Impaired Physical Function Research Articles

Reasons for unmet care needs in older adults with cancer: Analyses from the 2015–2019 National Health and Aging Trends Study.

11112 Background: Despite extensive research on unmet care needs in older adults (ages ≥65) with cancer, few studies explore the reasons for unmet care needs, knowledge of which can inform future interventions. We aimed to identity reasons for unmet care needs in older adults with cancer and associated factors. Methods: Our analyses included community-dwelling older adults with cancer from the 2015–2019 National Health and Aging Trends Study (NHATS). NHATS captures unmet care needs in 12 activities from three domains: activities of daily living (ADL), instrumental ADL (IADL), and mobility. We separately evaluated two categories of reasons for unmet care needs: “difficulty performing activities independently” (for participants without a caregiver), and “caregivers’ inability to help” (for those receiving caregiver assistance). Personal characteristics included demographic (gender, age, marital status, race, ethnicity, educational level), clinical (cancer type, years since cancer diagnosis), and health variables (physical function, nutritional status, cognition, psychological status). We built logistic models to assess characteristics associated with unmet care needs, adjusting for NHATS year and cancer type. In exploratory analyses, we further evaluated associations of years since cancer diagnosis with unmet care needs. All models were built separately for participants with and without a caregiver. Results: Our analysis included 1829 participants. In 2015, participants had a mean age of 81 years; more than half were female (55%), White (79%), non-Hispanic (96%), had impaired physical function (92%), and received caregiver assistance (51%). From 2015 to 2019, 29% to 32% participants without a caregiver reported any unmet care needs due to difficulty with performing the activity independently, with toileting (45-53%) and managing medications (27-31%) being the most prevalent. Between 18% and 20% participants with a caregiver reported any unmet care needs due to caregivers’ inability to help, with toileting (26-44%) and going around inside home (20-29%) being the most prevalent. Hispanic ethnicity, being separated/divorced, living alone or with non-spouses, and worse health status were independently associated with unmet care needs due to either reason. Compared to pre-diagnosis, being 1-2, [odds ratio (OR) 1.7], 3-4 (OR 1.8) and 5+ (OR 2.2) years from cancer diagnosis was significantly associated with higher odds of unmet care needs among those without a caregiver, but not those with a caregiver. Conclusions: Unmet care needs due to difficulty performing activities independently are common among older adults with cancer. Caregivers generally meet care recipients’ needs in IADLs, but may face challenges in toileting and mobility needs. Tailored interventions addressing specific reasons for unmet needs are needed, particularly for those at greater risk.

Global perspective on nonalcoholic fatty liver disease and nonalcoholic steatohepatitis - prevalence, clinical impact, economic implications and management strategies.

The metabolically-based liver disease, nonalcoholic fatty liver disease (NAFLD), is the most common cause of chronic liver disease currently affecting 38% of the world's adult population. NAFLD can be progressive leading to nonalcoholic steatohepatitis (NASH), liver transplantation, liver cancer, liver-related mortality and is associated with decreased quality of life from impaired physical functioning and increased healthcare resource utilisation. However, screening for NAFLD is cost-prohibitive but screening for high risk NAFLD (NAFLD with F2 fibrosis or greater) is imperative. To review the global perspective on NAFLD and NASH METHODS: We retrieved articles from PubMed using search terms NAFLD, prevalence, clinical burden, economic burden and management strategies. NAFLD/NASH shows geographical variation across the globe. Highest prevalence rates are in South America and the Middle East and North Africa; lowest prevalence is in Africa. NAFLD's economic impact is from direct and indirect medical costs and loss in worker productivity. It is projected that, over the next two decades, the total cost of NAFLD and diabetes will exceed $1.5 trillion (USD). Risk stratification algorithms identifying "high risk NAFLD" were made following non-invasive tests for NAFLD identification and fibrosis development. These algorithms should be used in primary care and endocrinology settings so timely and appropriate interventions (lifestyle and cardiometabolic risk factor management) can be initiated. To reduce the burgeoning burden of NAFLD/NASH, management should include risk stratification algorithms for accurate identification of patients, linkage to appropriate settings, and initiation of effective treatment regimens.

Understanding breast cancer (BC) from the patient (pt) perspective: A qualitative study of symptoms, impacts and health-related quality of life (HRQoL) in hormone receptor-positive, HER2-negative (HR+, HER2–) BC.

