Effect of non-pharmacological interventions on symptoms and quality of life in patients with hematological malignancies - A systematic review.

BACKGROUND: Non-pharmacological interventions have the potential to enhance health-related quality of life (HRQoL) through symptom management. This systematic review aims to identify, collate, and assess randomized controlled trials investigating the effect of non-pharmacological interventions on symptoms and HRQoL within hematology. METHODS: MEDLINE/PUBMED, EMBASE, CINAHL, PSYCINFO and COCHRANE were searched up to April 2021. Outcomes were changes in symptoms and HRQoL. RESULTS: Sixty-five studies were categorized into five intervention types: Mind/body (n=9), Web-based (n=9), Music/art (n=6), Consultation-based (n=4), and Physical activity (n=37). We found significantly reduced fatigue (n=12 studies), anxiety (n=8) and depression (n=7), with 11 studies showing significant improvements in HRQoL. CONCLUSIONS: The evidence for non-pharmacological interventions shows substantial variation in efficacy and methodological quality. While specific symptoms and HRQoL outcomes significantly favored the intervention, no particular intervention can be emphasized as more favorable, given the inability to conduct a meta-analysis.

A Shifting Paradigm Toward Family-Centered Care in Neuro-Oncology: A Longitudinal Quasi-Experimental Mixed-Methods Feasibility Study.

Family-centered intervention can help families facing illness-related issues. We investigated the feasibility of Family and Network Conversations (FNCs) in high-grade glioma patients and their families. Quasi-experimental feasibility study with longitudinal mixed-methods design. Patients and families were invited to three FNCs over 1 year. They completed questionnaires at four time points and expressed their perspectives on the intervention through telephone interviews. Nurses' perspectives were collected in a focus group. Twenty-one patients and 47 family members were included. On average, patients were 66 years old, mainly male, married, living with caregivers, with unifocal cancer. On average, caregivers were 47 years old, mainly female, being spouses or children of the patient. Quantitative and qualitative data did not always match and expanded each other. Nurse-delivered FNCs holistically addressed families' needs while strengthening family's dialogue and union. Nurses felt empowered, underling that advanced competencies were required. Nurse-delivered FNCs are feasible to provide family-centered care, but they should be tailored to each family's needs.

Family caregiver quality of life and symptom burden in patients with hematological cancer: A Danish nationwide cross-sectional study.

OBJECTIVE: To investigate the quality of life (QoL) and the impact of caregiving in family caregivers of hematological cancer patients and its association with patient symptom burden. METHODS: A cross-sectional study including Danish patients (n = 375) and caregivers (n = 140). Caregivers completed scales for anxiety and depression using the Hospital Anxiety and Depression Scale, sleep quality using the Pittsburgh Sleep Quality Index, health related QoL using the 12-item Short-Form Health Survey, and caregiver roles using the Caregiver Roles and Responsibilities Scale. Patients reported symptoms using the MD Anderson Symptom Inventory. Analysis of covariance was used to examine associations between patient symptom burden and caregivers' QoL outcomes. RESULTS: The results show that caregivers experience sleep difficulties, moderate anxiety, and reduced QoL. Patient symptom burden was significantly associated with caregiver anxiety (p = 0.009), and mental well-being (p = 0.002), while patient treatment status was a significant factor associated with caregiver anxiety (p = 0.016), depression (p = 0.009), emotional well-being (p = 0.002), and sleep (p = 0.01). CONCLUSION: Caregivers of patients with hematological cancers undergoing active treatment face a high symptom burden, which significantly impacts their QoL, including sleep, psychological well-being, and emotional health. Patients reported a high symptom burden, and patient symptom burden was significantly associated with caregiver QoL. Adequate patient and caregiver support is needed to promote their well-being and mitigate adverse health effects in caregivers, and this should be acknowledged in the context of caring for patients with hematological cancer.

The iBLAD study: patient-reported outcomes in bladder cancer during oncological treatment: a multicenter national randomized controlled trial.

