Quality of life endpoints in cancer cachexia clinical trials: Systematic review 3 of the cachexia endpoints series.

The use of patient-reported outcomes (PROMs) of quality of life (QOL) is common in cachexia trials. Patients' self-report on health, functioning, wellbeing, and perceptions of care, represent important measures of efficacy. This review describes the frequency, variety, and reporting of QOL endpoints used in cancer cachexia clinical trials. Electronic literature searches were performed in Medline, Embase, and Cochrane (1990-2023). Seven thousand four hundred thirty-five papers were retained for evaluation. Eligibility criteria included QOL as a study endpoint using validated measures, controlled design, adults (>18 years), ≥40 participants randomized, and intervention exceeding 2 weeks. The Covidence software was used for review procedures and data extractions. Four independent authors screened all records for consensus. Papers were screened by titles and abstracts, prior to full-text reading. PRISMA guidance for systematic reviews was followed. The protocol was prospectively registered via PROSPERO (CRD42022276710). Fifty papers focused on QOL. Twenty-four (48%) were double-blind randomized controlled trials. Sample sizes varied considerably (n = 42 to 469). Thirty-nine trials (78%) included multiple cancer types. Twenty-seven trials (54%) featured multimodal interventions with various drugs and dietary supplements, 11 (22%) used nutritional interventions alone and 12 (24%) used a single pharmacological intervention only. The median duration of the interventions was 12 weeks (4-96). The most frequent QOL measure was the EORTC QLQ-C30 (60%), followed by different FACIT questionnaires (34%). QOL was a primary, secondary, or exploratory endpoint in 15, 31 and 4 trials respectively, being the single primary in six. Statistically significant results on one or more QOL items favouring the intervention group were found in 18 trials. Eleven of these used a complete multidimensional measure. Adjustments for multiple testing when using multicomponent QOL measures were not reported. Nine trials (18%) defined a statistically or clinically significant difference for QOL, five with QOL as a primary outcome, and four with QOL as a secondary outcome. Correlation statistics with other study outcomes were rarely performed. PROMs including QOL are important endpoints in cachexia trials. We recommend using well-validated QOL measures, including cachexia-specific items such as weight history, appetite loss, and nutritional intake. Appropriate statistical methods with definitions of clinical significance, adjustment for multiple testing and few co-primary endpoints are encouraged, as is an understanding of how interventions may relate to changes in QOL endpoints. A strategic and scientific-based approach to PROM research in cachexia trials is warranted, to improve the research base in this field and avoid the use of QOL as supplementary measures.

Older adults' perceptions and experiences of interprofessional communication as part of the delivery of integrated care in the primary healthcare sector: a meta-ethnography of qualitative studies.

BACKGROUND: Communication between patients and healthcare providers, and effective interprofessional communication, are essential to the provision of high-quality care. Implementing a patient-centred approach may lead to patients experiencing a sense of comfort, validation, and active participation in own healthcare. However, home-dwelling older adults' perspectives on interprofessional communication (IPC) are lacking. The aim is therefore to explore how home-dwelling older adults experience communication in connection with the delivery of integrated care. METHODS: The meta-synthesis was conducted in line with Noblit and Hare's seven phases of meta-ethnography. A systematic literature search was conducted by two university librarians in seven databases using the search terms 'older adults', 'communication', 'integrated care' and 'primary care'. All articles were reviewed by two authors independently. 11 studies were included for analysis. RESULTS: Older adults are aware of IPC and have preferences regarding how it is conducted. Three main themes were identified in the reciprocal analysis: (1) Inconsistent care perceived as lack of IPC, (2) individual preferences regarding involvement and awareness of IPC and (3) lack of IPC may trigger negative feelings. CONCLUSIONS: This meta-ethnography shows the perspective of older adults on IPC as part of integrated care. Our study shows that older adults are concerned about whether healthcare personnel talk to each other or not and recognise IPC as fundamental in providing consistent care. The perspectives of older adults are relevant for clinicians and politicians, as well as researchers, when developing and implementing future integrated care services for home-dwelling older adults.