e23184 Background: HR+, HER2– is the predominant BC subtype. Treatment (tx) options across stages are broad; however, there are limited published qualitative data providing insights on pt disease and tx experiences to inform healthcare decision-making. This study aimed to identify the most important disease- and tx-related symptoms and impacts on HRQoL, including exploring how bothersome and worrisome symptoms were, and attribution to tx and disease, in HR+, HER2– early (e) and metastatic (m)BC. Methods: This was an international qualitative study with pt steering committee input. Individual pt concept elicitation interviews were conducted (until saturation). Interviews were audio-recorded, translated into English, transcribed, and anonymized. Transcripts were coded and analyzed thematically. Two pt-centered conceptual models were developed to summarize data for eBC and mBC. Results: Twenty-four female pts (12 eBC; 12 mBC), aged 33–70 yrs old, were interviewed; 17 were postmenopausal. The most common tx was hormone therapy (n = 10) in eBC and cyclin-dependent kinase 4/6 inhibitors (n = 7) in mBC. The most frequently reported symptoms were fatigue (eBC n = 11; mBC n = 10) and pain (eBC n = 9; mBC n = 11). In eBC, fatigue was ranked most bothersome (n = 3) and pain most worrisome (n = 3). In mBC, pain was ranked most bothersome and worrisome (n = 7). In eBC, sleep problems, hot flashes, and difficulty concentrating/brain fog were also frequently reported (≥50% of pts) and ranked most bothersome. In mBC, sleep problems and hot flashes were also frequently reported (≥50% of pts), with hot flashes ranked most bothersome; nausea was less frequently reported but ranked most bothersome by two pts. The majority of pts with eBC attributed their most frequently reported symptoms to tx, whereas pts with mBC attributed them to tx alone or tx and their disease. The most frequently reported impacts in eBC were limited exercise/strenuous activity (n = 10), and fatigue, difficulty concentrating, and anxiety (n = 9 each). The most frequently reported impacts in mBC were limited participation in social activities (n = 10), and difficulties with activities of daily living, trouble with mobility, anxiety, and frustration (n = 9 each). Conclusions: These qualitative data highlight similarities in pt symptoms across eBC and mBC (pain and fatigue), with differences in symptom attribution. Compared with eBC, pts with mBC had greater physical functioning impairment and may have experienced more disease-related symptoms. Overall, these data improve understanding of pts’ experience in HR+, HER2– BC, identify the distinct and clinically relevant concepts most important to them, and can help to optimize the selection and development of pt-reported outcomes in research and clinical practice to further inform treatment decision-making.

#1391 Evaluating effect on frailty of a home-based training program developed for kidney transplant recipients (HOMETRAIN-KTR)

Abstract Background and Aims Frailty and impaired physical function are prevalent among patients undergoing kidney transplantation (KTx), and is an independent risk factor for poor outcome after transplantation. Limited number of studies have prospectively investigated the efficacy of exercise training for KTx-recipients with low pre-transplant physical function. Our aim is to evaluate the effect of a structured 12 week home-based physical training program delivered to recipients with low pre transplant physical function, on physical function and frailty at 1-year post transplant. Method HOMETRAIN-KTR is a 2-arm unblinded Norwegian clinical trial with RCT design (Fig. 1). Patients will be recruited at admission for KTx at Oslo University Hospital, Rikshospitalet. Patients who score below 60 at 36-Item Short Form Survey (SF-36) will be included and tested with 6-minute walking test (6MWT), Clinical Frailty Scale (CFS), hand-grip strength, 30 seconds Sit-to-Stand test, and questionnaire about physical activity and psychological distress. Included patients are randomized to either training group or control group (standard of care). The training group will, under supervision by a physiotherapist, start a 12-week structured home-based training program from week 4 post-KTx. The training program consist of a combination of strength training, cardio training and optional activities. During the intervention period, the intervention group will are receive regular follow-up by phone. The training sessions will be documented via patients logs and heart rate monitor (Fitbit). At one year post-KTx, all patients will undergo the same tests as at inclusion. Results Inclusion of patients will start in January 2024, and continue for the next 2-3 years. We aim to include 200 patients, 100 in each arm. The study will evaluate physical function, frailty, graft function, patient survival, HRQoL and physiological distress during the time-span of the study. Conclusion The HOMETRAIN-KTR study is supposed to bring new knowledge about the effect of a physical training program on frail KTx-recipients. Such information is highly relevant to improve KTx outcomes and to optimize the utilization of the limited source of donor organs.

#2870 Association between frailty and a history of falls in patients on hemodialysis

Abstract Background and Aims Patients with end-stage renal disease on hemodialysis have a higher prevalence of frailty that is associated with relevant outcomes such as disability, hospitalization, and mortality. Moreover, these patients have musculoskeletal and physical function impairments that contribute to a higher risk of falling. Therefore, the aim of this study was to evaluate the association between frailty and a history of falls in patients on hemodialysis. Method This cross-section multicenter study included patients aged ≥18 years who were undergoing regular hemodialysis treatment for at least three months. Patients were excluded if presented severe and unstable comorbidities, psychiatric or cognitive disorders, and physical limitations including neurological, musculoskeletal and osteoarticular diseases which prevented the correct execution of the physical function tests. Frailty was assessed by Fried phenotype and the criteria were as follows: unintentional weight loss ≥ 4.5 kg in the past year; exhaustion was assessed using the vitality domain of the SF-36 quality of life questionnaire; weakness was measured using a handgrip dynamometer; walking speed was assessed by timing the 4.6 m distance covered at the participant's normal pace; and physical activity level was measured by the Human Activity Profile questionnaire. Patients were stratified into three groups: a score of 0/5 for non-frail, a score of 1-2/5 for pre-frail, and a score of 3-5/5 for frail. The retrospective history of falls was assessed for the last 12 months, and a fall was defined as an “unexpected event in which the individual comes to rest on the ground, floor or lower level”. The association between frailty stratification and a history of falls was analyzed using multivariate multinomial logistic regression model with non-frail group as reference. Then, a model adjusted for potential confounders was constructed. Results This study included 199 patients (59.1 ± 12.5 years, 41.2% female). The prevalences of frailty and pre-frailty were 17.6% and 54.8%, respectively. Patients classified as non-frail showed lower prevalence of a history of falls compared to patients classified as pre-frail and frail (26%, 36% and 54%, respectively, p < 0.001). The absence of a history of falls decreased the chance of patients being classified as frail (OR = 0.23, 95% CI = 0.07-0.78, p = 0.018). After adjusting for age, educational level, time on dialysis, hemoglobin and presence of cardiovascular disease, this association remained significant (OR = 0.16, 95% CI = 0.04-0.57, p = 0.005). Conclusion The prevalence of pre-frailty was approximately three times higher than that of frailty in patients on hemodialysis. A history of falls was associated with frailty in these patients.

