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A multidisciplinary team-based approach with lifestyle modification and symptom management to address the impact of androgen deprivation therapy in prostate cancer: A randomized phase II study.
Pollock, Y, Zhang, L, Kenfield, SA, Van Blarigan, EL, Rodvelt, T, Rabow, M, Macaire, G, Weinberg, R, Topp, K, Friedlander, T, et al
Urologic oncology. 2021;(10):730.e9-730.e15
Abstract
BACKGROUND Androgen deprivation therapy (ADT) is associated with numerous toxicities that are potentially modifiable. We sought to evaluate the impact of participation in a multidisciplinary clinic, STAND (Supportive Therapy in Androgen Deprivation) Clinic, designed to provide individualized lifestyle modification and management of ADT-related side effects. METHODS This phase II study recruited men with prostate cancer who had started ADT <6 months prior to enrollment, and in whom ADT was planned for at least 12 months following enrollment. Patients were randomized in a 1:1 ratio to either the STAND Clinic or usual care. Patients randomized to the STAND Clinic were provided monthly multidisciplinary assessment and counseling on exercise, nutrition, and symptom management for 12 months on a rotating schedule. Primary outcome was change from baseline to 12 months in percent body fat. Feasibility outcomes were also assessed by measuring percentage of completed visits. Secondary outcomes included change from baseline to 12 months in 3 domains: (1) metabolic impact and bone health, (2) quality of life (QOL), and (3) physical activity. RESULTS A total of 25 men were randomized to STAND clinic, and 23 were randomized to usual care. The study did not meet its accrual target of 32 men in each arm and was closed early due to lack of financial support. Overall, 91% (295 of 325) of STAND clinic visits were completed. Eighteen out of the 25 patients in STAND clinic arm (72%) completed all 12 months of STAND clinic visits, and 80% (20 of 25) completed the first 6 months. For all primary and secondary outcomes, there were no statistically significant differences between treatment arms. CONCLUSION Individualized and comprehensive management of ADT toxicities in a multidisciplinary clinic was well attended by patients. However, we did not find any differences in the outcomes assessed between the intervention arm and control.
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Vision-related quality of life in patients treated for myopic choroidal neovascularization: A post hoc analysis of the OLIMPIC study.
Virgili, G, Parravano, M, Viola, F, Varano, M
European journal of ophthalmology. 2020;(5):1069-1075
Abstract
PURPOSE To investigate vision-related quality of life in patients referred to the Italian Retina Services for intravitreal ranibizumab treatment for choroidal neovascularization due to pathologic myopia. DESIGN Post hoc analysis of a multicenter, interventional phase IIIb study (OLIMPIC). METHODS Patients with either previously untreated (naïve) or treated choroidal neovascularization due to pathologic myopia were enrolled. Vision-related quality of life was measured using the Italian version of the Impact of Vision Impairment Questionnaire with scores from 0 (no impact) to 5 (severe impact). Burden of illness data were collected regarding income, and personal and public resource use. RESULTS In the 200 included subjects, mean best-corrected visual acuity in the better eye was 68.3 Early Treatment Diabetic Retinopathy Study letters (standard deviation: 15.2) compared with 42.5 Early Treatment Diabetic Retinopathy Study letters (standard deviation: 23.3) in the worse eye. The proportion of better eyes affected by choroidal neovascularization was 147/200 (73.5%). In multivariable analyses, lower better eye, but not worse eye, best-corrected visual acuity was associated with lower vision-related quality of life (per 10 fewer letters, beta: + 0.17, p < 0.001). An annual income below 20,000 euros was also associated with lower vision-related quality of life (beta: + 0.38; standard error: 0.13, p = 0.004). Moreover, in univariate analyses, increasing income level was linearly associated with better presenting best-corrected visual acuity in the better eye (p < 0.003), with a difference of 15 Early Treatment Diabetic Retinopathy Study letters for patient income <20,000 euros compared with >70,000 euros. CONCLUSION Italian patients with myopic choroidal neovascularization and a low income presented with lower better-eye best-corrected visual acuity and lower vision-related quality of life compared with those with a higher income. Future research should investigate disease awareness and candidacy issues that may influence the quality of life of patients.
