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Background: With dramatically rising obesity rates in the US, obesity at breast cancer diagnosis is common; further compounding the problem is that breast cancer treatment often results in additional weight gain. Among women undergoing breast cancer treatment, both obesity at diagnosis and post-diagnosis weight gain are associated with increased all-cause mortality and increased breast cancer mortality. We tested a WFPB dietary intervention in metastatic breast cancer patients to improve cardiometabolic and cancer-related outcomes, as it has been shown to reduce weight and improves cardiometabolic health in overweight and obese individuals. Methods: Women with stage 4 breast cancer receiving treatment were randomized 2:1 into 2 arms: 1) a WFPB diet (N=21) or 2) usual diet (N=11) for 8 weeks with assessments at baseline, 4, and 8 weeks. Our WFPB diet consisted of an ad libitum whole food, plant-based diet; 3 meals/day were provided to WFPB subjects, which included fruits, vegetables, whole grains, nuts and seeds, and excluded meat, dairy, eggs, and added oils/solid fats. WFPB subjects received weekly education regarding diet. Subjects in the usual care group were asked to continue their usual diet for the next 8 weeks. Outcomes include cardiometabolic risk factors, related sex hormones, and cancer progression markers. Effects of the WFPB diet on the outcomes were assessed by comparing marginal means by arm estimated at 8 weeks from the analysis of covariance model controlling for the baseline value. Results: Of the 32 subjects randomized, 30 subjects (20 WFPB and 10 usual care) completed all 3 assessments. Reductions in weight, BMI, total cholesterol, and LDL cholesterol were statistically significant as well as clinically meaningful, both within the WFPB group and between the groups. In the WFPB group, subjects lost a mean of 6.2% of their body weight versus 0.7% body weight loss in the control group (p< 0.01). LDL cholesterol was reduced by a mean of 20.0% in the WFPB subjects versus a 10.6% increase in control subjects (p< 0.01). Reductions in insulin and HOMA-IR, a measure of insulin sensitivity, were statistically significant within the WFPB group and trended towards significance between the groups. Sex hormone binding globulin (SHBG) levels increased significantly both within the WFPB group and between groups. There was a significant decrease in both IGF-1 and free testosterone within the WFPB group from baseline to week 8. Conclusions: Our WFPB intervention resulted in improvements in several cardiometabolic and hormonal markers. The intentional weight loss, which was clinically large given the duration of the trial, was accompanied by reduced cholesterol, insulin resistance, free testosterone, and IGF-1. Given the moderate to large effect sizes noted, further study is warranted to evaluate the sustainability of benefits over time and to assess their potential impact on cancer-related outcomes. Table 1: Cardiometabolic and Cancer-Related Outcomes Citation Format: Erin Campbell, Thomas Campbell, Eva Culakova, Nellie Wixom, Joseph Guido, Lisa Blanchard, James Fetten, Michelle Janelsins, Karen Mustian, Luke Peppone. A whole food, plant-based (WFPB) dietary intervention to improve cardiometabolic and cancer-related outcomes in women with breast cancer [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P4-07-31.

Background: Women diagnosed with breast cancer commonly gain weight during and after treatment; this obesity/weight change is associated with decreased quality of life (QOL) and other patient-reported outcomes (PROs) such as cognitive dysfunction. Whole-food, plant-based (WFPB) dietary interventions lead to weight loss and cardiometabolic improvements, but their feasibility among metastatic breast cancer patients and their effect on cancer-related PROs have not previously been studied. Methods: Women with stage 4 breast cancer and stable disease were randomized 2:1 into: 1) a WFPB dietary intervention (N=21) or 2) usual care (N=11) for 8 weeks with assessments at baseline, 4 and 8 weeks. Our WFPB diet consisted of weekly educational visits and an ad libitum whole-food, plant-based diet. Three prepared meals a day were provided for the duration of the trial. The diet included fruits, vegetables, whole grains, legumes, nuts and seeds and excluded meat, dairy, eggs, and added oils/solid fats. Effects of the WFPB diet on the outcomes were assessed by comparing marginal means by arm estimated at 8 weeks from the analysis of covariance model controlling for baseline. Results: Of 32 subjects randomized, 20 intervention subjects and 10 control subjects completed all 3 assessments. Baseline and week 8 dietary intake among the intervention subjects is shown in table 1. Cognitive function, as measured by the Functional Assessment of Cancer Therapy – Cognitive Function (FACT-COG) questionnaire and a modified MD Anderson Symptom Inventory (MDASI), showed significant improvement within the intervention group as well as in comparison to the control group (Table 2). Overall quality of life, emotional and physical wellbeing, and breast cancer-specific symptoms, as measured by Functional Assessment of Cancer Therapy – Breast (FACT-B) questionnaire improved significantly within the intervention group. Mean fatigue was lower at 8 weeks within the intervention group as measured by the Brief Fatigue Inventory (BFI), but this did not reach statistical significance (p=0.10). When intervention subjects were asked, “On a scale from 1 to 10 [1 being “would not recommend” and 10 being “highly recommend”], how strongly would you recommend that other cancer patients be given this type of nutrition and support intervention if they were able and willing to participate?” participants’ mean score was 9.5. Conclusion: Our WFPB intervention was feasible and acceptable, with high compliance despite asking subjects to make major changes in dietary intake. Clinically and statistically significant improvements in several PROs, including cognitive function, overall QOL, physical and emotional wellbeing were noted for those in the WFPB group. Given the benefits to QOL and PROs, longer studies are required to demonstrate durability of behavior changes and outcomes. Table 1: Nutrient Intake of the Intervention Group (n=19*) *One participant was missing one three-day food record Table 2. Patient-Reported Outcomes Citation Format: Thomas Campbell, Erin Campbell, Eva Culakova, Nellie Wixom, Joseph Guido, Lisa Blanchard, Michelle Janelsins, Karen Mustian, James Fetten, Luke Peppone. Feasibility of a Whole-Food, Plant-Based Intervention Among Women with Metastatic Breast Cancer and its Effect on Patient-Reported Outcomes [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P5-07-07.

This perspectives paper provides an overview of how to read and interpret a Sankey, examples using symptom data from older adults with advanced cancer, a synopsis of medical literature, and comments on creating and using the diagram for presentation of data. From prior reports and our own, we conclude Sankeys are an excellent tool for visualizing the changing status of older patients with cancer. Older adult symptom data is used as an example with data dispalyed in a range of Sankey flow diagrams. Because there is large heterogeneity in aging, different subgroups can be examined. In a single diagram, Sankey can show both the likelihood and variability of patients' future status from their current status.

