Geriatric assessment-guided interventions for older adults with multiple myeloma: A feasibility and acceptability study.

INTRODUCTION: Geriatric assessment (GA)-guided supportive care programs have been successful in improving treatment outcomes for older adults with solid-organ cancers. This study aimed to evaluate the feasibility of a GA-guided supportive care program among older adults treated for multiple myeloma (MM). MATERIALS AND METHODS: The study utilized an existing registry of adults with plasma cell disorders at the University of North Carolina. Patients with MM, aged 60 or older, and having a GA-identified deficit in one or more problem area were offered referrals to supportive care resources during routine visits. Problem areas included physical function deficits, polypharmacy, and anxiety or depression. Patients with physical function deficits were offered referral to physical therapy (PT), those with polypharmacy to an Oncology Clinical Pharmacist Practitioner (CPP), and those with mental health symptoms to the Comprehensive Cancer Support Program (CCSP). RESULTS: Of the 58 individuals identified as having at least one deficit on the GA, PT was the most commonly identified relevant resource (79%), followed by CPP visits (57%). Among individuals that were offered referral(s) to at least one new supportive care resource, the acceptance rate was 50%. Referral acceptance rates were highest among those recommended for a CPP visit (55% of those approached) and lowest for CCSP (0%). DISCUSSION: The study examined the feasibility and acceptability of a referral program for supportive care resources among older adults with MM who have deficits on GA. The most commonly identified deficit was physical functioning, followed by polypharmacy and mental health. The study found that physical interventions and referrals to CPPs were the most accepted interventions. However, the low proportion of patients who accepted physical therapy referrals indicates the need for tailored and more personalized approaches. Further research is needed to explore the feasibility and impact of supportive care referral programs for older adults with MM.

Dose Intensity in Real-World Patients With Metastatic Renal Cell Carcinoma Taking Vascular Endothelial Growth Factor Receptor Tyrosine Kinase Inhibitors.

BACKGROUND: Tyrosine kinase inhibitors (TKIs) that target the vascular endothelial growth factor receptor (VEGFR) are oral therapies used to treat metastatic renal cell carcinoma (mRCC). VEGFR TKI treatment is often complicated by dose-limiting adverse events (AE). We sought to describe dose intensity and clinical outcomes in a real-world cohort of patients treated with VEGFR TKIs to better characterize dosing patterns and toxicity management compared with previously reported clinical trials. MATERIALS AND METHODS: We conducted a retrospective chart review of sequential patients with mRCC treated with VEGFR TKIs at 1 academic medical center from 2014 to 2021. RESULTS: 139 patients (75% male, 75% white, median age 63 years) were treated with 185 VEGFR TKIs in our real-world cohort. Per International Metastatic RCC Database Consortium criteria, 24% had good risk, 54% intermediate risk, and 22% poor risk mRCC. With their first VEGFR TKI, median relative dose intensity (RDI) was 79%. 52% of patients required a dose reduction, 11% discontinued treatment due to AEs, 15% visited the ED, and 13% were hospitalized for treatment-related adverse events. Cabozantinib had the highest rate of dose reductions (72%) but a low rate of discontinuation (7%). Real-world patients consistently had lower RDI than reported clinical trials with more frequent dose reductions, fewer drug discontinuations, shorter progression-free survival, and shorter overall survival. CONCLUSION: Real-world patients were less able to tolerate VEGFR TKIs compared to patients treated on clinical trials. Low real-world RDI, high dose reductions, and low overall discontinuation rates can inform patient counseling prior to treatment initiation and during therapy.

A randomized double-blind placebo-controlled trial of intravenous thiamine for prevention of delirium following allogeneic hematopoietic stem cell transplantation.

