Significant Higher Quality Of Life Research Articles

Preliminary Efficacy and Safety of Reishi & Privet Formula on Quality of Life Among Non-Small Cell Lung Cancer Patients Undergoing Chemotherapy: A Randomized Placebo-Controlled Trial.

Background:Cancer patients often experience decreased quality of life during chemotherapy. This study aimed to determine the preliminary efficacy and safety of Reishi & Privet Formula (RPF) for maintaining quality of life among patients with non–small cell lung cancer (NSCLC) undergoing chemotherapy.Methods:We conducted a phase II randomized, double-blind, placebo-controlled clinical trial in China. Adults with NSCLC scheduled to receive chemotherapy were randomly assigned (3:1 ratio) to receive oral RPF (3.36 g/day) or placebo daily for 6 weeks. The main outcome was the Functional Assessment of Cancer Therapy–Lung (FACT-L). We evaluated RPF’s safety profile using the Common Terminology Criteria for Adverse Events and assessed changes in outcome measures from baseline to weeks 3 and 6 using a linear mixed effects model.Results:We enrolled 82 participants across 8 cancer centers in China. The median age was 59 years, 56 (68%) had advanced cancer. Compared with the placebo group, the RPF group had nonstatistically significant higher quality of life as measured by the FACT-L total score (P = .086) over 2 cycles of chemotherapy. The RPF group was associated with a nonsignificant better general health (P = .050) and emotional well-being (P = .090) than the placebo group. Adverse events rates did not differ between groups.Conclusions:This study demonstrated preliminary safety and suggests a promising trend in RPF’s effect on maintaining quality of life and emotional well-being among NSCLC patients undergoing chemotherapy. Future adequately powered randomized-controlled trials are needed to verify the efficacy and safety of RPF in cancer patients undergoing chemotherapy.

Nocturnal temperature-controlled laminar airflow device for adults with severe allergic asthma: the LASER RCT.

Severe asthma exacerbations are costly to patients and the NHS, and occur frequently in severely allergic patients. To ascertain whether or not nocturnal temperature-controlled laminar airflow (TLA) device usage over 12 months can reduce severe exacerbations and improve asthma control and quality of life compared with a placebo device, while being cost-effective and acceptable to adults with severe allergic asthma. A pragmatic, multicentre, randomised, double-blind, placebo-controlled, parallel-group, superiority trial with qualitative interviews. The trial included an internal pilot with qualitative focus groups. Fourteen hospitals in the UK that manage patients with severe asthma. Adults (16-75 years) with severe, poorly controlled, exacerbation-prone asthma despite high-intensity treatment, and who are sensitised to a perennial indoor aeroallergen. Nocturnal, home-based TLA treatment using an Airsonett® (Airsonett AB, Ängelholm, Sweden) device. The comparator was a placebo device that was identical to the active device except that it did not deliver the laminar airflow. Participants were allocated 1 : 1 to TLA therapy or placebo, minimised by site, origin of case, baseline severe exacerbation frequency, maintenance oral corticosteroid use and pre-bronchodilator forced expiratory volume in 1 second. Primary outcome - frequency of severe asthma exacerbations occurring within the 12-month follow-up period, defined as worsening of asthma requiring systemic corticosteroids [≥ 30 mg of prednisolone or equivalent daily (or ≥ 50% increase in dose if on maintenance dose of ≥ 30 mg of prednisolone)] for ≥ 3 days. Secondary outcomes - changes in asthma control, lung function, asthma-specific and global quality of life for participants, adherence to the intervention, device acceptability, health-care resource use and cost-effectiveness. Between May 2014 and January 2016, 489 patients consented to participate in the trial, of whom 249 failed screening and 240 were randomised (n = 119 in the treatment group and n = 121 in the placebo group); all were analysed. In total, 202 participants (84%) reported use of the device for 9-12 months. Qualitative analyses showed high levels of acceptability. The mean [standard deviation (SD)] rate of severe exacerbations did not differ between groups [active 1.39 (1.57), placebo 1.48 (2.03); risk ratio 0.92, 95% CI 0.66 to 1.27; p = 0.616]. There were no significant differences in secondary outcomes for lung function, except for a reduction in mean daily peak expiratory flow [mean (SD) difference 14.7 l/minute (7.35 l/minute), 95% CI 0.32 to 29.1 l/minute; p = 0.045) for those in the active device group. There were no differences in asthma control or airway inflammation and no serious harms related to the device. No significant difference between the groups in quality-adjusted life-years gained over 1 year was observed. In addition, there was no difference in generic or disease-specific health-related quality of life overall, although statistically significant higher quality of life at month 6 was observed. Increases in quality of life were not sufficient to offset the annual costs associated with use of the TLA device. Missing outcome data could have resulted in an underestimation of exacerbations and rendered the study inconclusive. Within the limits of the data, no consistent benefits of the active device were demonstrated, and the differences observed were not sufficient to make the device cost-effective. The types of patients who may benefit from the TLA device, and the reasons for large reductions in exacerbation frequency in severe asthma trials, which also incorporate other methods of recording exacerbations, need to be explored. Current Controlled Trials ISRCTN46346208. This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 29. See the NIHR Journals Library website for further project information.

