Psychological Distress among Caregivers for Patients Who Die of Cancer: A Preliminary Study in Japan.

BACKGROUND: In Japan, little is known of the severity of and factors associated with psychological distress among caregivers of patients with advanced or recurrent cancer who die. METHODS: This prospective cohort study of cancer patients at the National Cancer Center Hospital East, Japan, and their caregivers followed the participants from the initial palliative care consultation (T1) to 6 months (T2) and 13 months (T3) after the patient's death. At T1, patients and caregivers were interviewed separately. After T1, telephone interviews were conducted periodically, and a mail survey was distributed at T2 and T3. The Patient Health Questionnaire-9 (PHQ-9) was used to assess depression, and the Distress and Impact Thermometer (DIT) was used to screen for psychological distress. Items on end-of-life attitudes, including awareness, discussion, and willingness of cancer care and death, were developed. RESULTS: Thirty-one of 86 eligible pairs participated in this study. The participation rate was low (36%) and enrollment was thus halted. Data were collected up to T3 for 22 pairs (completion rate 71%). PHQ-9 scores at T2 and T3 were higher than at T1, but the difference was not significant (p = 0.07). PHQ-9 score at T3 was significantly associated with caregiver PHQ-9 and distress at T1, with patient distress and impact at T1, and with caregiver health problems at T2. CONCLUSIONS: Caregiver depression persisted up to 13 months after the patient's death, which suggests that pre-bereavement screening with the DIT might be useful. The present paired enrollment process requires improvement.

Early specialized palliative care for patients with metastatic lung cancer receiving chemotherapy: a feasibility study of a nurse-led screening-triggered programme.

BACKGROUND: Strategies to implement early specialized palliative care have not yet been established. The present study investigated the feasibility of a nurse-led, screening-triggered early specialized palliative care intervention programme and obtained data to design a randomized controlled trial. METHODS: Patients with metastatic lung cancer undergoing first-line platinum-based chemotherapy were eligible. The intervention consisted of (1) a questionnaire-based screening programme and (2) advanced-level nurse counselling and care coordination with interdisciplinary team approach. The primary endpoint was the completion rate of the assessment questionnaire after the second course of first-line chemotherapy (T2). Secondary endpoints included changes in Functional Assessment of Cancer Therapy-Lung scores, depression and anxiety rates based on the Patient Health Questionnaire 9 and the Hospital Anxiety and Depression Scale, and the contents of specialized palliative care. RESULTS: A total of 50 patients were enrolled between August 2012 and March 2014. Median age was 66 years (range, 40-78 year) and 84% were male. A total of 38 patients had stage IV non-small cell lung carcinoma and 12 had extensive disease small-cell lung carcinoma. The completion rate was 70% (95% confidence interval 56.0-81.0). The median duration between baseline and T2 was 53 days. Improvement from baseline were observed at T2 in Functional Assessment of Cancer Therapy-Lung scores (86.0 ± 18.1 vs 94.9 ± 18.2, P = 0.057), depression (16.0 vs 5.7%; P = 0.26) and anxiety (32.0 vs 22.9%; P = 0.65); however, these results were not statistically significant. CONCLUSIONS: This early specialized palliative care intervention is feasible and could be useful in improving patients' quality of life. The present results justify the initiation of a randomized control trial.

A Population-Based Mortality Follow-Back Survey Evaluating Good Death for Cancer and Noncancer Patients: A Randomized Feasibility Study.