OBJECTIVE: To determine if high dose intravenous (IV) thiamine can prevent delirium during hospitalization following allogeneic HSCT. Secondarily, we evaluated the effects of high dose IV thiamine on thiamine levels and explored risk factors for delirium. METHODS: Randomized, double-blind, placebo-controlled trial in patients undergoing allogeneic HSCT at a U.S. academic medical center between October 2017 and March 2020. 64 participants were randomized 1:1 to thiamine 200 mg IV three times daily for 7 days or placebo. We used the Delirium Rating Scale to assess for delirium. Delirium incidence was compared between groups using the chi-square test. Group differences in time to onset and duration of delirium were compared using the Kaplan-Meier method. Fisher's Exact and Wilcoxon Rank Sum tests were used to examine associations between pre-transplantation variables and delirium. RESULTS: 61 participants were analyzed. Delirium incidence (25% vs. 21%, Chi-square (df = 1) = 0.12, p = 0.73), time to onset, duration, and severity were not different between study arms. Immediately following the intervention, thiamine levels were higher in the thiamine arm (275 vs. 73 nmol/L, t-test (df = 57) = 13.63, p < 0.0001), but not predictive of delirium. Variables associated with delirium in our sample included disease severity, corticosteroid exposure, infection, and pre-transplantation markers of nutrition. CONCLUSION: High dose IV thiamine did not prevent delirium in patients receiving allogeneic HSCT. Given the multiple contributors to delirium in this population, further research regarding the efficacy of multicomponent interventions may be needed. TRIAL REGISTRATION: Clinical Trials NCT03263442. FUNDING: Rising Tide Foundation for Clinical Cancer Research.

Feasibility and delivery of patient-reported outcomes in clinical practice among racially diverse bladder and prostate cancer patients.

OBJECTIVE: To assess the feasibility of enrollment and collecting patient-reported outcome (PRO) data as part of routine clinical urologic care for bladder and prostate cancer patients and examine overall patterns and racial variations in PRO use and symptom reports over time. SUBJECTS/PATIENTS AND METHODS: We recruited 76 patients (n = 29 Black and n = 47 White) with prostate or bladder cancer at a single, comprehensive cancer center. The majority of prostate cancer patients had intermediate risk (57%) disease and underwent either radiation or prostatectomy. Over half (58%) of bladder cancer patients had muscle invasive disease and underwent cystectomy. Patients were asked to complete PRO symptom surveys using their preferred mode [web- or phone-based interactive voice response (IVR)]. Symptom summary reports were shared with providers during visits. Surveys were completed at 3 time points and assessed urinary, sexual, gastrointestinal, anxiety/depression, and sleep symptoms. Feasibility of enrollment and survey completion were calculated, and linear mixed effects models estimated differences in outcomes by race and time. RESULTS: Sixty three percent of study participants completed all PRO measures at all 3 time points. Black patients were more likely to select IVR as their survey mode (40% vs. 13%, P < 0.05), and less likely to complete all surveys (55% vs. 74%, P = 0.13). Patients using IVR were also less likely to complete all surveys (41% vs. 69%, P = 0.046). CONCLUSIONS: Reported preferences for survey mode and completion rates differ by race, which may influence survey completion rates and highlight potential obstacles for equitable implementation of PROs into clinical care.

Design of a randomized placebo controlled trial of high dose intravenous thiamine for the prevention of delirium in allogeneic hematopoietic stem cell transplantation.

BACKGROUND: Delirium is a highly prevalent and preventable neuropsychiatric condition with major health consequences. Thiamine deficiency is a well-established cause of delirium in those with chronic, severe alcoholism, but there remains an underappreciation of its significance in non-alcoholic populations, including patients with cancer. Treatment of suspected thiamine-related mental status changes with high dose intravenous (IV) thiamine has preliminary evidence for improving a variety of cognitive symptoms in oncology inpatient settings but has never been studied for the prevention of delirium in any population. OBJECTIVES: The primary objective of this clinical trial is to determine if high dose IV thiamine can prevent delirium in patients receiving allogeneic hematopoietic stem cell transplantation (HSCT) for treatment of cancer. Secondary objectives are to determine if thiamine status is predictive of delirium onset and if high dose IV thiamine can attenuate the deleterious impact of delirium on health-related quality of life (HRQOL), functional status, and long-term neuropsychiatric outcomes. METHODS: In this phase II study, we are recruiting 60 patients undergoing allogeneic HSCT, randomizing them to treatment with high dose IV thiamine (n = 30) versus placebo (n = 30), and systematically evaluating all participants for delirium and related comorbidities. We use the Delirium Rating Scale to measure the severity and duration of delirium during hospitalization for HSCT. We obtain thiamine levels weekly during the transplantation hospitalization. We assess HRQOL, functional status, depression, post-traumatic stress symptoms, and cognitive function prior to and at one, three, and six months after transplantation.