Context Systematic collection of patient-reported outcomes (PROs) reduces symptom burden and improves quality of life. The ability of older adults to complete PROs, however, has not been thoroughly studied. Objectives To determine whether older adults with advanced cancer received assistance completing PROs, the nature of the assistance, the factors associated with receiving assistance, and how the prevalence of assistance changed over time. Methods Data were obtained from a multisite cluster randomized controlled study of geriatric assessment (Clinicaltrials.gov: NCT02107443). Adults ≥70 years with advanced cancer completed multiple PROs at 4 time points (enrollment, 6 weeks, 3 months, 6 months). Factors associated with receipt of assistance were assessed with bivariate and multivariate analyses. Results The study included 541 adults (range 70-96 years, 49% female, mixed incurable cancer diagnoses). Twenty-eight percent (153/541) received assistance completing PROs. Of these, 42% received assistance from caregivers, 37% from research staff, and 15% from both. Factors associated with receiving assistance included older age [Adjusted Odds Ratio (AOR) 3.71, 95% Confidence Interval (CI) 1.03-13.38], lower education level (3.92, 2.11-7.29), impaired cognition (1.90, 1.23-2.93), impaired functional status (2.16, 1.33-3.52), and impaired hearing (1.38, 1.05-1.80). Eighty percent of individuals who received assistance were identified at study initiation. Receiving assistance decreased over time from 28% to 18%, partially due to drop-outs. Conclusion Over a quarter of older adults with advanced cancer in this study received assistance completing PROs. Completing PROs is a key aspect of many clinical programs and cancer trials; assistance in completing PROs should be offered and provided.

Objective Nursing homes (NHs) are serving an increasing proportion of residents with cognitive issues (e.g. dementia) and mental health conditions. This study aims to: 1) implement unsupervised machine learning to cluster NHs based on residents' dementia and mental health conditions; 2) examine NH staffing related to the clusters; and 3) investigate the association of staffing and NH quality (measured by number of deficiencies and deficiency scores) in each cluster. Data sources 2009-2017 Certification and Survey Provider Enhanced Reporting (CASPER) were merged with LTCFocUS.org data on NHs in the United States. Study design Unsupervised machine learning algorithm (K-means) clustered NHs based on percent residents with dementia, depression, and serious mental illness (SMI, e.g. schizophrenia, anxiety). Panel fixed-effects regressions on deficiency outcomes with staffing-cluster interactions were conducted to examine the effects of staffing on deficiency outcomes in each cluster. Data extraction methods We identified 110,463 NH-year observations from 14,671 unique NHs using CAPSER data. Principal findings Three clusters were identified: low dementia and mental illnesses (Post-acute Cluster); high dementia and depression, but low SMI (Long-stay Cluster); and high dementia and mental illnesses (Cognitive-mental Cluster). From 2009-2017, the number of Post-acute Cluster NHs increased from 3074 to 5719, while number of Long-stay Cluster NHs decreased from 6745 to 3058. NHs in Long-stay/Cognitive-Mental Clusters reported slightly lower nursing staff hours in 2017. Regressions suggested the effect of increasing staffing on reducing deficiencies is statistically similar across NH clusters. For example, one hour increase in registered nurse hours per resident day was associated with -0.67 [standard error (SE) =0.11], -0.88 (SE = 0.12), and - 0.97 (SE = 0.15) deficiencies in Post-acute Cluster, Long-stay Cluster, and Cognitive-Mental Cluster, respectively. Conclusions Unsupervised machine learning detected a changing landscape of NH serving residents with dementia and mental illnesses, which requires assuring staffing levels and trainings are suited to residents' needs. This article is protected by copyright. All rights reserved.

Introduction Treatment toxicities are common in older adults with cancer and consequently, treatment modifications are sometimes considered. We evaluated the prevalence and factors associated with treatment modifications at the first cycle in older patients receiving palliative systemic treatment. Methods Patients (n = 369) from the GAP 70+ Trial ( NCT02054741 ; PI: Mohile) usual care arm were included. Enrolled patients were aged 70+ with advanced cancer and ≥ 1 Geriatric Assessment (GA) domain impairment. Treatment modification was defined as any change from National Comprehensive Cancer Network guidelines or published clinical trials. Baseline variables included: 1) sociodemographic factors; 2) clinical variables; 3) GA domains; and 4) physician beliefs about life expectancy. Bivariate analyses and multivariable cluster-weighted generalized estimating equation model were conducted to assess the association of baseline variables with cycle 1 treatment modifications. Results Mean age was 77.2 years (range: 70–94); 62% had lung or gastrointestinal cancers, and 35% had treatment modifications at cycle 1. Increasing age by one year (odds ratio (OR) 1.1, 95% confidence interval [CI] 1.0–1.2), receipt of ≥second line of chemotherapy (OR 1.8, CI 1.1–3.0), functional impairment (OR 1.6, CI 1.1–2.3) and income ≤$50,000 (OR 1.7, CI 1.1–2.4) were independently associated with a higher likelihood of cycle 1 treatment modification. Conclusion Treatment modifications occurred in 35% of older adults with advanced cancer at cycle 1. Increasing age, receipt of ≥second line of chemotherapy, functional impairment, and lower income were independently associated with treatment modifications. These findings emphasize the need for evidence-based regimens in older adults with cancer and GA impairments.

PURPOSE Providing a geriatric assessment (GA) summary with management recommendations to oncologists reduces clinician-rated toxicity in older patients with advanced cancer receiving treatment. This secondary analysis of a national cluster randomized clinical trial (ClinicalTrials.gov identifier: NCT02054741 ) aims to assess the effects of a GA intervention on symptomatic toxicity measured by Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE). METHODS From 2014 to 2019, the study enrolled patients age ≥ 70 years, with advanced solid tumors or lymphoma and ≥ 1 GA domain impairment, who were initiating a regimen with high prevalence of toxicity. Patients completed PRO-CTCAEs, including the severity of 24 symptoms (11 classified as core symptoms) at enrollment, 4-6 weeks, 3 months, and 6 months. Symptoms were scored as grade ≥ 2 (at least moderate) and grade ≥ 3 (severe/very severe). Symptomatic toxicity was determined by an increase in severity during treatment. A generalized estimating equation model was used to assess the effects of the GA intervention on symptomatic toxicity. RESULTS Mean age was 77 years (range, 70-96 years), 43% were female, and 88% were White, 59% had GI or lung cancers, and 27% received prior chemotherapy. In 706 patients who provided PRO-CTCAEs at baseline, 86.1% reported at least one moderate symptom and 49.7% reported severe/very severe symptoms at regimen initiation. In 623 patients with follow-up PRO-CTCAE data, compared with usual care, fewer patients in the GA intervention arm reported grade ≥ 2 symptomatic toxicity (overall: 88.9% v 94.8%, P = .035; core symptoms: 83.4% v 91.7%, P = .001). The results for grade ≥ 3 toxicity were comparable but not significant ( P > .05). CONCLUSION In the presence of a high baseline symptom burden, a GA intervention for older patients with advanced cancer reduces patient-reported symptomatic toxicity.

