Breakthrough pain management using fentanyl buccal tablet (FBT) in combination with around-the-clock (ATC) opioids based on the efficacy and safety of FBT, and its relationship with ATC opioids: results from an open-label, multi-center study in Japanese cancer patients with detailed evaluation.

OBJECTIVE: Rapid analgesic onset opioids, particularly fentanyl buccal tablet, is preferable for managing breakthrough pain. The efficacy and safety of fentanyl buccal tablet and its association with around-the-clock opioids needs to be explored with an option of dose adjustments, more closely reflecting administration in clinical practice. The aim of the study was to assess the safety and efficacy of fentanyl buccal tablet in breakthrough pain management in combination with around-the-clock opioids with the dose adjustment option, and explore the dose adjustment's influence on breakthrough pain management using detailed evaluation. METHODS: The 12-week open-label, multi-center study was conducted throughout Japan. Cancer patients aged 20 years or older, experiencing persistent pain controlled with around-the-clock opioids and breakthrough pain with supplemental medications were enrolled. Fentanyl buccal tablet and around-the-clock opioid doses could be adjusted under protocol-specified conditions. Efficacy variables were assessed at each fentanyl buccal tablet administration. Safety was assessed mainly by adverse events. RESULTS: All efficacy variables showed sustained analgesic effect. Nearly half the patients stayed on the same dose; most fentanyl buccal tablet administrations did not require additional supplemental medications. Dose increase of fentanyl buccal tablet and around-the-clock opioids seemed to improve breakthrough pain intensity and frequency, respectively. Fentanyl buccal tablet and around-the-clock opioid doses were not strongly associated. Treatment-related adverse events were all common with opioid treatment and did not increase over time. CONCLUSIONS: Fentanyl buccal tablet can stably and safely manage breakthrough pain in cancer patients with independent dose adjustment based on detailed evaluation of each patient's condition. Breakthrough pain management using fentanyl buccal tablet with around-the-clock opioids at optimal doses may be an important factor in palliative care for cancer patients with breakthrough pain.

A randomized, double-blind, placebo-controlled study of fentanyl buccal tablets for breakthrough pain: efficacy and safety in Japanese cancer patients.

CONTEXT: Rapid-onset opioids for treating breakthrough pain (BTP) in patients with cancer are needed in the Japanese care setting. OBJECTIVES: To examine the efficacy and safety of fentanyl buccal tablets (FBTs) for treating BTP in Japanese cancer patients. METHODS: This was a randomized, double-blinded, placebo-controlled study. In subjects receiving around-the-clock (ATC) opioids at doses of 30 mg or more to less than 60 mg or 60-1000 mg of oral morphine equivalents (low and high ATC groups), dose titration was started from 50 to 100 µg FBT, respectively. Subjects whose effective dose was identified were randomly allocated to a prearranged administration order of nine tablets (six FBTs and three placebos), one tablet each for nine episodes of BTP (double blinded). Efficacy and safety of FBT were assessed for patients overall, and also for the low and high ATC groups. RESULTS: A significant difference was observed between FBT and placebo for the primary endpoint of pain intensity difference at 30 minutes. The analgesic onset of FBT was observed from 15 minutes in several secondary variables (e.g., pain relief). Adverse events were somnolence and other events associated with opioids were mostly mild or moderate. Of the low and high ATC group subjects, an effective FBT dose was identified in 72.2% and 73.1%, respectively. CONCLUSION: The safety of FBT and its analgesic effect on BTP were confirmed in Japanese cancer patients receiving opioids. Our findings suggest that analgesic onset may occur from 15 minutes after FBT, and that FBT can be administered to patients with low doses of ATC opioids.

Development of a predicting tool for survival of terminally ill cancer patients.

