Impact of FOLFOXIRI and bevacizumab (bev) compared to FOLFOX and bev on health related quality of life (HRQOL) in patients with metastatic colorectal cancer (MCRC): Analysis of the CHARTA-AIO 0209 trial.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 3544-3544 ◽  
Author(s):  
Julia Quidde ◽  
Hans-Joachim Schmoll ◽  
Benjamin Garlipp ◽  
Christian Junghanss ◽  
Malte Leithaeuser ◽  
...  

3544 Background: FOLFOXIRI/bev is a highly efficacious first line regimen in MCRC. Despite higher rates of neutropenia, diarrhea and stomatitis, FOLFOXIRI/bev is tolerable and feasible in MCRC patients. To date nothing is known about the impact of this regimen on HRQOL. Methods: 250 patients were randomized to FOLFOX/bev (arm A) or FOLFOXIRI/bev (arm B). HRQOL were assessed at baseline, every 8 weeks during induction treatment (6 months) and every 12 weeks during maintenance treatment, using the EORTC QLQ-C30, QLQ-CR29 and QLQ-CIPN20. The mean values of every score were calculated as the average of week 8, 16 and 24 assessment. Test concerning mean values were performed as t-test, with global type I error set at 0.05. HRQOL deterioration and improvement rates were analyzed and compared between treatment groups using chi² tests. Results: For HRQOL analysis, 237 patients were eligible (arm A: 118; arm B: 119). Compliance rate with the HRQOL questionnaires was 95.4% at baseline, 72.6% at week 8, 59.5 % at week 16 and 43.5% at week 24. Whereas mean global quality of life score (GHS/QOL) was similar between arm A and B (59.8 vs. 58.8; p = 0.726), mean scores for nausea/vomiting (9.4 vs. 16.0; p = 0.015) and diarrhea (23.7 vs. 32.1; p = 0.051) significantly or borderline significantly favored arm A during induction period. Furthermore, at week 8 scores of nausea/vomiting (9.2 versus 17.3, p = 0.006) appetite loss (19.5 vs. 29.4; p = 0.035) and financial problems (18.3 vs. 29.5; p = 0.021) and at the end of treatment physical functioning (75.0 vs. 65.8; p = 0.048) were significantly better for arm A compared to arm B. No significant differences were observed in the remaining EORTC scores. The rates of deterioration and improvement between baseline and week 8 of at least 10 points in the EORTC scores were similar (e.g. deterioration-rate GHS/QOL score 21.5% vs. 26.5% for arm A vs. B; p = 0.461). Conclusions: Although no remarkable detriment in HRQOL was noted, the better efficacy of FOLFOXIRI/bev compared to FOLFOX/bev is associated with a decrease in mainly gastrointestinal QOL scores. Further subgroup-analyses will be presented at the meeting. Clinical trial information: NCT01321957.

2018 ◽  
Vol 14 (1) ◽  
pp. 264-269 ◽  
Author(s):  
Patricia Ciminelli ◽  
Sergio Machado ◽  
Manoela Palmeira ◽  
Mauro Giovanni Carta ◽  
Sarah Cristina Beirith ◽  
...  

Background: Emotional stress is frequently associated with otologic symptoms as tinnitus and dizziness. Stress can contribute to the beginning or worsening of tinnitus. Objective: The objective of the study is to evaluate the presence of stress symptoms in patients with chronic, subjective tinnitus, and correlate its presence to annoyance associated with tinnitus. Methods: This is a cross-sectional study. One hundred and eighty patients with chronic, subjective tinnitus were included. Patients answered the Tinnitus Handicap Inventory (THI) to evaluate the impact of tinnitus in the quality of life and answered the Lipp's inventory symptoms of stress for adults (ISSL). The data obtained was organized using Excel® 2010, mean values, linear regression and p-value were calculated. Results: Of the 180 patients included in the study, 117 (65%) had stress symptoms, 52 of the 117 (44%) were in the resistance phase and 23 of the 117 (20%) in the exhaustion phase, the remaining was in the alert phase. There was a clear progressive increase in stress as THI raised, with more impact of tinnitus in quality of life. Conclusion: The presence of stress symptoms, measured by ISSL was observed in most of our patients with chronic subjective tinnitus, specially in the resistance and exhaustion phases and it is directly associated with tinnitus annoyance.


