Narrative review of malignant ascites: epidemiology, pathophysiology, assessment, and treatment.

BACKGROUND AND OBJECTIVE: Malignant ascites (MA) is common in patients with advanced cancer, and about 60% of patients with MA experience distressing symptoms. In addition, MA has been identified as a poor prognostic factor, therefore, making the management of MA an important issue. We aimed to review literature describing MA provide a narrative synthesis of relevant studies. METHODS: A literature search of articles published between 1971 and May 2023 was performed in PubMed, and Cochrane library using the words "ascites/malignant ascites" and the theme of each section. Authors independently selected the articles used and summarized. Finally, this manuscript was obtained consensus through discussed among all authors. KEY CONTENT AND FINDINGS: The pathophysiological mechanism of ascites formation involves increased vascular permeability and impaired fluid drainage through the lymphatic system, which explain the occurrence of peritoneal carcinomatosis, portal hypertension due to liver tumors, liver cirrhosis in the background of hepatocellular carcinoma, and Budd-Chiari syndrome caused by tumor occlusion of the hepatic vein. The efficacy and safety of various treatments and procedures have been investigated previously; however, no treatment guidelines have been established yet. Diuretics and paracentesis are often selected as the first lines of treatment. Intraperitoneal drug administration (catumaxomab, bevacizumab, aflibercept, hyperthermic intraperitoneal chemotherapy, triamcinolone), indwelling peritoneal catheters, peritoneovenous shunting, and cell-free and concentrated ascites reinfusion therapy are commonly used to manage refractory ascites. A new device for this purpose is alfapump, which transfers ascites fluid from the peritoneum into the urinary bladder. In addition, thoracic epidural analgesia may be effective for managing ascites-related symptoms. CONCLUSIONS: Despite these options, no standard treatment for MA has been established yet because few trials have been conducted in this area. There are many issues to be investigated, and future research and treatment development are expected.

Impacts of fluid retention on prognostic abilities of cachexia diagnostic criteria in cancer patients with refractory cachexia.

BACKGROUND & AIMS: The international cancer cachexia criteria with a cutoff of 5% weight loss (WL) was proposed in Western patients. The Asian Working Group for Cachexia (AWGC) developed new criteria in Asian patients. The AWGC criteria are not cancer-specific and employ a cutoff of 2% WL. However, it is unclear whether both criteria are useful in patients with very advanced cancer because WL can be underestimated owing to fluid retention. Therefore, this study aimed to investigate the impacts of fluid retention on the prognostic abilities of both criteria in cancer patients with weeks of survival. METHODS: This study involved a secondary analysis of a prospective cohort study. The inclusion criteria constrained the study to adult patients with advanced cancer. Patients were divided into Non-cachexia and Cachexia groups using the international criteria and AWGC criteria. We performed time-to-event analyses using the Kaplan-Meier method and log-rank tests, and by conducting univariate and multivariate Cox regression analyses. RESULTS: A total of 402 patients were included in the analysis. Using the international criteria, the p-values for the log-rank test and stratified log-rank test for the mixed patients with and without fluid retention were 0.55 and 0.18, respectively. Using the AWGC criteria, the p-values for the log-rank test and stratified log-rank test for the mixed patients with and without fluid retention were 0.38 and 0.12, respectively. Without considering the impacts of fluid retention, no significant differences were observed between the Non-cachexia and Cachexia groups for both criteria. After adjusting for the status of fluid retention, significantly higher risks of mortality were not observed in the Cox proportional hazard model for the Cachexia group compared with the Non-cachexia group, for both criteria. However, significant associations were observed between fluid retention and overall survival. CONCLUSIONS: The international criteria and AWGC criteria lost their prognostic abilities in cancer patients with weeks of survival. Since measurements of %WL were significantly confounded by fluid retention, fluid retention-adjusted criteria for cachexia need to be developed for cancer patients with refractory cachexia.

Factors associated with multimodal care practices for cancer cachexia among registered dietitians.