MP75-05 FAST TRACK STENT STUDY (FAST): SHORT TERM EXTERNAL URETER STENTING SHOWS SIGNIFICANT BENEFIT IN COMPARISON TO ROUTINE DJ STENT PLACEMENT AFTER URETERORENOSCOPIC STONE EXTRACTION – A PROSPECTIVE-RANDOMIZED TRAIL

You have accessJournal of UrologyStone Disease: Surgical Therapy VII1 Apr 2017MP75-05 FAST TRACK STENT STUDY (FAST): SHORT TERM EXTERNAL URETER STENTING SHOWS SIGNIFICANT BENEFIT IN COMPARISON TO ROUTINE DJ STENT PLACEMENT AFTER URETERORENOSCOPIC STONE EXTRACTION – A PROSPECTIVE-RANDOMIZED TRAIL Peter Bach, Alina Reicherz, Lisa Dahlkamp, Nicolas von Landenberg, Rein-Jueri Palisaar, Joachim Noldus, and Christian von Bodman Peter BachPeter Bach More articles by this author , Alina ReicherzAlina Reicherz More articles by this author , Lisa DahlkampLisa Dahlkamp More articles by this author , Nicolas von LandenbergNicolas von Landenberg More articles by this author , Rein-Jueri PalisaarRein-Jueri Palisaar More articles by this author , Joachim NoldusJoachim Noldus More articles by this author , and Christian von BodmanChristian von Bodman More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2017.02.2153AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Does short-term ureter stenting using an external ureter catheter (UC) for 6 hours following ureterorenoscopic stone extraction (URS) provide an equivalent outcome in comparison to postoperative double-J (DJ) ureter stenting? METHODS Between 08/2014 and 08/2015, 141 patients initially treated with a DJ insertion for 7 days were prospectively randomized to UC for 6 hours vs DJ insertion for 3-5 days after stone extraction via URS (incl. flexible URS) in a single academic center. Exclusion criteria were acute urinary tract infection, a solitary kidney or a stone mass more than 25mm. Study endpoints were ureter-stent related symptoms and pain assessed by a validated questionnaire (USSQ) and visual analogue scale (VAS) before and 3-5 weeks after surgery. Parameters of both groups were compared using unpaired t-test. Level of significance was p<0.05. BMI, stone size, age, and need for analgetics, reintervention rate and comorbidities were recorded. RESULTS Endoscopic procedures performed by 9 surgeons resulted in more than 90% stone removal in all cases (n=141) in a mean operation time of 24 minutes (range 5-63 min). Groups did not differ in mean age (48 years), mean BMI (28.1) and stone size (5.4 mm). Patients, who received short-term UC, showed a significant higher quality of life (USSQ) compared to patients with a long-term DJ: In the UC group the urinary index score was significantly lower (16.8 vs. 27.8; p <0.0001) as well as the pain score (9.7 ± 1.3 vs. 20.2 ± 1.5; p<0.0001) and general health index (15.3 ± 0.7 vs. 8.5 ± 0.6; p<0.0001). Consultation of a physician and antibiotic treatment were rarely needed (1.3 ± 0.1 vs. 1.6 ± 0.1; p=0.027). The UC study group returned to work earlier (3.0 ± 0.8 days) compared to the DJ study group (7.0 ± 0.9 days; p<0.0009). Furthermore, most of the UC population (88.3%) recommended treatment and would prefer an UC in case of another stone treatment in the future. Only two patients of the UC study group reported prolonged complaints lasting 2 days. No re-intervention was needed in both groups during the follow-up of 6 weeks. CONCLUSIONS In patients who had a DJ prior to secondary ureteroscopic stone removal postoperative short-term ureteral stenting should be standard of care rather than routine DJ insertion. © 2017FiguresReferencesRelatedDetails Volume 197Issue 4SApril 2017Page: e1005 Advertisement Copyright & Permissions© 2017MetricsAuthor Information Peter Bach More articles by this author Alina Reicherz More articles by this author Lisa Dahlkamp More articles by this author Nicolas von Landenberg More articles by this author Rein-Jueri Palisaar More articles by this author Joachim Noldus More articles by this author Christian von Bodman More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

Abstract P4-13-07: Impact of physical activity/exercise on adverse events and quality of life during treatment with everolimus and exemestane for ER+ women - Results of the 3rd interim analysis of BRAWO