BackgroundAging-related deficits that eventually manifest as frailty may be associated with poor emotional health in older patients with advanced cancer. This study aimed to examine the relationship between frailty and emotional health in this population.MethodsThis was a secondary analysis of baseline data from a nationwide cluster randomized trial. Patients were aged ≥70 years with incurable stage III/IV solid tumors or lymphomas, had ≥1 geriatric assessment (GA) domain impairment, and had completed the Geriatric Depression Scale, Generalized Anxiety Disorder-7, and Distress Thermometer. Frailty was assessed using a Deficit Accumulation Index (DAI; range 0–1) based on GA, which did not include emotional health variables (depression and anxiety), and participants were stratified into robust, prefrail, and frail categories. Multivariate logistic regression models examined the association of frailty with emotional health outcomes. Adjusted odds ratios (aORs) and 95% confidence intervals (CIs) were reported.ResultsFive hundred forty-one patients were included (mean age: 77 years; 70–96). DAI ranged from 0.04 to 0.94; 27% of patients were classified as robust, 42% prefrail, and 31% frail. Compared with robust patients, frail patients had an increased risk of screening positive for depression (aOR = 12.8; 95% CI = 6.1–27.0), anxiety (aOR = 6.6; 95% CI = 2.2–19.7), and emotional distress (aOR = 4.62; 95% CI = 2.9–8.3). Prefrail compared with robust patients also had an increased risk of screening positive for depression (aOR = 2.22; 95% CI = 1.0–4.8) and distress (aOR = 1.71; 95% CI = 1.0–2.8).ConclusionIn older patients with advanced cancer, frailty is associated with poorer emotional health, which indicates a need for an integrated care approach to treating these patients.Implications for PracticeA relationship exists between frailty and poor emotional health in older adults with advanced cancer. Identifying areas of frailty can prompt screening for emotional health and guide delivery of appropriate interventions. Alternatively, attention to emotional health may also improve frailty.

Cancer-related fatigue is a common, burdensome symptom of cancer and a side-effect of chemotherapy. While a Mediterranean Diet (MedDiet) promotes energy metabolism and overall health, its effects on cancer-related fatigue remain unknown. In a randomized controlled trial, we evaluated a rigorous MedDiet intervention for feasibility and safety as well as preliminary effects on cancer-related fatigue and metabolism compared to usual care. Participants had stage I–III cancer and at least six weeks of chemotherapy scheduled. After baseline assessments, randomization occurred 2:1, MedDiet:usual care. Measures were collected at baseline, week 4, and week 8 including MedDiet adherence (score 0–14), dietary intake, and blood-based metabolic measures. Mitochondrial respiration from freshly isolated T cells was measured at baseline and four weeks. Participants (n = 33) were 51.0 ± 14.6 years old, 94% were female, and 91% were being treated for breast cancer. The study was feasible, with 100% completing the study and >70% increasing their MedDiet adherence at four and eight weeks compared to baseline. Overall, the MedDiet intervention vs. usual care had a small-moderate effect on change in fatigue at weeks 4 and 8 (ES = 0.31, 0.25, respectively). For those with a baseline MedDiet score

Purpose. Chemotherapy-induced peripheral neuropathy (CIPN) is a common dose-limiting side effect of taxane and platinum chemotherapy for breast cancer. Clinicians cannot accurately predict CIPN severity partly because its pathophysiology is poorly understood. Although inflammation may play a role in CIPN, there are limited human studies. Here, we identified the strongest predictors of CIPN using variables measured before taxane- or platinum-based chemotherapy, including serum inflammatory markers.Methods. 116 sedentary women with breast cancer (mean age 55 years) rated (1) numbness and tingling and (2) hot/coldness in hands/feet on 0-10 scales before and after six weeks of taxane- or platinum-based chemotherapy. A sub-study was added to collect cytokine data in the final 55 patients. We examined all linear models to predict CIPN severity at 6 weeks using pre-chemotherapy assessments of inflammatory, behavioral, clinical, and psychosocial factors. The final model was selected via goodness of fit.Results. The strongest pre-chemotherapy predictors of numbness and tingling were worse fatigue/anxiety/depression (explaining 27% of variance), older age (9%), and baseline neuropathy (5%). The strongest predictors of hot/coldness in hands/feet were worse baseline neuropathy (11%) and fatigue/anxiety/depression (6%). Inflammation was a risk for CIPN, per more pro-inflammatory IL-1β (6%) predicting numbness/tingling and less anti-inflammatory IL-10 predicting numbness and tingling (6%) and hot/coldness in hands/feet (9%).Conclusions. The strongest pre-chemotherapy predictors of CIPN included worse fatigue/anxiety/depression and baseline neuropathy. A pro-inflammatory state also predicted CIPN. Because this is an exploratory study, these results suggest specific outcomes (e.g., IL-1β) and effect size estimates for designing replication and extension studies.Trial Registration. NCT00924651

Background: Polypharmacy and potentially inappropriate medications (PIMs) are prevalent in older adults with cancer, but their associations with physical function are not often studied. This study examined the associations of polypharmacy and PIMs with physical function in older adults with cancer, and determined the optimal cutoff value for the number of medications most strongly associated with physical functional impairment. Methods: This cross-sectional analysis used baseline data from a randomized study enrolling patients aged ≥70 years with advanced cancer starting a new systemic cancer treatment. We categorized PIM using 2015 American Geriatrics Society Beers Criteria. Three validated physical function measures were used to assess patient-reported impairments: activities of daily living (ADL) scale, instrumental activities of daily living (IADL) scale, and the Older Americans Resources and Services Physical Health (OARS PH) survey. Optimal cutoff value for number of medications was determined by the Youden index. Separate multivariate logistic regressions were then performed to examine associations of polypharmacy and PIMs with physical function measures. Results: Among 439 patients (mean age, 76.9 years), the Youden index identified ≥8 medications as the optimal cutoff value for polypharmacy; 43% were taking ≥8 medications and 62% were taking ≥1 PIMs. On multivariate analysis, taking ≥8 medications was associated with impairment in ADL (adjusted odds ratio [aOR], 1.64; 95% CI, 1.01–2.58) and OARS PH (aOR, 1.73; 95% CI, 1.01–2.98). PIMs were associated with impairments in IADL (aOR, 1.72; 95% CI, 1.09–2.73) and OARS PH (aOR, 1.97; 95% CI, 1.15–3.37). A cutoff of 5 medications was not associated with any of the physical function measures. Conclusions: Physical function, an important component of outcomes for older adults with cancer, is cross-sectionally associated with polypharmacy (defined as ≥8 medications) and with PIMs. Future studies should evaluate the association of polypharmacy with functional outcomes in this population in a longitudinal fashion.