BACKGROUND: Patient-reported outcomes (PROs) are getting widely implemented, but little is known of the impact of applying PROs in specific cancer diagnoses. We report the results of a randomized controlled trial (RCT) of the active use of PROs in patients with locally advanced or metastatic bladder cancer (BC) undergoing medical oncological treatment (MOT) with focus on determining the clinical effects of using PROs during chemo- or immunotherapy compared to standard of care. METHODS: We recruited patients from four departments of oncology from 2019 to 2021. Inclusion criteria were locally advanced or metastatic BC, initiating chemo- or immunotherapy. Patients were randomized 1:1 between answering selected PRO-CTCAE questions electronically once weekly with a built-in alert-algorithm instructing patients of how to handle reported symptoms as a supplement to standard of care for handling of side effects (intervention arm (IA)) vs standard procedure for handling of side effects (control arm (CA)). No real-time alerts were sent to the clinic when PROs exceeded threshold values. Clinicians were prompted to view the completed PROs in the IA at each clinical visit. The co-primary clinical endpoints were hospital admissions and treatment completion rate. Secondary endpoints were overall survival (OS), quality of life (EORTC's QLQ-C30 and QLQ-BLM30) and dose reductions. RESULTS: 228 patients with BC were included, 76% were male. 141 (62%) of the patients had metastatic disease. 51% of patients in the IA completed treatment vs. 56% of patients in the CA, OR 0.83 (95% CI 0.47-1.44, p = 0.51). 41% of patients in the IA experienced hospitalization vs. 32% in the CA, OR 1.48 (95% CI 0.83-2.65, p = 0.17). OS was comparable between the two arms (IA: median 22.3mo (95% CI 17.0-NR) vs. CA: median 23.1mo (95% CI 17.7-NR). Patient and clinician compliance was high throughout the study period (80% vs 94%). CONCLUSIONS: This RCT did not show an effect of PRO on completion of treatment, hospitalizations or OS for BC patients during MOT despite a high level of patient and clinician compliance. The lack of real-time response to alerts remains the greatest limitation to this study.

Value of gym-based group exercise versus usual care for young adults receiving antipsychotic medication: study protocol for the multicenter randomized controlled Vega trial.

BACKGROUND: Exercise is recommended to protect physical health among people with severe mental illness and holds the potential to facilitate long-term recovery. An inclusive exercise community provides an opportunity for life skill training and social connectedness and may reduce the experience of loneliness and internalized stigmatization which together may improve personal recovery. Using a pragmatic randomized design, we aim to examine the effectiveness of a gym-based exercise intervention tailored to young adults in antipsychotic treatment (i.e., Vega Exercise Community) compared to usual care. It is hypothesized that the Vega Exercise Community will be superior to usual care for personal recovery at four months. METHODS: The trial will be conducted at four sites in Denmark from which 400 participants, aged 18 to 35 years, who are in current treatment with antipsychotic medications for the management of schizophrenia spectrum or affective disorders, will be recruited. Participants will be randomized (2:1) to Vega Exercise Community or usual care. Vega Exercise Community includes three weekly group-based exercise sessions hosted in commercial functional training centers delivered by certified Vega instructors. After four months, participants in Vega Exercise Community will be randomized (1:1) to minimal versus extended support with regards to sustained physical activity. Data will be collected at baseline, four, six and 12 months. The primary outcome is personal recovery assessed by Questionnaire about the Process of Recovery at four months. Behavioral symptoms, health-related quality of life, metabolic health, and program costs will be evaluated to further determine the effectiveness and cost-effectiveness of the Vega Exercise Community. Finally, the quality of life and physical and mental health of the participants' primary relative will be evaluated. DISCUSSION: The results of this trial may have important implications for health, sustained physical activity, and recovery for individuals in treatment with antipsychotics. Given the pragmatic design, positive results may readily be implemented by mental health care professionals to promote exercise as an integrated part of treatment of severe mental illness. TRIAL REGISTRATION: Clinical Trials.gov (NCT05461885, initial registration June 29th, 2022). WHO Universal Trial Number (UTN): U1111-1271-9928.

Impact of Training in Serious Illness Communication and Work Life Balance on Physicians' Self-Efficacy, Clinical Practice and Perception of Roles.