CONTEXT: Evaluation of end-of-life care is a key element in quality improvement, and population-based mortality follow-back designs have been used in several countries. This design was adapted to evaluate a good death in Japan. OBJECTIVES: This study aimed to explain the scientific background and rationale for assessing the feasibility of a mortality follow-back survey using a randomized design. DESIGN: We used a cross-sectional questionnaire survey to assess feasibility using response rate, sample representativeness, effect on response rate with two methods, and survey acceptability. SETTING/PARTICIPANTS: The subjects were 4812 bereaved family members of patients who died from the major five causes of death: cancer, heart disease, cerebrovascular disease, pneumonia, or kidney failure, using mortality data. RESULTS: Overall, 682 (14.2%) questionnaires could not be delivered, and 2294 (55.5%) family members agreed to participate in the survey. There was little difference in the distribution of characteristics between the study subjects and the full population, and sample representativeness was acceptable. Sending the questionnaire with a pen achieved a higher response rate than without (weighted: 48.2% vs. 40.8%; P < 0.001). In follow-up contact, there was no difference in response rate between resending the questionnaire and a reminder letter alone (weighted: 32.9% vs. 32.4%; P = 0.803). In total, 84.8% (weighted) of the participants agreed with improving quality of care through this kind of survey. CONCLUSION: This study demonstrated the feasibility of conducting a population-based mortality follow-back survey using a randomized design. An attached pen with the questionnaire was effective in improving the response rate.

Nurse-led, screening-triggered, early specialised palliative care intervention programme for patients with advanced lung cancer: study protocol for a multicentre randomised controlled trial.

INTRODUCTION: It has been suggested that palliative care integrated into standard cancer treatment from the early phase of the disease can improve the quality of life of patients with cancer. In this paper, we present the protocol for a multicentre randomised controlled trial to examine the effectiveness of a nurse-led, screening-triggered, early specialised palliative care intervention programme for patients with advanced lung cancer. METHODS AND ANALYSIS: A total of 206 patients will be randomised (1:1) to the intervention group or the control group (usual care). The intervention, triggered with a brief self-administered screening tool, comprises comprehensive need assessments, counselling and service coordination by advanced-level nurses. The primary outcome is the Trial Outcome Index of the Functional Assessment of Cancer Therapy (FACT) at 12 weeks. The secondary outcomes include participants' quality of life (FACT-Lung), depression (Patient Health Questionnaire-9), anxiety (Generalized Anxiety Disorder-7), illness perception (Prognosis and Treatment Perceptions Questionnaire), medical service use and survival. A mixed-method approach is expected to provide an insight about how this intervention works. ETHICS AND DISSEMINATION: This study has been approved by the Institutional Review Board of the National Cancer Center Japan (approval number: 2016-235). The findings will be disseminated through peer-reviewed publications and conference presentations and will be reflected on to the national healthcare policy. TRIAL REGISTRATION NUMBER: UMIN000025491.

The association between health-related quality of life and achievement of personalized symptom goal.

PURPOSE: The aim of study was to explore the potential association between patient's self-reported physical symptom management goals as personalized symptom goal (PSGs) and health-related quality of life (HRQOL) in cancer patients. The secondary outcome was to investigate the relationship between number of physical symptoms not achieving the PSGs and HRQOL in cancer patients. METHODS: This single-center prospective observational study comprised 140 consecutive outpatients. We evaluated the PSGs and HRQOL using the Functional Assessment of Cancer Therapy-General (FACT-G). Patients were administered a self-report questionnaire, including reports on their physical symptom intensity and PSGs using Edmonton Symptom Assessment System-revised (ESAS-r) scores. We investigated the correlation between PSGs achievement (ESAS-r score ≤ PSG score) and FACT-G total scores, and relationship between and number of physical symptoms not achieving the PSGs (ESAS-r score > PSG score) and FACT-G total scores. RESULTS: The patients who did not achieve PSGs of pain, tiredness, lack of appetite, and shortness of breath had a lower FACT-G total score (p < 0.05). Multivariate linear regression showed that higher number of physical symptoms not achieving the PSGs correlated with lower FACT-G scores (decreasing by 1.826 points for each such symptom, p < 0.01). Predictors of increased number of physical symptoms not achieving the PSGs were younger age and a higher symptom intensity of anxiety. CONCLUSION: PSGs achievement was associated with HRQOL in cancer patients. Additionally, the number of unachieved PSGs were independent determinant of poor HRQOL, particularly in younger cancer patients and those with higher symptom intensity of anxiety.

Usefulness of painDETECT and S-LANSS in identifying the neuropathic component of mixed pain among patients with tumor-related cancer pain.