Appetite and dietary intake endpoints in cancer cachexia clinical trials: Systematic Review 2 of the cachexia endpoints series.

There is no consensus on the optimal endpoint(s) in cancer cachexia trials. Endpoint variation is an obstacle when comparing interventions and their clinical value. The aim of this systematic review was to summarize and evaluate endpoints used to assess appetite and dietary intake in cancer cachexia clinical trials. A search for studies published from 1 January 1990 until 2 June 2021 was conducted using MEDLINE, Embase and Cochrane Central Register of Controlled Trials. Eligible studies examined cancer cachexia treatment versus a comparator in adults with assessments of appetite and/or dietary intake as study endpoints, a sample size ≥40 and an intervention lasting ≥14 days. Reporting was in line with PRISMA guidance, and a protocol was published in PROSPERO (2022 CRD42022276710). This review is part of a series of systematic reviews examining cachexia endpoints. Of the 5975 articles identified, 116 were eligible for the wider review series and 80 specifically examined endpoints of appetite (65 studies) and/or dietary intake (21 studies). Six trials assessed both appetite and dietary intake. Appetite was the primary outcome in 15 trials and dietary intake in 7 trials. Median sample size was 101 patients (range 40-628). Forty-nine studies included multiple primary tumour sites, while 31 studies involved single primary tumour sites (15 gastrointestinal, 7 lung, 7 head and neck and 2 female reproductive organs). The most frequently reported appetite endpoints were visual analogue scale (VAS) and numerical rating scale (NRS) (40%). The appetite item from the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30/C15 PAL (38%) and the appetite question from North Central Cancer Treatment Group anorexia questionnaire (17%) were also frequently applied. Of the studies that assessed dietary intake, 13 (62%) used food records (prospective registrations) and 10 (48%) used retrospective methods (24-h recall or dietary history). For VAS/NRS, a mean change of 1.3 corresponded to Hedge's g of 0.5 and can be considered a moderate change. For food records, a mean change of 231 kcal/day or 11 g of protein/day corresponded to a moderate change. Choice of endpoint in cachexia trials will depend on factors pertinent to the trial to be conducted. Nevertheless, from trials assessed and available literature, NRS or EORTC QLQ C30/C15 PAL seems suitable for appetite assessments. Appetite and dietary intake endpoints are rarely used as primary outcomes in cancer cachexia. Dietary intake assessments were used mainly to monitor compliance and are not validated in cachexia populations. Given the importance to cachexia studies, dietary intake endpoints must be validated before they are used as endpoints in clinical trials.

The association between age and long-term quality of life after curative treatment for prostate cancer: a cross-sectional study.

OBJECTIVE: We aimed to investigate the associations between age at radical prostate cancer treatment and long-term global quality of life (QoL), physical function (PF), and treatment-related side effects. MATERIAL AND METHODS: This single-center, cross-sectional study included men treated for localized prostate cancer with robotic-assisted radical prostatectomy (RARP) or external beam radiotherapy (EBRT) in 2014-2018. Global QoL and PF were assessed by the European Organisation of Research and Treatment in Cancer Quality of life Questionnaire-C30 (QLQ-C30), side effects by the Expanded Prostate Cancer Index Composite (EPIC-26). Adjusted linear regression models were estimated to assess associations between age (continuous variable) at treatment and outcomes. QLQ-C30 scores were compared to normative data after dividing the cohort in two groups, <70 years and ≥70 years at treatment. RESULTS: Of 654 men included, 516 (79%) had undergone RARP, and 138 (21%) had undergone EBRT combined with androgen deprivation therapy for 93%. Mean time since treatment was 57 months. Median age at treatment was 68 (min-max 44-84) years. We found no statistically significant independent association between age at treatment and global QoL, PF or side effects, except for sexual function (regression coefficient [RC] -0.77; p < 0.001) and hormonal/vitality (RC 0.30; p = 0.006) function. Mean QLQ-C30 scores were slightly poorer than age-adjusted normative scores, for men <70 years (n = 411) as well as for men ≥70 years (n = 243) at treatment, but the differences were not beyond clinical significance. CONCLUSIONS: In this cohort of prostate cancer survivors, age at treatment had little impact on long-term QoL and function. Due to the cross-sectional design, short term impact or variation over time cannot be ruled out.