Abstract Introduction BRAWO is a non-interventional study collecting data of 3000 breast cancer patients treated with everolimus and exemestane (advanced or metastatic, hormone-receptor-positive, HER2-negative breast cancer). We introduce results of the 3rd preplanned interim analysis with data cut-off 08/01/ 2015, including 1300 patients. Since physical activity/exercise was reported to influence side effects as well as quality of life (QoL) of various cancer types and therapies, this analysis focuses on the impact of the physical activity/exercise history, development on adverse effects (AE) of the medical treatment and QoL. Methods Patients were asked to complete the EORTC QLQ-C30 QoL questionnaire and visual analogue scales (VAS-KAS) measuring their present-, past ten year- and lifetime physical activity/exercise level. To differentiate between activity/exercise levels, VAS were divided in three equal components (inactive, somewhat active, very active). Questionnaires and information about AE (e. g. stomatitis, fatigue, nausea, diarrhea, etc.) were collected before starting the medical treatment and were repeated each three months. Logistic regression model was used to estimate the impact of baseline physical activity/exercise on AE at any time point of the therapy. ANOVA models were used to calculate the impact of the baseline activity/exercise level on QoL at the last completed data set of each patient. Results Median age of patients was 66 years, median weight was 70 kg, median BMI was 25.9, median time since primary diagnosis was 6.2 years, and 54.4% had visceral metastases at baseline. The median PFS for the first 1300 patients was 7.1 months (95% CI, 6.5-8.0). Patients who reported to be very active (exercise) at the week prior to baseline (4.4%) showed significant lower numbers of AE compared to patients who indicate to be somewhat (14.8%) or inactive (80.8%). In contrast to the exercise level, physical activity in everyday life did not affect the AE incidence. Neither lifetime nor past ten year activity/exercise level is associated with the occurrence of AE. Regarding QoL, very active as well as somewhat active women (measured at baseline for almost each time period) showed significant higher QoL values compared to inactive women during the last assessment before death/progress. Conclusion Exercise prior to medical treatment with Everolimus and Exemestane may impact AE during therapy. Since physical activity did not show such a relation, this analysis highlights the importance of specific guidelines for preventive/rehabilitative exercise programs. More knowledge about dose-response relationships is needed. Furthermore a livelong healthy, "active" lifestyle may increase QoL, even in patients with advanced and terminal breast cancer disease. Citation Format: Bloch W, Baumann F, Zimmer P, Grischke E-M, Fasching PA, Decker T, Uleer C, Schneeweiss A, Salat C, Wimberger P, Mundhenke C, Förster F, Kluth-Pepper B, Schubert J, Tesch H, Schütz F, Lüftner D, Jackisch C. Impact of physical activity/exercise on adverse events and quality of life during treatment with everolimus and exemestane for ER+ women - Results of the 3rd interim analysis of BRAWO. [abstract]. In: Proceedings of the Thirty-Eighth Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2015 Dec 8-12; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2016;76(4 Suppl):Abstract nr P4-13-07.

Effects of medical causes, role concepts and treatment stages on quality of life in involuntary childless men

Goal of this study was to investigate differences in quality of life in men contingent upon various fertility treatment stages, infertility causes and adoption of roles. A quantitative study with n=115 men in three German fertility centres was devised. Participants completed a standardised, fertility-specific questionnaire devised for men (TLMK), sociodemographic and role items. Men having experienced severe medical conditions, for example cancer, reported significant higher quality of life compared to men with other infertility reasons [F(1,56)=12.77, P=0.001]. Furthermore, allocating participants into distinctive groups by means of kind and duration of treatment revealed significant group differences [F(2,111)=4.94, P=0.009], with quality of life decreasing with the use of more invasive fertility methods. A higher satisfaction with life was also stated by men adopting many tasks in the treatment process. The high quality of life displayed by men having experienced severe medical conditions contains valuable and far-reaching information about possible resilience factors that need to be researched more in detail. The finding of decreasing quality of life in men with the use of more invasive methods in treatment applies for increased psychosocial services in fertility clinics.

Quality of Life After Breast Reduction

The purpose of this study is to compare health-related quality of life in women with symptomatic macromastia before and after breast reduction. Two comparable groups of women were enrolled in the study, those waiting for breast reduction (group 1) and those who underwent surgery approximately 2 years before (group 2). To evaluate the specific beneficial effects of breast reduction, we used a unique combination of general and specific questionnaires: the Short Form 36 Health Survey Questionnaire (SF-36), the European Quality of Life-5 Dimensions (EQ-5D), the Rosenberg Self-Esteem Scale (RSE), the Self-Consciousness Scale (SCS), and the Derriford Appearance Scale 59 (DAS-59). The esthetic appearance of the breast was also evaluated using a visual analog scale (VAS). In both groups, preoperative back pain was present in more than 50% of patients. Complaints were significantly reduced after surgery. SF-36 showed significant higher quality of life in group 2 with regard to 7 of 8 investigated domains. Increased self-esteem after surgery, increased personal and public self-consciousness were observed. Moreover, the condition-specific DAS-59 showed that insecurity, pain, shame, and unattractiveness were significantly scored higher in the nonoperated group. Subjective esthetic score was significantly higher in the operated group (2.5 vs. 7.1). The data of this study provide further evidence that women who have been operated for breast hypertrophy have a significant improvement in quality of life compared with those who are not yet operated. These data are further evidence that breast hypertrophy is not solely an esthetic problem.