#2947 Exploring various approaches for assessing fatigue in patients receiving hemodialysis using the CONVINCE study population

Abstract Background and Aims In nephrology, there is a growing interest in identifying patients’ priorities to achieve meaningful outcomes. A particular relevant outcome in end stage kidney disease is fatigue, with prevalence ranging from 60% to 97% in patients receiving hemodialysis. Different approaches for assessing fatigue exist. The objective of this study was to investigate how self-reported peri-/intra-dialytic and post-dialysis fatigue relate to overall fatigue levels and to certain risk factors of patients receiving hemodialysis. Method The CONVINCE trial is an international multi-center, prospective, randomized, open label, controlled trial, comparing all-cause mortality of high-flux hemodialysis with high-dose hemodiafiltration. Patient-related outcomes (PROs) were examined as secondary outcomes. Fatigue was assessed using tailored short forms from the Patient-Reported Outcome Measurement Information System (PROMIS) to measure overall fatigue, the newly developed Convince Dialysis Fatigue Scale (CDFS) to capture peri-/intra-dialytic fatigue and the Convince Time to Recovery (CTTR-1) to measure post-dialysis fatigue. PROs were collected every 3 months for 24 months, except for CTTR-1 and a PROMIS fatigue short form, which were collected on a monthly basis from the 1st to 5th months. To investigate the agreement between overall fatigue, peri-/intra-dialytic and post-dialysis fatigue, Spearman's correlation was calculated. In addition, we examined whether general health, depression, physical function, sex and dialysis vintage were related to peri-/intra-dialytic, post-dialysis and overall fatigue in a cross-sectional study design (irrespective of dialysis modality). To test for change over time as well as differences between groups Cohen's d effect sizes were calculated. Results Data for PROs was collected from 1282 participants at baseline and 804 after 24 months. The PROMIS fatigue score and the CDFS correlated strongly at each measurement point (Spearman r≥0.67). The PROMIS fatigue score and CTTR-1 correlated moderately (Spearman r≥0.41). We found large effect sizes for mean differences for peri-/intra-dialytic fatigue between patients with/without at least mild depression (Cohen's d 1.27 (95%CI 1.11 to 1.44)) as well as between patients with/without at least moderately impaired physical function (Cohen's d 1.04 (95% CI 0.89 to 1.19)). Patients, who reported CTTR-1 ≥12 hours, showed also large effect sizes for mean differences for overall fatigue between patients with/without at least mild depression (Cohen's d 0.9 (95% CI 0.48 to1.39)) as well as between patients with/without at least moderately impaired physical function (Cohen's d of 1.1 (95% CI 0.7 to 1.67)). In almost half of the patients, the time to recovery was > 4 hours, and patients who reported having to recover for a longer time after dialysis were, on average, more fatigued overall. Overall fatigue, with an observed mean change of 2.10 (SD 9.69) of PROMIS fatigue score, and peri-/intra dialytic fatigue, with an observed mean change of 1.98 (SD 6.98) of CDFS, showed a small increase over the study course. Prevalence of clinically relevant overall fatigue, as defined by a PROMIS fatigue score ≥59, was 15.9% at baseline and increased to 19.8 % after 24 months. Conclusion The three fatigue measurements correlated moderately to strongly and showed small change over time. The relations of various risk factors with fatigue, including self-reported depression, were similar, irrespective of the measure used, indicating that the discrimination between these constructs is imperfect. Furthermore, we discovered that the overall level of fatigue in the study population was comparable to the general population and the prevalence of clinically relevant fatigue was less than reported previously. This is surprising, given the emphasis on fatigue as a significant outcome for patient receiving dialysis. To assess the experience and impact of fatigue in patients receiving hemodialysis, greater attention is warranted, particularly in the timing of fatigue, the time span studied, and the severity of fatigue, especially when investigating a specific fatigue treatment.

E-PROOF: E-intervention for protein intake and resistance training to optimize function: A study protocol.

Accounting for more than 60% of cancer survivors, older (≥65 years) cancer survivors have a 2- to 5-fold risk of physical function impairment, compared to cancer-free peers. One strategy to improve physical function is dietary and resistance training interventions, which improve muscle strength and mass by stimulating muscle protein synthesis. The E-PROOF (E-intervention for Protein Intake and Resistance Training to Optimize Function) study will examine the feasibility, acceptability, and preliminary efficacy of a 12-week randomized controlled trial of an online, tailored nutritional and resistance training education and counseling intervention to improve physical function and associated health outcomes (muscle strength, health-related quality of life (HRQoL), self-efficacy, and weight management). In this study, 70 older cancer survivors will be randomized to one of two groups: experimental (receiving remote behavioral counseling and evidence-based education and resources), and control (general survivorship education). We will examine the intervention effects on physical function, muscle strength, HRQoL, self-efficacy, weight, and waist circumference during a 12-week period between the experimental and control groups. Three months following the end of the intervention, we will conduct a follow-up assessment to measure physical function, muscle strength, and HRQoL. This study is the first synchronous, online protein-focused diet and resistance training intervention among older cancer survivors. This novel study advances science by promoting independent health behaviors among older cancer survivors to improve health outcomes, and provide foundational knowledge to further address this growing problem on a wider scale through online platforms.