Food for Soul-Older Immigrants' Food Habits and Meal Preferences After Immigration: A Systematic Literature Review.

There are few primary studies that focused on the older immigrants' food habits and meal preferences after immigration and settlement in a new country. A comprehensive database search for literature was conducted in May 2021 and upgraded in September 2021. Ten databases (Medline (Ovid), EMBASE (Ovid), PsycInfo (Ovid), Cinahl (EBSCOhost), Food Science Source (EBSCOhost), SocIndex (EBSCOhost), Social Care Online, Applied Social Sciences Index & Abstracts (ASSIA), Web of Science and Google Scholar), were scanned for original, peer-reviewed papers published in English. The review was conducted and reported in accordance with the PRISMA 2020 guidelines and SWiM items. Out of 3069 records, 10 papers were included for thematic synthesis. A data synthesis across all studies resulted in three main findings: (i) the significance of food in maintaining cultural identity, (ii) the continuity of traditional food culture and (iii) adapting to the host country's food culture. Although different forms of dietary acculturation occur throughout life, older immigrants often want to maintain their traditional food habits and meal preferences. For them, traditional eating habits offer comfort and security by serving as a means of identifying who they are and reminding them where they have come from. Public health and social services play an important role in providing cultural nutritional care to older immigrants; therefore, this issue should be carefully addressed by professionals and future research.Registration: The review protocol was registered in the International Prospective Register of Systematic Reviews (PROSPERO) on 27 September 2022 with registration number CRD42022358235.

Physical function endpoints in cancer cachexia clinical trials: Systematic Review 1 of the cachexia endpoints series.

In cancer cachexia trials, measures of physical function are commonly used as endpoints. For drug trials to obtain regulatory approval, efficacy in physical function endpoints may be needed alongside other measures. However, it is not clear which physical function endpoints should be used. The aim of this systematic review was to assess the frequency and diversity of physical function endpoints in cancer cachexia trials. Following a comprehensive electronic literature search of MEDLINE, Embase and Cochrane (1990-2021), records were retrieved. Eligible trials met the following criteria: adults (≥18 years), controlled design, more than 40 participants, use of a cachexia intervention for more than 14 days and use of a physical function endpoint. Physical function measures were classified as an objective measure (hand grip strength [HGS], stair climb power [SCP], timed up and go [TUG] test, 6-min walking test [6MWT] and short physical performance battery [SPPB]), clinician assessment of function (Karnofsky Performance Status [KPS] or Eastern Cooperative Oncology Group-Performance Status [ECOG-PS]) or patient-reported outcomes (physical function subscale of the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaires [EORTC QLQ-C30 or C15]). Data extraction was performed using Covidence and followed PRISMA guidance (PROSPERO registration: CRD42022276710). A total of 5975 potential studies were examined and 71 were eligible. Pharmacological interventions were assessed in 38 trials (54%). Of these, 11 (29%, n = 1184) examined megestrol and 5 (13%, n = 1928) examined anamorelin; nutritional interventions were assessed in 21 trials (30%); and exercise-based interventions were assessed in 6 trials (8%). The remaining six trials (8%) assessed multimodal interventions. Among the objective measures of physical function (assessed as primary or secondary endpoints), HGS was most commonly examined (33 trials, n = 5081) and demonstrated a statistically significant finding in 12 (36%) trials (n = 2091). The 6MWT was assessed in 12 trials (n = 1074) and was statistically significant in 4 (33%) trials (n = 403), whereas SCP, TUG and SPPB were each assessed in 3 trials. KPS was more commonly assessed than the newer ECOG-PS (16 vs. 9 trials), and patient-reported EORTC QLQ-C30 physical function was reported in 25 trials. HGS is the most commonly used physical function endpoint in cancer cachexia clinical trials. However, heterogeneity in study design, populations, intervention and endpoint selection make it difficult to comment on the optimal endpoint and how to measure this. We offer several recommendations/considerations to improve the design of future clinical trials in cancer cachexia.

