naldemedine 200 mcg was prescribed for relieving urinary retention. OUTCOME: The day after starting naldemedine, urinary retention completely reversed and pain was well-controlled. LESSONS: The rational of using naldemedine was based on the component of opioid-induced urinary retention due to involvement of peripheral receptors in the bladder and sphincter. VIEW: In this case report, the effect of the peripheral opioid antagonist was prompt and long-lasting. Future studies of this neglected adverse effect of opioids should be performed to confirm this observation.

High flow nasal therapy in the management of hypoxemic dyspnea at the end of life.

Refractory dyspnea is challenging for physicians treating patients near to the end of life. High-flow nasal therapy (HFNT). We report a case in which HFNS was effective in a patient in the last days of life to mitigate dyspnea allowing a minimal quality of life for some days before dying. HFNT may be helpful for severely hypoxemic patients who are unresponsive to common measured adopted in the last weeks-days of life of advanced cancer patients. Future studies should assess an early use of this device in combination with lower doses of opioids or as an alternative.

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.

Insomnia in patients with advanced lung cancer admitted to palliative care services.

AIM: To assess the prevalence of insomnia and possible associated factors in patients with advanced lung cancer admitted to different settings of palliative care. METHODS: Secondary analysis of a consecutive sample of patients with advanced lung cancer receiving palliative care. Epidemiological and clinical data, treatments received in the last month, Karnofsky status, Edmonton Symptom Assessment System (ESAS), Athens Insomnia Scale and the Hospital Anxiety and Depression Scale (HADS), as well as concomitant medical treatment were recorded. RESULTS: One-hundred-eight-two patients with advanced lung cancer were surveyed. The mean age was 69.9 years (SD 10.8), and 121 patients (66%) were men. The majority of patients showed consistent levels of insomnia. A poor Karnofsky level, pain, nausea, and drowsiness, time from diagnosis (1-3 years), HADS anxiety, and HADS depression, were positively associated with insomnia. CONCLUSIONS: About 50% of patients with advanced lung cancer admitted to palliative care services had relevant insomnia. Several factors associated with insomnia have been identified and should prompt physicians for a careful examination and subsequent treatment.

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.

Breakthrough Cancer Pain in Patients Receiving Low Doses of Opioids for Background Pain.

BACKGROUND: This study aimed to assess the characteristics of breakthrough cancer pain (BTcP) in patients receiving low doses of opioids for background pain in comparison with patients receiving at least 60 mg of oral morphine equivalents (OME). MATERIALS AND METHODS: Patients with advanced cancer receiving less than 60 mg/day of OME with episodes of BTcP were included in the analysis (group L). Data were compared with patients receiving doses of opioids ≥60 mg of OME (group H). Pain intensity, current analgesic therapy, number of BTcP episodes, intensity of BTcP, its predictability and triggers, onset duration, interference with daily activities, BTcP medications, and time to meaningful pain relief were collected. Adverse effects imputable to a BTcP medication were recorded. RESULTS: A total of 1,418 and 2,474 patients were included in groups L and H, respectively. A lower number of BTcP episodes (p = .005), a lower BTcP intensity (p = .0001), a faster BTcP onset (p = .024), and a longer time to meaningful pain relief after taking a BTcP medication (p = .009) were found in group L as compared with group H. In group L, BTcP interference on daily activity was less than in group H (p = .009). Patients in group L were less likely to be prescribed an opioid as BTcP medication in comparison with patients in group H (p = .0001). Opioid doses used for BTcP were significantly higher in group H. Patients in group L were more likely to be less satisfied (p = .003) than patients in group H. No adverse effects of severe intensity were reported in both groups. CONCLUSION: Patients receiving lower doses of opioids exhibit some differences in BTcP presentation: fewer episodes with lower intensity and a faster onset, a longer time to meaningful pain relief, and less satisfaction with BTcP medication. A relevant percentage of patients was receiving fentanyl preparations normally reserved for patients receiving higher doses of opioids. IMPLICATIONS FOR PRACTICE: Breakthrough pain is present in patients receiving low doses of opioids. It has its own peculiarities: less frequent, lower intensity, faster onset, longer time to meaningful pain relief, and less satisfaction with medication. Many patients were prescribed fentanyl preparations, which are normally reserved for patients receiving higher doses of opioids.

Effects of age and gender in patients receiving doses of opioids for breakthrough pain proportional to background opioid doses.

AIM: To identify the role of age and gender in analgesic and adverse effects after administering fentanyl products for breakthrough pain (BT), given in doses proportional to opioid doses given for background pain. METHODS: Data from nine studies, in which patients with BP were given fentanyl products in doses proportional to their basal opioid regimen, were analyzed. RESULTS: A total 462 patients presenting 1905 episodes of BP were included in this analysis. In older patients, the decrease in pain intensity was more pronounced 15 min after administration of a BP medication. No gender differences were found. No significant differences in frequency and intensity of adverse effects for age and gender were found. CONCLUSION: Fentanyl products given for BP in doses proportional to background opioid regimen were more effective in older patients without adding risks of adverse effects. Gender did not influence analgesia and adverse effects of fentanyl products.

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.