Purpose: Serious illness communication is a core task in hemato-oncology that require advanced communication skills and can be emotionally demanding. A 2-day course was implemented as a mandatory part of the 5-year hematology specialist training program in Denmark in 2021. The aim of this study was to assess the quantitative and qualitative effect of course participation on self-efficacy in serious illness communication and measure the prevalence of burnout among physicians in hematology specialist training. Methods: For quantitative assessment course participants answered three questionnaires: Self-efficacy Advance care planning (ACP), Self-efficacy Existential communication (EC) and the Copenhagen Burnout Inventory at baseline, 4 and 12 weeks after the course. The control group answered the questionnaires once. Qualitative assessment was performed as structured group interviews with course participants 4 weeks after the course, transcribed, coded, and transformed into themes. Results: All self-efficacy EC scores and 12 out of 17 self-efficacy ACP scores improved after the course, though mostly non-significant. Course participants reported altered clinical practice and perception of role as a physician. The physicians' confidence that they could find the time to discuss ACP were low and remained low. The prevalence of burnout was high. Burnout levels were non-significantly lower after the course. Conclusion: A mandatory course of formal training can increase physician self-efficacy in serious illness communication and alter clinical practice and perception of roles. The high level of burnout among physicians in hemato-oncology calls for institutional interventions in addition to training.

Reasons for lack of treatment in patients with locally advanced, unresectable or metastatic urothelial carcinoma.

BACKGROUND: The proportion of patients with locally advanced, unresectable or metastatic urothelial carcinoma that do not receive systemic anticancer treatment and the reasons for lack of treatment are largely unknown. The aim of this study was to investigate the prevalence and overall survival of this patient group and reasons for omission of treatment. MATERIAL AND METHODS: This retrospective, single-center cohort study from Rigshospitalet, Denmark included patients diagnosed with locally advanced, unresectable or metastatic urothelial carcinoma during the study period from 1 January 2010 to 31 March 2016 who did not receive systemic anticancer treatment. Patients were identified through the Danish Pathology Register and the electronic medical records. RESULTS: 100 patients were included, representing 34% of all patients diagnosed with locally advanced, unresectable or metastatic urothelial carcinoma at Rigshospitalet during the study period. Lack of treatment was most often due to poor physical condition (59%), decreased renal function (15%), or patient preferences (14%). Median overall survival was 1.9 months (95% CI: 1.6-2.8 months). CONCLUSION: One in three patients diagnosed with locally advanced, unresectable or metastatic urothelial carcinoma in the pre-immunotherapy era did not receive systemic anticancer treatment. Prompt identification of advanced disease and interventions to optimize these patients for treatment are essential. Our findings underscore the compelling need for novel, better tolerated treatment regimens in this frail patient group.

Family caregiver ambassador support for caregivers of patients with newly diagnosed hematological cancer: a feasibility study.

PURPOSE: This study investigated the feasibility of a one-on-one peer support intervention in family caregivers of newly diagnosed patients with a hematological cancer during initial treatment. METHODS: The study was a one-arm feasibility study including family caregivers of newly diagnosed patients with hematological cancer (n = 26) and caregiver ambassadors who were family caregivers of previously treated patients as peer supporters (n = 17). The one-on-one peer support intervention consisted of three components: a caregiver ambassador preparatory course; 12 weeks of one-on-one peer support, and caregiver ambassador network meetings. RESULTS: Family caregivers reported high satisfaction with the delivery and flexibility of one-on-one peer support and improved in most psychosocial outcomes over time. Telephone and text messages were the most used form of contact between the peers. Caregiver ambassadors reported high satisfaction with the preparatory course and used the available support from the network meetings. No adverse events were reported. CONCLUSION: One-on-one peer support provided by a caregiver ambassador is feasible and safe in family caregivers of newly diagnosed hematological cancer patients during their initial treatment. Utilizing volunteer caregiver ambassadors has the potential to be a new support model in family caregivers of hematological cancer patients across diagnostic groups within a clinical setting. CLINICAL TRIAL REGISTRATION NUMBER: NCT04039100, July 29, 2019.