OBJECTIVE: To develop a predicting tool for survival of terminally ill cancer patients. METHODS: This prospective, multicenter study was composed of two cohorts of samples: development and test. In the development sample of terminally ill cancer patients, 32 candidate predictors were studied to develop a new tool, Japan Palliative Oncology Study-Prognostic Index using the Cox proportional hazard model. Then the test sample was studied to validate Japan Palliative Oncology Study-Prognostic Index and compared it with the conventional predicting tools, such as palliative prognostic score and simplified palliative prognostic index. RESULTS: Five significant predictors, physician's clinical prediction of survival, consciousness, pleural effusion, white blood cell count and lymphocyte % were derived from the analysis of 201 patients, and Japan Palliative Oncology Study-Prognostic Index was developed using these predictors. It could divide patients into three risk groups: low (A), intermediate (B) and high (C). Median survival times for Groups A, B and C were 51, 35 and 16 days, respectively. Survival probability for more than 30 days for Groups A, B and C in the development sample was 78%, 61% and 16%, respectively. Japan Palliative Oncology Study-Prognostic Index was studied in subsequent 208 patients for the test sample, and constant results (median survival times for Groups A, B and C; 67, 31 and 10 days, and survival probability for more than 30 days for Groups A, B and C; 81, 48 and 11%) were obtained. Palliative prognostic score can also predict three risk groups well, but simplified palliative prognostic index could not discriminate low risk from intermediate risk group. CONCLUSION: Japan Palliative Oncology Study-Prognostic Index, a tool to predict survival, has been developed. Its reliability should be confirmed further in the future study, comparing with palliative prognostic score.

Endocrinological evaluations of brief hand massages in palliative care.

BACKGROUND AND OBJECTIVES: Some patients with advanced cancer make use of complementary therapies for the reduction of anxiety and stress. These patients can suffer distressing end-of-life symptoms, which conventional treatments might not relieve satisfactorily. Although previous studies have suggested that complementary therapies could be useful for reducing distress in patients with cancer, it has remained unclear whether these benefits are applicable at the end-of-life stage. The current study examined to validate salivary chromogranin A (CgA) as a biomarker for relieving stress by hand massage in terminally ill patients. METHODS: The study group comprised 34 inpatients in palliative care units. Each of these patients received a 5-minute massage to the upper extremity. Before and after the massage, saliva samples were collected in order to measure the CgA levels. RESULTS: The brief hand massage appears to reduce levels of stress according to the salivary CgA (p < 0.05). In addition, we found statistically significant changes in patient satisfaction with hand massage. CONCLUSIONS: Salivary CgA could potentially be used as a biomarker to measure relieving stress by hand massage in a palliative-care setting.

Attitudes toward and current practice of complementary and alternative medicine in Japanese palliative care units.

Complementary and alternative medicine (CAM) might enhance the quality of life of patients with cancer. The aim of this study was to investigate the current practice of CAM in Japanese palliative care units. A 17-item questionnaire was mailed to all 150 certified palliative care units in Japan, 80% of which responded. In total, 75 institutions (64%) provided at least one modality of CAM. Only 33% of the palliative care units surveyed had any regulations about patient usage of CAM, and 42% rejected some types of CAM because they caused difficulties for other patients (34%), required medical procedures (26%), used fire (5%), or required outside practitioners (4%). In total, 92% of surveyed palliative care units had no regulation and actually provided CAM. The obstacles to the use of CAM included the availability of certified practitioners, costs, added responsibilities for staff members, and insufficient evidence of efficacy. We concluded that Japanese palliative care units generally had a positive attitude toward CAM, and were willing to provide this type of therapy to patients.

Physician and nurse attitudes toward artificial hydration for terminally ill cancer patients in Japan: results of 2 nationwide surveys.

This study investigated physician and nurse attitudes toward artificial hydration in terminally ill cancer patients and compared differences in attitudes between these 2 professions and among clinical settings in Japan. The response rate was 53% (584/1,123) for physicians and 79% for nurses (3,328/4,210). More physicians answered that artificial hydration alleviates the sensation of thirst. More palliative care unit physicians and nurses answered that withholding artificial hydration alleviated several physical symptoms. Oncologists answered that artificial hydration alleviated the sensation of thirst and fatigue. Discussion among patient-centered teams and individualized decision making are important. Because the differences identified here are attributable to differences in knowledge of artificial hydration for terminal cancer patients, oncologists should place greater emphasis on the opinion of palliative care specialists. Medical practitioners caring for terminal cancer patients should consider a broader range of views on hydration therapy, with a focus on effective hydration techniques and alternative interventions.

Nurse views of the adequacy of decision making and nurse distress regarding artificial hydration for terminally ill cancer patients: a nationwide survey.