Purpose Cancer-related fatigue is a prevalent, debilitating condition that can persist for months or years after treatment. In a single-arm clinical trial, the feasibility and safety of a time-restricted eating (TRE) intervention were evaluated among cancer survivors, and initial estimates of within-person change in cancer-related fatigue were obtained. Methods Participants were 4–60 months post-cancer treatment, were experiencing fatigue (≥ 3 on a scale 0–10), and were not following TRE. TRE entailed limiting all food and beverages to a self-selected 10-h window for 14 days. Participants reported their eating window in a daily diary and completed the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Brief Fatigue Inventory (BFI), and symptom inventory pre- and post-intervention. Results Participants (n = 39) were 61.5 ± 12.4 years old and 1.8 ± 1.3 years post-treatment; 89.7% had had breast cancer. The intervention was feasible in that 36/39 (92.3%) of participants completed all questionnaires and daily diaries. It was also safe with no severe adverse events or rapid weight loss (average loss of 1.1 ± 2.3 pounds, p = 0.008). Most adhered to TRE; 86.1% ate within a 10-h window at least 80% of the days, and the average eating window was 9.33 ± 1.05 h. Fatigue scores improved 5.3 ± 8.1 points on the FACIT-F fatigue subscale (p p p

A poor prognostic understanding regarding curability is associated with lower odds of hospice use among patients with cancer. However, the association between poor prognostic understanding or prognostic discordance and health care use among older adults with advanced incurable cancers is not well characterized.To evaluate the association of poor prognostic understanding and patient-oncologist prognostic discordance with hospitalization and hospice use among older adults with advanced cancers.This was a post hoc secondary analysis of a cluster randomized clinical trial that recruited patients from October 29, 2014, to April 28, 2017. Data were collected from community oncology practices affiliated with the University of Rochester Cancer Center National Cancer Institute Community Oncology Research Program. The parent trial enrolled 541 patients who were aged 70 years or older and were receiving or considering any line of cancer treatment for incurable solid tumors or lymphomas; the patients' oncologists and caregivers (if available) were also enrolled. Patients were followed up for at least 1 year. Data were analyzed from January 3 to 16, 2021.At enrollment, patients and oncologists were asked about their beliefs regarding cancer curability (100%,50%, 50%,50%, and 0%; answers other than 0% reflected poor prognostic understanding) and life expectancy (≤6 months, 7-12 months, 1-2 years, 2-5 years, and5 years; answers of5 years reflected poor prognostic understanding). Any difference between oncologist and patient in response options was considered discordant. Outcomes were any hospitalization and hospice use at 6 months captured by the clinical research associates.Among the 541 patients, the mean (SD) age was 76.6 (5.2) years, 264 of 540 (49%) were female, and 486 of 540 (90%) were White. Poor prognostic understanding regarding curability was reported for 59% (206 of 348) of patients, and poor prognostic understanding regarding life expectancy estimates was reported for 41% (205 of 496) of patients. Approximately 60% (202 of 336) of patient-oncologist dyads were discordant regarding curability, and 72% (356 of 492) of patient-oncologist dyads were discordant regarding life expectancy estimates. Poor prognostic understanding regarding life expectancy estimates was associated with lower odds of hospice use (adjusted odds ratio, 0.30; 95% CI, 0.16-0.59). Discordance regarding life expectancy estimates was associated with greater odds of hospitalization (adjusted odds ratio, 1.64; 95% CI, 1.01-2.66).This study highlights different constructs of prognostic understanding and the need to better understand the association between prognostic understanding and health care use among older adult patients with advanced cancer.ClinicalTrials.gov Identifier: NCT02107443.

Background Inflammation may contribute to cognitive difficulties in patients with breast cancer. We tested 2 hypotheses: inflammation is elevated in patients with breast cancer vs noncancer control participants and inflammation in patients is associated with worse attention and processing speed over the course of chemotherapy. Methods Serum cytokines (interleukin [IL]–4, 6, 8, 10; tumor necrosis factor [TNF]–α) and soluble receptors [sTNFRI, II]) were measured in 519 females with breast cancer before and after chemotherapy and 338 females without cancer serving as control participants. Attention and processing speed were measured by Rapid Visual Processing (RVP), Backward Counting (BCT), and Trail Making-A (TMT-A) tests. Linear regression models examined patient vs control cytokines and receptor levels, adjusting for covariates. Linear regression models also examined relationships between patient cytokines and receptor levels and test performance, adjusting for age, body mass index, anxiety, depression, cognitive reserve, and chemotherapy duration. Statistical tests were 2-sided (α = .05). Results sTNFRI and sTNFRII increased over time in patients relative to controls, whereas IL-4, IL-6, and IL-10 decreased. Prechemotherapy, higher IL-8 associated with worse BCT (β = 0.610, SE = 0.241, P = .01); higher IL-4 (β = −1.098, SE = 0.516, P = .03) and IL-10 (β = −0.835, SE = 0.414, P = .04) associated with better TMT-A. Postchemotherapy, higher IL-8 (β = 0.841, SE = 0.260, P = .001), sTNFRI (β = 6.638, SE = 2.208, P = .003), and sTNFRII (β = 0.913, SE = 0.455, P = .045) associated with worse BCT; higher sTNFRII also associated with worse RVP (β = −1.316, SE = 0.587, P = .03). At prechemotherapy, higher IL-4 predicted RVP improvement over time (β = 0.820, SE = 0.336, P = .02); higher sTNFRI predicted worse BCT over time (β = 5.566, SE = 2.367, P = .02). Longitudinally, increases in IL-4 associated with BCT improvement (β = −0.564, SE = 0.253, P = .03). Conclusions Generally, worse attention and processing speed were associated with higher inflammatory cytokines and receptors and lower anti-inflammatory cytokines in patients; future confirmatory studies are needed.

Many older patients with myeloid neoplasms experience treatment-related toxicities. We previously demonstrated that a home-based, progressive aerobic walking and resistance exercise program (EXCAP) improved physical and psychological outcomes in patients with cancer. However, older patients have more difficulty adhering to exercise than younger patients. Reasons may include low motivation, difficulty with transportation, and limited access to exercise professionals. To improve exercise adherence, we integrated a mobile app with EXCAP (GO-EXCAP) and assessed its feasibility and usability in a single-arm pilot study among older patients with myeloid neoplasms undergoing outpatient chemotherapy. GO-EXCAP intervention lasts for 2 cycles of treatment, and the primary feasibility metric was data reporting on the app. Usability was evaluated via the system usability scale (SUS). Patients were interviewed at mid and postintervention to elicit their feedback, and deductive thematic analysis was applied to the transcripts. Twenty-five patients (mean age, 72 years) were recruited. Recruitment and retention rates were 64% and 88%, respectively. Eighty-two percent (18/22) of patients entered some exercise data on the app at least half of the study days, excluding hospitalization (a priori, we considered 70% as feasible). Averaged daily steps were 2848 and 3184 at baseline and after intervention, respectively. Patients also performed resistance exercises 26.2 minutes per day, 2.9 days per week at low intensity (rate of perceived exertion 3.8/10). Usability was above average (SUS, 70.3). In qualitative analyses, 3 themes were identified, including positive experience with the intervention, social interactions, and flexibility. The GO-EXCAP intervention is feasible and usable for older patients with myeloid neoplasms undergoing outpatient chemotherapy. This trial was registered at www.clinicaltrials.gov as #NCT04035499.

