BACKGROUND:Urinary incontinence (UI) affects over half of adult women in the United States and negatively impacts physical and psychological health. Our understanding of UI self-management is limited to older, urban women despite the prevalence of UI in all women, particularly during the midlife period. PURPOSE:The purpose of this study was to examine how contextual factors influence UI self-management behaviors of rural, midlife women with UI. METHODS:A convergent, mixed-methods study was conducted with 31 rural women aged 30-60 years who were recruited via social media. Participants completed a demographics questionnaire, individual interview, and questionnaires to assess contextual factors: UI subtype, incontinence severity, access to care, and quality of life (QOL) impact. Analyses included qualitative description, descriptive statistics and correlations, and data integration to assess for convergence. RESULTS:Qualitative interview results have been published. The strongest correlation was seen between incontinence severity and QOL impact. Significant correlations were found between postmenopausal status, UI subtype, incontinence severity, and QOL impact. Integration of qualitative and quantitative data revealed difference between incontinence severity and the qualitative themes self-management behaviors and medical encounters. As incontinence severity increased, the intensity of self-management behaviors increased. Lacking knowledge about symptom reduction and providers' fatalistic attitudes were barriers to improving UI self-management in this rural sample. CONCLUSION:Findings demonstrate a need for specific health care educational resources and supportive interactions to reduce the QOL impact of UI in rural midlife women.

BACKGROUND:The importance of physical activity to support health has been widely demonstrated. Hematopoietic cell transplantation (HCT) requires lengthy hospitalizations resulting in substantial decreases in physical activity. Understanding the factors associated with physical activity during hospitalization and immediately following hospital discharge is vital to support the transition from hospital to home. OBJECTIVE:To examine the associations among personal factors (exercise self-efficacy, physical and mental health, and symptom severity and interference) and physical activity immediately following HCT. METHODS:In this prospective observational pilot study, accelerometers measured physical activity during hospitalization on HCT days 0 to 4 (T1) and days 5 to 9 (T2), and in the first 7 days after hospital discharge (T3). Personal factors were assessed at T1, T2, and T3. Physical activity and personal factors were evaluated for change over time (Friedman test) and associations (Spearman correlations). RESULTS:Participants' (n = 26, 57% male; median age, 55 years [40-65.3]) accelerometer data revealed light and moderate to vigorous physical activity, and median steps decreased significantly as symptoms severity and interference increased from T1 to T2. Exercise self-efficacy was moderate to high from T1 to T3 and was correlated with increased steps at T2 (r = 0.57, P = .05) and increased light physical activity (r = 0.55, P = .05) and steps (r = 0.61, P = .01) at T3. CONCLUSIONS:This pilot study provides preliminary evidence of the relationships between physical activity and symptoms, symptom severity, and exercise self-efficacy. IMPLICATIONS FOR PRACTICE:Maintaining high levels of physical activity during hospitalization for HCT may not be possible. Nurses can help patients set realistic expectations for physical activity during hospitalization and immediately after hospital discharge.

How to select the appropriate intensity of chemotherapy in older adults with acute myeloid leukemia (AML) remains an unanswered question. In a phase II trial of older adults ≥ 60 years with AML (n = 73), we used geriatric assessment (measures of comorbidity burden, physical and cognitive function) to determine fitness for intensive chemotherapy. We integrated the geriatric assessment and genetic test results to personalize the selection of chemotherapy intensity with a goal to reduce early mortality (NCT03226418). Broad eligibility criteria allowed enrolling patients representative of those treated in real-world practices: 45% of patients were ≥ 70 years, 57% had ≥ 2 comorbidities, 27% had a history of solid malignancies, and 74% had impairments in ≥ 2 geriatric assessment domains used to assign treatment intensity. Thirty-two percent of patients resided in rural areas, and 45% were comanaged with community oncologists. The median time from enrollment to therapy initiation was 1 day (range 0-13). Eight patients (11%) received intensive chemotherapy; others received low-intensity chemotherapy. Mortality at 30 days from diagnosis was 6.8% (95% confidence interval, CI 3.0%-15.1%) and at 90 days was 21.9% (95% CI 14.0%-32.7%). One-year survival was 45.9% (95% CI 35.6%-59.3%). Our study demonstrates that pre-treatment geriatric assessment in older adults with AML is feasible, can identify several functional impairments, and guide the selection of treatment intensity. A randomized trial is necessary to confirm the survival benefit of this approach over the traditional approach of treatment selection. Trial Registration: NCT03226418.