We evaluated nurse views on the adequacy of decision-making discussion among nurses and physicians regarding artificial hydration for terminally ill cancer patients and nurse distress arising from artificial hydration issues, as well as factors related to this distress. A self-administered questionnaire consisting of 4 questions about nurse views of discussions regarding artificial hydration and 6 questions about nurse distress arising from artificial hydration issues was distributed in participating institutions in October 2002 and returned by mail. A total of 3328 responses (79%) were analyzed. Almost half of the nurses felt that discussion of terminal hydration issues was insufficient. Among responses, 39% of oncology nurses and 78% of palliative care unit (PCU) nurses agreed that patients and medical practitioners discuss the issue of artificial hydration adequately, and 49% and 79%, respectively, agreed that medical practitioners discuss the issue of artificial hydration with other physicians adequately. As for distress on behalf of patients and families who refuse artificial hydration, 44% of oncology nurses and 57% of PCU nurses experienced such distress for patients, and 19% and 28% did so for families, respectively. Furthermore, 48% of oncology nurses and 47% of PCU nurses experienced distress arising from disagreements among medical practitioners about withholding artificial hydration, whereas 44% and 43% experienced distress about medical practitioners refusing artificial hydration, respectively. Discussion among care providers regarding artificial hydration is insufficient, particularly in general wards. Medical practitioners caring for terminally ill cancer patients should engage in greater discussion among patient-centered teams and facilitate individualized decision making.

Development of a national clinical guideline for artificial hydration therapy for terminally ill patients with cancer.

BACKGROUND: Although differences in physician practices of artificial hydration therapy for terminally ill patients with cancer can cause unnecessary suffering from overhyrdration or underhydration of patients, no clinical guideline is available in Japan. This paper illustrates a summary of a nationwide project to construct a clinical guideline for artificial hydration therapy. METHODS: The Japanese Society of Palliative Medicine constructed a national multidisciplinary committee to develop a clinical guideline for artificial hydration therapy for terminally ill patients with cancer, using evidence-based and formal consensus-building methods with the Delphi technique. RESULTS: After systematic literature review, three sequential sessions of discussion using the Delphi method, and an external review, a clinical guideline was established. This guideline includes general recommendations, specific recommendations (31 recommendations for medical aspects, 9 recommendations for nursing, and 7 recommendations for ethics), background descriptions, case examples, communication examples, a complete reference list, and structured abstracts of all relevant original articles. CONCLUSION: The Japanese Society of Palliative Medicine constructed a clinical guideline for artificial hydration therapy for terminally ill patients with cancer, using evidence-based and formal consensus-building methods. The clinical efficacy of this guideline should be tested in the future.

Efficacy and toxicity of vinorelbine with doxorubicin/cyclophosphamide combination chemotherapy in a phase I-II study for advanced or recurrent breast cancer patients.

BACKGROUND: To evaluate the efficacy and toxicity of vinorelbine (VNB) with doxorubicin/cyclophosphamide (AC) combination chemotherapy, a phase I-II study was carried out in patients with advanced or recurrent breast cancer. METHODS: The phase I part of this study was carried out to determine the treatment schedule and acceptable dose of VNB for the phase II study. In phase I, VNB was initially given as a short infusion on days 1, 8 and 15, every 4 weeks. The initial dose of vinorelbine was 15 mg/m2. In the AC regimen, 20 mg/m2 of doxorubicin (ADM) was given intravenously (i.v.) on days 1 and 8, and 100 mg/body of cyclophosphamide (CPA) was administered orally from days 1 to 14. Subsequently, a phase II study was carried out at the maximum acceptable dose (MAD). RESULTS: Twenty-three patients were entered into this study. In patients receiving VNB at a dose of 15 mg/m2, neutropenia (> or = grade 3) frequently occurred on day 15. The treatment schedule of this study was therefore changed to VNB given i.v. on days 1 and 8 with AC combination chemotherapy. In this treatment schedule, grade 4 neutropenia lasting for more than 4 days occurred in patients given VNB at a dose of 20 mg/m2 with AC more frequently than in those given 15 mg/m2 of VNB. Therefore, the MAD of VNB was determined to be 20 mg/m2 in this regimen. At this recommended dose, there were 1 complete (CR) and 8 partial responses (PRs) in 15 patients, with an overall response rate of 60.0%. No treatment-related death occurred. CONCLUSIONS: These data indicate that VNB plus AC combination chemotherapy was effective and well tolerated for breast cancer patients. A randomized trial of VNB plus AC vs. AC combination chemotherapy may be required to ascertain the benefit of this regimen for advanced or recurrent breast cancer patients.

Artificial hydration therapy, laboratory findings, and fluid balance in terminally ill patients with abdominal malignancies.