OBJECTIVE: One primary source of psychological distress in patients with cancer and their caregivers is uncertainty. However, the uncertainty trajectory and its relationship between older adults with advanced cancer and their caregivers have rarely been examined. This study describes the uncertainty trajectory in patient-caregiver dyads, explores the effect of geriatric assessment (GA) intervention on trajectory, and examines the interdependent relationship of uncertainty. METHODS: This secondary analysis used longitudinal data from a national cluster-randomized controlled trial examining a GA intervention compared to usual care. Participants completed the modified 9-item Mishel Uncertainty in Illness Scale at enrollment, 4–6 weeks, 3 months, and 6 months. The dyadic growth model and cross-lagged actor-partner interdependence model were used. RESULTS: A total of 397 dyads (patient age M = 76.81 ± SD5.43; caregiver age M = 66.69 ± SD12.52) were included. Both had a trend of decreased uncertainty over time (b = −0.16, p < 0.01). There was a greater decrease in uncertainty among caregivers in the GA group than those in the usual care group (b = −0.46, p = 0.02). For both patients and caregivers, their past uncertainty was a significant predictor of their own current uncertainty (i.e., actor effect, p < 0.01). The individual’s past uncertainty was a significant predictor of the other dyad member’s current uncertainty (i.e., partner effect, p < 0.05), indicating an interdependent relationship between patient and caregiver uncertainty over time. CONCLUSIONS: Findings suggest patient and caregiver function as a unit with uncertainty levels affecting each other. Future interventions could build on GA to address uncertainty for older patients with advanced cancer and caregivers.

ImportanceOlder adults with advanced cancer who have high pretreatment symptom severity often experience adverse events during cancer treatments. Unsupervised machine learning may help stratify patients into different risk groups.ObjectiveTo evaluate whether clusters identified from baseline patient-reported symptom severity were associated with adverse outcomes.Design, Setting, and ParticipantsThis secondary analysis of the Geriatric Assessment Intervention for Reducing Toxicity in Older Patients With Advanced Cancer (GAP70+) Trial (2014-2019) included patients who completed the National Cancer Institute Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) before starting a new cancer treatment regimen and received care at community oncology sites across the United States. An unsupervised machine learning algorithm (k-means with Euclidean distance) clustered patients based on similarities of baseline symptom severities. Clustering variables included severity items of 24 PRO-CTCAE symptoms (range, 0-4; corresponding to none, mild, moderate, severe, and very severe). Total severity score was calculated as the sum of 24 items (range, 0-96). Whether the clusters were associated with unplanned hospitalization, death, and toxic effects was then examined. Analyses were conducted in January and February 2022.ExposuresSymptom severity.Main Outcomes and MeasuresUnplanned hospitalization over 3 months (primary), all-cause mortality over 1 year, and any clinician-rated grade 3 to 5 toxic effect over 3 months.ResultsOf 718 enrolled patients, 706 completed baseline PRO-CTCAE and were included (mean [SD] age, 77.2 [5.5] years, 401 [56.8%] male patients; 51 [7.2%] Black and 619 [87.8%] non-Hispanic White patients; 245 [34.7%] with gastrointestinal cancer; 175 [24.8%] with lung cancer; mean [SD] impaired Geriatric Assessment domains, 4.5 [1.6]). The algorithm classified 310 (43.9%), 295 (41.8%), and 101 (14.3%) into low-, medium-, and high-severity clusters (within-cluster mean [SD] severity scores: low, 6.3 [3.4]; moderate, 16.6 [4.3]; high, 29.8 [7.8]; P P = .046). Moderate- and high-severity clusters were associated with a higher risk of death (moderate: hazard ratio, 1.31; 95% CI, 1.01-1.69; P = .04; high: hazard ratio, 2.00; 95% CI, 1.43-2.78; P Conclusions and RelevanceIn this study, unsupervised machine learning partitioned patients into distinct symptom severity clusters; patients with higher pretreatment severity were more likely to experience hospitalization and death.Trial RegistrationClinicalTrials.gov Identifier: NCT02054741

Background: Older adults (age ≥65 years) receiving chemotherapy are at risk for hospitalization. Predictors of unplanned hospitalization among older adults receiving chemotherapy for cancer were recently published using data from a study conducted by the Cancer and Aging Research Group (CARG). Our study aimed to externally validate these predictors in an independent cohort including older adults with advanced cancer receiving chemotherapy. Methods: This validation cohort included patients (n=369) from the GAP70+ trial usual care arm. Enrolled patients were aged ≥70 years with incurable cancer and were starting a new line of chemotherapy. Previously identified risk factors proposed by the CARG study were ≥3 comorbidities, albumin level Results: Mean age of the cohort was 77 years, 45% of patients were women, and 29% experienced unplanned hospitalization within the first 3 months of treatment. The proportions of hospitalized patients with 0–3, 4–5, and 6–7 identified risk factors were 24%, 28%, and 47%, respectively (P=.04). Impaired ADLs (odds ratio, 1.76; 95% CI, 1.04–2.99) and albumin level Conclusions: The presence of a higher number of risk factors was associated with increased odds of unplanned hospitalization. This association was largely driven by impairment in ADLs and low albumin level. Validated predictors of unplanned hospitalization can help with counseling and shared decision-making with patients and their caregivers. ClinicalTrials.gov identifier: NCT02054741

IntroductionRadiation-induced cognitive decline (RICD) occurs in 50%–90% of adult patients 6 months post-treatment. In patients with low-grade and benign tumours with long expected survival, this is of paramount importance. Despite advances in radiation therapy (RT) treatment delivery, better understanding of structures important for RICD is necessary to improve cognitive outcomes. We hypothesise that RT may affect network topology and microstructural integrity on MRI prior to any gross anatomical or apparent cognitive changes. In this longitudinal cohort study, we aim to determine the effects of RT on brain structural and functional integrity and cognition.Methods and analysisThis study will enroll patients with benign and low-grade brain tumours receiving partial brain radiotherapy. Patients will receive either hypofractionated (>2 Gy/fraction) or conventionally fractionated (1.8–2 Gy/fraction) RT. All participants will be followed for 12 months, with MRIs conducted pre-RT and 6-month and 12 month post-RT, along with a battery of neurocognitive tests and questionnaires. The study was initiated in late 2018 and will continue enrolling through 2024 with final follow-ups completing in 2025. The neurocognitive battery assesses visual and verbal memory, attention, executive function, processing speed and emotional cognition. MRI protocols incorporate diffusion tensor imaging and resting state fMRI to assess structural connectivity and functional connectivity, respectively. We will estimate the association between radiation dose, imaging metrics and cognitive outcomes.Ethics and disseminationThis study has been approved by the Research Subjects Review Board at the University of Rochester (STUDY00001512: Cognitive changes in patients receiving partial brain radiation). All results will be published in peer-reviewed journals and at scientific conferences.Trial registration numberClinicalTrials.govNCT04390906.