Investigating the effects of synbiotic supplementation on functional movement, strength and muscle health in older Australians: a study protocol for a double-blind, randomized, placebo-controlled trial

BackgroundAging has been associated with a progressive loss of skeletal muscle quality, quantity and strength, which may result in a condition known as sarcopenia, leading to a decline in physical performance, loss of independence and reduced quality of life. While the cause of impaired physical functioning observed in elderly populations appears to be multifactorial, recent evidence suggests that age-associated alterations in gut microbiota could be a contributing factor. The primary objective will be to assess the effects of a dietary synbiotic formulation on sarcopenia-related functional outcomes such as handgrip strength, gait speed and physical performance within older individuals living independently. The secondary objective will be to examine associations between changes in gut microbiota composition, functional performance and lean muscle mass.MethodsSeventy-four elderly (60–85 years) participants will be randomized in a double-blind, placebo-controlled fashion to either an intervention or control group. The intervention group (n = 37) will receive oral synbiotic formulation daily for 16 weeks. The control group (n = 37) will receive placebo. Assessments of physical performance (including Short Physical Performance Battery, handgrip strength and timed up-and-go tests) and muscle ultrasonography will be performed at 4 time points (baseline and weeks 8, 16 and 20). Likewise, body composition via bioelectric impedance analysis and blood and stool samples will be collected at each time point. Dual-energy X-ray absorptiometry will be performed at baseline and week 16. The primary outcomes will be between-group changes in physical performance from baseline to 16 weeks. Secondary outcomes include changes in body composition, muscle mass and architecture, fecal microbiota composition and diversity, and fecal and plasma metabolomics.DiscussionGut-modulating supplements appear to be effective in modifying gut microbiota composition in healthy older adults. However, it is unclear whether these changes translate into functional and/or health improvements. In the present study, we will investigate the effects of a synbiotic formulation on measures of physical performance, strength and muscle health in healthy older populations.Trial registrationThis study was prospectively registered with the Australian New Zealand Clinical Trials Registry (ACTRN12622000652774) in May 2022.

Abstract GS02-01: Randomized phase 3 study of datopotamab deruxtecan vs chemotherapy for patients with previously-treated inoperable or metastatic hormone receptor-positive, HER2-negative breast cancer: Results from TROPION-Breast01

Abstract Background: The global, phase 3 TROPION-Breast01 trial (NCT05104866) assessed the TROP2-directed antibody-drug conjugate (ADC) datopotamab deruxtecan (Dato-DXd) compared with investigator’s choice of chemotherapy (ICC) in patients (pts) with inoperable or metastatic hormone receptor-positive, HER2-negative (HR+/HER2‒) breast cancer (BC). Primary results were presented at ESMO 2023 (Bardia A, et al. Abstract LBA11). Here we report expanded data from TROPION-Breast01. Methods: Pts aged ≥18 years who had inoperable or metastatic HR+/HER2‒ BC, had disease progression on endocrine therapy (ET) and for whom ET was unsuitable, and had received 1‒2 prior lines of systemic chemotherapy (CT), were eligible. Pts were randomized 1:1 to Dato-DXd (6 mg/kg Q3W) or ICC (eribulin, vinorelbine, capecitabine, or gemcitabine) until progression or unacceptable toxicity. The dual primary endpoints were progression-free survival (PFS) by blinded independent central review (BICR) per RECIST 1.1, and overall survival (OS). Results: In total, 732 pts were randomized: 365 to the Dato-DXd arm and 367 to ICC. At data cut-off (Jul 17, 2023), 93/39 pts in the Dato-DXd/ICC groups were ongoing treatment. Pts receiving Dato-DXd had significantly improved PFS vs ICC (HR 0.63 [95% CI 0.52‒0.76]; p<0.0001). Hazard ratios for PFS favored Dato-DXd over ICC across prespecified pt subgroups, including prior lines of CT in the metastatic setting (1 vs 2), prior use of CDK4/6 inhibitor (≤12 months vs >12 months), prior use of endocrine therapy in the metastatic setting ( <6 months vs ≥6 months) and brain metastases (yes vs no). OS data were not mature at this data cut-off. In the Dato-DXd vs ICC arms, 192 (53%) vs 247 (67%) pts had received a subsequent therapy after study treatment discontinuation, including 15 (4%) vs 52 (14%) who received subsequent ADC therapy, and 165 (45%) vs 186 (51%) who received subsequent CT. Median time to first subsequent therapy was 8.2 months in the Dato-DXd arm vs 5.0 months in the ICC arm (HR 0.53 [95% CI 0.45–0.64). Overall, rate of grade ≥3 treatment-related adverse events (TRAEs) with Dato-DXd was less than half that with ICC. The secondary patient-reported outcome endpoints showed that time to deterioration in physical functioning, pain, and global health status/quality of life were delayed in the Dato-DXd arm compared with ICC. Conclusions: TROPION-Breast01 met its dual primary endpoint of PFS, demonstrating statistically significant and clinically meaningful improvement in PFS with Dato-DXd compared with ICC across all subgroups. Overall, the safety profile and QoL with Dato-DXd was favorable compared with ICC. These data support Dato-DXd as a potential new therapeutic option for pts with inoperable or metastatic HR+/HER2‒ BC who have received 1‒2 prior lines of CT. Citation Format: Aditya Bardia, Komal Jhaveri, Seock-Ah Im, Michelino De Laurentiis, Binghe Xu, Sonia Pernas, Giuliano Borges, David Cescon, Masaya Hattori, Yen-Shen Lu, Noelia Martínez-Jáñez, Erika Hamilton, Shusen Wang, Junji Tsurutani, Kevin Kalinsky, Lu Xu, Sabrina Khan, Neelima Denduluri, Hope Rugo, Barbara Pistilli. Randomized phase 3 study of datopotamab deruxtecan vs chemotherapy for patients with previously-treated inoperable or metastatic hormone receptor-positive, HER2-negative breast cancer: Results from TROPION-Breast01 [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr GS02-01.