BackgroundExercise intensity (eg, target heart rate [HR]) is a fundamental component of exercise prescription to elicit health benefits in cancer survivors. Despite the validity of chest-worn monitors, their feasibility in community and unsupervised exercise settings may be challenging. As wearable technology continues to improve, consumer-based wearable sensors may represent an accessible alternative to traditional monitoring, offering additional advantages. ObjectiveThe purpose of this study was to examine the agreement between the Polar H10 chest monitor and Fitbit Inspire HR for HR measurement in breast cancer survivors enrolled in the intervention arm of a randomized, pilot exercise trial. MethodsParticipants included breast cancer survivors (N=14; aged 38-72 years) randomized to a 12-week aerobic exercise program. This program consisted of three 60-minute, moderate-intensity walking sessions per week, either in small groups or one-on-one, facilitated by a certified exercise physiologist and held at local community fitness centers. As originally designed, the exercise prescription included 36 supervised sessions at a fitness center. However, due to the COVID-19 pandemic, the number of supervised sessions varied depending on whether participants enrolled before or after March 2020. During each exercise session, HR (in beats per minute) was concurrently measured via a Polar H10 chest monitor and a wrist-worn Fitbit Inspire HR at 5 stages: pre-exercise rest; midpoint of warm-up; midpoint of exercise session; midpoint of cool-down; and postexercise recovery. The exercise physiologist recorded the participant’s HR from each device at the midpoint of each stage. HR agreement between the Polar H10 and Fitbit Inspire HR was assessed using Lin concordance correlation coefficient (rc) with a 95% CI. Lin rc ranges from 0 to 1.00, with 0 indicating no concordance and 1.00 indicating perfect concordance. Relative error rates were calculated to examine differences across exercise session stages. ResultsData were available for 200 supervised sessions across the sample (session per participant: mean 13.33, SD 13.7). By exercise session stage, agreement between the Polar H10 monitor and the Fitbit was highest during pre-exercise seated rest (rc=0.76, 95% CI 0.70-0.81) and postexercise seated recovery (rc=0.89, 95% CI 0.86-0.92), followed by the midpoint of exercise (rc=0.63, 95% CI 0.55-0.70) and cool-down (rc=0.68, 95% CI 0.60-0.74). The agreement was lowest during warm-up (rc=0.39, 95% CI 0.27-0.49). Relative error rates ranged from –3.91% to 3.09% and were greatest during warm-up (relative error rate: mean –3.91, SD 11.92%). ConclusionsThe Fitbit overestimated HR during peak exercise intensity, posing risks for overexercising, which may not be safe for breast cancer survivors’ fitness levels. While the Fitbit Inspire HR may be used to estimate exercise HR, precautions are needed when considering participant safety and data interpretation. Trial RegistrationClinicaltrials.gov NCT03980626; https://clinicaltrials.gov/study/NCT03980626?term=NCT03980626&rank=1