Older Adults with Cancer: A Randomized Controlled Trial of Occupational and Physical Therapy.

OBJECTIVES: The impact of occupational therapy (OT) and physical therapy (PT) on functional outcomes in older adults with cancer is unknown. DESIGN: Two-arm single-institution randomized controlled trial of outpatient OT/PT. SETTING: Comprehensive cancer center with two off-site OT/PT clinics. PARTICIPANTS: We recruited adults 65 years and older with a recent diagnosis or recurrence of cancer within 5 years, with at least one functional limitation as identified by a geriatric assessment. Participants were randomized to OT/PT or usual care. INTERVENTION: Rehabilitation consisted of individualized OT and PT that addressed functional activities and strength/endurance needs. MEASUREMENTS: Primary outcome was functional status as measured by the Nottingham Extended Activities of Daily Living scale. Secondary outcomes were Patient-Reported Outcomes Measurement Information System-Global Mental Health (GMH) and Global Physical Health (GPH), ability to participate in Social Roles (SR), physical function, and activity expectations and self-efficacy (Possibilities for Activity Scale [PActS]). RESULTS: Among those recruited (N = 63), only 45 patients (71%) were evaluable due to loss of follow-up and/or nonreceipt of intervention. The median age was 74 years; 53% were female, and 91% were white. Overall, 30% patients had hematologic malignancies, 30% breast cancer, and 16% colorectal cancers. A total of 65% were in active treatment; 49% had stage 3 or 4 disease. At follow-up, both OT/PT (P = .02) and usual care (P = .03) groups experienced a decline in functional status. PActS scores between groups (P = .04) was significantly improved in the intervention group. GMH and SR met criteria for minimally important clinical difference favoring the intervention, but not statistical significance. Several barriers were noted in the implementation of the intervention program: recruitment, concerns about cost, distance, scheduling, and limited treatment provided. CONCLUSION: OT/PT may positively influence activity expectations and self-efficacy. Future research needs to address significant barriers to implementation to increase use of OT/PT services and access to quality care. J Am Geriatr Soc 67:953-960, 2019.

The Effects of Exercise on Patient-Reported Outcomes and Performance-Based Physical Function in Adults With Acute Leukemia Undergoing Induction Therapy: Exercise and Quality of Life in Acute Leukemia (EQUAL).

INTRODUCTION: Fatigue is a distressing symptom for adults with acute leukemia, often impeding their ability to exercise. OBJECTIVES: 1) Examine effects of a 4-week mixed-modality supervised exercise program (4 times a week, twice a day) on fatigue in adults with acute leukemia undergoing induction chemotherapy. 2) Evaluate effects of exercise program on cognition, anxiety, depression, and sleep disturbance. 3) Evaluate effect of intervention on adherence to exercise. METHODS: 17 adults (8 intervention, 9 control), aged 28-69 years, newly diagnosed with acute leukemia were recruited within 4 days of admission for induction treatment. Patient-reported outcomes (PROs) (fatigue, cognition, anxiety, depression, sleep disturbance, mental health, and physical health) and fitness performance-based measures (Timed Up and Go [TUG], Karnofsky Performance Status, and composite strength scoring) were assessed at baseline and at discharge. Changes in PRO and performance-based physical function measures from baseline to time of discharge were compared between groups using Wilcoxon Rank Sum tests. RESULTS: With PROMIS (Patient-Reported Outcomes Measurement Information System) Fatigue, we found a median change in fatigue (-5.95) for the intervention group, which achieved a minimally important difference that is considered clinically relevant. Intervention group reduced their TUG performance by 1.73 seconds, whereas the control group remained fairly stable. A concerning finding was that cognition decreased for both groups during their hospitalization. 80% adherence of visits completed with a mean of 6 sessions attended per week. CONCLUSIONS: Our study provides information on the impact of exercise on symptomatology, with focus on fatigue and other psychosocial variables in acute leukemia.

Workforce Characteristics in Urology.