To explore the association between hydration volume and laboratory findings, and between calculated fluid balance and changes in clinical signs of dehydration and fluid retention in terminally ill cancer patients, a secondary analysis of a large multicenter, prospective, observational study was performed. The study enrolled 125 abdominal cancer patients who received laboratory examinations in the last week before death. Patients were classified into two groups: the hydration group (n = 44), who received 1L or more of artificial hydration per day both 1 and 3 weeks before death, and the nonhydration group (n = 81). The mean albumin level 1 week before death was significantly lower in the hydration group than in the nonhydration group, and the interaction between hydration group and decrease in the albumin level was statistically significant after adjusting multiple covariates (from 2.8 +/- 0.68 mg/dL 3 weeks before death to 2.4 +/- 0.56 mg/dL 24 hours before death in the hydration group vs. a decrease of 2.8 +/- 0.53 to 2.6+ /- 0.45 mg/dL in the nonhydration group, P = 0.015). There was no significant difference between the groups in the mean blood urea nitrogen/creatinine, sodium, or potassium levels 1 week before death. Among 53 patients who had oral fluid intake of less than 500 mL/day throughout the last 3 weeks and completed a fluid balance study, the median of calculated fluid balance was -400 mL/day 3 weeks before death, -521 mL/day 1 week before death, and -421 mL/day 24 hours before death. Calculated fluid balances did not significantly differ between the patients with deterioration of dehydration signs, edema, ascites, and pleural effusion during the final 3 weeks and those without. These data suggest that active artificial hydration might result in hypoalbuminemia, with no clear beneficial effects on normalizing blood urea nitrogen/creatinine, sodium, or potassium levels. Fluid balance did not significantly correlate with changes in dehydration-and fluid retention-signs. Calculated fluid balance is not an appropriate alternative to direct monitoring of patient symptoms. More studies are needed to determine the clinical efficacy of artificial hydration for terminally ill cancer patients.

Physician- and nurse-reported effects of intravenous hydration therapy on symptoms of terminally ill patients with cancer.

PURPOSE: To clarify physician- and nurse-reported effects of intravenous hydration therapy on symptoms of terminally ill patients with cancer. METHODS: A cross-sectional questionnaire survey of Japanese physicians and nurses. The respondents were requested to report their clinical observations about improvement or deterioration of seven symptoms of terminally ill patients with lung or gastric cancer receiving 0.5-1 L/d intravenous hydration therapy, 1.5-2 L/d intravenous hydration therapy, and reduction of intravenous hydration volume from 1.5-2 L/d to 0.5-1 L/d. RESULTS: The responses from a total of 413 oncologists, 88 palliative care physicians, 2735 oncology nurses, and 593 palliative care nurses were analyzed (response rates, 53% in physicians and 83% in nurses). Fewer than 30% of the respondents in all specialties reported that they often or very often observed improvement of dehydration symptoms with 0.5-1 L/d or 1.5-2 L/d intravenous hydration therapy. Deterioration of fluid retention symptoms was reported by 5.8%-13% of the oncologists and 20%-50% of the other specialists with 0.5-1 L/d intravenous hydration therapy for patients with lung cancer, and by 9.3%-24% of the oncologists and 16%-68% of the other specialties with 1.5-2.0 L/d hydration for patients with gastric cancer. By reducing intravenous hydration volume, 20%-70% of the palliative care physicians and nurses reported that they often or very often observed improvement of fluid retention symptoms, while less than 7.0% of all specialists reported that they often or very often observed deterioration of dehydration symptoms. CONCLUSIONS: The physicians and nurses in both oncology and palliative care settings frequently observed deterioration of fluid retention symptoms with limited benefits in alleviating dehydration symptoms by intravenous hydration therapy for terminally ill patients with cancer. It is suggested that routine use of artificial hydration therapy should not be recommended, and individualized treatment policy based on the comprehensive assessment of each patient's needs is strongly required.

Concerns of family members of patients receiving palliative sedation therapy.