This letter to the editor responds to comments on an article that reported on the prevalence of frailty, anxiety, depression, and distress and the relationships between frailty and emotional health in older patients with advanced cancer.

Cancer-related fatigue is a prevalent and debilitating condition that persists for years into survivorship. Studies evaluating both fish oil supplementation on fatigue and associations between fish oil consumption and fatigue have shown mixed effects; it is unknown what factors contribute to these differential effects. Herein, we investigate whether the nutritional status of cancer survivors was associated with serum omega-3 concentration or change in serum omega-3s throughout a fish oil supplementation study, and then if any of these factors were associated with fatigue. Breast cancer survivors 4–36 months post-treatment with moderate-severe fatigue were randomized to take 6 g fish oil, 6 g soybean oil, or 3 g of each daily for 6 weeks. Baseline nutritional status was calculated using the Controlling Nutritional Status tool (serum albumin, lymphocytes, cholesterol). At baseline and post-intervention, serum fatty acids were quantified and fatigue was assessed using the Multidimensional Fatigue Symptom Inventory. Participants (n = 85) were 61.2 ± 9.7 years old with a body mass index of 31.9 ± 6.7 kg/m2; 69% had a good nutritional score and 31% had light-moderate malnutrition. Those with good nutritional status had greater total serum omega-3s at baseline (p = 0.013) and a greater increase in serum omega-3s with supplementation (p = 0.003). Among those who were supplemented with fish oil, greater increases in serum omega-3s were associated with greater improvements in fatigue. In conclusion, good nutritional status may increase uptake of fatty acid supplements, increasing their ability to improve fatigue.

INTRODUCTION: We have shown the Exercise for Cancer Patients (EXCAP(©®)) exercise program improved physical function and symptoms and reduced inflammatory markers in patients with cancer. However, adherence to exercise was lower in older adults compared to their younger counterparts. We then leveraged a mobile app to deliver EXCAP(©®) and adapted the intervention [Geriatric-Oncology (GO)-EXCAP] for older patients with myeloid neoplasms. In this pilot randomized trial, the primary goal is to determine effect sizes. We propose to assess the preliminary efficacy of GO-EXCAP compared to a behavioral placebo control on physical function, patient-reported outcomes (fatigue, mood, and quality of life), and inflammatory markers in 100 patients aged ≥60 years with myeloid neoplasms receiving outpatient chemotherapy. METHODS: GO-EXCAP consists of the EXCAP(©®) exercise prescription (daily home-based progressive aerobic walking and resistance exercises with rated perceived exercise of 5–8), EXCAP(©®) kit (i.e., activity tracker, resistance bands, print manual, bag), a mobile app, and an in-person or virtual session with the exercise physiologist to deliver exercise prescription. The intervention will last for three cycles of chemotherapy (approximately 12 weeks). The primary outcome measure will be physical function (Short Physical Performance Battery). Secondary outcome measures include fatigue (Brief Fatigue Inventory), mood (Center for Epidemiologic Studies Depression Scale), and quality of life (Functional Assessment of Cancer Therapy-Leukemia). Exploratory outcome measures include inflammatory markers. DISCUSSION: Older adults with myeloid neoplasms receiving outpatient chemotherapy serve as an ideal model for studying an individually tailored mobile health exercise intervention in vulnerable older patients receiving cancer treatments to prevent physical function decline and improve symptoms.

Purpose To quantify the impact of diabetes on the trajectory of cancer-related fatigue (CRF) from pre-chemotherapy to 6 months post-chemotherapy for patients with breast cancer compared to non-cancer controls.Methods This was a secondary analysis from a nationwide prospective longitudinal study of female patients with breast cancer undergoing chemotherapy and age-matched women without cancer (controls). CRF was measured using the Multidimensional Fatigue Symptom Inventory (MFSI) pre-, post-, and 6-months post-chemotherapy in patients; controls were assessed at equivalent time points. Diabetes status was obtained at baseline. Repeated measures mixed models estimated the association between CRF and diabetes controlling for cancer (y/n), body mass index, exercise and smoking habits, baseline anxiety and depressive symptoms, menopausal status, marital status, race, and education.Results A total of 439 patients and 235 controls (age: 52.8±10.5 years) had available data on diabetes status. Diabetes was twice as prevalent among patients as controls (11.6% vs. 6.8%). Patients had worse fatigue than controls throughout treatment (p Diabetes was associated with worse CRF with a clinically meaningful difference of 4.7±1.7 points on the fatigue measure in all participants (p=0.009) and patients alone (p=0.030). For MFSI subdomains, diabetes was associated with worse general (p=0.002), physical (p=0.005), and mental fatigue (p=0.025) but not worse emotional fatigue or vigor (p>0.14) among patients. Conclusions Diabetes was twice as prevalent in women with breast cancer compared to controls, and diabetes was associated with more severe CRF in patients before and after chemotherapy and at 6 months post-chemotherapy. Interventions that address diabetes management may also help address CRF during chemotherapy treatment

BACKGROUND A geriatric assessment (GA) intervention improves communication about aging-related concerns, but its effect on communication in patients with various levels of frailty is unknown. METHODS This was a secondary analysis of a nationwide trial of patients aged ≥70 years with incurable cancer and impairment on 1 or more GA domains (ClinicalTrials.gov Identifier NCT02107443; principal investigator Supriya G. Mohile). Practice sites were randomized to either the GA-intervention or usual care. Frailty was assessed with a deficit accumulation index (range, 0-1), and patients were stratified as robust (0 to

Psychophysiologists often record electrodermal activity (EDA) exosomatically to derive measures of slow, tonic activity—skin conductance level (SCL)—and faster, more punctate changes—skin conductance responses (SCRs). An SCR is considered relevant when its amplitude exceeds a researcher-determined threshold (e.g., 0.05 μS), typically fixed across study participants and conditions. However, fixed SCR thresholds may detect more SCRs in samples with higher SCL because the number and amplitude of SCRs correlate positively with SCL. To address this issue, we developed a novel fixed plus adaptive (FA) thresholding method that adjusts SCR detection as a function of the prevailing SCL. We hypothesized greater statistical power to detect a difference in the rate of SCRs across high vs. low arousal stimuli using FA thresholding compared to fixed thresholding. Study 1 consisted of 254 young adults measured in a laboratory using wired EDA sensors during exposure to evocative images and sounds. Study 1 constituted our exploratory dataset, wherein we found an optimal FA threshold of 1.9% that maximized the ability to detect a difference in SCR rate between high vs. low arousal stimuli. Study 2 involved 20 children with autism repeatedly measured in a clinic using wireless EDA sensors during several behavioral tasks. Study 2 constituted our validation dataset, wherein FA thresholding at 1.9% increased statistical power to detect a difference in SCR rate between high vs. low arousal tasks, compared to fixed thresholding at 0.05 μS. Future research should test for reproducibility and generalizability of our results in other tasks, samples, and contexts.