INTRODUCTION: In this study we holistically describe and characterize the current state of urology practice by evaluating compensation, workload and practice factors as they relate to our demographic makeup as a specialty. METHODS: We collaborated with the American Urological Association to query its domestic membership of practicing urologists regarding socioeconomic, workforce and quality of life issues. The survey consisted of 26 questions and took approximately 13 minutes to complete. A total of 733 responders had complete data for the factors statistically analyzed in the study. RESULTS: Mean yearly compensation for urologists surveyed was $404,755 and median compensation was $380,000 (IQR $300,000-480,000). Female respondents had a significantly lower median yearly compensation vs males ($318,422 vs $400,000) on univariate and multivariate analysis. Respondents reported a median of 60 work hours per week (IQR 50-60) and the median number of call days per month was 7 (IQR 5-10). Of the respondents 62% indicated that they use advanced practice providers in their practice. In addition, 30% reported employed status, 49% reported self-employed status and 21% reported academic status. Overall 20% of respondents plan to retire within 5 years and 40% within 10 years. CONCLUSIONS: Higher income was associated with greater job satisfaction and hourly wage appeared to decrease at increased work hours per week. Several workplace and demographic factors drive compensation, number of hours worked per week, number of call days per month and job satisfaction.

Neoadjuvant Systemic Therapy Use for Younger Patients with Breast Cancer Treated in Different Types of Cancer Centers Across the United States.

BACKGROUND: Multiple clinical trials have shown that neoadjuvant systemic therapy has a benefit in women who are borderline lumpectomy candidates and in those with locally advanced breast cancers by reducing the mastectomy rate and making inoperable tumors operable. The study aim was to examine the patterns of neoadjuvant chemotherapy and endocrine therapy use among younger women in the United States treated at different types of cancer centers. STUDY DESIGN: Data from the National Cancer Data Base for 118,086 women younger than 65 years with clinical stage IIA (T2N0 only) to IIIC breast cancer. Following the National Comprehensive Cancer Network guideline categorization, patients were grouped into those who were borderline lumpectomy candidates (clinical stage IIA [T2N0 only], IIB, or IIIA [T3N1 only]) or those with locally advanced disease (clinical stage IIIA [T0-3N2 only], IIIB, or IIIC). The main outcome was the proportion of women who received neoadjuvant systemic therapy. RESULTS: Use of neoadjuvant chemotherapy ranged from 17% (stage IIA) to 79% (stage IIIB). Across almost all stage and receptor subtypes, the use was lower in community vs academic centers. On multivariable analysis, use of neoadjuvant chemotherapy was decreased in community vs academic centers (borderline lumpectomy candidates: adjusted risk ratio = 0.73; 95% CI, 0.69-0.77; locally advanced disease: adjusted risk ratio = 0.78; 95% CI, 0.74-0.83). CONCLUSIONS: Use of guideline-concordant neoadjuvant chemotherapy is significantly higher among women treated at academic vs community centers in young and healthy women who do not commonly have contraindications to this treatment. Our study identified a potential disparity in cancer care by type of center where patients receive treatment.

Impact of Acute Intermittent Exercise on Natural Killer Cells in Breast Cancer Survivors.

BACKGROUND: Current research examining the effect of exercise on immune responses in cancer survivors is limited. OBJECTIVE: The aim of this pilot study was to examine the effect of 1 bout of intermittent exercise on natural killer (NK) cell numbers in breast cancer survivors. METHODS: A total of 9 women with stage I to III invasive breast cancer who were 3 to 6 months posttreatment and 9 sedentary women without a history of cancer completed 10 three-minute intervals of aerobic exercise on the cycle ergometer at 60% of VO2peak (peak oxygen uptake). Whole blood samples were taken pre-exercise, immediately postexercise, and at 2 hours and 24 hours postexercise. NK cell counts were assessed using flow cytometry. RESULTS: In both groups, NK cell counts significantly increased immediately postexercise compared with pre-exercise (P = .004-.008) and returned to near pre-exercise levels during recovery (P = .129-.547). Absolute NK cell counts were significantly lower in breast cancer survivors immediately postexercise when compared with controls (P = .046). CONCLUSIONS: The breast cancer survivor group exhibited NK cell responses to 30 minutes of moderate-intensity intermittent aerobic exercise that were comparable with that in the group of physically similar women without a history of cancer. Immune changes related to cancer treatments may be related to the lower absolute NK cell counts observed in the breast cancer survivor group. Although the results of this study are preliminary in nature, they suggest that this type of exercise does not disrupt this aspect of innate immunity in recent breast cancer survivors, thereby supporting current exercise recommendations for this population.

