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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.

Purpose The Scored Patient-Generated Subjective Global Assessment (PG-SGA(C)) is a globally recognized and used nutritional screening, assessment, monitoring, and triaging tool. The aim of this study was to translate and culturally adapt the original English PG-SGA for the Japanese speaking populations and to assess its linguistic validity (i.e., comprehensibility, difficulty) and content validity, as perceived by Japanese patients and healthcare professionals. Methods In accordance with methodology used in previous Dutch, Thai, German, and Norwegian PG-SGA studies, we followed the ten steps of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Principles of Good Practice for Translation and Cultural Adaptation for Patient-Reported Outcome Measures. The study enrolled 50 patients and 50 healthcare professionals (HCPs) to evaluate the comprehensibility and difficulty of the translated and culturally adapted PG-SGA. The HCPs also evaluated the content validity of the translation. We evaluated each item and quantified scale indices for content validity (item content validity index (I-CVI), scale content validity index (S-CVI)), comprehensibility (item comprehensibility index (I-CI), scale comprehensibility index (S-CI)), and difficulty (item difficulty index (I-DI), scale difficulty index (S-DI)). Results Patients evaluated the comprehensibility and difficulty of the patient component as excellent (S-CI = 0.97, S-DI = 0.96). The professionals rated the Japanese version of both components of the PG-SGA as very relevant (S-CVI = 0.94). The professionals evaluated the comprehensibility of the professional component as being acceptable (S-CI = 0.88) but difficult (S-DI = 0.69), based predominantly on items related to physical examination (I-DI = 0.33-0.67). Conclusion The PG-SGA was systematically translated and culturally adapted for the Japanese setting according to the ISPOR process. The Japanese version of the PG-SGA was perceived as comprehensive, easy to use, and relevant. Perceived difficulty in professional components, specifically in the context of metabolic demand and physical examination, will require appropriate training for professionals in order to optimize implementation.

Summary: Background & Aims: The prevalence of artificially administered nutrition and hydration (AANH) in different age groups among patients with advanced cancer remains unknown. The present study investigated the current utilization of AANH according to age groups in palliative care units. Methods: This was a secondary analysis of a prospective cohort study. We obtained information on primary nutritional administration routes during the first week of admission and data on the averaged calorie sufficiency rate or total calorie intake on the 7th day of admission. Patients were divided into five age groups (18–39, 40–59, 60–74, 75–89, and 90- years). Among patients receiving AANH, the proportions of higher-calorie AANH were compared between the five age groups. Results: A total of 1453 patients were included. The proportion of patients categorized as receiving nutrition and hydration via the parenteral route was the highest in the 18–39 and 40–59 groups (52.4 and 41.1%, respectively). Among patients receiving AANH (n = 534), the proportions of patients categorized into the

Objective: No standard treatment for cancer-related fatigue (CRF) for inpatients in a palliative care setting exists. The aim of this study was to validate the previous study-derived efficacy of dexamethasone 8 mg for CRF among inpatients in a palliative care setting. Methods: Inpatients with moderate fatigue (≥4/10) were enrolled in a multicenter phase II trial. Dexamethasone 8 mg p.o. or 6.6 mg i.v. was administered for seven days and 4 mg p.o. or 3.3 mg i.v. for seven consecutive days. The primary endpoint was a threshold average change of Functional Assessment of Chronic Illness Therapy (FACIT)-fatigue subscale score of 3. The secondary endpoints were evaluated with the anorexia-cachexia subscale (ACS), and the Edmonton symptom assessment scale-revised Japanese version. Results: A total of 32 patients were enrolled. On day 8, the mean change of FACIT-fatigue subscale from day 1 was 5.2 (95% confidence interval 0.8–10.0), in which the lower bound was above 0 but not above the prespecified threshold value of 3.0 (p = 0.72). Edmonton symptom assessment system (ESAS)-fatigue was significantly improved by day 3 (p = 0.02), but not on day 8 or day 15. ACS, physical well-being, and ESAS-lack of appetite significantly improved by day 8 and day 15. Adverse events were tolerable. Conclusion: This study showed that dexamethasone 8 mg failed to achieve the preset efficacy for CRF among inpatients in a palliative care setting. However, this treatment improved fatigue and would be an option for CRF. jRCT (jRCTs031180068).