PURPOSE: Tumor-related cancer pain often comprises mixed pain with both nociceptive and neuropathic components. Whether tumor-related cancer pain includes a neuropathic component impacts the therapeutic strategy. The aim of this cross-sectional study was to investigate the usefulness of two screening tools for neuropathic pain, painDETECT and Self-Report Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS), in identifying the neuropathic component of mixed pain among patients with tumor-related cancer pain. METHOD: This cross-sectional study recruited consecutive inpatients and outpatients at a single site. The diagnostic accuracy of painDETECT and S-LANSS was evaluated using receiver operating characteristic curve analysis and classification probability. RESULTS: Of the study group, 106 patients had tumor-related cancer pain. Analyses of the nociceptive and mixed pain groups (n = 104) showed that neither painDETECT nor S-LANSS had satisfactory areas under the curve (AUCs) for identifying the neuropathic component of mixed pain (0.59 for painDETECT and 0.56 for S-LANSS). By pain intensity, the AUC for painDETECT was significantly higher in the mild pain group than in the moderate or severe pain group (0.77 vs. 0.43, P = 0.002). All parameters of classification probability for both tools were higher in the mild pain group than in the moderate or severe pain group. CONCLUSIONS: painDETECT and S-LANSS could not identify the neuropathic component of mixed pain among patients with tumor-related cancer pain, especially when pain was moderate or severe. Contrarily, these screening tools might be useful for identifying the neuropathic component of mixed pain for mild pain.

Fan Therapy Is Effective in Relieving Dyspnea in Patients With Terminally Ill Cancer: A Parallel-Arm, Randomized Controlled Trial.

CONTEXT: Dyspnea is a common distressing symptom among patients with advanced cancer. OBJECTIVE: The objective of this study was to determine the effect of fan therapy on dyspnea in patients with terminally ill cancer. METHODS: This parallel-arm, randomized controlled trial included 40 patients with advanced cancer from a palliative care unit at the National Cancer Center Hospital in Japan. All patients experienced dyspnea at rest with a score of at least three points on a subjective 0- to 10-point Numerical Rating Scale (NRS), showed peripheral oxygen saturation levels of ≥90%, had an Eastern Cooperative Oncology Group grade of 3 or 4, and were aged 20 years or more. In one group, a fan was directed to blow air on the patient's face for five minutes. This group was compared to a control group wherein air was blown to the patient's legs. Patients were randomly assigned to each group. The main outcome measure was the difference in dyspnea NRS scores between fan-to-face and fan-to-legs groups. RESULTS: No significant differences were seen in baseline dyspnea NRS between groups (mean score, 5.3 vs. 5.1, P = 0.665). Mean dyspnea changed by -1.35 points (95% CI, -1.86 to -0.84) in patients assigned to receive fan-to-face and by -0.1 points (-0.53 to 0.33) in patients assigned to receive fan-to-legs (P < 0.001). The proportion of patients with a one-point reduction in dyspnea NRS was significantly higher in the fan-to-face arm than in the fan-to-legs arm (80% [n = 16] vs. 25% [n = 5], P = 0.001). CONCLUSION: Fan-to-face is effective in alleviating dyspnea in patients with terminally ill cancer.

Breakthrough Cancer Pain Influences General Activities and Pain Management: A Comparison of Patients with and without Breakthrough Cancer Pain.

BACKGROUND: Breakthrough cancer pain (BTcP) is a predictor of interference with general activities and poor pain management. The extent of this influence has not yet been determined. OBJECTIVE: This study aimed to investigate the influence of BTcP on general activities, and pain management in patients with controlled background pain. DESIGN: Single-center prospective observational study. SETTING/SUBJECTS: The study cohort comprised 258 consecutive patients (female, 40.0%; mean age, 64.5 years) who had received opioid medication for cancer pain for over 2 weeks. MEASUREMENTS: A recommended diagnostic algorithm was used to quantitate and compare interference with general activities, average background pain intensity over the previous 24 hours (24h-PI), and achievement of personalized pain goals (PPGs) (24h-PI≤PPG) of 119 patients with and 139 patients without BTcP. RESULTS: Interference with general activities, 24h-PI, and PPG scores [mean (standard deviation)] in patients with BTcP were 2.8 (2.2), 3.0 (1.7), and 1.8 (1.4), respectively, which are all significantly higher than for those without BTcP [1.3 (2.0), p < 0.01; 1.7 (1.6), p < 0.01; 1.5 (1.3), p = 0.03], respectively. A significantly smaller percentage of patients with BTcP than without BTcP achieved their PPGs (36.1% vs. 67.6%, p < 0.01). CONCLUSIONS: BTcP has a negative impact on general activities and pain management. Healthcare providers should recognize that management of BTcP is important in improving general activities and management of cancer pain.