Hearing Impairment and Physical Activity and Physical Functioning in Older Adults: Baseline Results From the ACHIEVE Trial.

Hearing loss is associated with restricted physical activity (PA) and impaired physical functioning, yet the relationship between severity of hearing impairment (HI) and novel PA measures in older adults with untreated HI is not well understood. Analyses included 845 participants aged ≥70 years (mean = 76.6 years) with a better-hearing ear pure-tone average (PTA) ≥30 and <70 dB in the Aging and Cognitive Health Evaluation in Elders (ACHIEVE) study who wore an ActiGraph accelerometer for 7 days. Physical functioning measures included grip strength and the Short Physical Performance Battery (SPPB). Linear regression models estimated the association by HI level (moderate or greater [PTA ≥ 40 dB] vs mild [PTA < 40 dB]) and continuous hearing with total daily activity counts, active minutes/day, activity fragmentation, grip strength, and gait speed. Logistic regression models estimated odds ratios (ORs) and 95% confidence intervals (CIs) of poor performance on the SPPB (≤6) and its subtests (≤2). Mixed-effects models estimated differences by HI level in activity by time of day. Participants with moderate or greater HI had poorer physical functioning, particularly balance (OR = 2.17, 95% CI = 1.29-3.67), versus those with mild impairment. There was no association of HI level with activity quantities or fragmentation. For diurnal patterns of activity, participants with moderate or greater HI had fewer activity counts in the afternoon (12:00 pm -05:59 pm). Older adults with worse hearing had shifted diurnal patterns and poorer balance performance. Exercise programs should be tailored to older adults with different levels of HI to maintain PA and physical functioning, particularly balance control.

Abstract PO1-11-06: Evaluating Symptom Clusters in Patients with Breast Cancer Experiencing Aromatase Inhibitor-Associated Musculoskeletal Symptoms

Abstract Background: Although treatment with an aromatase inhibitor (AI) for 5-10 years decreases 10-year breast cancer mortality by about 40%, up to 25% of patients will stop treatment early because of treatment-related, intolerable joint and muscular pain and stiffness, called aromatase inhibitor-associated musculoskeletal symptoms (AIMSS). We previously identified that nociplastic pain, or chronic pain in the absence of tissue damage or inflammation, is associated with increased likelihood of developing AIMSS. Other studies have found that symptom clusters, such as the SPPADE symptoms (sleep disturbance, pain, physical function impairment, anxiety, depression, and low energy/fatigue) are prevalent and co-occur in patients with cancer. Here we examine the prevalence of SPPADE symptoms for patients experiencing AIMSS and willing to enroll on a clinical trial examining use of cannabidiol (CBD) to treat their symptoms. Methods: Patients with stage 0-3 hormone receptor-positive breast cancer experiencing AIMSS (defined as worst joint pain ≥4/10 during prior 7 days that developed or worsened since starting AI therapy) were eligible for enrollment in this single arm, single center phase 2 open label clinical trial (NCT04754399). Enrolled patients completed validated questionnaires at baseline and then received CBD (Epidiolex) for 15 weeks. Patient-reported outcomes (PRO) data was collected serially, including the following questionnaires which addressed SPPADE symptoms: Brief Pain Inventory (BPI) to assess pain, PROMIS Profile 29+2 v2.1 to assess multiple symptoms, and Fibromyalgia Survey (FMS) to assess nociplastic pain. Results: 39 patients enrolled on this clinical trial. The median age at enrollment was 57 (range 37-59) and 21% of patients were over age 70. The majority of patients were white (92%) and average BMI was 31 (SD 6.6). Anastrozole was the most used aromatase inhibitor (74%), followed by exemestane (18%), and letrozole (8%). 5 patients (13%) required concomitant GnRHa therapy. Baseline PRO data was obtained from 37 patients. BPI average pain score over the week prior to enrollment was 5.1 (SD 1.5) and worst pain score was 7.2 (SD 1.3). Pain interference reported on the BPI was 4.1 (SD 2.1). Compared to the general population, enrolled patients reported better physical function (T-score 60.2, SE 3.7), less depression (T-score 45.5, SE 4.7) and fatigue (T-score 46.7, SE 5.1), and similar levels of anxiety (T-score 51, SE 7.1) and sleep disturbance (T-score 49.5, SE 5.9) on the PROMIS Profile. On the FMS, 62% of patients had evidence of nociplastic pain, with average score 13.3 (SD 5.7). The median number of sites of pain in the body reported by patients was 8 (range 1-16). Conclusions: While patients enrolling on an AIMSS clinical trial reported a high degree of daily pain that regularly interferes with their activities, for most patients these symptoms did not appear to have a negative impact on mood, affect, or other symptoms that typically cluster with pain. Though it is difficult to extrapolate results from a small population, the unexpected absence of co-occurring symptoms in this population raises additional questions about the interplay of AIMSS and other symptoms commonly reported in interventional AIMSS studies. Follow-up PRO data will be obtained in this clinical trial, allowing us to examine the impact of CBD use on pain, pain interference, and other patient-reported symptoms, as well as to explore which patients are more likely to obtain benefit from CBD treatment. Funding support provided by Conquer Cancer, the ASCO Foundation and the Rising Tide Foundation for Clinical Cancer Research. Citation Format: Fleege Nicole, N. Lynn Henry. Evaluating Symptom Clusters in Patients with Breast Cancer Experiencing Aromatase Inhibitor-Associated Musculoskeletal Symptoms [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO1-11-06.