Efficacy and Acceptability of Intermittent Aerobic Exercise on Polysomnography-Measured Sleep in People With Rheumatoid Arthritis With Self-Reported Sleep Disturbance: A Randomized Controlled Trial.

OBJECTIVE: This study's objective was to investigate the efficacy and acceptability of intermittent aerobic exercise training on sleep parameters, fatigue, pain, depressive symptoms, physical function, and cardiorespiratory fitness in people with rheumatoid arthritis (RA). METHODS: Thirty-eight people with RA were assigned to intermittent aerobic exercise training (three sessions/week for 6 weeks; intervention group, n = 17) or usual care (control group, n = 21). The primary outcome was a change in polysomnography-assessed sleep efficiency from baseline to the end of the intervention. Secondary outcomes were sleep quality (Pittsburgh Sleep Quality Index), fatigue (Bristol Rheumatoid Arthritis Fatigue Multi-Dimensional Questionnaire), depression (Center for Epidemiological Studies-Depression), and cardiorespiratory fitness (watt max test). RESULTS: No between-group differences were found in changes in polysomnography-assessed sleep efficiency (0.04; 95% confidence interval [CI]: -0.02 to 0.09, P = 0.17). In the intervention group, sleep efficiency was improved significantly from baseline (0.84; 95% CI: 0.80-0.88) compared with the end of the intervention (6 weeks) (0.88; 95% CI: 0.85-0.92); however, there was no significant difference in the control group. Fatigue and depression measures were significantly lower in the intervention group than in the control group. Between-group differences were overall fatigue (-16.1; 95% CI: -25.1 to -7.0, P = 0.001), physical fatigue (-5.0; 95% CI: -7.3 to -2.7, P = 0.0001), cognitive fatigue (-2.4; 95% CI: -4.2 to 0.6, P = 0.009), living with fatigue (-2.5; 95% CI: -4.5 to -0.5, P = 0.01), and depressive symptoms (-6.8; 95% CI: -12.4 to -1.1, P = 0.02). CONCLUSION: The intervention yielded no significantly better sleep efficiency compared with usual care. However, aspects of fatigue, including physical and cognitive fatigue, and depressive symptoms were significantly improved in the intervention group.

Needs assessment in patients surgically treated for head and neck cancer-a randomized controlled trial.

PURPOSE: To investigate the effect and feasibility of a head and neck cancer-specific needs assessment tool integrated into nursing rehabilitation consultations early in the post-surgical period on quality of life, symptom burden, and referrals for multidisciplinary follow-up. METHODS: Ninety-two surgically treated patients with head and neck cancer were enrolled in a two-arm randomized controlled trial. All participants received nursing rehabilitation consultations prior to discharge, and two weeks and two months post-operative. The intervention group had their needs assessed using Patient Concerns Inventory, while standard care used a systematic questioning approach. Primary outcome was quality of life. Secondary outcomes were symptom burden and referrals for multidisciplinary rehabilitation follow-up. RESULTS: No significant differences were found in quality of life or symptom burden between groups. However, 35% more patients in the intervention group were referred for rehabilitation. The attrition rate was similar in both groups, with a dropout rate of six in each group. No patients declined using the Patient Concerns Inventory. CONCLUSION: The intervention showed no improvement in QoL or symptom burden compared to standard care. However, the results suggest that important needs were identified and addressed. Especially emotional and existential needs, which were accommodated through referrals and professional advice. Nursing rehabilitation consultations using the Patient Concerns Inventory are feasible and may ensure that patient preferences and priorities are incorporated in their care. TRIAL REGISTRATION: ClinicalTrials.com (NCT03443258). Date of registration: May 31st, 2018.

Neuro-Oncological Symptoms: A Longitudinal Quantitative Study of Family Function, Perceived Support, and Caregiver Burden.