Author(s):  
Ruben Berrocal Timmons

Objective: Treatment of joint pain with an injection of the amniotic membrane has not been adequately studied. This study retrospectively reviewed Visual Analog Scale (VAS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and analgesic usage data from patients treated with the injection of cryopreserved amniotic membrane (CAM) in their knees to determine the impact of treatment on patients’ pain, quality of life, and analgesic usage. Methods: Chart review was conducted on 40 patients. Institutional Review Board (IRB) approval was obtained prior to initiation of the project. The membrane was utilized as per the FDA guidance of 21CFR1271. Retrospective data, including demographics, medical history, pain score, quality of life score, analgesic usage and adverse events, were collected from their medical records for each consenting patient through 6 months after CAM injection. Results: A total of 40 patients were considered in the final analysis. Mean VAS for pain level improved from 7.0 to 2.6 (p<0.001). WOMAC daily activity function score improved from a mean score of 52 to 28 (p<0.001). Opioid and non-steroidal anti-inflammatory drug (NSAID) usage decreased from 97% to 25% (p<0.001). No adverse events were reported. Conclusion: Mean values for VAS and WOMAC scores significantly improved at all time points and the number of patients who used analgesics decreased as compared to baseline. CAM injection into painful knee joints decreases pain, improves physical function, and decreases the use of analgesics in the absence of adverse events.


Author(s):  
Ute Goerling ◽  
Thomas Gauler ◽  
Andreas Dietz ◽  
Viktor Grünwald ◽  
Stephan Knipping ◽  
...  

Introduction: CeFCiD was a multicenter phase II study comparing the efficacy of cetuximab, 5-flourouracil, cisplatin with the same regimen adding docetaxel in recurrent/metastatic head and neck cancer. The primary analysis trial did not demonstrate survival benefit from therapy intensification in first-line recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN). The current analysis of the trial assessed the impact of treatment on quality of life (QoL). Methods: The European Organization for Research and Treatment of Cancer Quality of life Questionnaire QLQ-C30 and the tumor specific module for head and neck cancer (QLQ-H&N35) were used to assess QoL at baseline (visit 1), after 2 (visit 3), 4 (visit 5), and 6 (visit 7) cycles of chemotherapy. Results: Of 180 patients included in this study, 86 patients (47.8%) completed the questionnaires at baseline. Considering selected scores over treatment time, there was no difference in global quality of life, dyspnea, swallowing and speech between the treatment arms in the course. For fatigue a significant increase from baseline to visit 3 (p=0.02), visit 5 (p=0.002), and to visit 7 (p=0.003) was observed for patients receiving docetaxel (D), cisplatin or carboplatin (P), 5-FU (F) and cetuximab (C). At the end of chemotherapy the manifestation of fatigue was similar compared in the two treatment arms. Discussion/Conclusion: Therapy intensification not adversely affect selected scores of QoL of patients with recurrent and/or metastatic SCCHN. Nevertheless, fatigue seems to be pronounced in patients treated with docetaxel.


2017 ◽  
Vol 102 (7) ◽  
pp. 878-881 ◽  
Author(s):  
Marcus Ang ◽  
Ryan Man ◽  
Eva Fenwick ◽  
Ecosse Lamoureux ◽  
Mark Wilkins

AimTo determine the impact of type I Boston keratoprosthesis (KPro) implantation on vision-related quality of life (VRQoL).MethodsProspective study in 33 patients (mean age 56±12 years, 67% male) with bilateral corneal blindness, who underwent a KPro implantation at a single tertiary eye hospital (June 2011–July 2015). VRQoL was evaluated using the Impact of Vision Impairment Questionnaire (IVI) at baseline and at 3–6 months postsurgery, after stabilisation of best-corrected visual acuity (BCVA). Rasch analysis was used to transform the IVI responses into interval-level measures comprising the ‘reading’, ‘mobility’ and ‘emotional’ subscales with effect sizes calculated for pre-post VRQoL scores.ResultsMean preoperative BCVA was counting-fingers at 2 feet in the operated eye (20/240 fellow eye). Preoperative VRQoL scores: −2.27, –2.91 and −3.06 logits for the reading, mobility and emotional subscales, respectively. Device retention rate was 90% over the follow-up period (mean 26±12 months). We observed large gains for reading and mobility of 1.92 logits (effect size 0.88), and 2.64 logits (effect size 0.89) respectively, with a moderate gain in the emotional subscale of 2.11 logits (effect size 0.59). These improvements did not vary significantly with BCVA on multivariate analysis (all p>0.05).ConclusionWe observed a differential short-term improvement to VRQoL after KPro implantation with a significant impact on emotional well-being, which may not be fully explained by visual improvement alone. Further studies are required to confirm if these improvements in VRQoL are sustained in the long-term and are generalisable to other populations.


2013 ◽  
Vol 16 (1) ◽  
pp. 7-13
Author(s):  
Zh E Belaya ◽  
N V Dragunova ◽  
L Ya Rozhinskaya ◽  
G A Melnichenko ◽  
L K Dzeranova ◽  
...  