The effect of nutritional interventions in acute radiation-induced diarrhoea in patients with primary pelvic cancer: A systematic review.

Acute radiation-induced diarrhoea (RID) is a well-known side effect of external radiation therapy for pelvic cancer. Acute RID is an unresolved clinical problem in approximately 80% of patients. We investigated the effect of nutritional interventions on acute RID in patients with pelvic cancer treated with curative radiotherapy. A search was conducted using PubMed, Embase.com, CINAHL, and Cochrane Library, from 1 January 2005 until 10 October 2022. We included randomised controlled trials or prospective observational studies. Eleven of the 21 identified studies had low quality of evidence, mainly because of low patient numbers distributed among several cancer diagnoses, and non-systematic assessment of acute RID. Interventions included probiotics (n = 6), prebiotics (n = 6), glutamine (n = 4), and others (n = 5). Five studies, of which two provided high quality evidence, showed that probiotics improved acute RID. Future well-designed studies investigating the effects of probiotics on acute RID are warranted. PROSPERO ID: CRD42020209499).

Mobile health technology, exercise adherence and optimal nutrition post rehabilitation among people with Parkinson's Disease (mHEXANUT) - a randomized controlled trial protocol.

BACKGROUND: Although it is well known that regular physical activity and exercise, as well as maintaining adequate nutritional status is important to delaying symptom development and maintaining physical capacity and function in people with Parkinson's Disease (PD), many are unable to follow self-management recommendations. Active interventions have shown short-term effects, but there is a need for interventions that facilitate self-management over the course of the disease. Until now, no studies have combined exercise and nutritional interventions with an individual self-management approach in PD. Thus, we aim to examine the effect of a six-month mobile health technology(m-health)-based follow-up programme, focusing on self-management in exercise and nutrition, after an in-service interdisciplinary rehabilitation programme. METHODS: A single-blinded, two-group randomised controlled trial. Participants are Adults aged 40 or older, with idiopathic PD, Hoehn and Yahr 1-3, living at home. The intervention group receives a monthly, individualized, digital conversation with a PT, combined with use of an activity tracker. People at nutritional risk get additional digital-follow-up from a nutritional specialist. The control group receives usual care. The primary outcome is physical capacity, measured by 6-min walk test (6MWT). Secondary outcomes are nutritional status, Health related quality of life (HRQOL), physical function and exercise adherence. All measurements are performed at baseline, after 3 months and after 6 months. Sample size, based on primary outcome, is set at 100 participants randomized into the two arms, including an estimated 20% drop out. DISCUSSION: The increasing prevalence of PD globally makes it even more important to develop evidence-based interventions that can increase motivation to stay active, promote adequate nutritional status and improve self-management in people with PD. The individually tailored digital follow-up programme, based on evidence-based practice, has the potential to promote evidence-based decision-making and to empower people with PD to implement exercise and optimal nutrition in their daily lives and, hopefully, increase adherence to exercise and nutritional recommendations. TRIAL REGISTRATION: ClinicalTrials.gov (NCT04945876). First registration 01.03.2021.

Nutrition impact symptoms and the risk of malnutrition in people with Parkinson's disease: A cross-sectional study.

BACKGROUND: People with Parkinson's disease (PD) often experience symptoms that affect their ability to eat. This may contribute to weight loss and increased risk of malnutrition. The present study aimed to quantify the extent of nutrition impact symptoms (NIS) in the population and a scoring system of NIS was incorporated in the tool used to identify malnutrition. METHODS: In this cross-sectional study, members of the Norwegian Parkinson's Association, with any PD diagnosis and stage of illness, were invited to respond to an online 24-item questionnaire. Questions from two validated questionnaires, comprising the abridged Patient-Generated Subjective Global Assessment (aPG-SGA) and the Radboud Oral Motor Inventory for Parkinson's disease (ROMP), were adapted to an online format. RESULTS: The questionnaire was sent to 3047 members, of which 508 persons (17%) responded (61% men). In total, 59% were categorised as well-nourished, 34% at risk of malnutrition and 6.5% as malnourished. One quarter of all participants reported symptoms that affected food intake. The most frequent symptoms were constipation (14.2%) and dry mouth (13.4%). Malnourished participants reported a mean ± SD of 3.4 ± 1.4 symptoms versus 0.1 ± 0.3 per well-nourished participant. Malnourished participants had more swallowing problems than well-nourished participants, with a mean ± SD total ROMP score of 15.5 ± 6.0 versus 9.0 ± 2.9 (p < 0.001). As the number of points in the ROMP score increased by one, the points in the aPG-SGA score increased with 37% (95% confidence interval = 0.309-0.428). CONCLUSIONS: Risk of malnutrition was largely related to NIS, especially dysphagia in people with PD. Symptoms affecting food intake should be systematically mapped and treated in conjunction with PD to prevent malnutrition.

