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Importance: Limited data suggest that early palliative care (EPC) improves quality of life (QOL) and survival in patients with advanced cancer., Objective: To evaluate whether comprehensive EPC improves QOL; relieves mental, social, and existential burdens; increases survival rates; and helps patients develop coping skills., Design, Setting, and Participants: This nonblinded randomized clinical trial (RCT) recruited patients from 12 hospitals in South Korea from September 2017 to October 2018. Patients aged 20 years or older with advanced cancer who were not terminally ill but for whom standard chemotherapy has not been effective were eligible. Participants were randomized 1:1 to the control (receiving usual supportive oncological care) or intervention (receiving EPC with usual oncological care) group. Intention-to-treat data analysis was conducted between September and December 2022., Interventions: The intervention group received EPC through a structured program of self-study education materials, telephone coaching, and regular assessments by an integrated palliative care team., Main Outcomes and Measures: The primary outcome was the change in overall QOL score (assessed with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 15 Palliative Care) from baseline to 24 weeks after enrollment, with evaluations also conducted at 12 and 18 weeks. Secondary outcomes were social and existential burdens (assessed with the McGill Quality of Life Questionnaire) as well as crisis-overcoming capacity and 2-year survival., Results: A total of 144 patients (83 males [57.6%]; mean [SD] age, 60.7 (7.2) years) were enrolled, of whom 73 were randomized to the intervention group and 71 to the control group. The intervention group demonstrated significantly greater changes in scores in overall health status or QOL from baseline, especially at 18 weeks (11.00 [95% CI, 0.78-21.22] points; P = .04; effect size = 0.42). However, at 12 and 24 weeks, there were no significant differences observed. Compared with the control group, the intervention group also showed significant improvement in self-management or coping skills over 24 weeks (20.51 [95% CI, 12.41-28.61] points; P < .001; effect size = 0.93). While the overall survival rate was higher in the intervention vs control group, the difference was not significant. In the intervention group, however, those who received 10 or more EPC interventions (eg, telephone coaching sessions and care team meetings) showed a significantly increased probability of 2-year survival (53.6%; P < .001)., Conclusions and Relevance: This RCT demonstrated that EPC enhanced QOL at 18 weeks; however, no significant improvements were observed at 12 and 24 weeks. An increased number of interventions sessions was associated with increased 2-year survival rates in the intervention group., Trial Registration: ClinicalTrials.gov Identifier: NCT03181854.

Background: The symptoms of adrenal insufficiency (AI) overlap with the common effects of advanced cancer and chemotherapy. Considering that AI may negatively affect the overall prognosis of cancer patients if not diagnosed in a timely manner, we analyzed the incidence, risk factors, and predictive methods of AI in cancer patients., Methods: We retrospectively analyzed the medical records of 184 adult patients with malignancy who underwent a rapid adrenocorticotrophic hormone stimulation test in the medical hospitalist units of a tertiary hospital. Their baseline characteristics and clinical features were evaluated, and the risk factors for AI were identified using logistic regression analysis., Results: Of the study patients, 65 (35%) were diagnosed with AI, in whom general weakness (63%) was the most common symptom. Multivariate logistic regression showed that eosinophilia (adjusted odds ratio [aOR], 4.28; 95% confidence interval [CI], 1.10-16.63; P = 0.036), history of steroid use (aOR, 2.37; 95% CI, 1.10-5.15; P = 0.028), and history of megestrol acetate use (aOR, 2.71; 95% CI, 1.38-5.33; P = 0.004) were associated with AI. Baseline cortisol levels of 6.2 μg/dL and 12.85 μg/dL showed a specificity of 95.0% and 95.4% for AI diagnosis, respectively., Conclusion: AI was found in about one-third of patients with cancer who showed general symptoms that may be easily masked by cancer or chemotherapy, suggesting that clinical suspicion of AI is important while treating cancer patients. History of corticosteroids or megestrol acetate were risk factors for AI and eosinophilia was a pre-test predictor of AI. Baseline cortisol level appears to be a useful adjunct marker for AI., Competing Interests: The authors have no potential conflicts of interest to disclose., (© 2022 The Korean Academy of Medical Sciences.)