Evaluation of the Appropriate Washout Period Following Fan Therapy for Dyspnea in Patients With Advanced Cancer: A Pilot Study.

OBJECTIVES: To clarify the duration required for dyspnea to return to baseline severity after fan therapy, to evaluate whether fan-to-legs therapy or no fan therapy would be a suitable control therapy, and to investigate changes in patients' face surface temperature after fan therapy. METHODS: In this pilot study, all participants received 3 interventions in the following order: no fan, fan to legs, and fan to face. Participants used a fan for 5 minutes, and they scored their dyspnea at 10-minute intervals for 60 minutes or until the score had returned to its baseline value, whichever occurred first. Nine patients with advanced cancer admitted to a palliative care unit were included; they had dyspnea at rest and rated its severity as at least 3 points on a 0- to 10-point numerical rating scale. Descriptive statistics and the Wilcoxon signed rank test were used to analyze the data. RESULTS: All patients completed the study. Of the 9 participants, 6 experienced a clinical benefit from using a fan to their faces. Of these patients, only 2 participants' (2 of 6) dyspnea scores returned to baseline by the end of the 60-minute assessment period after exposure to fan-to-face therapy. In fan-to-legs and no fan settings, there was no change in the dyspnea scores. There were significant differences between the baseline face surface temperature and that after fan-to-face and fan-to-legs settings. CONCLUSION: When using a crossover design to investigate the effect of fan therapy on dyspnea, 1 hour is an insufficient washout period.

Low Transthyretin Levels Predict Poor Prognosis in Cancer Patients in Palliative Care Settings.

OBJECTIVES: Although transthyretin (TTR) is a nutritional indicator and is influenced by systemic inflammation, it may be a good prognostic indicator for cancer patients in palliative care settings. This study investigates the correlation between low TTR levels and survival among cancer patients in palliative care settings. METHODS: This was a sub-analysis of a prospective, multicenter cohort study. Patients who had advanced-stage cancer and who were newly referred to palliative care services were eligible to participate; however, those receiving anti-tumor therapy were excluded. Survival analyses were performed to clarify predictors of poor prognosis. RESULTS: A total of 144 patients were enrolled (45.1% female; median age, 72 years). Cox regression analysis revealed that low TTR levels (<10.9 mg/l) (hazard ratio 1.74, P = 0.025), poor muscle power (1.71, P = 0.045), and fatigue (1.89, P = 0.024) were predictors of poor prognosis. Median survival in patients with low TTR levels (<10.9 mg/l) was 26 days, which was significantly shorter than those with high TTR levels (≥10.9 mg/l) (50 days; P < 0.001). CONCLUSION: Low TTR levels may be indicators for poor prognosis among cancer patients in palliative care settings.

Comparison of Indicators for Achievement of Pain Control With a Personalized Pain Goal in a Comprehensive Cancer Center.

CONTEXT: The achievement of a personalized pain goal (PPG) is advocated as an individualized pain relief indicator. OBJECTIVES: Pain relief indicators, including PPG, pain intensity (PI), and interference with daily activities (interference), were compared herein. METHODS: This was a single-center cross-sectional study. Adult patients with cancer on opioid medications who visited the outpatient clinic at the National Cancer Center Hospital East between March and September 2015 were consecutively enrolled. Patients conducted a self-report questionnaire, including reports of average PI, interference, PPG, and the need for further analgesic treatment. We compared the proportion of patients achieving PPG (PI ≤ PPG) and other pain relief indicators including PI ≤3 or interference ≤3 and the percentage of patients who did not need further analgesic treatment among those who fulfilled each pain relief indicator. RESULTS: A total of 347 patients (median age 64; 38% females) were analyzed. Median (interquartile range [IQR]) of PPG, PI, and interference was 2 (IQR 1-3), 2 (IQR 1-4), and 2 (IQR 0-5), respectively. The proportion of patients achieving PPG was 45.3% and significantly lower than those with PI ≤3 (69.0%; P < 0.001) and interference ≤3 (70.2%; P < 0.001). Eighty percent of patients achieving PPG did not need further analgesic treatment, whereas 70.8% of patients with PI ≤3 (P < 0.001) and 73.3% with interference ≤3 did need further analgesic treatment (P < 0.001). CONCLUSION: The achievement of PPG was a stricter pain relief indicator than PI and interference and may reflect a real need for pain control.