269 Background: Older adults with advanced cancer are at increased risk of treatment-related toxicities, which can compromise physical performance and independence in daily functioning. However, studies evaluating the relationship of toxicities with functional capacity in this population are scarce. The aim of this analysis is to assess the effect of clinician-reported toxicities (CRTs) and patient-reported symptomatic toxicities (PRSTs) on physical performance and independence in daily functioning. Methods: This is a secondary analysis of GAP 70+ (NCT02054741, n = 718), a cluster randomized trial of older patients (70+ years) with advanced cancer initiating a new systemic therapy regimen. Impairments in physical performance [measured by Short Physical Performance Battery (SPPB)], and functional independence [measured by activities of daily living (ADL), and instrumental ADL (IADL)] were classified by established cut points. CRTs were collected by Common Terminology Criteria for Adverse Events (CTCAE) and PRSTs by Patient-Reported Outcome version of CTCAE (PRO-CTCAE). PRST grade was determined by severity of the items (0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe). To count as a PRST event, symptom severity had to increase from pre-treatment level (baseline adjusted method). Patients without baseline impairment in SPPB, IADL, and ADL (n = 104, 308, 461, respectively), who provided data after baseline were included in the analysis. To assess the association of experiencing toxicity within 3 months and developing functional impairment within 6 months, generalized estimating equation (GEE) modeling was used. Models were adjusted for practice sites (random effect) and the study arm. Results: Patients were 70-96 years old (mean 77), 56% were male, and majority (87%) were white. Gastrointestinal (34%) and lung (25%) were the most common cancer types. During treatment, impairments in SPPB developed in 57.7% (60/104), in IADL 47.4% (146/308), and in ADL 31.0% (143/461). There was no association of CRT grade with developing impairment in SPPB (p = 0.92). A greater proportion of patients who experienced grade ≥ 3 CRT, compared to those with grade 2 and grade ≤ 1 CRT, developed impairment in IADL (54.4 vs 38.3 vs 25.2%, p = 0.01) and also in ADL (34.8 vs 23.9 vs 22.7%, p = 0.02). Patients who experienced grade ≥ 3 PRST, compared to those with grade 2 and grade ≤ 1 PRST, were more likely to developed impaired SPPB (73.6 vs 50.4 vs 27.8%, p = 0.01), IADL (50.8 vs 45.4 vs 31.5%, p = 0.20), and ADL (38.1 vs 18.5 vs 19.7%, p < 0.01). Conclusions: Assessing both patient- and clinician-reported toxicity provides insight into loss of independent functioning. Information patients provide about symptoms can help with early detection of decline in physical performance in older adults. These findings may help to guide interventions to mitigate functional decline. Clinical trial information: NCT02054741.

PURPOSE Physical activity (PA) is a promising intervention for cancer-related cognitive decline, yet research assessing its use during chemotherapy is limited. This study evaluated patterns of PA before, during, and after chemotherapy in patients with breast cancer and the association between PA and cognitive function. METHODS In a nationwide, prospective cohort study, we assessed PA (Aerobics Center Longitudinal Study PA measure) and perceived and objectively measured cognitive functioning (Functional Assessment of Cancer Therapy–Cognitive, Delayed Match to Sample, and Rapid Visual Processing measures) at prechemotherapy (T1), postchemotherapy (T2), and 6 months postchemotherapy (T3) in patients with breast cancer and cancer-free, age-matched controls at equivalent time points. Longitudinal linear mixed-effects models (LMMs) characterized PA changes over time between patients and controls, adjusting for demographic and clinical factors. LMMs further estimated the role of prechemotherapy PA and changes in PA during chemotherapy on cognitive changes over time. RESULTS Patients with stage I-IIIC breast cancer (n = 580; age M [standard deviation] = 53.4 [10.6] years) and controls (n = 363; age M [standard deviation] = 52.6 [10.3] years) were included. One third of patients met national PA guidelines at T1, dropping to 21% at T2 before rising to 37% at T3. LMMs revealed declines in PA from T1 to T2 in patients compared with controls (all P < .001). Patients meeting guidelines at T1 demonstrated better cognitive scores over time on the Functional Assessment of Cancer Therapy–Cognitive and Rapid Visual Processing (all P < .05), with similar patterns of objectively-measured cognitive function as controls. In patients, greater moderate-to-vigorous PA at the previous time point was significantly associated with better cognitive trajectories (all P < .05), and adherence to PA guidelines throughout chemotherapy was associated with better self-reported cognition ( P < .01). CONCLUSION This nationwide study demonstrates that PA maintenance before and during chemotherapy is associated with better cognitive function immediately and 6 months after chemotherapy completion.

PURPOSE: To assess the impact of obesity on cancer-related fatigue (CRF) in patients with breast cancer, through a secondary analysis of a large, longitudinal, nationwide study of breast cancer patients beginning chemotherapy. METHODS: All patients (N = 565; aged 53 ± 10.6) with breast cancer completed the multidimensional fatigue symptom inventory and the symptom inventory to measure CRF symptoms at baseline, post-chemotherapy, and 6 months post-chemotherapy. Height and weight at baseline were used to categorize subjects based on body mass index (BMI): obese (≥ 30.0 kg/m(2); n = 294), overweight (25.0–29.9 kg/m(2); n = 146), and normal weight (18.5–24.9 kg/m(2); n = 125). Multivariate regression models evaluated the relationship of obesity level to CRF over time, controlling for age, menopausal status, race, Karnofsky Performance Status, cancer stage, radiation, and exercise status. RESULTS: At baseline, the obese had significantly higher CRF symptoms than the normal weight subjects for both the Multidimensional fatigue symptom inventory (MFSI) total (obese = 11.2 vs normal weight = 6.3; p = 0.03) and Symptom Inventory (SI) (obese = 3.5 vs normal weight = 2.9; p = 0.03). Significantly higher SI fatigue scores persisted at post-chemotherapy for the obese (obese = 5.0 vs normal weight = 4.4; p = 0.02). At 6 months post-chemotherapy, the obese patients still had significantly higher SI fatigue scores (obese = 3.5 vs normal weight = 3.0; p = 0.05). CONCLUSION: Obese patients suffered greater CRF from pre-chemotherapy through 6 months post-chemotherapy. Recommendations for weight loss or weight maintenance may impact CRF levels in obese breast cancer patients before and after chemotherapy.