The aim of this study was to establish preliminary quantitative evidence for the longitudinal change in family function, perceived support, and caregiver burden, acknowledging that physical and emotional symptoms are important variables for quality of life in families affected by a brain cancer diagnosis. This longitudinal quantitative study measured patient-reported and family member-reported outcomes at four different time points in 1 year. The patients reported that the symptom burden hindered their relationships with other people. Furthermore, the generally high level of strain due to the caregiver burden had an especially negative impact on close social relationships. Data indicate that family functioning was continually negatively affected as perceived by both patients and family caregivers. No significant changes over time were identified. The results underline the importance of providing systematic and ongoing support to the whole family that acknowledges their contribution as a valuable social support system for the individual experiencing high-grade glioma.

Effects of a 12-Week Multimodal Exercise Intervention Among Older Patients with Advanced Cancer: Results from a Randomized Controlled Trial.

BACKGROUND: Older patients with cancer are at risk of physical decline and impaired quality of life during oncological treatment. Exercise training has the potential to reduce these challenges. The study aim was to investigate the feasibility and effect of a multimodal exercise intervention in older patients with advanced cancer (stages III/IV). PATIENTS AND METHODS: Eighty-four older adults (≥65 years) with advanced pancreatic, biliary tract, or non-small cell lung cancer who received systemic oncological treatment were randomized 1:1 to an intervention group or a control group. The intervention was a 12-week multimodal exercise-based program including supervised exercise twice weekly followed by a protein supplement, a home-based walking program, and nurse-led support and counseling. The primary endpoint was change in physical function (30-second chair stand test) at 13 weeks. RESULTS: Median age of the participants was 72 years (interquartile range [IQR] 68-75). Median adherence to the exercise sessions was 69% (IQR 21-88) and 75% (IQR 33-100) for the walking program. At 13 weeks, there was a significant difference in change scores of 2.4 repetitions in the chair stand test, favoring the intervention group (p < .0001). Furthermore, significant beneficial effects were seen for physical endurance (6-minute walk test), hand grip strength, physical activity, symptom burden, symptoms of depression and anxiety, global health status (quality of life), and lean body mass. No effects were seen for dose intensity, hospitalizations, or survival. CONCLUSION: A 12-week multimodal exercise intervention with targeted support proved effective in improving physical function in older patients with advanced cancer during oncological treatment.

Long-term postoperative health-related quality of life in patients with subfrontal meningiomas.

OBJECTIVE: Subfrontal meningiomas grow insidiously in areas with high cerebral compliance and a relative scarcity of eloquent function. Symptoms develop progressively, are nonspecific, and include anosmia, changes in personality and cognition, depressive symptoms, headaches, visual disturbances, and seizures. Patients with subfrontal meningiomas carry the highest risk of developing psychological symptoms, which makes patient-reported outcome in terms of long-term health-related quality of life (HRQOL), anxiety, and depression of particular importance. This observational study aimed to investigate long-term HRQOL, anxiety, and depression in patients with subfrontal meningiomas who underwent a bifrontal craniotomy (subfrontal) approach between 2008 and 2017 at a single tertiary center. Correlations between preoperative, perioperative, and postoperative factors and HRQOL, anxiety, and depression were analyzed to detect prognostic factors. METHODS: Seventy-seven consecutive patients who underwent operations at Rigshospitalet, Copenhagen, Denmark, between 2008 and 2017 were retrospectively analyzed. Patients were prospectively invited to respond to the Functional Assessment of Cancer Therapy-General, Functional Assessment of Cancer Therapy-Brain, and Hospital Anxiety and Depression Scale. Information regarding preoperative, perioperative, and postoperative factors were collected from the patients' medical records and scans. RESULTS: Patients with subfrontal meningiomas exhibited better HRQOL and lower levels of anxiety and depression than general populations and other meningioma and glioblastoma cohorts. The only statistically significant prognostic factors for long-term HRQOL were number of symptoms at diagnosis and whether patients were discharged home or to a local hospital postoperatively. Tumor and peritumoral brain edema volumes were not prognostic factors. CONCLUSIONS: Patients with subfrontal meningiomas exhibited better long-term postoperative HRQOL and were less likely to have anxiety or depression than the reference populations. This information on long-term prognosis is very valuable for patients, next of kin, and neurosurgeons and has not been previously studied in detail.