C-reactive protein, symptoms and activity of daily living in patients with advanced cancer receiving palliative care.

BACKGROUND: The association between C-reactive protein (CRP) level, symptoms, and activities of daily living (ADL) in advanced cancer patients is unclear. METHODS: Secondary data analysis of a multicenter prospective cohort study consisted of 2426 advanced cancer patients referred to palliative care settings was conducted to examine the cross-sectional relationships between CRP level, symptoms, and ADL disabilities. Laboratory data, symptoms, ADL, and manual muscle testing (MMT) results were obtained at baseline. Participants were divided into four groups: low (CRP < 1 mg/dl), moderate (1 = < CRP <5 mg/dl), high (5 = < CRP < 10 mg/dl), and very high CRP (10 mg/dl = < CRP). The proportions of eight symptoms, five ADL disabilities, and three categories of MMT according to the CRP groups were tested by chi-square tests. Multiple-adjusted odd ratios (ORs) were calculated by using ordinal logistic regression after adjustment for age, gender, site of primary cancer, metastatic disease, performance status, chemotherapy, and setting of care. RESULTS: A total of 1702 patients were analysed. Positive rates of symptoms and ADL disabilities increased with increasing CRP level. In the very high-CRP group, rates of positivity for anorexia, fatigue, and weight loss were 89.8%, 81.0%, and 79.2%, respectively, and over 70% of patients received assistance for bathing, dressing, going to the toilet, and transfer. The grade of MMT also deteriorated with increasing CRP level. Adjusted ORs for the accumulated symptoms significantly increased with increasing CRP level in the moderate-CRP, high-CRP, and very high-CRP groups [1.6 (95% confidence interval 1.2-2.0), P < 0.001; 2.5 (1.9-3.2), P < 0.001; 3.5 (2.7-4.6), P < 0.001, respectively]. Adjusted ORs for the accumulated ADL disabilities significantly increased in the very high-CRP groups [2.1 (1.5-2.9), P < 0.001]. CONCLUSIONS: Associations between CRP level, symptoms, and ADL were observed in advanced cancer patients receiving palliative care.

Screening using the fifth vital sign in the electronic medical recording system.

PURPOSE: To investigate the usefulness of screening for patient symptoms as the fifth vital sign using an electronic medical recording system. PATIENTS AND METHODS: In the electronic medical recording system, all admitted patients received routine nurse-based assessment of discomfort (defined as any physical symptom) at every vital sign check regarding item 2 of the Support Team Assessment Schedule Japanese version (STAS-J). All cancer patients admitted to oncology units were screened at 1-week intervals. Screening-positive was defined when patients had a STAS-J score of 2 or more at least two times in a week. For all screening-positive patients, the palliative care team reviewed each patient's medical records, and provided written recommendations as needed. The primary outcomes were the proportion of screening-positive patient, and the proportion of patients deemed to need additional palliative treatment in the screening-positive patients. RESULTS: Of 2427 patients screened, 223 (9.1%; 95% confidence interval, 8-10%) met the screening-positive criterion. A total of 12 (5.4%; 95% confidence interval, 3-9%) of them were deemed to need additional palliative care, including six patients referred to the PCT within 1 week. In the remaining 211 screening-positive patients, 100 had received adequate palliative care, 68 had already been referred to the palliative care team and 43 had self-limiting transient discomfort. CONCLUSION: This screening system was feasible but the majority of screening-positive patients did not require additional palliative care interventions.