Geriatric impairments are associated with reduced quality of life and physical function in older patients with cancer receiving radiotherapy - A prospective observational study.

INTRODUCTION: Quality of life (QoL) and function are important outcomes for older adults with cancer. We aimed to assess differences in trends in patient-reported outcomes (PROs) during radiotherapy (RT) between (1) groups with curative or palliative treatment intent and (2) groups defined according to the number of geriatric impairments. MATERIALS AND METHODS: A prospective observational study including patients aged ≥65 years receiving curative or palliative RT was conducted. Geriatric assessment (GA) was performed before RT, and cut-offs for impairments within each domain were defined. Patients were grouped according to the number of geriatric impairments: 0, 1, 2, 3, and ≥ 4. Our primary outcomes, global QoL and physical function (PF), were assessed by The European Organisation for Research and Treatment of Cancer Quality-of-Life Core Questionnaire (EORTC) (QLQ-C30) at baseline, RT completion, and two, eight, and sixteen weeks later. Differences in trends in outcomes between the groups were assessed by linear mixed models. RESULTS: 301 patients were enrolled, mean age was 73.6 years, 53.8% received curative RT. Patients receiving palliative RT reported significantly worse global QoL and PF compared to the curative group. The prevalence of 0, 1, 2, 3 and ≥ 4 geriatric impairments was 16.6%, 22.7%, 16.9%, 16.3% and 27.5%, respectively. Global QoL and PF gradually decreased with an increasing number of impairments. These group differences remained stable from baseline throughout follow-up without any clinically significant changes for any of the outcomes. DISCUSSION: Increasing number of geriatric impairments had a profound negative impact on global QoL and PF, but no further decline was observed for any group or outcome, indicating that RT was mainly well tolerated. Thus, geriatric impairments per se should not be reasons for withholding RT. GA is key to identifying vulnerable patients in need of supportive measures, which may have the potential to improve treatment tolerance. Registered at clinicaltrials.gov (NCT03071640).

The Norwegian Directorate of Health recommends malnutrition screening tool (MST) for all adults.

BACKGROUND & AIMS: Malnutrition is underdiagnosed and undertreated in Norway. In a revision of a national guideline on malnutrition, the Norwegian Directorate of Health aimed for a harmonization and standardization of the malnutrition screening practice, including a recommendation of one malnutrition screening tool to be used among all adults in Norwegian health and care services. METHODS: A working group was appointed by the Norwegian Directorate of Health. Evidence-based practice, a pragmatic decision-making process based on a literature review, the Grading of Recommendations Assessment, Development and Evaluation (GRADE), and the DECIDE decision-making model was used as a guidance in order to convert evidence into recommendations. RESULTS: The criteria and properties of the four most frequently validated malnutrition screening tools were identified and ranked by the working group. The tools were prioritized in the following order: 1: Malnutrition Screening Tool (MST), 2: Malnutrition Universal Screening Tool (MUST), 3: Nutritional Risk Screening 2002 (NRS-2002), and 4: Mini-Nutritional Assessment short form (MNA). CONCLUSIONS: The Norwegian Directorate of Health recommends use of MST for screening for malnutrition among all adults (≥18 years), across all health care settings, and diagnoses or conditions in Norway.

Harmonization and standardization of malnutrition screening for all adults - A systematic review initiated by the Norwegian Directorate of Health.