PURPOSE: This study aimed to determine factors associated with multimodal care practices for cancer cachexia among registered dietitians (RDs) working in cancer care. METHODS: A secondary analysis was performed using RDs' data. Data on knowledge, skills, and confidence in multimodal care were obtained. Nine items regarding multimodal care practices were evaluated. Subjects were divided into two groups based on their answers associated with the nine items. Comparisons were obtained using the Mann-Whitney U test or chi-squared test. Multiple regression analysis was performed to identify the critical factors involved in practicing multimodal care by determining the variables with significant differences between the two groups. RESULTS: Two hundred thirty-two RDs were included in this study. Significant differences were observed in their primary area of practice (p = 0.023), the number of clinical guidelines used (p < 0.001), the number of items used in cancer cachexia assessment (p = 0.002), the number of symptoms used in cancer cachexia assessment (p = 0.039), training for cancer cachexia (p < 0.001), knowledge of cancer cachexia (p < 0.001), and confidence in cancer cachexia management (p < 0.001). The number of symptoms used in cancer cachexia assessment (B = 0.42, p = 0.019), knowledge of cancer cachexia (B = 6.60, p < 0.001), and confidence in cancer cachexia management (B = 4.31, p = 0.010) were identified as critical factors according to the multiple regression analysis. CONCLUSION: The RDs' knowledge and confidence in cancer cachexia management were associated with their multimodal care practices.

Investigating the efficacy and safety of olanzapine prophylaxis for opioid-induced nausea and vomiting (JORTC-PAL20): a study protocol for an open-label, single-arm exploratory study.

INTRODUCTION: In opioid therapy for cancer pain, opioid-induced nausea and vomiting (OINV) occur in 20%-40% of patients during initial opioid treatment or increasing opioid doses. OINV result in failure to achieve pain relief due to poor opioid adherence. Therefore, antiemetics are used to prevent OINV, but their efficacy and safety in this context have not yet been fully elucidated. Olanzapine is a promising antiemetic for the prophylaxis of chemotherapy-induced nausea and vomiting. METHODS AND ANALYSIS: This single-arm, single-centre exploratory study will evaluate the prophylactic antiemetic efficacy and safety of 5 mg olanzapine in patients with cancer pain who are withholding initial regular opioid therapy. Thirty-five patients will be enrolled. The primary endpoint is the proportion of patients achieving complete control (CC) of OINV during 5 days of opioid treatment. CC was defined as the absence of emetic episodes, no need for rescue medication to treat nausea, and minimal or no nausea (3 or less on an 11-point categorical scale). Secondary endpoints include the complete response, defined as no emetic episodes and no use of rescue medication during the overall assessment period, the time from opioid initiation to first emetic episode, the time from opioid initiation to first rescue antiemetic administration, and adverse events graded by Patient-Reported Outcome (PRO) Common Terminology Criteria for Adverse Events (CTCAE) version 1.0 and CTCAE version 5.0. ETHICS AND DISSEMINATION: This study protocol was approved by National Cancer Center Hospital Certified Review Board. The results will be used as preliminary data to conduct a validation study. TRIAL REGISTRATION NUMBER: Japan Registry of Clinical Trials (jRCT) jRCTs031220008.

Fluid retention and weight loss in refractory cancer cachexia.

OBJECTIVES: It is unknown to what extent the fluid retention (FR) status disrupts the detection of weight loss rate (WLR) in adult patients with advanced cancer. This study aimed to determine the association of FR status with WLR. METHODS: This study was a secondary analysis of a prospective cohort study. FR was evaluated as follows: oedema (0, no; 1, yes), pleural effusion (0, no; 1, yes but asymptomatic; 2, symptomatic) and ascites (0, no; 1, yes but asymptomatic; 2, symptomatic). Patients were divided into three groups according to their FR scores: no-FR (0), moderate-FR (1-2) and high-FR (3-5). Multiple regression analysis was performed. RESULTS: Four hundred and twenty patients were categorised: no-FR group (n=164), moderate-FR group (n=158) and high-FR group (n=98). The prevalence of oedema, pleural effusion and ascites was 63.9%, 27.8% and 36.7% in the moderate-FR group, and 93.9%, 61.3% and 82.6% in high-FR group. The means of WLR were 9.2, 8.4 and 3.8 in the groups. The high-FR group and the FR score of 5 were correlated with WLR (estimate -4.71, 95% CI -7.84 to -1.58; estimate -10.29, 95% CI -17.84 to -2.74). CONCLUSIONS: The coexistence of FR was significantly correlated with WLR.