IntroductionIn patients with incurable advanced cancer, preferences about treatment and how to spend their final days are not adequately discussed. This process of discussion is called “advanced care planning” (ACP), and timely intervention is recommended. As the communication attitude of healthcare providers is a critical factor in ACP facilitation, improving their communication attitudes may reduce patient distress, improve care satisfaction, and reduce unnecessarily aggressive treatment. Digital mobile devices are being developed for behavioral interventions due to their low space and time restrictions, and the ease of sharing information. The purpose of this study is to evaluate the effectiveness of a facilitation program utilizing a mobile app developed to improve communication between cancer patients and healthcare providers regarding ACP.Methods and analysisThis study utilizes a parallel-group, evaluator-blind, randomized controlled trial design. We plan to recruit 264 adult patients with incurable advanced cancer. Intervention group participants will use a mobile app ACP program and undergo a 30-minute interview with a trained intervention provider to discuss with the oncologist at the next patient visit. Control group participants will continue their usual treatment. The primary outcome is the oncologist’s communication behavior score assessed using audio recordings of the consultation. The secondary outcomes include communication between patients and oncologists and the patients’ distress, quality of life, care goals and preferences, and medical care utilization. We will use a full analysis set with the registered participant population who received at least a part of the intervention.Ethics and disseminationThe study protocol was reviewed and approved by the Scientific Advisory Board of the Japan Supportive, Palliative and Psychosocial Oncology Group (Registration No. 2104) and the Institutional Review Board of the National Cancer Center Hospital (registration No. 2020-500). The results of the RCT will be published in peer-reviewed scientific journals and presented at scientific meetings.Strengths and limitations of this studyRandomized controlled trials using mobile apps for behavior change and psychological interventions are increasing, and this study is unique in its focus on facilitating communication about advanced care planning (ACP).The intervention will include mobile apps which can be used in environments the participants find relaxing and engaging. The benefit is particularly significant for patients with advanced cancer who need to express their values and what is crucial to them.There is currently no gold standard for evaluating ACP discussions between patients and healthcare providers. The methods facilitate ACP discussions in various aspects of this study to produce a variety of practical insights.The timing of introducing ACP discussions must be individualized to each patient, and it is anticipated that some participants may find this intervention burdensome. Therefore, more careful ACP referrals are needed, and qualitative exploration of study dropouts is needed.Multiple intervention components make it difficult to determine which is most effective. Individualized assessments of app usage, intervention adherence, and patient satisfaction could clarify the challenges and help determine next steps.

Parenteral morphine is widely used for dyspnea of imminently dying cancer patients (terminal dyspnea). However, the efficacy of other opioids such as oxycodone remains largely unknown.To explore the efficacy of parenteral oxycodone vs. morphine by continuous infusion over 24 hours in cancer patients with terminal dyspnea.This was a pre-planned subgroup analysis of a multicenter prospective observational study. Inclusion criteria were advanced cancer patients admitted to palliative care units, Eastern Cooperative Oncology Group performance status = 3-4, and a dyspnea intensity ≥2 on the Integrated Palliative care Outcome Scale (IPOS) for which oxycodone or morphine was initiated by continuous infusion. We measured dyspnea IPOS scores over 24 hours.We analyzed 164 patients who received oxycodone (n = 26) and morphine (n = 138) for dyspnea (median survival = 5 days). The mean age was 70 years, 58 patients (35%) had lung cancer, and 97 (59%) had lung metastases. Complete case analysis revealed that mean dyspnea IPOS scores decreased from 3.0 (standard deviation = 0.7) to 1.5 (0.7) in the oxycodone group (difference in means = 1.5; P 0.001), and from 2.9 (0.7) to 1.6 (1.0) in the morphine group (difference in means = 1.3; P 0.001). No significant between-group differences existed in the IPOS scores at 24 hours (P = 0.753). Adverse events were seen in no and 5 patients in the oxycodone and morphine groups, respectively.Parenteral oxycodone may be equally effective and safe as morphine in the treatment of terminal dyspnea in cancer patients. Future randomized controlled trials should confirm the efficacy and safety of opioids other than morphine for terminal dyspnea.