Background: The aim of the study was to assess health-related quality of life (HRQOL) in outpatients receiving anti-cancer treatment., Methods: Observational, cross-sectional, single-center study that assessed HRQOL in cancer patients receiving antineoplastic treatment., Results: A total of 184 patients were included in the study; the median total FACT-G score was 66 ± 12.9; the scores for the physical well-being, social/family well-being, emotional well-being and functional well-being domains were 17.8 + 4.8, 19.1 ± 4.4, 14.8 ± 3.8 and 14.3 ± 4.7 respectively. Patients with adverse events had poorer HRQOL compared to those without them (FACT-G score 62.2 vs. 67.3; p < 0.05). In the multivariate analysis the variables associated with poorer HRQOL in the form of a gradient were tumor stage and performance status (ECOG); female sex was also associated with poorer HRQOL., Conclusion: In our study, the neoplastic disease and anti-cancer treatment toxicities had an impact on HRQOL. Patients had poorer scores in the functional well-being domain and higher ones in the social/family well-being domain. Variables associated with worse HRQOL were tumor stage, performance status (ECOG) and female sex., (© 2021. The Author(s).)

Context: The goal of palliative care is to maximize the quality of life and thus maintain the dignity of patients facing problems associated with a life-threatening illness. The Patient Dignity Inventory (PDI) is an instrument used to measure various sources of distress that can impact patients' sense of dignity at the end of life., Objectives: We aimed to obtain a Korean translation of the PDI (PDI-K) and evaluate its psychometric properties in patients with advanced cancer., Methods: Translation and cultural adaptation of the PDI were performed to obtain the Korean version. In a sample of 131 inpatients and outpatients with advanced cancer, psychometric properties, including factor structure, internal consistency, and concurrent validity, were examined. Concurrent validity was evaluated using the Edmonton Symptom Assessment System, the Hospital Anxiety and Depression Scale, and the 12-item Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being., Results: Cronbach's α for the PDI-K was 0.96. Four factors were identified by exploratory factor analysis, accounting for 68.7% of the overall variance: Dependency and Physical Symptoms, Psychological Distress, Existential Distress, and SocialSupport. Concurrent validity was confirmed by significant correlations between PDI-K and Edmonton Symptom Assessment System (r = 0.40 to 0.59, P < 0.001), Hospital Anxiety and Depression Scale (r = 0.78 to 0.81, P < 0.001), and Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being (r = -0.32 to -0.57, P < 0.001)., Conclusion: Our findings indicate that the PDI-K is a valid and reliable instrument to measure dignity-related distress in patients with advanced cancer. This tool provides a four-factor Korean language alternative to the PDI., (Copyright © 2021. Published by Elsevier Inc.)

Objectives: This study investigated the effectiveness of early medication treatment and metformin use for cancer prevention in type 2 diabetes patients., Methods: Population-based cohort data were used from the Korean National Health Insurance Service-National Sample Cohort database (KNHIS-NSC) for 2002-2013. Patient-specific medication prescription status was defined by the landmark time (LMT; a fixed time after cohort entry), considering both pre- and post-LMT prescriptions to control methodological biases in observational research. The LMT was set to 2 years. Logistic regression analysis with multivariable adjustment was conducted to analyze cancer incidence by patient-specific medication prescription status., Results: Only 33.4% of the subjects were prescribed medication early (before the LMT) with compliance. Cancer incidence in individuals with early prescription and compliance was 25% lower (odds ratio [OR], 0.75; 95% confidence interval [CI], 0.67 to 0.84) than in those without. As early-prescribed medications, metformin monotherapy and metformin combination therapy were associated with 34% (OR, 0.66; 95% CI, 0.51 to 0.83) and 25% (OR, 0.75; 95% CI, 0.64 to 0.88) lower cancer risk than non-use, respectively. Patients who were prescribed late (post-LMT) but did not comply with the prescription had a 24% (OR, 1.24; 95% CI, 0.97 to 1.58) higher cancer incidence than non-users. Among patients who started monotherapy early without changes throughout the entire follow-up period, those who started on metformin had a 37% (OR, 0.63; 95% CI, 0.41 to 0.99) lower risk of cancer than non-metformin users., Conclusions: Doctors must prescribe antidiabetic medication early, and patient compliance is required, regardless of the prescription time, to prevent cancer. Metformin monotherapy or combination therapy is recommended as an early prescription.

