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.

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.

Feasibility and Preliminary Effectiveness of Behavioral Activation for Patients with Cancer and Depression in Japan.

Background: Though the effectiveness of behavioral activation (BA) for patients with cancer and depression were reported, there is no evidence in Japan. Objectives: This study aimed at examining the feasibility and preliminary effectiveness of BA for patients with cancer and depression in Japan. Methods: This pre-post study without a control group was conducted in patients with cancer and depression in Japan. The program completion rate was compared with those of previous studies to examine feasibility. To examine the preliminary effectiveness, outcomes were evaluated four times: before and immediately after the program, and two weeks and three months after the program ended. The primary outcome was the remission rate of depression using the 17-item version of the GRID Hamilton Rating Scale for Depression (HAMD17). Secondary outcomes were self-reported depression, anxiety, quality of life, changes in behavior, values, and perceived reward of activity and environmental factors. Pre- and post-program data were compared using paired-samples t-tests, and data obtained at four time points were analyzed using one-way repeated-measures analysis of variance. Results: Of the 68 patients recruited from February 2018 to January 2022, 32 were registered. The completion rate was 75% (24/32), which was similar to previous studies. The total HAMD17 score significantly improved after the program. The remission rate of depression was 62.5% (20/32), which was above the defined threshold value (30%). All but two secondary outcomes significantly improved after the program (p < 0.05). Conclusions: The feasibility and preliminary effectiveness of BA for patients with cancer and depression in Japan were suggested.The Clinical Trial Registration number: UMIN 000036104.

A multi-centre, double-blind, randomized, placebo-controlled trial to evaluate the effectiveness and safety of ramelteon for the prevention of postoperative delirium in elderly cancer patients: a study protocol for JORTC-PON2/J-SUPPORT2103/NCCH2103.

Postoperative delirium is an important issue in cancer patients, affecting surgical outcomes and the quality of life. Ramelteon is a melatonin receptor agonist with high affinity for MT1 and MT2 receptors. Clinical trials and observational studies in Japan, including in surgical cancer patients, have shown efficacy of ramelteon in delirium prevention, with no serious safety concerns. However, clinical trials from the USA have reported conflicting results. A Japanese phase II study investigated the efficacy and safety of ramelteon for delirium prevention following gastrectomy in patients aged ≥75 years, with findings suggesting the feasibility of a phase III trial. The aim of this multi-centre, double-blind, randomized placebo-controlled phase III trial is to evaluate the effectiveness and safety of oral ramelteon for postoperative delirium prevention in cancer patients aged ≥65 years as advanced medical care. The trial protocol is described here.

Behavioral activation for depression in patients with advanced cancer: study protocol for a multicenter randomized controlled trial.

BACKGROUND: Though behavioral activation (BA) has been shown to be effective for depression, evidence in patients with advanced cancer has not been established. This study aimed to examine the effectiveness of a BA program on depression in this population. METHODS: A randomized controlled trial with a wait-list control group (waiting group) of 38 patients with advanced cancer and depression will be conducted at three sites in Japan. The BA program consists of seven sessions. Outcome measures will be evaluated at three times in the intervention group; at the entry, at the end of the intervention and 4 months after the end of the intervention and four times in the waiting group: at the entry, before the intervention, at the end of the intervention, and 4 months after the end of the intervention. Primary outcome is Beck Depression Inventory-II (BDI-II) score. To examine the main effect of the intervention, two-way repeated measures analysis of variance (ANOVA) will be conducted, with timing and intervention status as the independent variables and BDI-II score as the dependent variable. One-way repeated measures ANOVA will be conducted to combine data from the intervention and control groups and examine changes in BDI-II scores by timing in both groups. Secondary endpoints (anxiety, quality of life, spirituality, degree of behavioral activation, value, and pain) will be evaluated with rating scales. Two-way repeated measures ANOVA will be conducted to examine whether there are differences between the groups before and after the intervention, with timing and intervention status as the independent variables and scores on each rating scale as the dependent variables. DISCUSSION: This multicenter randomized controlled trial is the first study to assess the effectiveness of BA on depression in patients with advanced cancer. Our findings will provide evidence about the effectiveness of BA on depression and provide an intervention option that is acceptable and feasible for the treatment of depression in this population. The results of this study will lead to improved mood and rebuilding to regain life purpose and value in this vulnerable population. TRIAL REGISTRATION NUMBER: jRCT, jRCT1030210687, Registered 22 March 2022, https://jrct.niph.go.jp/en-latest-detail/jRCT1030210687 .