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Incidence of peripheral neuropathy associated with eribulin mesylate versus vinorelbine in patients with metastatic breast cancer: sub-group analysis of a randomized phase III study.
Wu, Y, Wang, Q, Zhang, J, Cao, J, Wang, B, Hu, X
Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer. 2020;(8):3819-3829
Abstract
BACKGROUND Chemotherapy-induced peripheral neuropathy (CIPN) is one of the most significant neurologic complications of chemotherapy, impacting patient's behavior and quality of life. CIPN is mostly sensory, with rare incidences of autonomic dysfunction and other neuropathy. METHODS We conducted a single-center sub-group analysis of patients with metastatic breast cancer enrolled in a phase III study (NCT02225470) set up to compare eribulin mesylate (1.4 mg/m2 on days 1 and 8 every 21 days) with vinorelbine (25 mg/m2 on days 1, 8, and 15 every 21 days). The analysis investigated incidence of peripheral neuropathy, time to onset of neuropathy, and safety. RESULTS Our analysis included 110 women with a mean age of 50.7 (SD = 10.9). The median accumulated dose of eribulin was 11.2 mg/m2 and 125.0 mg/m2 for vinorelbine. Among patients in the eribulin group, a performance status (ECOG PS) of 2 was correlated with peripheral sensory neuropathy (p = 0.015), and accumulated eribulin dose (≥ 10 mg/m2) was associated with all neuropathy and peripheral sensory neuropathy (p = 0.003 and p = 0.007, respectively). In the vinorelbine group, patient age (≥ 65 years) was positively associated with all neuropathy (p = 0.043). The time to onset of neuropathy appeared to be longer for eribulin versus vinorelbine (35.3 vs. 34.6 weeks; p = 0.046), with a significantly higher incidence of autonomic neuropathy at weeks 2 and 10 observed among patients receiving vinorelbine (p = 0.008 and p = 0.043, respectively). CONCLUSION Vinorelbine is associated with a higher incidence of autonomic neuropathy than eribulin in patients with metastatic breast cancer. Furthermore, the onset of neurotoxicity appears to occur earlier with vinorelbine than eribulin.
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Vision-Related Quality of Life in Patients with Diabetic Macular Edema Treated with Intravitreal Aflibercept: The AQUA Study.
Garweg, JG, Stefanickova, J, Hoyng, C, Schmelter, T, Niesen, T, Sowade, O, Sivaprasad, S, ,
Ophthalmology. Retina. 2019;(7):567-575
Abstract
PURPOSE To examine vision-related quality of life in patients with diabetic macular edema (DME) treated with intravitreal aflibercept (EYLEA, Regeneron Pharmaceuticals, Inc, Tarrytown, NY). DESIGN AQUA was a multicenter, open-label, single-arm, phase 4 study. PARTICIPANTS Adults 18 years of age or older with type 1 or 2 diabetes mellitus and DME. METHODS Patients received intravitreal aflibercept 2 mg every 8 weeks for 52 weeks, after 5 initial doses every 4 weeks. MAIN OUTCOME MEASURES The primary outcome was the change in 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) total score from baseline to week 52. Secondary outcomes included the change in NEI VFQ-25 near and distant activities subscale scores, best-corrected visual acuity (BCVA; Early Treatment Diabetic Retinopathy Study [ETDRS] letters), and central retinal thickness (CRT) from baseline to week 52. Change in NEI VFQ-25 score at week 52 for better-seeing eyes (BSEs) and worse-seeing eyes (WSEs) also was evaluated. RESULTS A total of 553 patients comprised the full analysis set, and 560 patients comprised the safety analysis set. At baseline, the mean NEI VFQ-25 total score was 70.12, mean BCVA was 61.5 ETDRS letters, and mean CRT was 464.81 μm. A mean of 8.8 injections were administered over 52 weeks. At week 52, the mean improvement from baseline in the NEI VFQ-25 total score was +6.11 (standard deviation [SD], 11.46); the corresponding improvements in near and distant activities were +11.37 (SD, 18.01) and +7.33 (SD, 17.32), respectively. Similarly, improvements in patients whose BSE and WSE were treated were 7.74 (SD, 13.59) and 5.48 (SD, 9.70), respectively. At week 52, mean change in BCVA was +10.0 ETDRS letters (SD, 8.0 ETDRS letters), and mean change in CRT was -175.38 μm (SD, 132.62 μm). Overall, 53.6% of patients reported treatment-emergent adverse events (TEAEs), of whom 26.8% experienced an ocular TEAE in the study eye. The most common serious ocular TEAE was endophthalmitis (0.5% [n = 3]). Five deaths (0.9%) were reported, but were not considered treatment related. CONCLUSIONS Intravitreal aflibercept was associated with clinically meaningful improvements in NEI VFQ-25 total score over 52 weeks in patients with DME; these were even more pronounced for near than for distant activities. Adverse events were consistent with the known safety profile of intravitreal aflibercept.