Purpose: To investigate the association between quality of life (QOL) and breakthrough cancer pain (BTCP) intensity in patients who met the commonly accepted definition of BTCP., Methods: This study was a subset analysis of a South Korean multicenter, non-interventional, cross-sectional, nationwide survey. Participants were recruited from March 2016 to December 2017. BTCP was defined as a controlled background pain of less than a numeric rating scale (NRS) of 3 and any flare-up pain intensity. Pain intensity data were collected using the Brief Pain Inventory (BPI), which includes an interference assessment of the affective and physical domains. Patients were categorized by BTCP intensity into mild (NRS 1-3), moderate (4-6), and severe (7-10) groups., Results: Of the 969 screened patients with cancer, 679 had ≤ NRS 3 background pain, of whom 438 completed the BPI. Of these 438 patients, 40, 204, and 194 were in the mild, moderate, and severe BTCP groups, respectively. The median NRS of BTCP was 6.0 (interquartile range = 5.0-8.0). Patients with moderate-severe BTCP had significantly higher interference with daily functioning (IDF) scores than did mild BTCP patients (3.3 vs. 5.7; p < 0.01). Both domains of IDF were significantly hampered proportionally by increased BTCP intensity (p < 0.001). The median total IDF scores of the no, moderate, and severe BTCP groups were 3.3, 5.0, and 6.9, respectively. Furthermore, IDF depended on BTCP intensity, duration, and frequency (p < 0.01) but not on pain type and cause., Conclusion: An increase in BTCP intensity is likely to result in IDF, regardless of the cause or type of BTCP.

Context: Few randomized controlled trials of advance care planning (ACP) with a decision aid (DA) show an effect on patient preferences for end-of-life (EOL) care over time, especially in racial/ethnic settings outside the U.S., Objectives: The objective of this study was to examine the effect of a decision aid consisting of a video and an ACP booklet for EOL care preferences among patients with advanced cancer., Methods: Using a computer-generated sequence, we randomly assigned (1:1) patients with advanced cancer to a group that received a video and workbook that both discussed either ACP (intervention group) or cancer pain control (control group). At baseline, immediately after intervention, and at 7 weeks, we evaluated the subjects' preferences. The primary outcome was preference for EOL care (active treatment, life-prolonging treatment, or hospice care) on the assumption of a fatal disease diagnosis and the expectation of death 1) within 1 year, 2) within several months, and 3) within a few weeks. We used Bonferroni correction methods for multiple comparisons with an adjusted P level of 0.005., Results: From August 2017 to February 2018, we screened 287 eligible patients, of whom 204 were enrolled to the intervention (104 patients) or the control (100 patients). At postintervention, the intervention group showed a significant increase in preference for active treatment, life-prolonging treatment, and hospice care on the assumption of a fatal disease diagnosis and the expectation of death within 1 year (P < 0.005). Assuming a life expectancy of several months, the change in preferences was significant for active treatment and hospice care (P < 0.005) but not for life-prolonging treatment. The intervention group showed a significant increase in preference for active treatment, life-prolonging treatment, and hospice care on the assumption of a fatal disease diagnosis and the expectation of death within a few weeks (P < 0.005). From baseline to 7 weeks, the decrease in preference in the intervention group was not significant for active treatment, life-prolonging treatment, and hospice care in the intervention group in the subset expecting to die within 1 year, compared with the control group. Assuming a life expectancy of several months and a few weeks, the change in preferences was not significant for active treatment and for life-prolonging treatment but was significantly greater for hospice care in the intervention group (P < 0.005)., Conclusion: ACP interventions that included a video and an accompanying book improved preferences for EOL care., (Copyright © 2019 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.)