Changes in Relatives' Perspectives on Quality of Death, Quality of Care, Pain Relief, and Caregiving Burden Before and After a Region-Based Palliative Care Intervention.

CONTEXT: A region-based palliative care intervention (Outreach Palliative Care Trial of Integrated Regional Model Study) increased home death, access to specialist palliative care, quality of care, and quality of death and dying. OBJECTIVES: The objective of this study was to examine changes in palliative care outcomes in different care settings (hospitals, palliative care units, and home) and obtain insights into how to improve region-level palliative care. METHODS: The intervention program was implemented from April 2008 to March 2011. Two bereavement surveys were conducted before and after intervention involving 4228 family caregivers of deceased cancer patients. Family-perceived quality of care (range 1-6), quality of death and dying (1-7), pain relief (1-7), and caregiver burden (1-7) were measured. RESULTS: Response rates were 69% (preintervention) and 66% (postintervention), respectively. Family-perceived quality of care (adjusted mean 4.89, 95% CI 4.54-5.23) and quality of death and dying (4.96, 4.72-5.20) at home were the highest and sustained throughout the study. Palliative care units were at the intermediate level between home and hospitals. In hospitals, both quality of care and quality of death and dying were low at baseline but significantly improved after intervention (quality of care: 4.24, 4.13-4.34 to 4.43, 4.31-4.54, P = 0.002; quality of death and dying: 4.22, 4.09-4.36 to 4.36, 4.22-4.50, P = 0.012). Caregiver burden did not significantly increase after intervention, regardless of place of death. CONCLUSIONS: The dual strategies of transition of place of death to home and improving quality of care in hospitals should be recognized as important targets for improving region-level palliative care.

Current Status of Distress Screening in Designated Cancer Hospitals: A Cross-Sectional Nationwide Survey in Japan.

BACKGROUND: The purpose of this study was to investigate the current status of distress screening implementation in Japanese designated cancer hospitals. SUBJECTS AND METHODS: This was a cross-sectional observational study. Palliative care team representatives in all designated cancer hospitals in Japan completed an ad hoc questionnaire. Demographic data in 2014 were obtained from the Ministry of Health, Labour and Welfare in Japan. RESULTS: Of 422 institutions, 389 responded (92%) and data were obtained from 379 (90%). Approximately 90% of institutions had implemented a distress screening program at some level, and approximately 60% had just started screening. Among those institutions that screened, 77% provided individualized triage to specialized services within the institutions, whereas 60% did not routinely follow-up with patients who had positive screening results. The estimated median percentage of screened patients referred to palliative care teams was 0.4% in outpatient settings and 6.3% in inpatient settings. Although 68% of respondents perceived that screening was useful overall, they also reported difficulties when conducting screening with patients, reporting "no established effective treatment for problems screened" (66%), "patients complain it is difficult to express their distress using scales" (58%), and that it was "difficult to manage screened problems because of lack of time" (49%). Eight perceived barriers to implementing distress screening programs in hospitals were identified; a lack of human resources ranked highest. CONCLUSIONS: Implementation of distress screening in designated cancer hospitals in Japan has just begun. Policymakers should acknowledge that screening can be beneficial for patients when it is implemented with appropriate resources and established methods.

Clinical Implications of C-Reactive Protein as a Prognostic Marker in Advanced Cancer Patients in Palliative Care Settings.