Cancer Pain Management in Patients Receiving Inpatient Specialized Palliative Care Services.

CONTEXT: Cancer pain is a common complication that is frequently undertreated in patients with cancer. OBJECTIVES: This study is aimed at assessing the time needed to achieve cancer pain management goals through specialized palliative care (SPC). METHODS: This was a multicenter, prospective, longitudinal study of inpatients with cancer pain who received SPC. Patients were continuously followed up until they considered cancer pain management successful, and we estimated this duration using the Kaplan-Meier method. We investigated the effectiveness of pain management using multiple patient-reported outcomes (PROs) and quantitative measures, including pain intensity change in the Brief Pain Inventory. A paired-sample t-test was used to compare the pain intensity at the beginning and end of the observation period. RESULTS: Cancer pain management based on the PROs was achieved in 87.9% (385/438) of all cases. In 94.5% (364/385) of these cases, cancer pain management was achieved within 1 week, and the median time to pain management was 3 days (95% confidence interval [CI], 2-3). The mean worst pain intensity in the last 24 h at the start and end of observation were 6.9 ± 2.2 and 4.0 ± 2.3, respectively, with a difference of -2.9 (95% CI, -3.2 to -2.6; p < 0.01). Overall, 81.6% of the patients reported satisfaction with cancer pain management, and 62 adverse events occurred. CONCLUSION: SPC achieved cancer pain management over a short period with a high level of patient satisfaction resulting in significant pain reduction and few documented adverse events.

Psychological symptom burden associated with malignant wounds: Secondary analysis of a prospective cohort study.

OBJECTIVES: Patients with malignant wounds suffer from physical and psychological symptom burden. Despite psychological support being required, the impact of malignant wounds on patients' psychological distress is poorly investigated. We evaluated psychological distress associated with malignant wounds for patients at their end of life. METHODS: This study used the secondary analysis of the results of a large prospective cohort study, which investigated the dying process among patients with advanced cancer in 23 palliative care units in Japan. The primary outcome of this study was the prevalence of moderate to severe psychological symptom burden, evaluated by the Integrated Palliative Care Outcome Scale (IPOS)-feeling at peace scores of 2-4. In addition, the factors affecting psychological symptoms were investigated. The quality of death was also evaluated upon death using the Good Death Scale score. RESULTS: Out of the total 1896 patients, 156 had malignant wounds (8.2%). Malignant wounds were more common in female and young people. The breast, head, and neck were the most prevalent primary sites. More patients with malignant wounds had IPOS-feeling at peace scores of 2-4 than patients without malignant wounds (41.0% vs. 31.3%, p = 0.024). Furthermore, psychological distress was associated with moderate to severe IPOS-pain and the frequency of dressing changes. The presence of malignant wounds did not affect the quality of death. SIGNIFICANCE OF RESULTS: This study showed increased psychological distress due to malignant wounds. Patients with malignant wounds require psychological support in addition to the treatment of physical symptoms for maintaining their quality of life.

Symptoms and Prognoses of Patients With Breast Cancer and Malignant Wounds in Palliative Care Units: The Multicenter, Prospective, Observational EASED Study.