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Quality of life in pediatric acute myeloid leukemia: Report from the Children's Oncology Group.
Nagarajan, R, Gerbing, R, Alonzo, T, Johnston, DL, Aplenc, R, Kolb, EA, Meshinchi, S, Barakat, LP, Sung, L
Cancer medicine. 2019;(9):4454-4464
Abstract
INTRODUCTION Objectives were used to describe guardian proxy-report and child self-report quality of life (QoL) during chemotherapy for pediatric acute myeloid leukemia (AML) patients. METHODS Patients enrolled on the phase 3 AML trial AAML1031 who were 2-18 years of age with English-speaking guardians were eligible. Instruments used were the PedsQL Generic Core Scales, Acute Cancer Module, and Multidimensional Fatigue Scale. Assessments were obtained at the beginning of Induction 1 and following completion of cycles 2-4. Potential predictors of QoL included the total number of nonhematological grade 3-4 Common Terminology Criteria for Adverse Event (CTCAE) submissions. RESULTS There were 505 eligible guardians who consented to participate and 348 of their children provided at least one self-report assessment. The number of submitted CTCAE toxicities was significantly associated with worse physical health summary scores (β ± standard error (SE) -3.00 ± 0.69; P < 0.001) and general fatigue (β ± SE -2.50 ± 0.66; P < 0.001). Older age was significantly associated with more fatigue (β ± SE -0.58 ± 0.25; P = 0.022). Gender, white race, Hispanic ethnicity, private insurance status, risk status, bortezomib assignment, and duration of neutropenia were not significantly associated with QoL. DISCUSSION The number of CTCAE toxicities was the primary factor influencing QoL among children with AML. Reducing toxicities should improve QoL; identifying approaches to ameliorate them should be a priority.
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The relationship between intensification of blood glucose-lowering therapies, health status and quality of life in type 2 diabetes: The Fremantle Diabetes Study Phase II.
Davis, TME, Bruce, DG, Curtis, BH, Barraclough, H, Davis, WA
Diabetes research and clinical practice. 2018;:294-302
Abstract
AIMS: To determine whether therapeutic intensification in type 2 diabetes influences health status and quality of life (QoL). METHODS We studied 930 participants in the longitudinal observational Fremantle Diabetes Study Phase II (mean age 65.3 years, 53.8% males, median diabetes duration 8.0 years) with valid data from baseline assessment and two biennial reviews (4 years of follow-up) between 2008 and 2015. The main outcome measures were the Short Form-12 version 2 physical and mental health composite scores (PCS, MCS) and the average weighted impact (AWI) score from the Audit of Diabetes Dependent QoL. RESULTS There were reductions in PCS at Year 4 compared with baseline and Year 2 in patients on stable diet-based management (n = 160), oral glucose-lowering medication (OGLM; n = 387), and insulin with/without OGLM (n = 168; P < 0.05), but no statistically significant temporal changes in MCS/AWI. Insulin-treated patients had the lowest PCS, MCS and AWI compared to the other two subgroups at each time-point (P ≤ 0.012). In participants initiating OGLM (n = 84) or insulin (n = 85), there were no differences in PCS, MCS or AWI at the biennial assessments either side of these therapeutic changes (P ≥ 0.08). CONCLUSIONS These real-life data show that treatment intensification, including insulin initiation, does not impact adversely on patient well-being in community-based type 2 diabetes. Since insulin use at entry was associated with longer diabetes duration, worse glycaemic control, and a greater risk of chronic complications, the burden of disease rather than treatment modality appears the primary determinant of health status and QoL.