CONTEXT: Plasma C-reactive protein (CRP) levels are elevated in patients with advanced cancer. OBJECTIVES: To investigate CRP as a prognostic marker in palliative settings. METHODS: This multicenter prospective cohort study comprised 2426 patients. Laboratory data were obtained at baseline, and all patients were followed until death or six months after their enrollment. A total of 1511 patients were eligible for the analyses. They were divided into four groups: low-CRP (CRP < 1 mg/dL), moderate-CRP (1 ≤ CRP <5 mg/dL), high-CRP (5 ≤ CRP <10 mg/dL), and very high-CRP (10 mg/dL ≤ CRP) groups. Survival was investigated by the Kaplan-Meier method with the log-rank test. The 30-, 60-, and 90-day mortality rates were tested by Chi-squared tests. Univariate- and multivariate-adjusted hazard ratios (HRs) and 95% CIs in each group were calculated using Cox proportional hazard models. RESULTS: Survival rate decreased and mortality rate increased with increasing CRP level. The differences in survival and 30-, 60-, and 90-day mortality rates among the groups were statistically significant (P < 0.001). Baseline CRP level was significantly associated with a higher risk of mortality after adjustment for age, gender, primary tumor site, metastasis, chemotherapy, Eastern Cooperative Oncology Group Performance Status, and setting of care (moderate-CRP: HR 1.47 [95% CI 1.24-1.73], high-CRP: HR 2.09 [95% CI 1.74-2.50], and very high-CRP: HR 2.55 [95% CI 2.13-3.05] vs. low-CRP). CONCLUSION: Clear dose-effect relationships between elevated CRP levels and prognoses indicate that CRP could be useful in predicting prognoses in patients with advanced cancer.

Effect of continuous deep sedation on survival in patients with advanced cancer (J-Proval): a propensity score-weighted analysis of a prospective cohort study.

BACKGROUND: Continuous deep sedation (CDS) before death is a form of palliative sedation therapy that has become a focus of strong debate, especially with respect to whether it shortens survival. We aimed to examine whether CDS shortens patient survival using the propensity score-weighting method, and to explore the effect of artificial hydration during CDS on survival. METHODS: This study was a secondary analysis of a large multicentre prospective cohort study that recruited and followed up patients between Sept 3, 2012, and April 30, 2014, from 58 palliative care institutions across Japan, including hospital palliative care settings, inpatient palliative care units, and home-based palliative care services. Adult patients (aged ≥ 20 years) with advanced cancer who received care through the participating palliative care services were eligible for this secondary analysis. Patients with missing data for outcome variables or who lived for more than 180 days were excluded. We compared survival after enrolment between patients who did and did not receive CDS. We used a propensity score-weighting method to control for patient characteristics, disease status, and symptom burden at enrolment. FINDINGS: Of 2426 enrolled patients with advanced cancer, we excluded 289 (12%) for living longer than 180 days and 310 (13%) with missing data, leaving an analysis population of 1827 patients. 269 (15%) of 1827 patients received CDS. Unweighted median survival was 27 days (95% CI 22-30) in the CDS group and 26 days (24-27) in the no CDS group (median difference -1 day [95% CI -5 to 4]; HR 0·92 [95% CI 0·81-1·05]; log-rank p=0·20). After propensity-score weighting, these values were 22 days (95% CI 21-24) and 26 days (24-27), respectively (median difference -1 day [95% CI -6 to 4]; HR 1·01 [95% CI 0·87-1·17]; log-rank p=0·91). Age (p(interaction)=0·67), sex (p(interaction)=0·26), performance status (p(interaction)=0·90), and volume of artificial hydration (p(interaction)=0·14) did not have an effect modification on the association between sedation and survival, although care setting did have a significant effect modification (p(interaction)=0·021). INTERPRETATION: CDS does not seem to be associated with a measurable shortening of life in patients with advanced cancer cared for by specialised palliative care services, and could be considered a viable option for palliative care in this setting. FUNDING: Japanese National Cancer Center Research and Development Fund.

The effects of community-wide dissemination of information on perceptions of palliative care, knowledge about opioids, and sense of security among cancer patients, their families, and the general public.