Development and evaluation of the feasibility, validity, and reliability of a screening tool for determining distress and supportive care needs of adolescents and young adults with cancer in Japan.

OBJECTIVES: This study aims to (i) develop a screening tool for determining distress and supportive care needs of adolescent and young adult cancer patients (AYAs) based on the NCCN's Distress Thermometer and Problem List (DTPL), (ii) evaluate its feasibility, discriminant validity, and test-retest reliability in clinical settings, and (iii) report prevalence of distress and unmet needs. METHOD: In the development phase, after translation of the Japanese version of the DTPL (DTPL-J) from English into Japanese and back translation, cognitive debriefing was performed. Items in the problem list were modified to better reflect AYAs' concerns after interviews. The modified items were reviewed and accepted unanimously by healthcare professionals. In the feasibility phase, the DTPL-J for AYAs was used in a clinical setting for 3 months. Descriptive statistics of participants' demographics, selected items, and DT scores were calculated to report prevalence of distress and unmet needs. Response and referral rates to experts were assessed to evaluate feasibility. Some items were compared with patient demographics to assess discriminant validity. Among the patients who responded at least twice, correlations between two consecutive screenings were assessed to evaluate test-retest reliability. RESULTS: The DTPL-J consisted of 49 items in five categories. Of 251 patients, 232 (92.4%) were provided the DTPL-J and 230 (91.6%) responded. Based on the DT cutoff of ≥4, 69 of 230 patients (30%) had high distress. Anxiety (n = 85, 36.6%) was the most commonly selected item. Primary nurses referred 45 (21.7%) patients to an attending physician or another expert. Referral rates after DTPL-J use were higher than rates before use, but the difference was not statistically significant (p = 0.06). The items compared were consistent with their social background. A positive correlation was observed between two responses for some items. SIGNIFICANCE OF RESULTS: The feasibility, discriminant validity, and test-retest reliability of the tool were suggested.

A Support System for Adolescent and Young Adult Patients with Cancer at a Comprehensive Cancer Center.

Cancer patients in adolescents and young adults (AYA) generation aged 15-39 years have various psychosocial needs during their treatment course such as school enrollment, finding employment, marriage, and fertility. It is difficult for medical professionals to gain experience related to providing medical care and consultation support to these kinds of AYA generation cancer patients. There is a need to provide information and establish both support and medical care systems that are able to meet the diverse needs unique to this generation. This review will explain how to launch an AYA support team (AST). We have worked and established the AST since 2016, which is medical care teams that provide support according to the life stage of each individual patient and build a multidisciplinary AYA generation patient support system. The team-building process consisted of two main projects: building and enlarging multidisciplinary team and establishing screening process of psychosocial needs of AYA generation patients. Multidisciplinary healthcare professionals got involved in the AST with already-existing patient support functions in our center: the patient support center, which is an outpatient department and the palliative care team, which is an inpatient interdepartmental team. The AST systematically finds patients in need of assistance and offers them support as a multidisciplinary team. The AST also established a procedure that systematically gathers information about the needs of patients by using a screening tool. In addition, the AST provides the following specialized services: reproductive medicine, supporting cancer patients with children, employment support, and peer support. The AST has been established and sophisticatedly worked. It can flexibly provide various psychosocial support services. This review will explain how to launch an AST.

A Hospital-Based Online Patients Support Program, Online Adolescent and Young Adult Hiroba, for Adolescent and Young Adult Cancer Patients at a Designated Cancer Center in Japan.

Adolescent and young adult (AYA) patients with cancer have few opportunities to interact with peers in their lives. To meet peers safely during the coronavirus disease 2019 (COVID-19) pandemic, a hospital-based online patients support program called Online AYA Hiroba was launched for AYA patients with cancer and held regularly by the National Cancer Center Hospital in Japan. This retrospective study suggested the degree of satisfaction with this program and issues about facilitating the sessions that are unique to the online environment. Our findings potentially contribute to the establishment of a hospital-based online patients support program for AYA patients with cancer at other hospitals.

A feasibility study of a peer discussion group intervention for patients with pancreatobiliary cancer and their caregivers.