Cancer patients with minor children are increasing; however, they do not receive sufficient support.This study aimed to investigate the association between loneliness and the frequency of using online peer support groups among cancer patients with minor children.A cross-sectional web-based survey was conducted from April to May 2019. Cancer patients with minor children were recruited from an online peer support group called "Cancer Parents." Individuals diagnosed with cancer and whose youngest children were younger than 18 years were enrolled. Materials included: the UCLA Loneliness Scale version 3 (UCLA-LS), K6 scale, abbreviated Lubben Social Network Scale, and the sociodemographic/clinical characteristics questionnaire. Multivariate logistics regression analysis was performed to determine the factors associated with the high loneliness group (defined as those above the median score on the UCLA-LS).A total of 334 patients participated (79.9% female; mean age 43.1 years, standard deviation 5.8). The most common primary cancer type was breast (34.1%). The median score of the UCLA-LS was 45 (interquartile range 37-53). The multivariate logistics regression analysis revealed that the high loneliness group was significantly associated with the frequent use of online peer support group less than once a week (odds ratio [OR] = 0.47; 95% CI = 0.26-0.85; P = 0.012), with a smaller social network (OR = 0.78; 95% CI = 0.73-0.83; P 0.001), and higher psychological distress (OR = 1.16; 95% CI = 1.09-1.23; P 0.001).Frequent use of online peer support groups was associated with less loneliness among cancer patients with minor children.

IntroductionTimely implementation of the discussion process of advance care planning (ACP) is recommended. The communication attitude of healthcare providers is critical in ACP facilitation; thus, improving their communication attitudes may reduce patient distress and unnecessary aggressive treatment while enhancing care satisfaction. Digital mobile devices are being developed for behavioural interventions owing to their low space and time restrictions and ease of information sharing. This study aims to evaluate the effectiveness of an intervention programme using an application intended to facilitate patient questioning behaviour on improving communication related to ACP between patients with advanced cancer and healthcare providers.Methods and analysisThis study uses a parallel-group, evaluator-blind, randomised controlled trial design. We plan to recruit 264 adult patients with incurable advanced cancer at the National Cancer Centre in Tokyo, Japan. Intervention group participants use a mobile application ACP programme and undergo a 30 min interview with a trained intervention provider for discussions with the oncologist at the next patient visit, while control group participants continue their usual treatment. The primary outcome is the oncologist’s communication behaviour score assessed using audiorecordings of the consultation. Secondary outcomes include communication between patients and oncologists and the patients’ distress, quality of life, care goals and preferences, and medical care utilisation. We will use a full analysis set including the registered participant population who receive at least a part of the intervention.Ethics and disseminationThe study protocol was reviewed and approved by the Scientific Advisory Board of the Japan Supportive, Palliative and Psychosocial Oncology Group (Registration No. 2104) and the Institutional Review Board of the National Cancer Centre Hospital (registration No. 2020-500). Written informed consent is obtained from the patients. The results of the trial will be published in peer-reviewed scientific journals and presented at scientific meetings.Trial registration numbersUMIN000045305,NCT05045040.

IntroductionElderly cancer patients often have ageing-related physical and psychosocial problems that should be fully shared with their oncologists. Geriatric assessment (GA) can assess these ageing-related problems and guide management. Communication support might also facilitate implementation of GA-guided management. We will conduct a multicentre, randomised controlled trial to examine the efficacy of a programme that combines a GA summary, management recommendations and communication support to facilitate ageing-related communications between elderly Japanese patients with cancer and their oncologists, and thus to implement programme-guided management.Methods and analysisWe plan to recruit a total of 210 patients aged ≥70 years, diagnosed with incurable cancers of gastrointestinal origin, and referred for first-line or second-line chemotherapy. In the intervention arm, a summary of management recommendations based on a GA and question prompt list (QPL) will be provided to patients and shared with their oncologists at the first outpatient visit after randomisation by trained intervention providers. For 5 months after the initial intervention, implementation of GA-guided management recommendations will be reviewed monthly with the patients and their oncologists to implement management as needed. The GA and QPL will be re-evaluated at 3 months, with a summary provided to patients and their oncologists. Those participants allocated to the usual care arm will receive usual oncology care. The primary endpoint is the number of conversations about ageing-related concerns at the first outpatient visit after randomisation.Ethics and disseminationThis study was approved by the institutional review board of the National Cancer Center Japan on 15 April 2021 (ID: 2020–592). Study findings will be disseminated through peer-reviewed journals and conference presentations.Trial registration numberUMIN000045428.