BACKGROUND & AIMS: The Norwegian Directorate of Health has identified a need to harmonize and standardize the malnutrition screening practice in Norwegian hospitals and primary health care settings, in order to provide a seamless communication of malnutrition screening along the patient pathway. Our aim was to perform a systematic review of the validity and reliability of screening tools used to identify risk of malnutrition across health care settings, diagnoses or conditions and adult age groups, as a first step towards a national recommendation of one screening tool. METHODS: A systematic literature search for articles evaluating validity, agreement, and reliability of malnutrition screening tools, published up to August 2020, was conducted in: MEDLINE, Embase, APA PsycInfo, Cinahl, Cochrane Databases, Web of Science, Epistemonikos, SveMed+, and Norart. The systematic review was registered in PROSPERO (CRD42022300558). For critical appraisal of each included article, the Quality Criteria Checklist by The Academy of Nutrition and Dietetics was used. RESULTS: The review identified 105 articles that fulfilled the inclusion and exclusion criteria. The most frequently validated tools were Mini Nutritional Assessment short form (MNA), Malnutrition Universal Screening Tool (MUST), Malnutrition Screening Tool (MST), and Nutritional Risk Screening 2002 (NRS-2002). MNA, MST and NRS-2002 displayed overall moderate validity, and MUST low validity. All four tools displayed low agreement. MST and MUST were validated across health care settings and age groups. In general, data on reliability was limited. CONCLUSIONS: The screening tools MST and NRS-2002 displayed moderate validity for the identification of malnutrition in adults, of which MST is validated across health care settings. In addition, MNA has moderate validity for the identification of malnutrition in adults 65 years or older.

Patients' Experiences of Using a Smartphone App After Cardiac Rehabilitation: Qualitative Study.

BACKGROUND: Exercise-based cardiac rehabilitation (CR) is a crucial part of the treatment of patients with cardiac diseases, and adherence to healthy behavior is a prerequisite to improve long-term prognosis. Unfortunately, adherence to healthy behavior adapted in CR is challenging for many cardiac patients in the long term. Recently, we demonstrated that follow-up conducted via an app for 1 year significantly improved adherence to healthy behavior after CR. To increase the knowledge and understanding of mobile Health (mHealth) interventions that can promote acceptance and adherence, qualitative research investigating patients' experiences with these interventions is warranted. OBJECTIVE: The aim was to investigate patient experiences with individualized long-term follow-up conducted via an app for 1 year and their thoughts about what features promoted adherence to healthy behavior after CR. The purpose was to increase the understanding of significant findings previously reported and to guide future development of similar interventions in the field of adherence. METHODS: A qualitative study with individual interviews was conducted from November 2018 to May 2019. A thematic interview guide was used when conducting the semistructured in-depth interviews. The interviews were audio recorded and transcribed successively during the period in which the interviews were conducted. Texts were managed and systematized by NVivo. Interviews were analyzed by qualitative content analysis. Codes and themes were inductively developed. RESULTS: Ten patients who had participated in a randomized controlled trial evaluating the effect of follow-up conducted via an app on adherence to healthy behavior after CR were included. The median patient age was 65 years (range 46-72 years), and both genders were represented. The analysis resulted in the following 4 themes describing the patients' experiences: (1) The person behind the app is crucial for motivation and adherence; (2) The app as a commitment; (3) The app as a path to independence; and (4) Suggestions for improvements. Features experienced as beneficial to promote adherence were individualized feedback and the use of goal setting. The significance of the person behind the app (the supervisor) who provided individualized feedback was a consistent finding. This person seemed to promote motivation in general and to enable other known behavioral change techniques. CONCLUSIONS: The person behind the app (the supervisor) seems to be one of the most significant success factors in promoting adherence to healthy behavior after CR. This indicates that a health care provider must actively participate in a patient's process of adherence to healthy behavior, even when using interventions, including an app. Future development of interventions in the field of adherence should strive to create tools that enable an ongoing collaborative relationship between the patient and the health care provider. The follow-up should be based on the patient's own goals, and individualized feedback should be provided.

Benefits of Study Participation for Patients with Advanced Cancer Receiving Radiotherapy: A Prospective Observational Study.