The glucocorticoid-induced TNFR family-related protein (GITR, TNFRSF18, CD357) is expressed on effector and regulatory T (Treg) cells. Previous studies demonstrated that GITR triggering by anti-GITR mAb enhanced T and B cell-mediated immune responses. GITR-deficient T cells, however, also proliferate more than normal T cells, and this effect is unexplained. Because the activities of mAbs are controlled by their Fc regions, the true effect of GITR signaling needs to be determined by examining its interaction with authentic ligand. Therefore, we generated a pentamerized form of the GITRL extracellular domain (pGITRL) for ligation to GITR and compared its effect on T cells with that of anti-GITR mAb. The pGITRL was more effective than anti-GITR mAb in enhancing the proliferation of effector and regulatory cells in vitro and in vivo. Nonetheless, the growth of MC38 adenocarcinoma cells in vivo was only suppressed for initial 15 d by pGITRL, whereas it was suppressed indefinitely by anti-GITR mAb. Detailed analysis revealed that pGITRL induced extensive proliferation of Foxp3(+)CD4(+) Treg cells and led to the accumulation of activated Treg cells in tumor tissue and draining lymph nodes. Because GITR signaling could not neutralize the suppressive activity of activated Treg cells, pGITRL seems to lose its adjuvant effect when sufficient activated Treg cells have accumulated in the lymph nodes and tumor tissue. Indeed, the antitumor effects of pGITRL were markedly enhanced by depleting CD4(+) cells. These results suggest that GITR signaling has stimulatory effects on effector T cells and inhibitory effects through Treg cells., (Copyright © 2015 by The American Association of Immunologists, Inc.)

Adoptive T-cell therapy is a promising approach to the immunotherapy of cancer, but for it to be a general cancer therapy a simple and standardized procedure for producing tumor-specific CD8 T cells is needed. On the basis of a unique property of 4-1BB (CD137), the selective expression on activated T cells, we have developed a simple and practical protocol to produce antigen-specific CD8 T cells from peripheral blood mononuclear cells. We have proved the feasibility of this procedure by isolating and expanding cytomegalovirus-specific CD8 T cells, and applied the procedure to produce Epstein-Barr virus (EBV)-specific CD8 T cells. By using this procedure, we could readily produce 10-10 antigen-specific CD8 T cells from 30 to 50 mL of blood in about 4 weeks. Moreover, our protocol allowed us to produce, from solid cancer patients, CD8 T cells that were specific for self/tumor antigens such as human telomerase reverse transcriptase (hTERT). It is interesting to note that, we were unable to amplify hTERT-specific CD8 T cells from healthy donors. Our protocol can be readily translated into cGMP-compliant production and is currently being used to produce EBV-specific CD8 T cells for phase I clinical trial. We believe that our method will provide a practical and effective option for adoptive T-cell therapy in the clinic.

Purpose: The objective of this study was to evaluate whether extended-release hydromorphone (osmotic-controlled release oral delivery system [OROS] hydromorphone) treatment provided pain relief in cancer patients whose pain was inadequately controlled by other analgesics., Methods: In this prospective, open-label, multicenter trial, patients who have sustained cancer pain with other analgesics were enrolled. After the baseline evaluation (visit 1), OROS hydromorphone was administered. Two evaluations (visits 2 and 3) were made: 29 ± 7 and 57 ± 7 days later, respectively. The primary end point was the pain intensity difference (PID) at visit 3 relative to visit 1 (expressed as percent PID)., Results: In total, 879 patients were screened and 432 completed all three visits. Of the 874 full analysis set patients, 343 (39.2 %) improved by more than 30 % PID. Of the 432 per-protocol patients, 282 (65.3 %) improved by more than 30 % PID. At visits 2 and 3, the degree of sleep disturbance, the number of awakenings, and the degree of sleep satisfaction were significantly better than at visit 1 (all P < 0.0001 for both visit 1-visit 2 and visit 1-visit 3). However, this pain relief was not associated with improved quality of life (P = 0.326 and P = 0.055 for visit 1-visit 2 and visit 1-visit 3, respectively)., Conclusions: This study suggested that active pain management using the strong opioid OROS hydromorphone was beneficial in the management of cancer pain that was not controlled by other analgesics.