Abstract PO2-12-09: Insomnia, Pain, Anxiety, Distress, Fatigue, and Functional Impairment in Patients with Breast Cancer

Abstract Background: SPPADE symptoms (Sleep disturbance, Pain, Physical function impairment, Anxiety, Depression/distress, and Energy deficits/fatigue) may result from cancer and its treatment. The aim of this analysis was to characterize SPPADE symptoms in patients with breast cancer. Methods. SPPADE data were drawn from the Enhanced, EHR-facilitated Cancer Symptom Control (E2C2) study, a stepped-wedge pragmatic cluster-randomized trial designed to evaluate a symptom management intervention in routine practice (NCT03892967). Symptom severity was measured on a 0-10 scale via a survey administered by patient portal, in-clinic tablet, or interactive voice response system (by phone) prior to, during, or soon after an outpatient oncology encounter. Scores of 4-6 were categorized as “moderate” and ≥7 as “severe.” In this analysis, only the data from each patient’s initial survey were included. Results. A total of 9,651 patients with breast cancer completed an initial E2C2 survey between March 2019 and January 2023. The proportion of patients with moderate or severe SPPADE symptoms were as follows: 22% moderate and 10% severe for insomnia; 18% moderate and 7% severe for pain; 17% moderate and 7% severe for anxiety; 15% moderate and 5% severe for emotional distress; 25% moderate and 12% severe for fatigue; and 22% moderate and 8% severe for impaired physical function. Table 1 presents score means and standard deviations by demographic subgroup. Conclusions. SPPADE symptoms are common in patients with breast cancer. These observations warrant routine implementation of symptom surveillance and management in breast oncology. Funding acknowledgement: The Improving the Management of symPtoms during And following Cancer Treatment (IMPACT) Consortium is a Cancer Moonshot Research Initiative under the authorization of the 2016 United States 21st Century Cures Act. This research was supported by the National Cancer Institute of the NIH, UM1CA233033 (Mayo Clinic, Rochester, MN). Insomnia, Pain, Anxiety, Distress, Fatigue, and Functional Impairment in Patients with Breast Cancer Citation Format: Kathryn Ruddy, Veronica Grzegorczyk, Deirdre Pachman, Sandra Mitchell, Bolun Liu, Deanne Smith, Ciara O'Sullivan, Shawna Ehlers, Jeph Herrin, Parvez Rahman, Andrea Cheville. Insomnia, Pain, Anxiety, Distress, Fatigue, and Functional Impairment in Patients with Breast Cancer [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO2-12-09.

Protein Intake and Physical Activity Levels as Determinants of Sarcopenia Risk in Community-Dwelling Older Adults.

Community screening for sarcopenia is complex, with barriers including access to specialized equipment and trained staff to conduct body composition, strength and function assessment. In the current study, self-reported dietary protein intake and physical activity (PA) in adults ≥65 years was assessed relative to sarcopenia risk, as determined by body composition, strength and physical function assessments, consistent with the European Working Group on Sarcopenia in Older People (EWGSOP) definition. Of those screened (n = 632), 92 participants (77% female) were assessed as being at high risk of developing sarcopenia on the basis of dietary protein intake ≤1 g∙kg-1∙day-1 [0.9 (0.7-0.9) g∙kg-1∙day-1] and moderate intensity physical activity <150 min.week-1. A further 31 participants (65% female) were defined as being at low risk, with both protein intake [1.2 (1.1-1.5) g∙kg-1∙day-1] and PA greater than the cut-off values. High-risk participants had reduced % lean mass [53.5 (7.8)% versus 54.8 (6.1)%, p < 0.001] and impaired strength and physical function. Notably, high-risk females exhibited greater deficits in lean mass and strength, with minimal differences between groups for males. In community-dwelling older adults, self-reported low protein intake and low weekly PA is associated with heightened risk for sarcopenia, particularly in older women. Future research should determine whether early intervention in older adults with low protein intake and PA attenuates functional decline.

Evaluating the effect of a mobile-based symptom monitoring system for improving physical function in patients with cancer during chemotherapy: study protocol for a multicentre randomised controlled trial

IntroductionSymptoms due to chemotherapy are common in patients with cancer. Cancer-related symptoms are closely associated with the deterioration of physical function which can be associated with decreased quality of life...

Mental Health Scores but not Sleep Quality are Lower in Veterans with Gulf War Illness that have Low Physical Function