Context: Poor understanding regarding the safe use, secure storage, and adequate disposal of unused opioids may contribute to the opioid epidemic. It is unclear what happens to unused opioids in the households of deceased cancer patients. Objectives: Our aim was to investigate the patterns of use, storage, and disposal of unused opioids among families of deceased cancer patients. Methods: A questionnaire was administered to families of deceased cancer patients. Questions were related to the use, storage, and disposal of opioids prescribed to their deceased family member. Results: Completed questionnaires were received from the families of 240 patients. Of these, 129 (53.8%) and 99 (41.3%) participants were aware of the danger of diversion and need for safe disposal, respectively. One (0.4%) participant reported diversion. In total, 177 participants (73.8%) stored opioids securely, 6 (2.5%) had unused opioids at home, and 142 (59.2%) returned unused opioids to medical health providers. Knowledge of safe opioid disposal increased the rate of returning opioids to medical health providers (84.8% vs. 53.2%; p

The Scored Patient-Generated Subjective Global Assessment (PG-SGAIn accordance with methodology used in previous Dutch, Thai, German, and Norwegian PG-SGA studies, we followed the ten steps of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Principles of Good Practice for Translation and Cultural Adaptation for Patient-Reported Outcome Measures. The study enrolled 50 patients and 50 healthcare professionals (HCPs) to evaluate the comprehensibility and difficulty of the translated and culturally adapted PG-SGA. The HCPs also evaluated the content validity of the translation. We evaluated each item and quantified scale indices for content validity (item content validity index (I-CVI), scale content validity index (S-CVI)), comprehensibility (item comprehensibility index (I-CI), scale comprehensibility index (S-CI)), and difficulty (item difficulty index (I-DI), scale difficulty index (S-DI)).Patients evaluated the comprehensibility and difficulty of the patient component as excellent (S-CI = 0.97, S-DI = 0.96). The professionals rated the Japanese version of both components of the PG-SGA as very relevant (S-CVI = 0.94). The professionals evaluated the comprehensibility of the professional component as being acceptable (S-CI = 0.88) but difficult (S-DI = 0.69), based predominantly on items related to physical examination (I-DI = 0.33-0.67).The PG-SGA was systematically translated and culturally adapted for the Japanese setting according to the ISPOR process. The Japanese version of the PG-SGA was perceived as comprehensive, easy to use, and relevant. Perceived difficulty in professional components, specifically in the context of metabolic demand and physical examination, will require appropriate training for professionals in order to optimize implementation.

The benefits of artificial nutrition and hydration in patients with advanced cancer remain unknown. Therefore, we conducted a prospective study to evaluate effects of enteral nutrition (EN) and parenteral nutrition and hydration (PNH) on survival in palliative care units.This study involved a secondary analysis of a multicenter cohort study. Data of primary nutritional administration routes during the first week after admission (oral intake, enteral tube feeding, parenteral nutrition, parenteral hydration, poor oral intake) were obtained. Data of averaged calorie sufficiency rate/total calorie intake [high (75% ≤ or 750 kcal/day ≤), moderate (50-75% or 500-750 kcal/day), low (25-50% or 250-500 kcal/day), very low (25% or250 kcal/day)] were also obtained. After investigating the implementation of artificial nutrition and hydration, participants were divided into three groups according to the nutritional administration route and calorie sufficiency rate/total calorie intake: EN, PNH, and control. We conducted time-to-event analyses using the Kaplan-Meier method, log-rank test, and univariate and multivariate Cox regression analyses.Patients were divided into the EN group (n = 730), PNH group (n = 190), and control group (n = 533). Differences in survival rates among the three groups were significant (Log-rank P 0.001). Median survival times were 43.0 (95% CI 40-46), 33.0 (95% CI 29-37), and 15.0 (95% CI 14-16) days, respectively (P 0.001). In the multivariate-adjusted model, a significantly lower risk of mortality was observed in Cox's proportional hazard model in the EN group and PNH groups (HR 0.43 [95% CI 0.37-0.49], P 0.001; and HR 0.52 [95% CI 0.44-0.62], P 0.001, respectively) than in the control group.This study indicated the clinical benefits of EN and PNH for patients with advanced cancer. Nevertheless, managing symptoms to improve oral intake is essential before initiation of PNH, because EN was superior to PNH.

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. 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. 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

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. 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. 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. 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.