Improving couples' quality of life through a Web-based prostate cancer education intervention

PURPOSE/OBJECTIVES: To evaluate the feasibility and acceptability of a newly developed web-based, couple-oriented intervention called Prostate Cancer Education and Resources for Couples (PERC). DESIGN: Quantitative, qualitative, mixed-methods approach. SETTING: Oncology outpatient clinics at the University of North Carolina (UNC) Lineberger Comprehensive Cancer Center at UNC­Chapel Hill. SAMPLE: 26 patients with localized prostate cancer (PCa) and their partners. METHODS: Pre- and postpilot quantitative assessments and a postpilot qualitative interview were conducted. MAIN RESEARCH VARIABLES: General and PCa-specific symptoms, quality of life, psychosocial factors, PERC's ease of use, and web activities. FINDINGS: Improvement was shown in some PCa-specific and general symptoms (small effect sizes for patients and small-to-medium effect sizes for partners), overall quality of life, and physical and social domains of quality of life for patients (small effect sizes). Web activity data indicated high PERC use. Qualitative and quantitative analyses indicated that participants found PERC easy to use and understand,as well as engaging, of high quality, and relevant. Overall, participants were satisfied with PERC and reported that PERC improved their knowledge about symptom management and communication as a couple. CONCLUSIONS: PERC was a feasible, acceptable method of reducing the side effects of PCa treatment­related symptoms and improving quality of life. IMPLICATIONS FOR NURSING: PERC has the potential to reduce the negative impacts of symptoms and enhance quality of life for patients with localized PCa and their partners, particularly for those who live in rural areas and have limited access to post-treatment supportive care.

Clinically relevant interaction between warfarin and scuppernongs, a quercetin containing muscadine grape: continued questions surrounding flavonoid-induced warfarin interactions.

We present a case of clinically relevant and probable interaction between warfarin and scuppernongs in a 73-year-old woman where ingestion of scuppernongs, a variety of quercetin-containing muscadine grapes, over a period of 2 months was associated with elevations in the International Normalised Ratio to supratherapeutic levels. While muscadine grapes and specifically scuppernongs are found primarily in Southeastern USA, the flavonoid in questionand quercetin is found worldwide as a dietary supplement.

Performance of coagulation tests in patients on therapeutic doses of rivaroxaban. A cross-sectional pharmacodynamic study based on peak and trough plasma levels.

Knowledge of anticoagulation status during rivaroxaban therapy is desirable in certain clinical situations. It was the study objective to determine coagulation tests most useful for assessing rivaroxaban's anticoagulant effect. Peak and trough blood samples from 29 patients taking rivaroxaban 20 mg daily were collected. Mass spectrometry and various coagulation assays were performed. "On-therapy range" was defined as the rivaroxaban concentrations determined by LC-MS/MS. A "misprediction percentage" was calculated based on how often results of each coagulation assay were in the normal reference range, while the rivaroxaban concentration was in the "on-therapy" range. The on-therapy range was 8.9-660 ng/ml. The misprediction percentages for prothrombin time (PT) and activated partial thromboplastin time (aPTT), using multiple reagents and coagulometers, ranged from 10%-52% and 31%-59%, respectively. PT, aPTT and activated clotting time (ACT) were insensitive to trough rivaroxaban: 59%, 62%, and 80% of samples had a normal result, respectively. Over 95% of PT and ACT values were elevated at peak. Four different rivaroxaban calibrated anti-Xa assays had R² values >0.98, demonstrating strong correlations with rivaroxaban drug levels. In conclusion, PT, aPTT and ACT are often normal in patients on therapeutic doses of rivaroxaban. However, PT and ACT may have clinical utility at higher drug plasma levels. Rivaroxaban calibrated anti-factor Xa assays can accurately identify low and high on-therapy rivaroxaban drug levels and, therefore, have superior utility in all clinical situations where assessment of anticoagulation status may be beneficial.

A pilot study of a home-based motivational exercise program for African American breast cancer survivors: clinical and quality-of-life outcomes.