The objective of this study was to investigate the prevalence of low traumatic fractures, the factors influencing fractures in endogenous Cushing’s syndrome (CS) of various etiologies and their contributions into functional abilities and quality of life in patients with CS. Materials and methods: the retrospective data of patients, who had received treatment due to endogenous CS, (2001-2011), was evaluated. All enrolled patients underwent standard spinal radiographs in lateral positions of the vertebrae Th4-L4. Recent low traumatic non-vertebral fractures were recorded in the medical cards. Bone mineral density (BMD) was measured by DXA GE Lunar Prodigy. Serum samples on octeocalcin (OC), carboxyterminal cross-linked telopeptide of type I collagen (CTx), latenight cortisol in serum were assayed by electrochemiluminescence (ECLIA). 24h urinary free cortisol (24hUFC) was measured by an immunochemiluminescence assay (extraction with diethyl ether). Functional assessment was performed using «chair rising», «up and go» and «tandem» tests. Universal pain assessment tool (verbal descriptor scale, Wong-Baker facial grimace scale, activity tolerance scale), EQ-5D and ECOS-16 questionnaires were given to patients and they self-reported their conditions. Results: Among 215 patients, 178 were females and 37 males, median age 35 (Q25-Q75 27-48); 88patients (40,9%) had low traumatic fractures, including vertebral fractures in 76 cases (in 60 cases multiple vertebral fractures) and non-vertebral fractures in 27 cases (17 patients had rib fractures, 3 -fractures of metatarsal bones, 2 fractures of radius, 2 fractures of tibia and fibula, 1 humerus, 1 breastbone; 1 hip fracture). Patients with fractures had higher 24hUFC, late-night cortisol in serum, lower OC, Total Hip BMD, but did not differ in age, BMI, CTx or etiology of CS. After applying the logistic regression analysis (adjusted for sex, age, BMI, BMD, OC), the main predictor of fractures was late-night serum cortisol level (p=0,001). Patients with late-night serum cortisol higher than 597 nmol/l were more likely to have low traumatic fractures (Odds ratio 2,86 (95%CI 1,55-5,28) p=0,001). Patients with fractures suffered from more pain and reported worse functional abilities. They had slightly worse results in «tandem» test, but did not differ in other functional tests, which assessed mainly muscle power. Conclusions: Patients with CS have very high risk of low traumatic fractures. The severity of hypercortisolemia is the best predictor of low traumatic fractures in patients with CS. Patients with fractures sufferedfrom more severe pain and because of this they restricted their daily activity even more than patients with CS without fractures. Consequently, patients with higher levels of late-night serum cortisol need earlier preventive treatment for osteoporosis.


2007 ◽  
Vol 29 (3) ◽  
pp. 213-221 ◽  
Author(s):  
Giulietta Cucchiaro ◽  
Paulo Dalgalarrondo

OBJECTIVE: To estimate the prevalence of mental health problems and to assess the quality of life in pre- and early adolescents living in two contrasting urban areas in Brazil, as well as to identify the impact of demographic factors on mental health, quality of life and school performance. METHOD: Using school samples, the Strength and Difficulties Questionnaire and the Quality of Life Inventory were administered to 424 (52%) boys and 387 (48%) girls (mean age 12.6 ± 1.3 years) in better-off central and poorer outer-city areas. RESULTS: In the total sample, the prevalence of probable psychiatric cases was 10.1% (n = 77). There were no significant differences in the overall prevalence of behavior problems or global quality of life between central and outer-city areas. However, boys from the outer-city had a higher prevalence of conduct problems (12% vs. 6.2%, p = 0.04), although girls did not differ significantly on any measure. In general, factors associated with poorer mental health were: having no religion, divorced parents, and being male. CONCLUSIONS: Living in the poorer outer-city was not associated with worse mental health or quality of life in this sample. This is in contrast with the findings of some other studies, and possible protective factors such as female gender and religion are discussed.


2017 ◽  
Vol 4 (2) ◽  
Author(s):  
Eisha Gohil ◽  
Ruby Charak, PhD ◽  
Haroon Rashid ◽  
Priyanka Sharma, PhD

Diabetes is a progressive chronic condition which places a significant burden of self management on the individual, such as daily monitoring and medications management, worry about the future and distress about the impact of diabetes on various aspects of life. It is a group of metabolic diseases characterized by elevated blood glucose levels (hyperglycemia) resulting from defects in insulin secretion, insulin action or both. The present study aimed to assess gender differences in quality of life and depression in patients suffering from type I diabetes. A sample of 70 participants (44 male and 26 female) in the age range of 40-80 years was collected from Jammu region, India. WHO Quality of life questionnaire and Beck’s Depression inventory-II were used as tools. Results indicated a significant difference on physical and psychological dimensions of quality of life and on depression across gender. The mean scores indicated that female participants had increased level of depression compared to the male participants. No significant difference was found between male and female on social and environmental dimensions of quality of life.