IntroductionAerobic exercise has been shown to improve cancer-associated cognitive decline (CACD) in breast cancer survivors (BCS), and recent findings suggest that one mechanism by which exercise may reduce cognitive decline is through alteration of the brain's functional organization. Many cognitive abilities and measures of functional brain organization change with age and disease, typically reflected in cognitive decline and reduced differentiation of brain networks, or “modularity.” Although previous research has identified associations between lifestyle interventions, such as exercise, and increased modularity, no studies have examined these relationships in cancer populations. The primary aim of this study was to investigate the preliminary effects of a 12-week aerobic exercise program on changes in brain network modularity in BCS. As a secondary aim, we explored correlations between changes in modularity with moderate-to-vigorous physical activity (MVPA) and cognitive function. Data were exploratory and used for hypothesis generation for a future, larger study.MethodsParticipants included a subsample of 10 BCS (M age = 65.9 ± 9.3 years) from a larger pilot study (N = 30 BCS) who were randomized to a 12-week aerobic exercise program (AE) or usual care (UC). The present study collected brain magnetic resonance imaging, Actigraph accelerometry, and cognitive task performance at baseline and 3-month follow-up (i.e., post-intervention; n = 4 AE, n = 6 UC). Intervention effects on modularity, MVPA, and cognition were quantified as magnitude of change between groups (Cohen's d). Changes in modularity were further explored via paired t-tests within groups. Associations between changes in modularity, MVPA, and cognitive performance were explored using Spearman's correlations.ResultsThe magnitude of changes in modularity between groups were small-to-moderate and favored the AE group (d = 0.23 to d = 0.67 across thresholds). Paired t-tests revealed a significant increase in modularity in the AE group from baseline to 3-month follow-up (t = 3.08, p = 0.03, d = 1.17), but not in the UC group. The correlation between changes in MVPA and changes in modularity were not statistically significant (r = 0.36, p = 0.39), and correlations between modularity and cognitive performance yielded mixed effects by cognitive domain.DiscussionFindings suggest that aerobic exercise may influence functional brain network organization and cognition in BCS. These data warrant further investigation in larger exercise trials.

Objective: Colorectal cancer (CRC) survivors report significant long-term physical and cognitive declines post-treatment. Our purpose was to combine task-evoked Event-Related Potential (ERP) and resting state func-tional magnetic resonance imaging (rsf/MRI) methodologies to characterize the physiological underpinnings and cognitive sequelae of chemotherapy-related cognitive impairment, including changes in Quality-Of-Life (QOL) in patients with CRC, as compared to healthy control (HC) participants.Methods: This descriptive study recruited and obtained baseline data from patients with CRC at medical and surgical oncology visits four to six weeks post-op and followed them at 12-and 24-weeks. Procedures employed ERP, pencil and paper neuropsychological testing (N-P), structural/functional rsf/MRI, and self-report QOL methodologies. Data analyses included correlations, one-way ANOVA, Chi-square tests, and linear mixed models.Results: Study participants (n = 40) across groups (n = 15, 11, 14) were balanced on age, sex, education, and race, but not marital status Several significant associations were found between changes in Dorsal Attention Network (DAN)-related ERP measures (P2, N2, N2P2, N2pc amplitudes), with QOL measures between baseline and last visits (p < 0.05-0.001). Additionally, rsf/MRI findings showed increased network activity in a single node of the DAN post-treatment, which was associated with poorer performance on N-P tests of attention and working memory, as well as a focal decline in grey matter volume in the area.Conclusions: Our methodology revealed structural and functional changes within the DAN associated with altered spatial attention, working memory, and ability to inhibit. These disruptions may be responsible for decreased QOL ratings in patients with CRC. This study provides a putative mechanism of understanding how altered brain structural/functional relationships impact cognition, QOL, and nursing care in patients with CRC. NCI Trial ID: NCI-2020-05952, University of Nebraska Medical Center, Clinical Trials.gov ID NCT03683004.

Urinary incontinence (UI) is experienced by approximately 60% of women in the United States and has a negative impact on self-esteem, sexual function, social participation, and quality of life. Rural women, who are underrepresented in the UI literature, face many health disparities and unique barriers to accessing care. The purpose of this qualitative descriptive study was to explore UI self-management behaviors in rural women with UI, including the contextual factors that influence their approach to self-management. This study recruited rural women, ages 30-60 years, using purposive sampling via social media. Demographic information was collected. A semi-structured interview guide was used to conduct individual, in-depth interviews via Zoom. Interview data were analyzed using qualitative description. Sections of interview text were coded using a priori and emergent codes, grouped into categories, and distilled into themes. A total of 31 participants (mean age = 47.2 years) met inclusion/exclusion criteria, enrolled, and completed the study. Qualitative analysis revealed rural as a cross-cutting theme and five major themes: self-management behaviors, familial influence, medical encounters, talking about UI, and resource scarcity. Participants described the rural environment as having a substantial impact on their approach to UI self-management. Specifically, rural social enmeshment made seeking care for UI in rural communities challenging. Findings shed light on how the rural environment influences various aspects of UI self-management in midlife women. Diverse perspectives in UI self-management are needed to advance knowledge in this field.