OBJECTIVES: The purpose of this feasibility study was to examine the impacts of a peer discussion group intervention called "the pancreatobiliary cancer salon" on psychological distress among patients with pancreatobiliary cancer and their caregivers. METHODS: We recruited patients with pancreatic or biliary tract cancer and their caregivers. We conducted a within-group pre-post comparison study. Participants were grouped by the type of cancer and treatment. Each group consisted of four to five patients or caregivers. Hospital staff members facilitated group discussions where participants freely talked for 1 h. We evaluated participants' psychological condition using the Profile of Mood States (POMS) and their impressions of the pancreatobiliary cancer salon. RESULTS: We analyzed data from 42 patients and 27 caregivers who joined the salon for the first time. Thirty-five patients (83.3%) had pancreatic cancer. Thirty-one patients (71.4%) had unresectable pancreatobiliary cancer and 14 patients (33.3%) were being treated with second-line or third-line chemotherapy at the time of the survey. Twenty-two patients (52.4%) participated in the salon within 6 months after diagnosis. Most participating caregivers were the patient's spouse/partner (51.9%) or child (34.6%). Both patients and caregivers experienced high levels of satisfaction with the pancreatobiliary cancer salon. Both patients and caregivers had significantly lower psychological distress as assessed by POMS after the salon. SIGNIFICANCE OF RESULTS: A peer discussion group intervention might be well-received and has potential to benefit for patients with pancreatobiliary cancer and their caregivers.

A Questionnaire Survey on Adolescent and Young Adult Hiroba, a Peer Support System for Adolescent and Young Adult Cancer Patients at a Designated Cancer Center in Japan.

Adolescent and young adult (AYA) cancer patients have few opportunities to interact with peers in the hospital. AYA Hiroba, a peer support system for AYA cancer patients, was launched and held regularly at the National Cancer Center Hospital in Japan. This questionnaire survey was conducted to investigate the degree of satisfaction and opinions of AYA cancer patients regarding this program. Participants reported that the content was satisfying and useful. Their impressions suggested that AYA Hiroba is potentially effective for promoting interaction with the same generation, change in mood, and acquisition of information.

Acute Brachial Arterial Embolic Occlusion Following Anticoagulant Discontinuation in a Renal Biopsy of a Nephrotic Syndrome Patient.

A 73-year-old woman with atrial fibrillation treated with rivaroxaban was hospitalized for nephrotic syndrome. After discontinuation of rivaroxaban to lower the risk of hemorrhagic events, a renal biopsy was performed. Rivaroxaban was scheduled to resume a week after the biopsy to prevent renal hemorrhaging. However, she developed acute brachial arterial embolic occlusion and mural thrombosis in the abdominal aorta before resuming rivaroxaban. If immune-mediated renal diseases are suspected in anticoagulated patients at a risk of thrombotic events, physicians should consider initiating glucocorticoid therapy without a renal biopsy in order to avoid hemorrhagic and thrombotic events.

Behavioral activation therapy for depression and anxiety in cancer patients: a case series study.

BACKGROUND: Behavioral activation therapy (BAT) directly addresses activities that individuals value most highly, and may be easily applicable to cancer patients. However, there is no established evidence of the use of BAT in this population. In this study, we examined the possibility of a BAT program for depression and anxiety in cancer patients. CASE PRESENTATION: We retrospectively reviewed the medical records of cancer patients with each of the following characteristics: 1) were outpatients or inpatients visiting the psycho-oncology division of the National Cancer Center Hospital in Japan; 2) met criteria for Major Depressive Disorder or Adjustment Disorders; and 3) participated in a BAT program. The primary outcome was the program completion percentage. Secondary outcomes were self-reported depression severity (Patient Health Questionnaire-9 (PHQ-9) score), anxiety disorder status (Generalized Anxiety Disorder-7 (GAD-7) score), and clinical improvement (Clinical Global Impression-Improvement (CGI-I) score) after the program. We analyzed both depression and anxiety by the matched paired t-test. Ten patients participated in the program, and nine completed it. One dropped out due to cognitive impairment secondary to brain metastasis. Both the PHQ-9 scores (pre: 14.4 (SD, 6.1); post: 5.1 (SD, 5.8)) and the GAD-7 scores (pre: 11.9 (SD, 4.9); post: 4.7 (SD, 5.5)) significantly improved after the program (PHQ-9: P = 0.0014; GAD-7: P = 0.0004). CGI-I scores ranged from 1 to 3, and all subjects except the patient who dropped out improved clinically. Among the ten patients, three distinctive cases could be observed as follows. Case 1; a 45-year-old housewife with breast cancer who did not agree to take antidepressants because of concerns about the side effects achieved remission without antidepressants and began to live an active life. Case 4; a 66-year-old housewife was so shocked after endometrial cancer diagnosis that she was absent-minded and her compliance with the assigned homework was poor, therefore, her depression did not improve much. Case 9; a 62-year-old man with laryngeal cancer who had recurrent anxiety. Increased business activity, on which he put great value, gradually allowed him to be able to live his life actively without concerns. CONCLUSIONS: This study suggests that BAT would be effective for the depression and anxiety of cancer patients.