Patient ambassador support in newly diagnosed patients with acute leukemia during treatment: a feasibility study.

PURPOSE: This study investigated the feasibility of patient ambassador support in newly diagnosed patients with acute leukemia during treatment. METHODS: A multicenter single-arm feasibility study that included patients newly diagnosed with acute leukemia (n = 36) and patient ambassadors previously treated for acute leukemia (n = 25). Prior to the intervention, all patient ambassadors attended a 6-h group training program. In the intervention, patient ambassadors provided 12 weeks of support for patients within 2 weeks of being diagnosed. Outcome measures included feasibility (primary outcome), safety, anxiety, and depression measured by the Hospital Anxiety and Depression Scale, quality of life by the Functional Assessment of Cancer Therapy-Leukemia and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, and symptom burden by MD Anderson Symptom Inventory, the Patient Activation Measure, and the General Self-Efficacy Scale. RESULTS: Patient ambassador support was feasible and safe in this population. Patients and patient ambassadors reported high satisfaction with the individually adjusted support, and patients improved in psychosocial outcomes over time. Patient ambassadors maintained their psychosocial baseline level, with no adverse events, and used the available support to exchange experiences with other patient ambassadors and to manage challenges. CONCLUSION: The patient ambassador support program is feasible and has the potential to be a new model of care incorporated in the hematology clinical care setting, creating an active partnership between patients and former patients. This may strengthen the existing supportive care services for patients with acute leukemia. TRIAL REGISTRATION: NCT03493906.

Familial disease history and fur color type are associated with urinary tract disease in farmed mink (Neovison vison).

Mink urinary tract disease (MUTD) and mink fatty liver disease (MFLD) constitute two important disease entities in the mink production associated with sudden mortality and economic loss. Genetic factors or heritability of the diseases have not previously been investigated. Since mortality associated with MUTD and MFLD mainly occurs in the young immature mink, a potential genetic predisposition would rarely be passed on by the mink itself but potentially by relatives. This study aimed to investigate familial aggregation of MUTD and MFLD based on data from four generations of mink on a research farm. The study included a total of 27,511 mink of brown and black color type with a post mortem prevalence of 0.8% for MUTD (n = 221) and 0.5% for MFLD (n = 138) within a year from birth. The prevalence in the color types brown and black were 0.6% and 1.6% for MUTD and 0.5% and 0.7% for MFLD. Family history of MUTD in breeding animals was found to be associated with a significantly higher probability of MUTD leading to mortality in offspring (p = 0.012, RR = 1.7; CI [1.1-2.4]), however this association was not significant for MFLD (p = 0.163, RR = 1.5; CI [0.9-2.7]). Mink of the color type black showed significantly higher risk of MUTD (RR = 2.6; CI [2.0-3.3]) and MFLD (R = 1.6; CI [1.1-2.2]) compared to brown mink. The results indicate that genetic factors may play a role in understanding MUTD and that selective breeding may contribute to reduce mortalities associated with this disease.

Interval Walking Improves Glycemic Control and Body Composition After Cancer Treatment: A Randomized Controlled Trial.