Background: Patients with advanced cancer and bone metastases may have unmet palliative care (PC) needs that go unnoticed during clinical oncological practice. This observational study describes interventions that were initiated as the patients participated in the Palliative Radiotherapy and Inflammation Study (PRAIS). It was hypothesized that the patients would benefit from study participation due to PC interventions initiated by the study team. Methods: A retrospective review of patients' electronic records. Patients with advanced cancer and painful bone metastases included in PRAIS were eligible. All patients met with the study team before start of radiotherapy, after completion of Patient Reported Outcome Measures. Interventions initiated by the study team were documented in the patients' electronic records. Results: A total of 133 patients were reviewed: 63% males, mean (standard deviation [SD]) age 65 (9.6) and mean (SD) Karnofsky performance status (KPS) score 73.2 (9.1). Interventions were initiated in 50% (n = 67) of the patients. Changes in opioid management (69%), treatment of constipation (43%), and nausea (24%) and nutritional advice were most frequent (21%). Patients receiving interventions had lower mean KPS (70 vs. 77 p < 0.001), shorter survival time after study inclusion (median 28 vs. 57.5 weeks p = 0.005) and were more often opioid naïve (12% vs. 39% p < 0.001) than those not receiving interventions by the study team. Conclusions: Patients with advanced cancer and painful bone metastasis benefited from study participation due to multiple PC interventions initiated by the study team. The findings call for a systematic integration of PC in patients with advanced cancer. Trial Registration: ClinicalTrials.gov NCT02107664.

Geriatric assessment with management for older patients with cancer receiving radiotherapy. Protocol of a Norwegian cluster-randomised controlled pilot study.

About 50% of patients with cancer are expected to need radiotherapy (RT), and the majority of these are older. To improve outcomes for older patients with cancer, geriatric assessment (GA) with management (GAM) is highly recommended. Evidence for its benefits is still scarce, in particular for patients receiving RT. We report the protocol of a cluster-randomised pilot study designed to test the effect, feasibility and health economic impact of a GAM intervention for patients ≥65 years, referred for palliative or curative RT. The randomising units are municipalities and city districts. The intervention is municipality-based and carried out in collaboration between hospital and municipal health services from the start of RT to eight weeks after the end of RT. Its main constituents are an initial GA followed by measures adapted to individual patients' impairments and needs, systematic symptom assessments and regular follow-up by municipal cancer nurses, appointed to coordinate the patient's care. Follow-up includes at least one weekly phone call, and a house call four weeks after the end of RT. All patients receive an individually adapted physical exercise program and nutritional counselling. Detailed guidelines for management of patients' impairments are provided. Patients allocated to the intervention group will be compared to controls receiving standard care. The primary outcome is physical function assessed by the European Organisation of Research and Treatment of Cancer Quality of Life Questionnaire C-30. Secondary outcomes are global quality of life, objectively tested physical performance and use of health care services. Economic evaluation will be based on a comparison of costs and effects (measured by the main outcome measures). Feasibility will be assessed with mixed methodology, based on log notes and questionnaires filled in by the municipal nurses and interviews with patients and nurses. The study is carried out at two Norwegian RT centres. It was opened in May 2019. Follow-up will proceed until June 2022. Statistical analyses will start by the end of 2021. We expect the trial to provide important new knowledge about the effect, feasibility and costs of a GAM intervention for older patients receiving RT. Trial registration: ClinTrials.gov, ID NCT03881137, initial release 13th of March 2019.

Mortality and microbial diversity after allogeneic hematopoietic stem cell transplantation: secondary analysis of a randomized nutritional intervention trial.