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A phase II study of HMB/Arg/Gln against oral mucositis induced by chemoradiotherapy for patients with head and neck cancer.
Yokota, T, Hamauchi, S, Yoshida, Y, Yurikusa, T, Suzuki, M, Yamashita, A, Ogawa, H, Onoe, T, Mori, K, Onitsuka, T
Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer. 2018;(9):3241-3248
Abstract
PURPOSE This phase II trial assessed the clinical benefit of beta-hydroxy-beta-methylbutyrate, arginine, and glutamine (HMB/Arg/Gln) for preventing chemoradiotherapy (CRT)-induced oral mucositis (OM) in patients with head and neck cancer (HNC). METHODS Patients with HNC receiving definitive or postoperative cisplatin-based CRT were enrolled. HMB/Arg/Gln was administered orally or per percutaneous endoscopic gastrostomy from the first day of CRT up to its completion. All patients received opioid-based pain control and oral care programs that we previously reported. The primary endpoint was the incidence of grade ≥ 3 OM (functional/symptomatic) according to the Common Terminology Criteria of Adverse Events version 3.0. Quality of life (EORTC QLQ-C30/PROMS) at baseline and upon radiotherapy at a dosage of 50 Gy were assessed. RESULTS Thirty-five patients with HNC were enrolled. Sixteen of them (45.7%) developed grade ≥ 3 OM (i.e., functional/symptomatic). The incidence of grade ≤ 1 OM (functional/symptomatic) was 51.5% at 2 weeks and 82.9% at 4 weeks after radiotherapy completion. Clinical examination revealed that 10 patients (28.6%) developed grade ≥ 3 OM. The incidence of grade ≤ 1 OM (clinical exam) was 80.0% at 2 weeks and 100% at 4 weeks after radiotherapy completion. Adverse events related to HMB/Arg/Gln were an increase in blood urea nitrogen and diarrhea, but were easily managed. CONCLUSIONS The addition of HMB/Arg/Gln to opioid-based pain control and oral care programs was feasible but still insufficient at reducing the incidence of CRT-induced severe OM. However, the benefit of HMB/Arg/Gln should not be neglected given the findings of clinical examinations and the rapid recovery from severe OM. TRIAL REGISTRATION UMIN000016453.
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Quality of Life and Performance Status From a Substudy Conducted Within a Prospective Phase 3 Randomized Trial of Concurrent Standard Radiation Versus Accelerated Radiation Plus Cisplatin for Locally Advanced Head and Neck Carcinoma: NRG Oncology RTOG 0129.
Xiao, C, Zhang, Q, Nguyen-Tân, PF, List, M, Weber, RS, Ang, KK, Rosenthal, D, Filion, EJ, Kim, H, Silverman, C, et al
International journal of radiation oncology, biology, physics. 2017;(4):667-677
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Abstract
PURPOSE/OBJECTIVE(S): To analyze quality of life (QOL) and performance status (PS) for head and neck cancer (HNC) patients treated on NRG Oncology RTOG 0129 by treatment (secondary outcome) and p16 status, and to examine the association between QOL/PS and survival. METHODS AND MATERIALS Eligible patients were randomized into either an accelerated-fractionation arm or a standard-fractionation arm, and completed the Performance Status Scale for the Head and Neck (PSS-HN), the Head and Neck Radiotherapy Questionnaire (HNRQ), and the Spitzer Quality of Life Index (SQLI) at 8 time points from before treatment to 5 years after treatment. RESULTS The results from the analysis of area under the curve showed that QOL/PS was not significantly different between the 2 arms from baseline to year after treatment (P ranged from .39 to .98). The results from general linear mixed models further supported the nonsignificant treatment effects until 5 years after treatment (P=.95, .90, and .84 for PSS-HN Diet, Eating, and Speech, respectively). Before treatment and after 1 year after treatment, p16-positive oropharyngeal cancer (OPC) patients had better QOL than did p16-negative patients (P ranged from .0283 to <.0001 for all questionnaires). However, QOL/PS decreased more significantly from pretreatment to the last 2 weeks of treatment in the p16-positive group than in the p16-negative group (P ranged from .0002 to <.0001). Pretreatment QOL/PS was a significant independent predictor of overall survival, progression-free survival, and local-regional failure but not of distant metastasis (P ranged from .0063 to <.0001). CONCLUSIONS The results indicated that patients in both arms may have experienced similar QOL/PS. p16-positive patients had better QOL/PS at baseline and after 1 year of follow-up. Patients presenting with better baseline QOL/PS scores had better survival.