2004 ◽  
Vol 14 (1) ◽  
pp. 45-52 ◽  
Author(s):  
S. Nicole Culos-Reed ◽  
Linda Carlson ◽  
Lisa Daroux ◽  
Susi Hately-Aldous

Physical activity provides a number of physical and psychological benefits to cancer survivors, including lessening the impact of detrimental cancer-related symptoms and treatment side effects (e.g., fatigue, nausea)and improving overall well-being and quality of life. The purpose of the present pilot study was to examine the physical and psychological benefits afforded by a seven-week Yoga program for cancer survivors within the framework of the theory of planned behavior. The Yoga program participants (M age=51.18 [10.33]; 92%female) included primarily breast cancer survivors, on average 55.95 (54.39) months post-diagnosis. Significant differences between the intervention group (n=20)and the control group (n=18) at post-intervention were seen in both psychosocial (i.e., global quality of life,stress, emotional function, emotional irritability, mood disturbance, tension, depression, anger, confusion) and physical (i.e., resting heart rate, cardiovascular endurance, cardiopulmonary arousal) variables (all p's&lt;.05). There were also significant improvements(all p's&lt;.05) in the program participants from pre- to post-intervention on a number of physical and psychosocial variables. These initial findings suggest that Yoga has significant potential and should be further explored as a beneficial physical activity option for cancer survivors. Future research might attempt to include a broader range of participants (e.g., other types of cancer diagnoses, more male subjects) in a randomized,controlled trial.


2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 19656-19656
Author(s):  
J. I. Arraras ◽  
F. Arias ◽  
A. Manterola ◽  
M. A. Dominguez ◽  
E. Villafranca ◽  
...  

19656 Background: the aims of the present study was to evaluate the impact of the radiotherapy in the Quality of Life (QL) in a sample of breast cancer elder patients with localized stages. Methods: The sample size was previously calculated using the program GRANMO 5.2 (Power O.8, a=0.01). During 2005, forty eight patients aged 65 years and older, stages I to III who started radiotherapy with or without hormonetherapy, have filled in the EORTC QLQ-C30 and QLQ-BR23 Quality of Life questionnaires three times: prior, end, and six weeks after the radiotherapy. Demographic data, performance status (Karnfosky scale), Daily Living Activities (DLA) with the IDDD scale, toxicity (CTC v2.0), co-morbidity and other clinical data have also been recorded Statistical analysis: Quality of Life and DLA scores, changes in them among the three assessments (Friedman, with Wilcoxon and Bonferroni criteria) have been calculated. Results: Quality of Life and DLA scores have been high in most dimensions in the three measurements. Moderate limitations (>30 points) have appeared in global Quality of Life, future worries, sexuality scales in the three measurements, and insomnia in the second. There are no significant differences in QL scores between the first and third measurements. In the second measurement there are moderate worsening (between 10 and 20 points) in fatigue, pain and breast symptoms and little (<10) in role, that have recovered in the third measurement. There has also been improvements between the second and third measurement in arm symptoms and global QL. No changes in DLA among the three measurements. Conclusions: Quality of Life in the elder patients has been good and the treatment adequately tolerated. Limited changes have appeared in treatment related areas that have recovered after a short follow-up period. Age should not be the only factor to consider when deciding the treatment protocol to administer. It would be desirable to confirm our results with a bigger sample. No significant financial relationships to disclose.


Author(s):  
Till Schrempf ◽  
Julia Finsel ◽  
Ingo Uttner ◽  
Albert C. Ludolph ◽  
Dorothée Lulé

Abstract Objective To investigate the association between neuropsychological deficits and psychological well-being in amyotrophic lateral sclerosis (ALS). Methods Subjective (Schedule for the Evaluation of the Individual Quality of Life-Direct Weighting, SEIQoL-DW) and global quality of life (QoL; Anamnestic Comparative Self-Assessment, ACSA) as well as depression (ALS-Depression-Inventory, ADI-12) as indicators for psychological well-being were measured in 214 patients with ALS and correlated with neurocognitive performance assessed by the Edinburgh Cognitive and Behavioural ALS Screen (ECAS). Primary caregivers evaluated behaviour. Patients were classified to be cognitively (ALSci) or behaviourally impaired (ALSbi) according to Strong criteria. Results ALSbi patients had poorer psychological well-being than patients without behavioural alterations, while the psychological well-being of patients with and without neurocognitive deficits was comparable. Conclusion The study provides evidence that minor neuropsychological deficits do not interfere with psychological well-being of ALS in contrast to alterations on behavioural level. Thus, abnormalities in individual cognitive domains have limited relevance for the patients’ everyday life in comparison to the impact of behavioural alterations.


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