Patient-Specific Relationship Between Hydraulic Permeability of Microvasculature and the Extent of Burden of Excess Fluid in Hemodialysis Patients.

We have reported a significant correlation between hydraulic permeability of microvasculature adjusted with ultrafiltration rate (AdjLpst) and excess fluid divided by dry weight (ExF/DW) in a cross-sectional study of hemodialysis patients. We aimed to study longitudinally whether a similar relationship between them exists in each patient. Twelve hemodialysis (HD) patients in whom AdjLpst and ExF/DW had been measured more than four times (total of 85 measurements) were enrolled. AdjLpst was calculated by monitoring blood volume during HD. ExF was calculated from the fluid volume measured via bioimpedance spectroscopy. The borders of overhydration were 1.66 mL/mm Hg per min for AdjLpst and a positive value for ExF/DW. There was a significant correlation between AdjLpst and ExF/DW (r = 0.517). When the 85 measurements were classified into four quadrants according to ExF/DW and AdjLpst, the evaluations of fluid status agreed in 66 measurements. In six patients, significant positive correlations were found. In nine patients, equal to or more than 80.0% of evaluations by AdjLpst and those by ExF/DW agreed. In only one patient was there neither significant correlation nor agreement. AdjLpst of two patients suffering from chronic heart failure and microscopic polyangiitis was reduced compared with that of others loaded with the same extent of excess fluid. We concluded that there was a significant correlation between AdjLpst and ExF/DW and high agreement between evaluation by AdjLpst and evaluation by ExF/DW in the majority of patients. However, the relationship between them was patient-specific to some extent.

[A case of thrombotic microangiopathy with glomerular subendothelial IgA deposition due to bevacizumab].

Bevacizumab, an inhibitor of vascular endothelial growth factor, is approved for the treatment of various cancers, but the incidence of proteinuria as a side effect has been reported to be 2-64%. We report a case of renal impairment due to thrombotic microangiopathy (TMA) accompanied with glomerular subendothelial deposition of IgA resulting from bevacizumab administration. A 57-year-old female with advanced breast cancer, to whom bevacizumab had been administered from October 2012, developed proteinuria and epithelial casts in her urine about a month later. Serum creatinine remained at 0.7-0.8 mg/dL until June 2013, but gradually increased to 1.3 mg/dL in September. She was referred to our hospital because her renal function had not improved despite termination of bevacizumab, and a renal biopsy was performed in October. At that time, the levels of proteinuria, serum creatinine and serum IgA were high at 1.3 g/g x Cr, 1.6 mg/dL and 430 mg/dL, respectively. Histological examinations showed prominent IgA deposits in the subendothelial area and glomerular infiltration of CD68 positive cells in addition to features of TMA, such as narrowed glomerular capillary lumina and double contours of the basement membranes. In consideration of her clinical history, a diagnosis of bevacizumab-induced TMA was made. Through follow-up care without readministration of bevacizumab, epithelial casts in her urine disappeared, and proteinuria decreased to 0.62 g/g x Cr in November. Serum creatinine remains high at around 1.3 mg/dL, but has not elevated further. Serum IgA gradually decreased and reached 289 mg/dL in April 2014. TMA due to bevacizumab described in several other reports was also accompanied by glomerular IgA deposition, thus a differential diagnosis of IgA nephropathy is required. TMA was recently added to a section of "significant adverse effects" in the package insert of bevacizumab. Nephrologists should be fully aware of this drug-induced nephropathy.