In 2021, the NCI issued updated guidance clarifying the mission and organizational structure for Community Outreach and Engagement (COE) for Cancer Center Support Grants. These guidelines outlined how cancer centers should address the cancer burden of the catchment area (CA) and define how COE would partner with the community to inform cancer research and implement programs to reduce the cancer burden. In this paper, the Common Elements Committee of the Population Science Working Group in the Big Ten Cancer Research Consortium describes their respective approaches to implementing these guidelines. We discuss our definitions and rationales for each CA, data sources used, and our approach to assessing the impact of COE efforts on the burden of cancer in our respective CA. Importantly, we describe methods of translating unmet CA needs into our cancer-relevant outreach activities, and cancer research addressing the needs of respective CAs. Implementing these new guidelines is a challenge, and we hope that sharing approaches and experiences will foster cross-center collaborations that may more effectively reduce the burden of cancer in the US and meet the mission of the NCI's Cancer Center Program.

PURPOSE Risk-reducing surgery for cancer prevention in solid tumors is a pressing clinical topic because of the increasing availability of germline genetic testing. We examined the short- and long-term outcomes of risk-reducing total gastrectomy (RRTG) and its lesser-known impacts on health-related quality of life (QOL) in individuals with hereditary diffuse gastric cancer syndrome. METHODS Individuals who underwent RRTG as part of a single-institution natural history study of hereditary gastric cancers were examined. Clinicopathologic details, acute and chronic operative morbidity, and health-related QOL were assessed. Validated questionnaires were used to determine QOL scores and psycho-social-spiritual measures of healing. RESULTS One hundred twenty-six individuals underwent RRTG because of a pathogenic or likely pathogenic germline CDH1 variant between October 2017 and December 2021. Most patients (87.3%; 110/126) had pT1aN0 gastric carcinoma with signet ring cell features on final pathology. Acute (<30 days) postoperative major morbidity was low (5.6%; 7/126) and nearly all patients (98.4%) lost weight after total gastrectomy. At 2 years after gastrectomy, 94% (64/68) of patients exhibited at least one chronic complication (ie, bile reflux, dysphagia, and micronutrient deficiency). Occupation change (23.5%), divorce (3%), and alcohol dependence (1.5%) were life-altering consequences attributed to total gastrectomy by some patients. In patients with a median follow-up of 24 months, QOL scores decreased at 1 month after gastrectomy and returned to baseline by 6-12 months. CONCLUSION RRTG is associated with life-changing adverse events that should be discussed when counseling patients with CDH1 variants about gastric cancer prevention. The risks of cancer-prevention surgery should not only be judged in the context of likelihood of death due to disease if left untreated, but also based on the real consequences of organ removal.

INTRODUCTION:Many older adults with acute myeloid leukemia (AML) do not receive chemotherapy because of physicians' and patients' concern for toxicities and functional decline. This highlights the critical and urgent need to generate knowledge of functional changes following new treatments. MATERIALS AND METHODS:As a part of a pragmatic single-center trial, 59 older adults ≥60 years with AML completed geriatric assessment and health-related quality of life measures before treatment and at one month and three months after chemotherapy initiation. Changes in scores of various geriatric assessment measures were computed by subtracting the baseline score from the one-month and three-month scores for each patient. Established cut-offs were used to determine a clinically meaningful change (improvement or worsening). This study provides results of descriptive exploratory analyses. RESULTS:Patients experienced significant comorbidity burden and a high prevalence of functional impairments before treatment, with 56% of patients having ≥2 comorbid conditions, 69% having abnormal cognitive function (using Montreal Cognitive Assessment), 69% having impaired objective physical function (using Short Physical Performance Battery), and 64% having a positive depression screen (Patient Health Questionnaire-9). Patients (n = 53) received treatment with predominantly low-intensity chemotherapy; six patients received intensive chemotherapy. Among those who completed some or all of the three-month evaluation (N = 43), from baseline before treatment to three months later, cognitive function improved (38.7%) or remained stable (38.7%), objective physical function improved (51.6%) or remained stable (22.6%), and depression scores improved (9.4%) or remained stable (53.1%). Global health status score and role functioning moderately improved by a score of >16. DISCUSSION:An exploratory analysis of our phase 2 trial demonstrated improvement or stabilization of cognitive and physical function and depression score at three months in a high proportion of older survivors of AML, despite a high prevalence of frailty and significant comorbidity burden at baseline. These results demonstrate success of treatment in improving cognitive and physical function and depression score, and, if confirmed in larger studies, should encourage oncologists to offer chemotherapy to older adults with AML. CLINICAL TRIAL REGISTRATION:The study is registered in the ClinicalTrials.gov ID: NCT03226418.