PURPOSE: Gulf War Illness (GWI) is a poorly understood illness that impacts about a third of Veterans who were deployed to the Gulf Region during the 1990-1991 Gulf War (GW). GW Veterans have twice the odds of having depression compared to non-deployed Veterans. Depression and sleep quality are associated with impaired physical function, which is notable since physical activity is a modifiable health behavior that can be an effective method to reduce mild to moderate depressive symptoms and improve sleep. We hypothesize that Veterans categorized with GWI and with high physical function scores will have fewer depressive symptoms and better sleep quality compared to those with low physical function. Evaluating the connection between physical and mental health in Veterans with GWI could support behavioral health interventions intended to improve symptom management. Methods: GW Veterans were enrolled in an ongoing VA multi-site remote clinical research study and completed web-based questionnaires: the Modified Kansas questionnaire, short-form 36 (SF-36), Patient Reported Outcomes Measurement Information System (PROMIS)-Emotional Distress Anxiety and Depression, and the Pittsburgh Sleep Quality Index (PSQI). The modified Kansas was used to designate GWI based on 6 self-reported symptom domains. Symptom onset was also required within 5 years of deployment. The SF-36 assessed eight functional domains, including physical functioning measuring mobility disability. GW Ill Veterans were grouped based on the SF-36 physical function score such that those with ≤70 were considered in the poor physical function group (low) and &gt;70 were in the high physical function group (high). The PROMIS Anxiety assessed anxiety and PROMIS Depression assessed negative mood and decreased positive affect. The PSQI global score assessed sleep quality over a one-month period and ranges from 0-21 where a greater score reflects poorer sleep quality. Data were analyzed using student t-tests and linear regressions using Graphpad Prism 9. RESULTS: 63 Veterans (low group: 12 females/35 males, 60±4 years old; high group: 3 females/13 males, 59±5 years old) completed the web-based questionnaires. Anxiety and depression scores were greater in the low vs high group (Anxiety= low: 70.0±29; high: 45.4±14.0, P=0.001; Depression= low: 64.2.0±34.5; high: 41.3±14.7, P=0.01). Sleep quality (low: 12.8±4.0; high: 11.9±4.7, P=0.44) was not different between the groups. Anxiety scores (R2=0.19, P=0.0004) and depression scores (R2=0.11, P=0.007) were related to physical function, thus greater physical function was associated with lower (better) mental health scores. Sleep quality (R2=0.07, P=0.03) was related to physical function, so greater physical function was associated with better sleep quality. CONCLUSIONS: Gulf War Illness is a chronic multi-symptom condition that can be debilitating. Insight about physical function, depression and sleep symptoms could guide therapeutic approaches. The SF-36 is recommended as a core data element in GWI research and as such can provide information on the physical aspects of health. These findings suggest that depression and anxiety differ in those with low versus high physical function and that physical function is related to mental health and sleep quality. Future research should examine how GW Veterans are able to maintain their physical function to improve overall health. VA CSR&amp;D. This is the full abstract presented at the American Physiology Summit 2024 meeting and is only available in HTML format. There are no additional versions or additional content available for this abstract. Physiology was not involved in the peer review process.

Prevalence of Sarcopenia and Its Defining Components in Non-alcoholic Fatty Liver Disease Varies According to the Method of Assessment and Adjustment: Findings from the UK Biobank

Sarcopenia may increase non-alcoholic fatty liver disease (NAFLD) risk, but prevalence likely varies with different diagnostic criteria. This study examined the prevalence of sarcopenia and its defining components in adults with and without NAFLD and whether it varied by the method of muscle mass assessment [bioelectrical impedance (BIA) versus dual-energy X-ray absorptiometry (DXA)] and adjustment (height2 versus BMI). Adults (n = 7266) in the UK Biobank study (45–79 years) with and without NAFLD diagnosed by MRI, were included. Sarcopenia was defined by the 2018 European Working Group on Sarcopenia in Older People definition, with low appendicular skeletal muscle mass (ASM) assessed by BIA and DXA and adjusted for height2 or BMI. Overall, 21% of participants had NAFLD and the sex-specific prevalence of low muscle strength (3.6–7.2%) and sarcopenia (0.1–1.4%) did not differ by NAFLD status. However, NAFLD was associated with 74% (males) and 370% (females) higher prevalence of low ASM when adjusted for BMI but an 82% (males) to 89% (females) lower prevalence when adjusted for height2 (all P < 0.05). The prevalence of impaired physical function was 40% (males, P = 0.08) to 123% (females, P < 0.001) higher in NAFLD. In middle-aged and older adults, NAFLD was not associated with a higher prevalence of low muscle strength or sarcopenia but was associated with an increased risk of impaired physical function and low muscle mass when adjusted for BMI. These findings support the use of adiposity-based adjustments when assessing low muscle mass and the assessment of physical function in NAFLD.

New therapeutic strategies in osteoarthritis

Osteoarthritis (OA) is the most prevalent arthritis-type and is a major contributor to chronic joint pain, impaired physical function, and limited mobility. By the end of 2020, a total of 595 million, equal to 7·6% of the global population, had OA; this figure is expected to rise exponentially by 2050. Even while the disorder's intricate pathophysiology is starting to appear intelligible, we are yet to have a cure for the disorder. OA is typically managed with traditional palliative measures, such as topical and systemic analgesics, including non-steroidal anti-inflammatory drugs, therapeutic exercise, and braces. Sometimes, intra-articular glucocorticoids, viscosupplementation, or regenerative interventions provide short-term pain relief and functional improvement; some may require arthroplasty. Researchers continue their efforts to unveil a new therapeutic target to be effective in OA that modifies symptoms and arrests disease progression as well. In the present literature review, insights into new therapeutic strategies in OA, for example, liposome-based dexamethasone, microspore-based triamcinolone, nerve growth factor antagonist, anti-ADAMTS-5 (A Disintegrin And Metalloproteinase Thrombospoidin Motifs - 5), pentosan polysulfate sodium, allogeneic stem cells, C-C chemokine receptor type-4 (CCR4) ligand 17 inhibitor, Wnt-signaling inhibitor, and anti-obesity medications are provided.