CONTEXT: Patients with colorectal cancer have increased risk of metabolic diseases including diabetes. Exercise training may counteract metabolic dysregulation, but the impact of exercise training on glycemic control, including postprandial glycemia, has never been explored in patients with colorectal cancer. OBJECTIVE: To examine the effects of home-based interval walking on aerobic and metabolic fitness and quality of life in patients with colorectal cancer. DESIGN: Randomized controlled trial. SETTING: Clinical research center. PARTICIPANTS: Thirty-nine sedentary (<150 minutes moderate-intensity exercise per week) patients with stage I to III colorectal cancer who had completed primary treatment. INTERVENTION: Home-based interval walking 150 min/wk or usual care for 12 weeks. MAIN OUTCOME MEASURES: Changes from baseline to week 12 in maximum oxygen uptake (VO2peak) by cardiopulmonary exercise test, glycemic control by oral glucose tolerance test (OGTT), body composition by dual-energy x-ray absorptiometry scan, blood biochemistry, and quality of life. RESULTS: Compared with control, interval walking had no effect on VO2peak [mean between-group difference: -0.32 mL O2 · kg-1 · min-1 (-2.09 to 1.45); P = 0.721] but significantly improved postprandial glycemic control with lower glucose OGTT area under the curve [-126 mM · min (-219 to -33); P = 0.009], 2-hour glucose concentration [-1.1 mM (-2.2 to 0.0); P = 0.056], and improved Matsuda index [1.94 (0.34; 3.54); P = 0.01]. Also, interval walking counteracted an increase in fat mass in the control group [-1.47 kg (-2.74 to -0.19); P = 0.025]. CONCLUSION: A home-based interval-walking program led to substantial improvements in postprandial glycemic control and counteracted fat gain in posttreatment patients with colorectal cancer, possibly providing an effective strategy for prevention of secondary metabolic diseases.

Repeated exposure to vegetable-enriched snack bars may increase children's liking for the bars - but not for the vegetables.

Most children do not consume enough vegetables and a key reason is their relatively low hedonic acceptance. The aims of this study were to test if integration of vegetables into a popular snack product might serve as a means to increase the liking for vegetables and to test how exposure frequency influences the intake and liking. Totally 256 children from 12 school classes, aged 7-10 years, participated in the study. School classes were assigned to one of six intervention groups based on the bar they were exposed to: beetroot/carrot (B/C), n = 45; spinach/Jerusalem artichoke (S/J), n = 34; pumpkin/sweet potato (P/S), n = 44; Neutral, n = 46, who received a neutral bar without vegetables; and a Boredom Group, who received the beetroot/carrot (b/c) bar at high frequency, n = 47. These groups received 8 exposures. The Boredom Group was exposed daily while the other groups were exposed every second day. A Control Group (n = 40) was not exposed. Liking for the bars was assessed at baseline and post-intervention and the intake of the bars was recorded during all exposures. Results showed increases in liking for the exposed bars in all groups except the Boredom Group, but changes were only significant in the B/C Group (p = 0.03) and the P/S Group (p = 0.02). Some increases towards unexposed bars were observed. Liking for vegetables remained stable or decreased. Intake of the bars during exposures did not differ significantly between groups, but was somewhat lower in the Boredom Group. In conclusion, repeated exposure may be a successful approach to increase liking for a vegetable bar, but does not generalize to changes in vegetable liking, and a lower exposure frequency may be advantageous.

CD8+ T cells induced by adenovirus-vectored vaccine are capable of preventing establishment of latent murine γ-herpesvirus 68 infection.

CD8+ T cells are known to control infections, but their role in preventing latent infection from establishing has not been thoroughly investigated. We hypothesized that a potent CD8+ T cell response patrolling the mucosal viral entry points could kill the first infected cells and thereby abrogate the infection before latency is established. To investigate this, replication deficient adenovirus serotype 5 vectors encoding murine γ-herpesvirus-68 CD8+ T cell epitopes linkedto the T cell adjuvant Invariant chain, were developed. We show that intranasal vaccination of mice reduces the risk of establishment of latent infection from multiple intranasal ID50 challenges with murine γ-herpesvirus-68 by 81% per exposure at 14 days post vaccination. Protection waned over time, but immune responses were extended by heterologous prime-boost vaccination applied simultaneously intramuscularly and intranasally, and animals vaccinated 66 days prior to challenge showed a strong trend of long-term protection. Our data provides evidence that CD8+ T cells are able to protect against establishment of latent infection. Although the protective efficacy is difficult to maintain over time, this proof-of-concept study suggests a role for a CD8+ T cell arm in future vaccine strategies against latent human viral infections caused by pathogens such as HIV and multiple herpes virus.

Football Compared with Usual Care in Men with Prostate Cancer (FC Prostate Community Trial): A Pragmatic Multicentre Randomized Controlled Trial.