BACKGROUND: This study sought to investigate the symptoms and prognoses of patients with breast cancer and malignant wounds in the palliative care unit setting. METHODS: This study was a sub-group analysis of a multicenter, prospective, observational study. Patients admitted to 23 palliative care units in Japan between January and December 2017 were enrolled. Data of patients with breast cancer were extracted. We compared demographic characteristics, symptoms, and prognoses by breast cancer malignant wound status. The primary outcome was overall survival. Secondary outcomes included Palliative Prognostic Index (PPI) score, malignant wound characteristics, and symptom burden. RESULTS: Of 1896 patients, 131 (6.9%) had breast cancer. In this cohort, 44 (33.6%) patients had malignant wounds. Most malignant wounds (88%) were on the back and chest. Malignant wounds were associated with skin redness, erosion, necrosis, or fistula. Symptoms included bleeding, exudate, odor, and pain. Twenty-eight patients (63.6%) needed dressing changes and 14 (31.8%) patients experienced bleeding. None died due to bleeding. In the malignant wounds group, 32 (72.8%) patients had used an opioid dose equivalent to 38 mg of oral morphine daily, compared to 25 mg by 57 (65.5%) patients in the non-malignant wounds group (P = .26). Median PPI scores at hospital admission were 4.5 vs 6.5 (P = .08). Median survival was 23 vs 21 days (P = .48). CONCLUSIONS: Patients with malignant wounds had a distinct symptom burden profile and tended to use a higher dose of opioids. The effect of malignant wounds on survival was unclear.

Low serum creatinine as a prognostic marker in advanced cancer.

OBJECTIVES: To evaluate whether low serum creatinine levels are associated with poor outcomes in patients with advanced cancer. METHODS: This is a secondary analysis of a prospective cohort study. Patients were divided into three groups according to their baseline serum creatinine levels. We performed time-to-event analyses using the Kaplan-Meier method and log-rank tests, and by conducting univariate and multivariate Cox regression analyses. RESULTS: 809 males were divided: male-low group (n=192), male-normal group (n=403) and male-high group (n=214). 808 females were divided: female-low group (n=239), female-normal group (n=389) and female-high group (n=180). Significant differences were observed in survival rates between the high and normal groups in the males and females (both log-rank p<0.001). Significantly higher risks of mortality were observed in the Cox proportional hazard model for the high group than for the normal group in both sexes (adjusted HR 1.292, 95% CI 1.082 to 1.542; adjusted HR 1.316, 95% CI 1.094 to 1.583, respectively). High serum creatinine was associated with shorter survival than normal creatinine, while low serum creatinine was not. CONCLUSIONS: Low serum creatinine levels did not have prognostic abilities in this population.

Prevalence of opioid-induced adverse events across opioids commonly used for analgesic treatment in Japan: a multicenter prospective longitudinal study.

PURPOSE: Although opioids have been shown to be effective for cancer pain, opioid-induced adverse events (AEs) are common. To date, little is known about the differences in risks of AEs by opioid type. This study was performed to compare the prevalence of AEs across opioids commonly used for analgesic treatment in Japan. METHODS: This study was conducted as a preplanned secondary analysis of a multicenter prospective longitudinal study of inpatients with cancer pain who received specialized palliative care for cancer pain relief. We assessed daily AEs until termination of follow-up. We rated the severity of AEs based on the Common Terminology Criteria for Adverse Events version 5.0. We computed adjusted odds ratios for each AE (constipation, nausea and vomiting, delirium, and drowsiness) with the following variables: opioid, age, sex, renal dysfunction, and primary cancer site. RESULTS: In total, 465 patients were analyzed. Based on the descriptive analysis, the top four most commonly used opioids were included in the analysis: oxycodone, hydromorphone, fentanyl, and tramadol. With respect to the prevalence of AEs among all analyzed patients, delirium (n = 25, 6.3%) was the most frequent, followed by drowsiness (n = 21, 5.3%), nausea and vomiting (n = 19, 4.8%), and constipation (n = 28, 4.6%). The multivariate logistic analysis showed that no single opioid was identified as a statistically significant independent predictor of any AE. CONCLUSION: There was no significant difference in the prevalence of AEs among oxycodone, fentanyl, hydromorphone, and tramadol, which are commonly used for analgesic treatment in Japan.

Preliminary Effectiveness of an In-Hospital Peer Support Program, Adolescent and Young Adult Hiroba, on Anxiety in Adolescent and Young Adult Patients with Cancer.