Introduction Black cancer survivors remain at a higher risk for secondary cancers, cancer recurrence, and comorbid conditions than non-Hispanic White survivors. Physical activity may help improve health outcomes and overall quality of life. We assessed cancer survivors’ physical activity by race/ethnicity and the effect of social determinants of health (SDH) constructs (i.e., economic stability, education, and access to health care) on physical activity. Methods This was a cross-sectional analysis of data from the 2016 Behavioral Risk Factor Surveillance System. The outcome variable was physical activity after cancer diagnosis and the predictor variables were SDH and race. Multivariable logistic regressions were used to examine associations between race and physical activity and the effect of SDH on physical activity. Results Among 3,787 cancer survivors, 91.6% self-identified as White and 8.4% as Black. Blacks were more likely than Whites to report low economic stability, low access to health care, and low health literacy (all ps Conclusions The findings suggest that though Black cancer survivors are less than White to engage in physical activity, and SDH partially explained the racial difference in physical activity behaviors. These findings highlight the need to address barriers to health-care access, economic stability, and educational attainment.

BACKGROUND/OBJECTIVE Exercise interventions improve anxiety and mood disturbances in patients with cancer. However, studies are limited in older adults with cancer. We assessed the effects of exercise on anxiety, mood, and social and emotional well-being in older patients with cancer during their first 6 weeks of chemotherapy. DESIGN Exploratory secondary analysis of a randomized controlled trial (RCT). SETTING Community oncology practices. PARTICIPANTS Older patients (aged 60 years or older) undergoing chemotherapy (N = 252). INTERVENTION Patients were randomized to Exercise for Cancer Patients (EXCAP) or usual care (control) for the first 6 weeks of chemotherapy. EXCAP is a home-based, low- to moderate-intensity progressive walking and resistance training program. MEASUREMENTS Analysis of covariance, with study arm as the factor, baseline value as the covariate, and study arm × baseline interaction, was used to evaluate arm effects on postintervention anxiety (State Trait Anxiety Inventory [STAI]), mood (Profile of Mood States [POMS]), and social and emotional well-being (Functional Assessment of Cancer Therapy-General subscales) after 6 weeks. RESULTS Median age was 67 years; 77% had breast cancer. Statistically significant group differences were observed in the STAI score (P = .001), POMS score (P = .022), social well-being (P = .002), and emotional well-being (P = .048). For each outcome, EXCAP patients with worse baseline scores had larger improvements at 6 weeks; these improvements were clinically significant for STAI score and social well-being. CONCLUSIONS Among older cancer patients receiving chemotherapy, a 6-week structured exercise program improved anxiety and mood, especially among those participants with worse baseline symptoms. Additional RCTs are needed to confirm these findings and evaluate the appropriate exercise prescription for managing anxiety, mood, and well-being in this patient population. J Am Geriatr Soc 67:1005-1011, 2019.

A growing body of research suggests that inflammation plays a role in many chemotherapy-related toxicities such as fatigue, anxiety, and neuropathy. Regular exercise can change levels of individual cytokines (e.g., reducing IL-6, increasing IL-10); however, it is not known whether exercise during chemotherapy affects relationships between cytokines (i.e., whether cytokine concentrations change collectively vs. independently). This study assessed how 6 weeks of exercise during chemotherapy affected relationships between changes in concentrations of several cytokines. This is a secondary analysis of a randomized trial studying 6 weeks of moderate-intensity walking and resistance exercise during chemotherapy compared with chemotherapy alone. At pre- and post-intervention, patients provided blood to assess serum concentrations of cytokines IL-1β, IL-6, IL-8, IL-10, and IFN-γ, and receptor sTNFR1. We investigated relationships between cytokines using the correlations between changes in cytokine concentrations from pre- to post-intervention. We obtained complete data from 293 patients (149 randomized to exercise). Exercise strengthened the correlation between concentration changes of IL-10 and IL-6 (r = 0.44 in exercisers vs. 0.11 in controls; p = 0.001). We observed the same pattern for IL-10:IL-1β and IL-10:sTNFR1. Exercise also induced an anti-inflammatory cytokine profile, per reductions in pro-inflammatory IFN-γ (p = 0.044) and perhaps IL-1β (p = 0.099, trend-level significance). Our hypothesis-generating work suggests that regular exercise during 6 weeks of chemotherapy may cause certain cytokine concentrations to change collectively (not independently). This work enhances our understanding of relationships between cytokines and complements traditional analyses of cytokines in isolation. Future work should test for replication and relationships to patient outcomes. Clinical Trials.gov, # NCT00924651, http://www.clinicaltrials.gov .

PURPOSE: Research by our group has shown that acupressure bands are efficacious in reducing chemotherapy-induced nausea (CIN) for breast cancer patients who expect nausea, and that their effectiveness in controlling CIN can largely be accounted for by patients’ expectations of efficacy, i.e., a placebo effect. The present research examined if the effectiveness of acupressure bands could be enhanced by boosting patients’ expectation of the bands’ efficacy. METHODS: 242 Chemotherapy-naïve patients with breast cancer who expected nausea were randomized. Arms 1 and 2 received acupressure bands, plus a relaxation MP3 and written handout that were either expectancy-enhancing (Arm 1) or expectancy-neutral (Arm 2). Arm 3 was the control without bands or MP3, and received standard care. All participants received guidelines specified antiemetics. RESULTS: Peak CIN for Arms 1, 2, and 3 on a 1–7 scale was 3.52, 3.55, and 3.87, respectively (p=0.46). Because no differences were observed between Arms 1 and 2 (primary analysis), we combined these two arms (intervention) and compared them to controls for the following analyses. Significant interaction was found between intervention/control and receiving doxorubicin-based chemotherapy (yes/no) and pre-treatment anxiety (high/low). Intervention patients receiving doxorubicin had lower peak CIN than controls (3.62 vs. 4.38; p=0.02). Similarly, intervention patients with high pre-treatment anxiety had a lower peak CIN than controls (3.62 vs. 4.62; p=0.01). CONCLUSIONS: In breast cancer patients undergoing chemotherapy and having high CIN expectation, acupressure bands combined with a relaxation recording were effective in reducing CIN for patients who received doxorubicin or had high anxiety.

BACKGROUND Older patients with advanced cancer who are 100% certain they will be cured pose unique challenges for clinical decision making, but to the authors' knowledge, the prevalence and correlates of absolute certainty about curability (ACC) are unknown. METHODS Cross-sectional data were collected in a geriatric assessment trial. ACC was assessed by asking patients, "What do you believe are the chances that your cancer will go away and never come back with treatment?" Response options were 100% (coded as ACC), >50%, 50/50

Key Objective: What do we know about cancer treatment tolerability in older adults and where are the gaps? Knowledge generated: While there is strong evidence that geriatric assessment findings can be helpful in predicting treatment tolerability in older adults with cancer, more research is needed on treatment tolerability assessment, monitoring, and mitigation efforts for older adults during and after completion of treatment. A model is proposed to guide research efforts and clinical care that incorporates multiple tolerability aspects and highlights the patient’s experience and functional status as important endpoints. Relevance: Incorporating patient reported outcomes, functional evaluation, as well as adverse event data provides a more comprehensive and accurate understanding of treatment tolerability in older adults.