The current study aimed to describe formal caregiver burden of nursing assistants in nursing homes. A descriptive, cross-sectional, convergent mixed methods approach identified attributes of formal caregiver burden using phenomenological interviews and established self-report measures. Themes included nursing assistants' experiences of stress, close relationships, extensive assistance of residents, balancing needs and routines, and feeling accomplished. Self-report measures demonstrated moderate stress, moderate caring behaviors, responsibility, and competence. MDS 3.0 results showed moderate cognitive impairment, minimal depressive symptoms, and decreased functional status of residents. The mixed methods synthesis confirmed the presence of five attributes of formal caregiver burden: perceived stress, caring for another, dependency of the older adult, responsibility, and competence. Burnout was not confirmed. Future investigation of attributes among a larger, diverse sample of nursing assistants, residents, and nursing homes will advance knowledge and inform research design and methods of interventions.

BACKGROUND:Evidence indicates continuous positive airway pressure (CPAP) therapy improves several important patient-centered outcomes. However, adherence to this safe and effective intervention remains poor.OBJECTIVES:Assess nine feasibility outcomes of a nurse practitioner-led, virtually delivered motivational enhancement and device support (MENDS) intervention to improve CPAP adherence in adults with Obstructive Sleep Apnea (OSA). Secondary aims compared the changes in CPAP adherence to patient-reported outcomes, patient activation, and perceived self-efficacy.METHODS:This two-group feasibility randomized controlled trial included 29 patients newly diagnosed with OSA and prescribed CPAP therapy. The study was conducted from July 2020 through December 2021 at a midwestern sleep/pulmonary clinic. Participants were randomized to the MENDS intervention group (n=14) (30-45 minute interactive tele-discussions on weeks 2, 4, 6, and 8) or to the usual care (n=15) group. Feasibility, patient-reported outcomes, and behavioral constructs were measured at baseline and 12 weeks. CPAP adherence was measured weekly.RESULTS:Feasibility of the MENDS sessions was demonstrated (56 sessions offered, 52 completed remotely without technical difficulties) with minimal participant attrition and no missing CPAP data. Generalized linear mixed models showed no statistically significant time-by-group interactions on adherence or patient-reported outcomes. Higher adherence and lower CPAP apnea-hypopnea index (AHI) scores were associated with declines in pre- to post-changes in fatigue and sleep disturbance. Lower CPAP AHI scores were associated with pre- to post-decreases in PROMIS Anxiety scores (r=.532, p=.005).CONCLUSION:The virtual MENDS intervention was feasible. Higher CPAP adherence and lower AHI levels led to positive improvements in fatigue, sleep disturbance, and anxiety.