Purpose: We tested whether a decision aid explaining how to discuss the approach of death with a family member with cancer would help family caregivers decide to discuss a terminal prognosis., Patients and Methods: We randomly assigned caregivers of terminally ill patients with cancer to a group that received a video and a companion workbook that showed either how they can discuss the prognosis with their patient (experimental arm) or how cancer pain can be controlled (control arm). At baseline and 1 month, we evaluated the decision to discuss terminal prognosis as the primary outcome. At 0, 1, 3, and 6 months, we assessed the caregivers' decisional conflict and satisfaction as secondary outcomes using a Decision Conflict Scale (DCS)., Results: We found no difference in changes in the decision to discuss terminal prognosis between the two groups. Conflict (P = .003), uncertainty (P = .019), and value clarity (P = .007) subscale scores and total DCS score (P = .008) improved from baseline to 1 month significantly more in the experimental arm than in the control arm. Over 6 months, the significant between-group differences continued for the conflict (P = .031), uncertainty (P = .014), and value clarity (P = .039) subscale scores and total DCS score (P = .040)., Conclusion: Decision aids can help caregivers, with the aid of trained professionals, to communicate with patients about their terminal illness.

Background: Fatigue is one of the most common problems experienced by cancer patients. The factors most frequently reported to correlate with cancer-related fatigue are symptom distress (pain, nausea/vomiting, dyspnea, and lack of appetite) and psychological distress (depression and anxiety)., Aims: This study was performed to examine the overall association of symptom and psychological distress with cancer-related fatigue using systematic literature review and meta-analysis. This study also aimed to determine which factors have a higher correlation with fatigue, and therefore should receive nursing priority., Methods: A meta-analysis of 30 primary studies identified by searching computer databases, which included MEDLINE, PubMed, and CINAHL., Results: Results showed that all symptoms (pain, dyspnea, nausea/vomiting, and lack of appetite) and psychological distress (depression and anxiety) included had a significant association with cancer-related fatigue with medium-to-large effect sizes, which were estimated using correlation coefficients. The overall correlations of psychological distress with cancer-related fatigue were found to be higher than those of symptom distress. The correlation of nausea/vomiting with cancer-related fatigue was higher than those of pain and dyspnea., Conclusions and Implications: Our findings highlight the importance of psychological distress in dealing with cancer-related fatigue in addition to the need to be attentive to a patient's symptom distress. Of the symptom distress, nausea/vomiting should be prioritized by nurses when managing cancer-related fatigue. This study provides sound empirical evidence that can be used to draft guidelines for the management of cancer-related fatigue., (Copyright ©2011 Sigma Theta Tau International.)

Purpose: This study was conducted to identify comprehensive predictors of fatigue in cancer patients., Methods: One hundred ten cancer patients visiting in-patient or out-patient clinics of a university hospital located in Incheon participated in this study., Results: The hematologic indicators (WBC and Hemoglobin) were significant for explaining fatigue. The psychological factors of fatigue were statistically significant. Both anxiety and depression, included as psychological factors, were significant in explaining fatigue in cancer patients. The influence of physical factors on fatigue was also statistically significant. Among the variables included as physical factors, pain, nausea/vomiting/anorexia, and sleep disturbance were significant whereas, dyspnea was not significant. The influence of the daily activity factor on fatigue was statistically significant. Among the variables included as daily activity factors, regular exercise or not and the usual activity level were significant in explaining fatigue of cancer patients, while the level of rest was not statistically significant., Conclusions: From the study results fatigue of cancer patients appeared to be influenced by multidimensional factors, such as physiological, physical, psychological, and activity related factors.

The purpose of this study was to develop and test a decision tree model of the treatment-seeking behaviors among Korean cancer patients. The study used methodological triangulation, applying the cognitive ethnographic decision tree modeling approach. The model was developed based on qualitative data collected from in-depth interviews with 29 cancer patients. The model was tested using qualitative and quantitative data collected from interviews and a structured questionnaire involving 165 cancer patients. The predictability of the decision tree model was quantified as the proportion of participants who followed the pathway predicted by the model. Two models were developed, the first for decision making about when to visit a doctor after detecting symptoms, and the second for decision making about treatment type following the diagnosis. Decision outcomes for the first model were categorized into immediate visit and delayed visit. The first model was influenced by the perceived seriousness of symptoms, the experiences of visiting a doctor previously with similar symptoms, social-group influences on visiting a doctor, and barriers to visiting a doctor. Decision outcomes for the second model were hospital treatment only, and a mixture of hospital treatment and alternative therapies. The second model was influenced by curability, social-group influences on alternative therapies, and confidence in alternative therapies. The predictabilities of the 2 models were 90.3% and 94.5%, respectively. This study result can help nurses understand the treatment-seeking behaviors of cancer patients, and hence develop nursing intervention strategies.