Purpose: Adolescent and young adult (AYA) patients with cancer have few opportunities to connect with patients of the same generation while hospitalized. Although anxiety is frequently reported by them, there are no reports on the psychological effectiveness of an in-hospital patient support program based on peer support. This study aimed to evaluate the effectiveness of a program, termed Adolescent and Young Adult Hiroba (AYA Hiroba), for anxiety in AYA patients with cancer. Methods: This single-center, prospective, observational study in 24 AYA patients with cancer was conducted at the National Cancer Center Hospital in Japan. The Hospital Anxiety and Depression Scale-Anxiety (HADS-A) was used to evaluate the primary outcome, anxiety. The Distress Thermometer (DT) was used to evaluate the secondary outcome, distress. The two outcomes were assessed before and after participation in AYA Hiroba. The Net Promoter Score (NPS) was used to evaluate satisfaction after participation in AYA Hiroba. Participants' free-text descriptions of the program were categorized according to similarities and differences. Results: The HADS-A and DT scores were significantly lower after the program than before (p < 0.001), as was the percentage of AYA patients with cancer with high distress (p = 0.04). The NPS was 27, which was lower than the value of 52 obtained in our previous study. Requests and suggestions to improve the program were grouped into three categories: content, facilitation, and online connection environment. Conclusion: This study suggests the preliminary effectiveness of the in-hospital peer support program for anxiety in AYA patients with cancer. The Clinical Trial Registration number: UMIN000045779.

Comparison of Symptom Severity and Progression in Advanced Cancer Patients Among Different Care Settings: A Secondary Analysis.

Background: Most people in Japan wish to spend their final days at home, but the majority fail to do so; earlier studies indicated a more pronounced worsening of symptoms if treated at home. Objectives: This study compared the prevalence of symptom worsening and explored associated factors between patients with advanced cancer receiving palliative care in palliative care units (PCUs) and at home. Design: We conducted a secondary analysis of two multicenter, prospective cohort studies involving patients with advanced cancer receiving palliative care in PCUs or at home. Setting/Subjects: One study was conducted at 23 PCUs (January to December 2017) and the other on 45 palliative home care services (July to December 2017) in Japan. Measurements: Symptom changes were categorized as stable, improved, or worse. Results: Of the 2998 registered patients, 2877 were analyzed. Among them, 1890 patients received palliative care in PCUs, and 987 at home. Patients receiving palliative care at home were more likely to have worsening of pain (17.1% vs. 3.8%; p < 0.001) and drowsiness (32.6% vs. 22.2%; p < 0.001) than those in PCUs. By multivariate logistic regression analysis, palliative care at home was significantly associated with worsening of the Palliative Prognostic Index dyspnea subscale in the unadjusted model (odds ratio, 1.42 [95% confidence interval, 1.08-1.88]; p = 0.014) but not for any symptoms in the adjusted model. Conclusions: After adjusting for patient background, the prevalence of symptom worsening was not different between patients with advanced cancer receiving palliative care at home and in PCUs.

Continuous Deep Sedation for Psycho-Existential Suffering: A Multicenter Nationwide Study.

Background: There is ongoing debate on whether continuous deep sedation (CDS) for psycho-existential suffering is appropriate. Objective: We aimed to (1) clarify clinical practice of CDS for psycho-existential suffering and (2) assess its impact on patients' survival. Methods: Advanced cancer patients admitted to 23 palliative care units in 2017 were consecutively enrolled. We compared patients' characteristics, CDS practices, and survival between those receiving CDS for psycho-existential suffering ± physical symptoms and only for physical symptoms. Results: Of 164 patients analyzed, 14 (8.5%) received CDS for psycho-existential suffering ± physical symptoms and only one of them (0.6%) solely for psycho-existential suffering. Patients receiving CDS for psycho-existential suffering, compared with those only for physical symptoms, were likely to have no specific religion (p = 0.025), and desired (78.6% vs. 22.0%, respectively; p < 0.001) and requested a hastened death more frequently (57.1% vs. 10.0%, respectively; p < 0.001). All of them had a poor physical condition with limited estimated survival, and mostly (71%) received intermittent sedation before CDS. CDS for psycho-existential suffering caused greater physicians' discomfort (p = 0.037), and lasted for longer (p = 0.029). Dependency, loss of autonomy, and hopelessness were common reasons for psycho-existential suffering that required CDS. The survival time after CDS initiation was longer in patients receiving it for psycho-existential suffering (log-rank, p = 0.021). Conclusion: CDS was applied to patients who suffered from psycho-existential suffering, which often associated with desire or request for a hastened death. Further studies and debate are warranted to develop feasible treatment strategies for psycho-existential suffering.