Eating Disorders Among Saudi Dietitians: Prevalence and Analysis

Eating disorders (EDs) involve persistently disturbed eating and related behaviors that result in altered consumption or absorption of food with potential physical or psychological function impairment. There are four major types of EDs: anorexia nervosa, bulimia nervosa, binge eating disorder, and eating disorders not otherwise specified. This investigation aimed to study the prevalence of EDs by assessing the nutritional status of nutrition students and dietitians from multiple provinces in Saudi Arabia. A cross-sectional study included 175 male and female nutrition students and dietitians. EDs were diagnosed using the Eating Attitudes Test – 26 item (EAT-26) and Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. Dietary intake was estimated using repeated 24-hour recall records. Diets were analyzed using food processor nutrition and fitness software. The intakes were compared with the recommended dietary allowances (RDA). The mean participant age was 24.62 ± 4 years. According to EAT-26 diagnostic criteria, the prevalence of EDs was 15.4%. The ED participants had normal body mass index values of 23.6 ± 3.47kg/m2. The diet analysis showed that these subjects had a lower intake of energy, macronutrients, and micronutrients but higher intakes of other micronutrients than the RDA. Nine (33.3%) of the subjects were students and 18 (66.7%) were dietitians. l EDs were more prevalent among dietitians than students. The EDs included a high number of other specified feeding or eating disorders and unspecified eating disorder cases. Subjects with ED had an unbalanced diet and poor nutrition. Our investigation concluded that the prevalence of EDs in Saudi Arabia was 15.4% among nutrition students and dietitians. Moreover, EDs were more prevalent in some provinces of Saudi Arabia. Intakes of energy, macronutrients, and some micronutrients were low, while those of other micronutrients were higher than the RDA.

Long-term quality of life of testicular cancer survivors differs according to applied adjuvant treatment and tumour type.

To evaluate the quality of life (QoL) in long-term testicular cancer (TC) survivors. QoL was assessed in TC survivors treated between March 1976 and December 2004 (n = 625) using the EORTC-QLQ-C30 questionnaire, including a TC module. The assessment was performed at two time points (2006: response rate: n = 201/625 (32.2%), median follow-up (FU): 12.9years (range 1.1-30.9); 2017: response rate: n = 95/201 (47.3%), median FU: 26.2years (range: 13.0-41.2)). TC survivors were grouped according to treatment strategy, tumour entity, clinical stage and prognosis group. Linear and multiple linear regression analyses were performed, with age and time of follow-up as possible confounders. Radiation therapy (RT) compared to retroperitoneal lymph node dissection (RPLND) was associated with a higher impairment of physical function (2017: β = - 9.038; t(84) = - 2.03; p = 0.045), role function (2017: β = - 12.764; t(84) = - 2.00; p = 0.048), emotional function (2006: β = - 9.501; t(183) = - 2.09; p = 0.038) and nausea (2006: β = 6.679; t(185) = 2.70; p = 0.008). However, RT was associated with a lower impairment of sexual enjoyment (2017: symptoms: β = 26.831; t(64) = 2.66; p = 0.010; functional: β = 22.983; t(65) = 2.36; p = 0.021). Chemotherapy (CT), compared to RPLND was associated with a higher impairment of role (2017: β = - 16.944; t(84) = - 2.62; p = 0.011) and social function (2017: β = - 19.160; t(79) = - 2.56; p = 0.012), more insomnia (2017: β = 19.595; t(84) = 2.25; p = 0.027) and greater concerns about infertility (2017: β = 19.830; t(80) = 2.30; p = 0.024). In terms of tumour type, nonseminomatous germ cell tumour (NSGCT) compared to seminoma survivors had significantly lower impairment of nausea (2006: β = - 4.659; t(187) = - 2.17; p = 0.031), appetite loss (2006: β = - 7.554; t(188) = - 2.77; p = 0.006) and future perspective (2006: β = - 12.146; t(175) = - 2.08; p = 0.039). On the other hand, surviving NSGCT was associated with higher impairment in terms of sexual problems (2006: β = 16.759; t(145) = 3.51; p < 0.001; 2017: β = 21.207; t(63) = 2.73; p = 0.008) and sexual enjoyment (2017: β = - 24.224; t(66) = - 2.76; p = 0.008). The applied adjuvant treatment and the tumour entity had a significant impact on the long-term QoL of TC survivors, even more than 25years after the completion of therapy. Both RT and CT had a negative impact compared to survivors treated with RPLND, except for sexual concerns. NSGCT survivors had a lower impairment of QoL compared to seminoma survivors, except in terms of sexual concerns. Implications for cancer survivors are to raise awareness of aspects of long-term and late effects on QoL in TC survivors; offer supportive care, such as psycho-oncological support or lifestyle modification, if a deterioration in QoL is noticed; and avoid toxic treatment without compromising a cure whenever possible.

Doxorubicin causes cachexia, sarcopenia, and frailty characteristics in mice.

While chemotherapy treatment can be lifesaving, it also has adverse effects that negatively impact the quality of life. To investigate the effects of doxorubicin chemotherapy on body weight loss, strength and muscle mass loss, and physical function impairments, all key markers of cachexia, sarcopenia, and frailty. Seventeen C57/BL/6 mice were allocated into groups. 1) Control (n = 7): mice were exposed to intraperitoneal (i.p.) injections of saline solution. 2) Dox (n = 10): mice were exposed to doxorubicin chemotherapy cycles (total dose of 18 mg/kg divided over 15 days). The body weight loss and decreased food intake were monitored to assess cachexia. To assess sarcopenia, we measured muscle strength loss using a traction method and evaluated muscle atrophy through histology of the gastrocnemius muscle. To evaluate physical function impairments and assess frailty, we employed the open field test to measure exploratory capacity. Doxorubicin administration led to the development of cachexia, as evidenced by a significant body weight loss (13%) and a substantial decrease in food intake (34%) over a 15-day period. Furthermore, 90% of the mice treated with doxorubicin exhibited sarcopenia, characterized by a 20% reduction in traction strength (p<0,05), a 10% decrease in muscle mass, and a 33% reduction in locomotor activity. Importantly, all mice subjected to doxorubicin treatment were considered frail based on the evaluation of their overall condition and functional impairments. The proposed model holds significant characteristics of human chemotherapy treatment and can be useful to understand the intricate relationship between chemotherapy, cachexia, sarcopenia, and frailty.