BACKGROUND: Physical activity has been shown to mitigate the unwanted psychological and physiological side effects of prostate cancer treatments, but sustainable exercise possibilities are limited. OBJECTIVE: Our objective was to examine whether football in a real-world setting (i.e., local football clubs) was safe and feasible in practice and could improve quality of life, mitigate decline in muscle mass and bone density, and increase fat mass in patients with prostate cancer. METHODS: In this pragmatic, multicentre, parallel randomized controlled trial, men diagnosed with prostate cancer were recruited from five Danish urological departments. Men (N = 214) diagnosed with prostate cancer were randomly allocated, using random generated lists (block size 4-8) stratified for center and androgen-deprivation therapy status, to either 1 h of football twice weekly in a local football club or to usual care, which was a 15- to 30-min telephone session covering their options for physical activity or free-of-charge rehabilitation delivered as standard in Denmark. Allocation was concealed from the trial investigator performing the randomization, but-given the nature of the intervention-this was not possible for personnel and participants. Assessments were performed at baseline, 12 weeks, and 6 months. The primary outcome was mean change difference in prostate cancer-specific quality of life at 12 weeks. Secondary outcomes were body composition, 12-Item Short Form Health Survey (SF-12) physical and mental health, and safety-reported as fractures, falls, and serious adverse events. RESULTS: Attrition was 1 and 3% at 12 weeks, and 5% and 5% at 6 months for the usual care and football groups, respectively. Prostate cancer-specific quality of life was equal between groups at 12 weeks (mean difference + 1.9 points, 95% confidence interval [CI] -1.0-4.8; P = 0.20) and at 6 months (+ 0.5 points, 95% CI -2.8-3.8; P = 0.76). Fractures were equally distributed, with two fractures in the usual care group and one in the football group. Likewise, body composition outcomes were equal. Mental health improved after 6 months of football (mean difference + 2.7 points, 95% CI 0.8-4.6; P = 0.006). CONCLUSIONS: In this trial, community-based football was a feasible exercise strategy for men with prostate cancer. Football did not improve prostate cancer-specific quality of life but did improve mental health; the clinical significance of this is unclear. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02430792.

Engaging the older cancer patient; Patient Activation through Counseling, Exercise and Mobilization - Pancreatic, Biliary tract and Lung cancer (PACE-Mobil-PBL) - study protocol of a randomized controlled trial.

BACKGROUND: Several intervention studies have demonstrated that exercise training has beneficial effects among cancer patients. However, older cancer patients are underrepresented in clinical trials, and only few exercise-based studies have focused specifically on older patients with cancer. In particular, research investigating the effects of exercise training among older patients with advanced cancer is lacking. The purpose of the current study is to investigate the effect of a 12-week multimodal and exercise-based intervention among older patients (≥65 years) with advanced pancreatic, biliary tract or lung cancer, who are treated with first-line palliative chemotherapy, immunotherapy or targeted therapy. METHODS: PACE-Mobil-PBL is a two-armed randomized controlled trial. Participants will be randomized 1:1 to an intervention group (N = 50) or a control group (N = 50). Participants in the intervention group will receive standard oncological treatment and a 12-week multimodal intervention, comprised of: (I) supervised exercise training, twice weekly in the hospital setting, (II) home-based walking with step counts and goal-setting, (III) supportive and motivational nurse-led counseling, and (IV) protein supplement after each supervised training session. Participants in the control group will receive standard oncological treatment. The primary outcome is physical function measured by the 30-s chair stand test. Secondary outcomes include measures of feasibility, activity level, physical capacity and strength, symptom burden, quality of life, toxicity to treatment, dose reductions, inflammatory biomarkers, body weight and composition, hospitalizations and survival. Assessments will be conducted at baseline, and after 6, 12 and 16 weeks. DISCUSSION: The current study is one of the first to investigate the effect of an exercise-based intervention specifically targeting older patients with advanced cancer. PACE-Mobil-PBL supports the development of health promoting guidelines for older patients with cancer, and the study results will provide new and valuable knowledge in this understudied field. TRIAL REGISTRATION: The study was prospectively registered at ClinicalTrials.gov on January 26, 2018 (ID: NCT03411200 ).