Introduction: Geriatric assessment can predict the risk of toxicities of chemotherapy in older adults. Genetic risk categories correlate with survival following intensive chemotherapy in AML. Integrating geriatric assessment for patient profiling and genetic profiling of leukemic cells represents an innovative precision medicine approach to personalize therapy selection in older adults with AML. We report results of a pre-planned interim analysis of a pragmatic phase II trial using such strategy that has an overarching goal to reduce early mortality (NCT03226418). Methods: Patients ≥60 years with a new diagnosis of AML underwent geriatric assessment prior to initiation of treatment. Geriatric assessment of physical function, cognitive function and comorbidity burden were used to determine fitness for intensive chemotherapy (Table 1). Additional assessment included Karnofsky Performance Scale (KPS), Patient Health Questionnaire-9 (PHQ-9), and Mini Nutritional Assessment-Short Form (MNA). Genetic profiling for therapy selection relied on karyotyping and followed the 2017 European LeukemiaNet criteria. While available mutation test results were incorporated to risk stratify, the study did not require to wait for the results prior to therapy initiation given an anticipated turnaround time of 1-2 weeks for mutation test results. Therapy selection followed the algorithm demonstrated in Figure 1. Patients with good or intermediate-risk AML received intensive chemotherapy such as 7+3 +/- gemtuzumab or midostaurin if determined to be fit. Patients with high-risk AML received low-intensity chemotherapy such as a hypomethylating agent with or without novel drugs, or CPX 351 if they were fit and met the FDA-approved indications. Patients with organ dysfunction (e.g. creatinine ≥2 mg/dl) and those requiring chemotherapy for other malignancy received low-intensity chemotherapy. Chemotherapy at diagnosis or follow up could be administered in community oncology settings. Patients were followed for assessment of quality of life, functional and oncologic outcomes. Results: Between July 2017-June 2019, a total of 31 patients (including 1 MDS patient considered screen failure) were enrolled. The pre-planned interim analysis results are based on the first 27 AML patients. Baseline characteristics included a median age of 70 years (range 60-84 years), 56% female, 96% white, and a median KPS of 80% (range 60-100%). As presented in Table 1, over half of the patients had ≥3 comorbidities, impairment in objective physical function (short physical performance battery) and Montreal Cognitive Assessment. Additionally, 67% had poor nutritional status (MNA score of ≤11) and 26% had abnormal depression screen (PHQ-9 score of ≥10). Risk categories included adverse (64%), intermediate (16%), and good-risk AML (20%). Patients had one or more of the following mutations: FLT3 ITD (11%), NPM1 (22%), biallelic CEBPA (4%), IDH1 (15%), IDH2 (8%), RUNX1 (15%), ASXL1 (22%), and TP53 (19%). Three patients received intensive chemotherapy; CPX 351 (n=2) or 7+3+ gemtuzumab (n=1). Other patients received decitabine or azacitidine alone (n=16), azacitidine and venetoclax (n=5) or decitabine and midostaurin (n=3). The median time from diagnosis to therapy initiation was 7 days (0-20 days) whereas the median time from enrollment to therapy initiation was 2 days (range 0-9). Mortality at 30 days from diagnosis was 3.7% (95% confidence interval, CI 0.7-18.3%) and at 90 days was 29.6% (95% CI 15.9-48.5%). Mortality compared favorably to an unmatched historical cohort of patients ≥60 years treated at our center between 2011-2016, where 30-day mortality was 30% (95% CI 22-40%) and 90-day was 41% (95% CI 32-52%) (Future Oncol. 2019;15:1989-95). Conclusions: Our model to personalize AML therapy selection represents an innovative approach to precision medicine that incorporates both geriatric assessment for patient profiling and genetic profiling of leukemia cells. Geriatric assessment demonstrated high frequency of impairment in objective physical and cognitive function. Patients were able to start therapy within a median of 2 days following enrollment. Pragmatic aspects of the trial included broad eligibility criteria and co-management of patients with community oncologists. Our pre-planned interim analysis data appear promising with lower rates of early mortality compared to unmatched historical controls. Disclosures Bhatt: Pfizer: Consultancy; CSL Behring: Consultancy; Agios: Consultancy; Abbvie: Consultancy; Partner therapeutics: Consultancy; Incyte: Consultancy, Research Funding; Tolero Pharmaceuticals: Research Funding; National Marrow Donor Program: Consultancy. Al-Kadhimi:Celldex Biotech: Other: Stocks; Seattle Genetics: Other: Stocks. Armitage:Oncology Analytics: Consultancy; Partner Therapeutics: Consultancy; Samus Therapeutics: Consultancy; Ascentage: Consultancy; Tesaro bio: Membership on an entity's Board of Directors or advisory committees; Union Pacific: Consultancy. Holstein:GSK: Consultancy; Genentech: Membership on an entity's Board of Directors or advisory committees; Sorrento: Consultancy; Celgene: Consultancy; Takeda: Membership on an entity's Board of Directors or advisory committees; Adaptive Biotechnologies: Membership on an entity's Board of Directors or advisory committees. Gundabolu:Samus Therapeutics: Research Funding; Jazz pharmaceuticals: Consultancy; Pfizer: Consultancy; Novartis: Consultancy. OffLabel Disclosure: Single agent azacitidine and decitabine as well as decitabine in combination with midostaurin are not approved by the US FDA for acute myeloid leukemia.