PURPOSE: Symptomatic sedation is often required in terminally ill cancer patients and could cause significant distress to their families. The aim of this study was to gather vivid family descriptions about their experiences in palliative sedation therapy. METHODS: This report is an additional analysis of a multicenter questionnaire survey. We performed content analysis on 48 statements described by 185 bereaved family members of patients who received palliative sedation therapy. RESULTS: Family members reported guilt, helplessness, and physical and emotional exhaustion when patients received palliative sedation therapy. They were concerned about whether sedated patients experienced distress, wished to know that the maximum efforts had been made, wished to prepare for patient death, wished to tell important things to patients before sedation, wished to understand patients' suffering, and wanted medical professionals to treat patients with dignity. CONCLUSIONS: To alleviate family distress, clinicians should understand families' emotional distress, ensure that unconscious patients feel no distress, reassure family members that the symptoms are truly refractory despite maximum efforts for symptom relief, give information and coordinate the situation to enable families to prepare for patient death and to tell important things to patients before sedation, help families to share patients' suffering, and treat patients the same as when they remained conscious.

Emotional burden of nurses in palliative sedation therapy.

BACKGROUND: Palliative sedation therapy is often required in terminally ill cancer patients, and may cause emotional burden for nurses. The primary aims of this study were 1) to clarify the levels of nurses' emotional burden related to sedation, and 2) to identify the factors contributing to the burden levels. METHODS: A questionnaire survey of 3187 nurses, with a response rate of 82%. RESULTS: Eighty-two percent of the nurses (n = 2607) had clinical experience in continuous-deep sedation. Thirty per cent reported that they wanted to leave their current work situation due to sedation-related burden (answering occasionally, often, or always). Also, 12% of the nurses stated that being involved in sedation was a burden, 12% that they felt helpless when patients received sedation, 11% that they would avoid a situation in which they had to perform sedation if possible, and 4% that they felt what they had done was of no value when they performed sedation. The higher nurse-perceived burden was significantly associated with shorter clinical experience, nurse-perceived insufficient time in caring for patients, lack of common understanding of sedation between physicians and nurses, team conference unavailability, frequent experience of conflicting wishes for sedation between patient and family, nurse-perceived inadequate interpersonal skills, belief that it was difficult to diagnose refractory symptoms, belief that sedation would hasten death, belief that sedation was ethically indistinguishable from euthanasia, nurse-perceived inadequate coping with their own grief, and nurses' personal values contradictory to sedation therapy. CONCLUSIONS: A significant number of nurses felt serious emotional burden related to sedation. To relieve nurses' emotional burden, we encourage 1) management efforts to reduce work overload, 2) a team approach to resolving conflicting opinions, especially between physicians and nurses, 3) co-ordination of early patient-family meetings to clarify their preferred end-of-life care, 4) education and training about sedation specifically focused on interpersonal skills, systematic approaches to diagnosing refractory symptoms, minimum life-threatening potency in sedation, and ethical principals differentiating sedation from euthanasia, and 5) exploring nurses' personal values through the patient-centered principle.

Incidence and underlying etiologies of bronchial secretion in terminally ill cancer patients: a multicenter, prospective, observational study.

Although bronchial secretion is frequently observed in terminally ill cancer patients and can cause significant distress for both patients and family members, the pathophysiology is unclear. The primary aim of this study was to investigate the incidence and underlying etiologies of bronchial secretion. A multicenter, prospective, observational study was conducted on consecutive terminally ill patients with lung or abdominal malignancies. Primary physicians and nurses prospectively evaluated patients' symptoms. Of 310 patients enrolled, bronchial secretions were observed in 41% in the final 3 weeks, and oral/bronchial suctioning, with considerable distress, was required in 9%; bronchial secretions were severe in 4.5% of all patients. Multiple logistic regression analyses revealed that the determinants of the development of bronchial secretion were primary lung cancer, pneumonia, and dysphagia. There were no statistically significant effects of severity of peripheral edema and pleural effusion on development of bronchial secretions and requirement for oral/bronchial suctioning. Etiology-based classification of bronchial secretion is useful to identify the most suitable palliative treatments and to clarify treatment efficacy in each specific pathophysiology.

Family experience with palliative sedation therapy for terminally ill cancer patients.