Factors Associated With Practice of Multimodal Care for Cancer Cachexia Among Physicians and Nurses Engaging in Cancer Care.

PURPOSE: Multimodal care for cancer cachexia is needed. This study examined factors associated with practicing multimodal cachexia care among physicians and nurses engaging in cancer care. METHODS: This was a preplanned secondary analysis of a survey investigating clinicians' perspectives on cancer cachexia. Data of physicians and nurses were used. Data on knowledge, skills, and confidence in multimodal cachexia care were obtained. Nine items on practicing multimodal cachexia care were evaluated. Participants were divided into two groups as practicing multimodal cachexia care (above median value for the nine items) or not. Comparisons were made using the Mann-Whitney U test or chi-square test. Multiple regression analysis was performed to identify the factors of practicing the multimodal care. RESULTS: Total of 233 physicians and 245 nurses were included. Significant differences were observed between the groups: female sex (P = .025), palliative care versus oncology specialization (P < .001), the number of clinical guidelines used (P < .001), the number of symptoms used (P = .005), training for cancer cachexia (P = .008), knowledge on cancer cachexia (P < .001), and confidence in cancer cachexia management (P < .001). Palliative care specialization (partial regression coefficient [B] = 0.85; P < .001), the number of clinical guidelines used (B = 0.44; P < .001), knowledge on cancer cachexia (B, 0.94; P < .001), and confidence in cancer cachexia management (B = 1.59; P < .001) were statistically significant in multiple regression analysis. CONCLUSION: Specialization in palliative care, specific knowledge, and confidence were associated with the practice of multimodal care for cancer cachexia.

Feasibility of an Electronic Patient-Reported Outcome Tool for Screening Distress and Supportive Care Needs of Adolescents and Young Adults with Cancer.

Purpose: Although adolescent and young adult (AYA) cancer patients are digital natives and have high digital communication needs, previous studies of screening tools for AYAs have primarily used paper when measuring patient-reported outcomes (PROs). There are no reports on using an electronic PRO (ePRO) screening tool with AYAs. This study evaluated the feasibility of such a tool in clinical settings, and assessed the prevalence of AYAs' distress and supportive care needs. Methods: An ePRO tool based on the Distress Thermometer and Problem List (DTPL)-Japanese (DTPL-J) version for AYAs was implemented in a clinical setting for 3 months. To determine the prevalence of distress and need for supportive care, descriptive statistics were calculated for participant characteristics, selected items, and Distress Thermometer (DT) scores. Response rates, referral rates to an attending physician and other experts, and time required to complete PRO tools were assessed to evaluate feasibility. Results: From February to April 2022, 244 (93.8%) of 260 AYAs completed the ePRO tool based on the DTPL-J for AYAs. Based on a DT cutoff of ≥5, 65 of 244 patients (26.6%) had high distress. Worry (n = 81, 33.2%) was the most frequently selected item. Primary nurses referred 85 (32.7%) patients to an attending physician or other experts. The referral rate resulting from ePRO screening was significantly higher than that after PRO screening (χ2(1) = 17.99, p < 0.001). The average response time did not differ significantly between ePRO and PRO screening (p = 0.252). Conclusion: This study suggests the feasibility of an ePRO tool based on the DTPL-J for AYAs.

Malignancy-related ascites in palliative care units: prognostic factor analysis.