Phase angle (PA) is a poor prognostic factor in patients with advanced cancer. This study aimed to identify possible correlations between PA and symptoms, quality of life, fluid retention, and laboratory data in cancer patients in palliative care settings.Individuals who visited the outpatient clinic or were admitted to the palliative care unit were eligible. Patients with a performance status of 4 and/or those unable to complete questionnaires were excluded. PA was evaluated using a bioanalyzer device. The correlation coefficient between PA and the variables of interest was analyzed.A total of 102 patients were analyzed. PA was weakly correlated with age (ρ = -0.22), performance status (ρ = -0.30), functional well-being (ρ = 0.20), anorexia/cachexia subscale (ρ = 0.22), and Functional Assessment of Anorexia/Cachexia Therapy trial outcome index (ρ = 0.26). PA was also correlated with fluid retention (ρ = -0.34) and albumin (ρ = 0.32), C-reactive protein (ρ = -0.31), and hemoglobin (ρ = 0.41) levels. Sub-analysis stratified according to sex revealed that males demonstrated the same results; however, female sex demonstrated a correlation between PA and social well-being (ρ = -0.43).PA was correlated with physical condition, but not with psychological well-being.

12097 Background: The integration of palliative care into standard cancer treatment during the early phase of the disease can improve cancer patients’ quality of life (QOL). The current study examined the effectiveness of a nurse-led, screening-triggered, early specialized palliative care intervention program for patients (pts) with advanced lung cancer. Methods: Pts with advanced lung cancer undergoing initial chemotherapy were randomized (1:1) to the intervention group (IG) or the usual care group (UG) between January 2017 and September 2019. The intervention, which was triggered using by a brief, self-administered screening tool, comprised comprehensive need assessments, counseling, and service coordination by advanced-leveled nurses. The primary endpoint was the change from baseline of the Functional Assessment of Cancer Therapy -Lung Trial Outcome Index (TOI) at week 12, and the secondary endpoints were TOI at week 20, depression (Patient Health Questionnaire-9), anxiety (Generalized Anxiety Disorder-7), and survival. Results: Pts were randomly allocated (102 for each group). The median age was 69 y (range, 27-91) and 77.5% were male. Seventy-two pts had extensive disease small-cell lung carcinoma and 132 Pts had stage IV non-small cell lung carcinoma. Because there was not a significant time-by-group interaction, we estimated main effects and the IG did not show a significant improvement in TOI from the baseline at week 12 and 20 compared to the UG (Mean group difference [the same applies hereafter] 2.13; 90% CI: -0.70, 4.95; P =.107, one-tailed). However, when we considered time-by-group interaction effects exploratorily, the IG did show significant improvement in TOI from baseline at week 20 compared to the UG (3.58; 90% CI: 0.15, 7.00; P = 0.043). There was no significant difference in change from baseline depression and anxiety between the two groups either at week 12 (depression −0.38; 95% CI: -1.81, 1.05; P = 0.60, anxiety -0.18; 95% CI: -1.45, 1.09; P = 0.78) or at week 20 (depression -1.27; 95% CI: -2.79, 0.25; P =.10, 1.26; 95% CI: -2.61, 0.09; P =.067). The 1-year survival rates were 49.5% (95% CI: 39.3, 58.9) in the IG and 43.4% (95% CI: 33.6, 52.8) in the UG. Conclusions: This trial failed to show statistical superiority of nurse-led, screening-triggered, early specialized palliative care intervention program over usual care, however, it’s possible delayed clinical benefits of improvement in QOL (TOI), depression and anxiety were suggested. The study design that some pts in the IG received later or no intervention, may dilute the difference of intervention between group differences. Further investigation, including the mixed method approach adopted in this study, is needed to uncover mediating factors for the effect of this low-cost, novel model of early palliative care. Clinical trial information: UMIN000025491.

IntroductionIt 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 analysisA 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 disseminationThis 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 numberUMIN000025491.

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.This study aimed to investigate the influence of BTcP on general activities, and pain management in patients with controlled background pain.Single-center prospective observational study.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.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.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).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.

The achievement of a personalized pain goal (PPG) is advocated as an individualized pain relief indicator.Pain relief indicators, including PPG, pain intensity (PI), and interference with daily activities (interference), were compared herein.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.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).The achievement of PPG was a stricter pain relief indicator than PI and interference and may reflect a real need for pain control.