PURPOSE: Prejudices against palliative care are a potential barrier to quality end-of-life care. There have been few large-scale community-wide interventions to distribute appropriate information about palliative care, and no studies have investigated their impact on cancer patients, their families, and the general public. Thus, we conducted a 3-year community intervention and evaluated the effects of distributing such information at the community level, and explored associations among levels of exposure, perceptions, knowledge, and the sense of security achieved. METHODS: Over a period of 3 years, we provided flyers, booklets, posters, and public lectures about palliative care in four regions of Japan, and carried out pre- and post-intervention surveys with repeated cross-sectional samplings of cancer patients (pre 859, post 857), bereaved family members (1110, 1137), and the general public (3984, 1435). The levels of exposure to the provided information were measured by a multiple-choice questionnaire after intervention. Multiple logistic regression analyses were used to estimate multivariable-adjusted odds ratios (ORs) for perceptions of palliative care, knowledge about opioids, and sense of security among the exposure groups. RESULTS: Overall perceptions of palliative care, opioids, and receiving care at home improved significantly among the general public and families, but not among the patients at the community level. However, multiple regression revealed that patients of extensive exposure category had significantly more positive perceptions of palliative care to those of non-exposure category (p = 0.02). The sense of security regarding cancer care of all patients, family members, and the general public improved. Among others, the respondents who reported extensive exposure in the general public and family members scored significantly higher sense of security. CONCLUSION: Our findings indicate that providing palliative care information via small media and lectures in the community is effective in improving perceptions of palliative care and knowledge about opioids among the community dwellers, especially for caregivers of the patients. The acquisition of adequate knowledge about palliative care from various information sources may improve people's sense of security regarding cancer.

Preferences of advanced cancer patients for communication on anticancer treatment cessation and the transition to palliative care.

BACKGROUND: The objective of this study was to clarify the communication preferences of patients with advanced cancer regarding discussions about ending anticancer treatment and transitioning to palliative care and to explore the variables associated with those preferences. METHODS: Participants were 106 Japanese patients with cancer who had been informed at least 1 week earlier about the cessation of their anticancer treatment. They completed a survey measuring their preferences for communication about ending anticancer treatment and transitioning to palliative care as well as their demographic characteristics. Medical records were also examined to investigate medical characteristics. RESULTS: Results of the descriptive analysis indicated that patients strongly preferred their physicians to listen to their distress and concerns (96%), to assure them that their painful symptoms would be controlled (97.1%), and to explain the status of their illness and the physical symptoms that would likely occur in the future (95.1%). Multiple regression analyses identified the factors associated with these preferences: telling patients to prepare mentally and informing them of their expected life expectancy were associated with cancer site; sustaining hope was associated with cancer site and children; and empathic paternalism was associated with duration since cancer diagnosis. CONCLUSIONS: The majority of patients preferred their physicians to be realistic about their likely future and wanted to be reassured that their painful symptoms would be controlled. For patients with cancer at certain sites, those with children, and those more recently diagnosed, physicians should communicate carefully and actively by providing information on life expectancy and mental preparation, sustaining hope, and behaving with empathic paternalism.

Survival prediction for advanced cancer patients in the real world: A comparison of the Palliative Prognostic Score, Delirium-Palliative Prognostic Score, Palliative Prognostic Index and modified Prognosis in Palliative Care Study predictor model.

PURPOSE: The aim of this study was to investigate the feasibility and accuracy of the Palliative Prognostic Score (PaP score), Delirium-Palliative Prognostic Score (D-PaP score), Palliative Prognostic Index (PPI) and modified Prognosis in Palliative Care Study predictor model (PiPS model). PATIENTS AND METHODS: This multicentre prospective cohort study involved 58 palliative care services, including 19 hospital palliative care teams, 16 palliative care units and 23 home palliative care services, in Japan from September 2012 to April 2014. Analyses were performed involving four patient groups: those treated by palliative care teams, those in palliative care units, those at home and those receiving chemotherapy. RESULTS: We recruited 2426 participants, and 2361 patients were finally analysed. Risk groups based on these instruments successfully identified patients with different survival profiles in all groups. The feasibility of PPI and modified PiPS-A was more than 90% in all groups, followed by PaP and D-PaP scores; modified PiPS-B had the lowest feasibility. The accuracy of prognostic scores was ⩾69% in all groups and the difference was within 13%, while c-statistics were significantly lower with the PPI than PaP and D-PaP scores. CONCLUSION: The PaP score, D-PaP score, PPI and modified PiPS model provided distinct survival groups for patients in the three palliative care settings and those receiving chemotherapy. The PPI seems to be suitable for routine clinical use for situations where rough estimates of prognosis are sufficient and/or patients do not want invasive procedure. If clinicians can address more items, the modified PiPS-A would be a non-invasive alternative. In cases where blood samples are available or those requiring more accurate prediction, the PaP and D-PaP scores and modified PiPS-B would be more appropriate.