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Caregiver-Reported Quality of Life in Youth with Down Syndrome.
Xanthopoulos, MS, Walega, R, Xiao, R, Prasad, D, Pipan, MM, Zemel, BS, Berkowitz, RI, Magge, SN, Kelly, A
The Journal of pediatrics. 2017;:98-104.e1
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Abstract
OBJECTIVES To describe caregiver-reported quality of life (QOL) in youth with Down syndrome (DS) and to examine the role of obesity on QOL. STUDY DESIGN Caregivers of youth with and without DS aged 10 through 20 years completed questionnaires examining QOL (Pediatric Quality of Life Questionnaire) and weight-related QOL (Impact of Weight on Quality of Life - Kids). Age- and sex-specific z scores were generated for body mass index. Obesity was defined as a body mass index ≥95th percentile for age and sex. RESULTS Caregiver-reported Total QOL, Physical Health, and Psychosocial Health summary scores were all lower in the DS group compared with the non-DS controls (P < .001). Social and School Functioning were also lower (P < .001), but Emotional Functioning did not differ between DS and non-DS groups (P = .31). Physical Functioning (P = .003) and Total scores (P = .03) differed between youth without DS with and without obesity, but no differences were reported between youth with DS with and without obesity. On the Impact of Weight on Quality of Life - Kids, caregivers of youth with DS reported greater Body Esteem (P = .020) and Social Life scores (P = .03) than caregivers of non-DS youth. Caregivers of youth with obesity, regardless of DS status, reported significantly lower weight-specific QOL scores than caregivers of youth without obesity. CONCLUSION Caregivers reported lower QOL in youth with DS compared with youth without DS with the exception of emotional functioning. Obesity influences most domains of weight-related QOL in youth with and without DS; therefore, providers should address weight concerns in youth with obesity even in the presence of DS. CLINICAL TRIAL REGISTRATION NCT01821300.
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Effect of a Short-Term Yoga-Based Lifestyle Intervention on Health-Related Quality of Life in Overweight and Obese Subjects.
Yadav, R, Yadav, RK, Pandey, RM, Kochar, KP
Journal of alternative and complementary medicine (New York, N.Y.). 2016;(6):443-9
Abstract
OBJECTIVE To study the effect of a short-term yoga-based lifestyle intervention on health-related quality of life (HRQOL) in overweight and obese persons. DESIGN AND SETTING Nonrandomized, single-arm interventional study conducted from August 2012 to March 2015 at Integral Health Clinic, Department of Physiology, All India Institute of Medical Sciences, New Delhi, India. PARTICIPANTS Overweight (body-mass index [BMI], 23-24.9 kg/m(2)) and obese (BMI, ≥25 kg/m(2)) persons (n = 279) aged 20-60 years. INTERVENTION Pretested yoga-based lifestyle intervention, including asanas (postures), pranayama (breathing exercises), relaxation techniques, lectures, group support, nutrition awareness program, and individualized advice. OUTCOME MEASURES Primary outcome measure was HRQOL, measured by using short version of World Health Organization Quality of Life (WHOQOL-BREF) questionnaire. Secondary outcome measures were anthropometric variables, systolic and diastolic blood pressure, pulse rate, lipid profile, and fasting glucose. A subgroup analysis according to sex was also performed. RESULTS The overall quality of life and health improved after short-term yoga-based lifestyle intervention in overweight and obese persons. Physical, psychological and environmental domain scores significantly increased from baseline to day 10, and efficacy was noted in both male and female subgroups. After 10 days of intervention, the following also decreased significantly: body weight, BMI, total body fat, waist and hip circumference, waist-to-hip ratio, systolic and diastolic blood pressure, total cholesterol, low-density lipoprotein, triglycerides, and fasting glucose. CONCLUSION A short-term yoga-based lifestyle intervention had a positive effect on HRQOL in overweight and obese persons.