INTRODUCTION: African American breast cancer survivors engage in less physical activity compared with their Caucasian counterparts. There is a need for exercise intervention research that focuses on improving the overall health and long-term survivorship of African American breast cancer survivors, especially because they often have worse outcomes than Caucasian survivors. Study objectives were to determine whether African American participants increase physical activity and explore whether exercise had a positive impact on fitness and health. METHODS: African American breast cancer survivors, stage 0 to IIIA, within 2 years of completing primary cancer treatments were recruited for a 16-week home-based aerobic and resistance training exercise pilot study. Outcome measures assessed at baseline and postintervention included physical activity questionnaires and accelerometry, cardiopulmonary function (VO2peak) with gas exchange, muscle strength, Selective Functional Movement Assessment, and dual energy X-ray absorptiometry scans for body composition analysis. Assessments for fatigue and quality of life (QOL) were also completed at baseline and postintervention. Motivational interviewing was utilized to determine goals and explore exercise facilitators/barriers. Participants completed weekly exercise logs and received weekly phone calls. Wilcoxon signed rank tests were used to detect significant changes in physical activity and also changes in fitness/health parameters, fatigue, and QOL. Spearman correlation coefficients were used to examine relationships between physical activity and health measures. RESULTS: A total of 17 women enrolled; 13 completed the intervention (76%). Mean age of the participants was 51 years. There was a significant increase in total minutes of weekly physical activity postintervention ( : = 271 minutes, S: = 151; : = .001). Significant improvements were found in cardiopulmonary fitness as measured by VO2peak with a mean increase of 2.03 mL/kg/min ( : = .01). Several strength measures significantly increased and also functional movement ( : = .005). Positive correlations existed between physical activity and several physical measures, with significant relationships between functional movement and some strength measures (eg, left arm extension: RS : = 0.61, : = .002). Total QOL and fatigue scores improved, but neither was significant. CONCLUSIONS: The intervention led to increased physical activity. As a result of increased levels of physical activity, improvements on several fitness/health parameters occurred.

Practice patterns in the perioperative treatment of patients undergoing septorhinoplasty: a survey of facial plastic surgeons.

IMPORTANCE The common practices used in the perioperative care of patients undergoing septorhinoplasty are diverse and controversial. A consensus statement on the preferred clinical pathway in the perioperative treatment of patients undergoing septorhinoplasty has yet to be approached formally. OBJECTIVES To investigate the perioperative treatment of patients undergoing septorhinoplasty and to identify common practice patterns based on the preferences of leading facial plastic surgeons. DESIGN, SETTING, AND PARTICIPANTS We distributed an online survey to members of the American Academy of Facial Plastic and Reconstructive Surgery. Specifically, fellowship directors and academic contact members were anonymously polled and stratified by the number of septorhinoplasties performed annually. MAIN OUTCOME AND MEASURE A cohesive clinical guide to perioperative treatment after rhinoplasty. RESULTS Of the 92 members surveyed, 67 (73%) successfully completed the survey. The distribution of respondents included 43 academicians (64%) and 24 physicians in private practice (36%). Twenty-eight surgeons (42%) performed fewer than 50 rhinoplasties a year and 39 (58%), more than 50, representing 3510 to 4549 septorhinoplasties in total among respondents. Forty-four surgeons (66%) refrained from using any packing, and 41 (61%) used intranasal splints, with polymeric silicone splints the most popular of these (n = 24 [59%]). Sixty-six surgeons (99%) used external nasal splints, including 49 (74%) who used a thermoplastic splint and 49 (74%) who left the external nasal splint in place for 7 days or longer. The most common postoperative interventions to reduce edema and ecchymosis were elevation of the head of bed by 62 (93%), ice packs by 50 (75%), and Arnica montana by 33 (49%). Only 12 surgeons (18%) used postoperative corticosteroids to reduce edema. Fifty-six respondents (84%) prohibited participation in contact sports until at least 6 weeks after surgery. CONCLUSIONS AND RELEVANCE Perioperative care and practices after nasal surgery vary among the most highly trained and leading rhinoplasty surgeons. No published communication or consensus on perioperative practices has been disseminated in this setting. Given the results from those surgeons performing the most rhinoplasties in our field, some surgeons may choose to vary their practices to coincide with those of experienced surgeons. These guidelines could facilitate future studies of patient outcomes.