OBJECTIVES: The prognostic factors in patients with malignancy-related ascites (MA) have been poorly investigated. This study aimed to evaluate both the prognostic impact of MA on terminally ill patients with cancer and the prognostic factors in those with MA. METHODS: This was a post hoc analysis of a multicentre, prospective cohort study. Patients with advanced cancer admitted to palliative care units at 23 institutions and aged≥18 years were enrolled between January and December 2017. Overall survival (OS) was compared according to MA. A multivariate analysis was conducted to explore prognostic factors in patients with MA. RESULTS: Of 1896 eligible patients, gastrointestinal and hepatobiliary pancreatic cancers accounted for 42.5%. 568 (30.0%) of the total had MA. Patients with MA had significantly shorter OS than those without MA (median, 14 vs 22 days, respectively; HR, 1.55; 95% CI, 1.39 to 1.72; p<0.01). A multivariate analysis showed that MA was a poor prognostic factor (HR, 1.30; 95% CI, 1.13 to 1.50; p<0.01) and that among patients with MA, significant poor prognostic factors were liver metastasis, moderately to severely reduced oral intake, delirium, oedema, gastric cancer, high serum creatinine, high serum C reactive protein, high serum total bilirubin, dyspnoea and fatigue, while significant good prognostic factors were female sex, good performance status, high serum albumin and colorectal cancer. CONCLUSIONS: MA had a negative impact on survival in terminally ill patients with cancer. A multivariate analysis revealed several prognostic factors in patients with terminal cancer and MA.

Perspectives of registered dietitians and factors associated with their personal accomplishment in the management of cancer cachexia.

PURPOSE: Registered dietitians (RDs) have the potential in cancer cachexia management. We investigated RDs' knowledge on cancer cachexia and assessed the effects of factors on RDs' perception of playing an important role in cancer cachexia management. METHODS: This is a secondary analysis of a survey examining the perspectives of health care professionals on cancer cachexia management. We sent the questionnaire to 451 RDs. RDs were divided into two groups: RDs with and without the perception. Comparisons were made using the Mann-Whitney U test or chi-square test. To examine the effects of factors on the perception, estimated crude and adjusted odds ratios (ORs) and 95% confidence intervals (CIs) for the logistic regression model were calculated. RESULTS: A total of 237 RDs were analyzed. Significant differences were observed in the number of cancer patients/month, the primary area of practice, the number of clinical guidelines used, the number of items used, the number of symptoms used, and training for cancer cachexia management (p values all < 0.05). After adjustments, the factors of cancer care experience ≥ 20 years (OR 8.32, 95% CI 1.22-56.70; p = 0.030), the number of patients/month ≥ 50 (OR 27.35, 95% CI 3.99-187.24; p = 0.001), using the clinical guidelines (OR 2.69, 95% CI 1.29-5.61; p = 0.008), the number of items ≥ 5 (OR 3.52, 95% CI 1.47-8.40; p = 0.005), and receiving training (OR 3.91, 95% CI 1.77-8.67; p = 0.001) significantly associated with the perception. CONCLUSION: Specific knowledge and training as well as abundant experience were associated with the perception.

Patient-reported outcome and quality of life research policy: Japan Clinical Oncology Group (JCOG) policy.

Assessments of patient-reported outcomes and health-related quality of life in cancer clinical trials have been increasingly emphasized recently because patient and public involvement in cancer treatment development has been promoted by regulatory authorities and academic societies. To assess patient experiences during and after cancer treatment, there is interest in implementing patient-reported outcome and health-related quality of life assessments into cancer clinical trials. The Japan Clinical Oncology Group quality of life ad hoc committee previously created a version of the Quality of Life Assessment Policy in 2006. Recently, there has been increasing demand from Japan Clinical Oncology Group researchers to assess patient-reported outcome/health-related quality of life in clinical trials. Although guidelines are available regarding planning and reporting clinical trials that include patient-reported outcome/health-related quality of life as an endpoint, there are still issues regarding the lack of consensus on standardized methods for analysing and interpreting the results. Hence, it was considered necessary to reorganize the Japan Clinical Oncology Group patient-reported outcome/quality of life research committee and to revise the former patient-reported outcome/quality of life research policy to promote patient-reported outcome/health-related quality of life research in future Japan Clinical Oncology Group trials. The purpose of this Japan Clinical Oncology Group patient-reported outcome/quality of life research policy is to define patient-reported outcome/health-related quality of life research and provide guidelines for including patient-reported outcome/health-related quality of life as an endpoint in Japan Clinical Oncology Group trials.