Gut mucosal barrier injury is common following allogeneic hematopoietic stem cell transplantation (allo-HSCT) and associated with poor clinical outcomes. Diet is critical for microbial diversity, but whether nutritional support affects microbiota and outcome after allo-HSCT is unknown. We present a secondary analysis of a randomized controlled nutritional intervention trial during allo-HSCT. We investigated if the intervention influenced gut microbiota, short-chain fatty acids (SCFAs), and markers of gut barrier functions, and if these parameters were associated with clinical outcomes. Fecal specimens were available from 47 recipients, and subjected to 16S rRNA gene sequencing. We found no significant differences between the intervention group and controls in investigated parameters. We observed a major depletion of microbiota, SCFAs, and altered markers of gut barrier function from baseline to 3 weeks post-transplant. One-year mortality was significantly higher in patients with lower diversity at 3 weeks post-HSCT, but not related to diversity at baseline. The relative abundance of Blautia genus at 3 weeks was higher in survivors. Fecal propionic acid was associated with survival. Markers of gut barrier functions were less strongly associated with clinical outcomes. Possibly, other strategies than dietary intervention are needed to prevent negative effects of gut microbiota and clinical outcomes after allo-HSCT.ClinicalTrials.gov (NCT01181076).

A comparison of two different refeeding protocols and its effect on hand grip strength and refeeding syndrome: a randomized controlled clinical trial.

PURPOSE: Optimal refeeding protocols in older malnourished hospital patients remain unclear. We aimed to compare the effect of two different refeeding protocols; an assertive and a cautious protocol, on HGS, mortality and refeeding syndrome (RFS), in patients ≥ 65 years METHODS: Patients admitted under medical or surgical category and at risk of RFS, were randomized to either an enteral nutrition (EN) refeeding protocol of 20 kcal/kg/day, reaching energy goals within 3 days (intervention group), or a protocol of 10 kcal/kg/day, reaching goals within 7 days (control group). Primary outcome was the difference in hand grip strength (HGS) at 3 months follow-up, in an intention to treat analysis. RFS (phosphate < 0.65 mmol/L) during the hospital stay and mortality rates at 3 months were secondary outcomes. RESULTS: A total of 85 patients were enrolled, with mean (SD) age of 79.8(7.4) and 54.1% female, 41 in the intervention group and 44 in the control group. HGS was similar at 3 months with mean change of 0.42 kg (95% CI - 2.52 to 3.36, p = 0.78). Serum phosphate < 0.65 mmol/L was seen in 17.1% in the intervention group and 9.3% in the control group, p = 0.29. There was no difference in mortality rates (39% vs 34.1%, p = 0.64). An indication of more respiratory distress was found in the intervention group, 53.6% vs 30.2%, p = 0.029. CONCLUSION: A more assertive refeeding protocol providing 20 kcal/kg/day did not result in improved HGS measured 3 months after discharge compared with a cautious refeeding (10 kcal/kg/day) protocol. No difference in incidence of mortality or RFS was found. TRIAL REGISTRATION: ClinicalTrials.gov Protocol Record 2017/FO148295, Registered: 21st of February, 2017.

Refeeding syndrome occurs among older adults regardless of refeeding rates: A systematic review.

Refeeding syndrome is a life-threatening clinical disorder that can occur when treating malnutrition. The aim was to examine the current knowledge of refeeding syndrome in patients ≥ 65 + years with special focus on the incidence of hypophosphatemia (HP) in relation to refeeding rate (kcal/kg/day), number of days until the lowest level of phosphate occurs (day of nadir), refeeding rates and adverse events, and death. Specifically, we hypothesized that higher energy provision would cause a higher incidence of HP. A search was conducted in the available databases. Two cohort studies, 1 case control, and a total of 12 case series/case reports, which accounted for 19 individual patient cases, were eligible. The incidence of HP (<0.5 mmol/L) was 15% and 25% in the 2 cohort studies and 4% in the case control study. The mean day of nadir was between days 2 and 3 in the cohort studies, day 11 in the case control study, and day 3 in the cases series/case reports. Importantly, a rapid drop in phosphate occurred receiving both 30 kcal/kg/day and 8 to 10 kcal/kg/day. The cohort studies reported high death rates-26% and 23%-using both 10 and 20 kcal/kg/day, respectively. Adverse events were noted in most all case series/case reports. Clinicians should be aware that HP may occur in up to 25% of older hospitalized adults, and importantly, it occurs even when refeeding cautiously. Hence, electrolytes should be closely monitored, especially between days 2 and 4, which is when the day of nadir occurs most frequently.