Symptomatic sedation is often required in terminally ill cancer patients, and could cause significant distress to their family. The aims of this study were to clarify the family experience during palliative sedation therapy, including their satisfaction and distress levels, and the determinants of family dissatisfaction and high-level distress. A multicenter questionnaire survey assessed 280 bereaved families of cancer patients who received sedation in 7 palliative care units in Japan. A total of 185 responses were analyzed(response rate, 73%). The families reported that 69% of the patients were considerably or very distressed before sedation. Fifty-five percent of the patients expressed an explicit wish for sedation, and 89% of families were clearly informed. Overall, 78% of the families were satisfied with the treatment, whereas 25% expressed a high level of emotional distress. The independent determinants of low levels of family satisfaction were: poor symptom palliation after sedation, insufficient information-giving, concerns that sedation might shorten the patient's life, and feelings that there might be other ways to achieve symptom relief The independent determinants of high levels of family distress were: poor symptom palliation after sedation, feeling the burden of responsibility for the decision, feeling unprepared for changes in the patient's condition, feeling that the physicians and nurses were not sufficiently compassionate, and shorter interval to patient death. Palliative sedation therapy was principally performed to relieve severe suffering based on family and patient consent. Although the majority of families were comfortable with this practice, clinicians should minimize family distress by regular monitoring of patient distress and timely modification of sedation protocols, providing sufficient information, sharing the responsibility of the decision, facilitating grief and providing emotional support.

[Palliative care complementing cancer treatment].

Palliative medicine had conventionally been initiated after all avenues of anticancer treatment were exhausted, and the treatment of other medical problems was considered inappropriate. However, it is increasingly being recognized that the palliative principles and interdisciplinary palliative care should be initiated when a patient becomes symptomatic with an incurable disease, and should never be withheld only after all modalities of anticancer treatment have failed. Palliative care should be regarded as being complementary to direct cancer treatment. It should be implemented long before the terminal phases of the disease, and integrated in a seamless manner with other aspects of support. Palliative care is no longer merely terminal care.

Attitudes of Japanese physicians toward terminal dehydration: a nationwide survey.

PURPOSE: To clarify physician attitudes toward terminal dehydration and identify the physician-related factors contributing to their attitudes. METHODS: A cross-sectional survey of Japanese physicians with a self-reported questionnaire was used. RESULTS: A total of 584 responses were analyzed (response rate, 53%). In the vignette of a gastric cancer patient with an estimated survival of 1 month and almost impossible oral intake due to intestinal obstruction, 50% chose intravenous hydration of 1,000 mL/d, while 24% selected more than 1,500 mL/d. For a lung cancer patient with cachexia, 58% chose 1,000 mL/d, while 26% selected no hydration or 500 mL. Multivariate analyses revealed that the physicians with more positive attitudes toward intravenous hydration were significantly less involved in end-of-life care, more likely to regard the physiologic requirement of fluid and nutrition as important in initiating intravenous hydration, more likely to believe that intravenous hydration is effective for symptom palliation, and more likely to believe that intravenous hydration is the minimum standard of care. CONCLUSION: Physicians have considerably divergent attitudes toward intravenous hydration for terminally ill cancer patients. To resolve the discrepancy, the priority in hydration research should be to clarify the appropriate physiologic requirements of fluid and nutrition in dying patients, the effects of intravenous hydration on patient symptoms, and the reasons why physicians consider intravenous hydration to be the minimum standard of care.

Satisfaction with rehydration therapy for terminally ill cancer patients: concept construction, scale development, and identification of contributing factors.

Comprehensive assessment is important in determination of the efficacy of rehydration therapy for terminally ill cancer patients. To validate a multidimensional satisfaction scale, a multicenter cross-sectional study was performed. The participants were requested to complete a questionnaire on their satisfaction levels with rehydration therapy, and the primary physician recorded each patient's background. A total of 173 patients were included in this study. After the development phase, the initial instrument was shortened to a 12-item scale. In the validation phase, an exploratory factor analysis revealed underlying three subscales: satisfaction with "information giving," "disturbance of daily activities," and "treatment effect." This factor structure was ascertained by a confirmatory factor analysis. The overall Cronbach's alpha coefficient was 0.73, and those for subscales ranged from 0.73 to 0.83. The total score was significantly correlated with global satisfaction score (rho=0.53), and the "treatment effect" subscale score was moderately correlated with self-perceived improvement of dehydration symptoms (rho=0.25-0.33). The test-retest examination showed fair reproductive reliability (intraclass correlation = 0.78 for total and 0.63-0.78 for subscale scores). Multivariate analyses identified that disclosure of the incurability, 15 min or more daily contact with physicians, presence of a primary responsible nurse, absence of cachexia, and absence of fluid retention symptoms were significantly associated with higher patient satisfaction. In conclusion, this scale had acceptable psychometric properties for measurement of patient satisfaction with rehydration therapy.