Components of Global Quality of Life In Multiple Myeloma

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 4735-4735
Author(s):  
Catherine D Williams ◽  
Irina Proskorovsky ◽  
Philip Lewis ◽  
K. Jack Ishak ◽  
Krista A Payne ◽  
...  

Abstract Abstract 4735 Introduction: Symptoms of multiple myeloma (MM) and the adverse events (AEs) associated with MM treatment can be debilitating on many levels. A better understanding of the extent to which patients are affected and how this in turn impacts global health-related quality of life (HRQOL) can improve management of patients. Methods: A survey in 11 centers in the United Kingdom and Germany gathered, among other items, data on HRQOL, measured by the European Organization for Research and Treatment of Cancer's (EORTC) generic cancer and MM modules (QLQ-C30 and QLQ-MY20 scales), from a cross-section of patients with multiple myeloma at various phases of the disease. The QLQ-C30 is comprised of a global QOL domain, 5 functional and 3 symptom domains, and 6 AE items; the QLQ-MY20 includes scales for disease symptoms, treatment side-effects, future perspective and body image. This analysis aimed to explore the association between individual QOL scales (from QLQ-C30 and QLQ-MY20) and global QOL. Values for each scale range from 0 to 100; higher values indicate better HRQOL for the global, functional, future perspective and body image scales, and worse HRQOL for the AE items, symptom domains, disease symptoms and side-effects scales. Scoring of the QLQ-C30 and MY-20 scales was described previously by Fayers et al. [i] and Cocks et al. [ii] respectively. The distribution and correlations (Spearman) between the various scales was explored. Moreover, a multiple linear regression analysis was carried out to assess the association between individual scales and global QOL (from QLQ-C30) with the aim to identify those that independently impact global QOL. Each scale was first considered alone as a predictor of global QOL; those with a statistically significant association at a p-value ≤ 0.10 were included in a multiple regression model. This was then trimmed to exclude scales that became non-significant (p-value > 0.10). Results: The survey included 154 patients: 63.0% were male and the mean age was 66.4 (SD: 10.0). Mean time since diagnosis was 3.7 years (SD: 3.7), 51.9% were currently on treatment, and 42.9% had at least one prior line of MM therapy. The mean global QOL score was 60.1 (SD: 25.5), with the middle two quartiles of patients scoring between 41.7 and 83.3. Cognitive and emotional functioning scores had means near or above 80, suggesting that these aspects of HRQOL were less affected than role (62.9 (IQR: 33.3–100)), social (63.9(IQR: 33.3–100)) and physical functioning (68.7(IQR:53.3-93.3)). While body image scores were generally high (77.9 (IQR:66.7-100)), future perspective appeared to be relatively more affected (59.9 (33.3-77.8)). Patients’ HRQOL is most affected by pain and fatigue (based on symptom and AE scales of the QLQ-C30), with means above 30, followed by insomnia and dyspnoea with means above 20, while diarrhea and nausea/vomiting scales had the lowest mean scores (below 10). The Disease Symptom (23.3 (IQR:0-38.9)) and Side Effect scale scores (19.5 (IQR:7.4-29.6)) from the QLQ-MY20 were consistent with the AE and symptom scales from the QLQ-C30. All of the domains except diarrhea and nausea/vomiting individually showed at least moderate correlations with global QOL (Spearman correlations above 0.25 in absolute value), but also exhibited strong correlations between themselves. The final multiple regression model retained physical and social functioning, fatigue, disease symptoms (QLQ-MY20) and future perspective scales (QLQ-MY20), all of which had relatively similar strength of association with global QOL. Conclusion: This study demonstrates that the impact of MM and treatment AEs can be seen on various dimensions of patients’ HRQOL, particularly reduced physical and social functioning, future perspective and various disease symptoms such as bone pain (as captured by the disease symptoms scale of the QLQ-MY20) and fatigue. Fayers P, Aaronson N, Bjordal K, Groenvold M, Curran D, Bottomley A: The EORTC QLQ-C30 Scoring Manual. 3 Edition EORTC Quality of Life Group, Brussels 2001. [ii]Cocks K, Cohen D, Wisloff F, et al. An international field study of the reliability and validity of a disease-specific questionnaire module (the QLQ-MY20) in assessing the quality of life of patients with multiple myeloma. Eur J Cancer 2007;43:1670-1678. Disclosures: Williams: Celgene: Honoraria; Jansen Cilag: Consultancy, Honoraria. Off Label Use: Some of the patients in the study received Thalidomide for the treatment of relapsed or refractory multiple myeloma. Proskorovsky:United BioSource Corporation: Consultancy, Research Funding. Lewis:Celgene International SARL: Employment. Ishak:United BioSource Corporation: Consultancy, Research Funding. Payne:United BioSource Corporation: Consultancy, Research Funding. Lordan:United BioSource Corporation: Consultancy, Research Funding. Davies:Celgene: Honoraria, Speakers Bureau; Ortho Biotech: Honoraria, Speakers Bureau. Peters:Celgene: Consultancy.

2020 ◽  
Author(s):  
Ravindri Jayasinghe ◽  
Ashan Fernando ◽  
Umesh Jayarajah ◽  
Sanjeewa Seneviratne

Abstract Background This study was conducted to evaluate post-treatment long-term quality of life (QOL) in breast cancer patients and to determine its association with the type of surgery.Methods All women with non-metastatic breast cancer who underwent surgery for breast cancer at the Professorial Surgical Unit, Colombo during 2015–2018 and completed a minimum of one year follow up after surgery were invited to participate in the study. Fifty-four women who responded were analysed using the validated EORTC QLQ-C30 and QLQ-BR23 questionnaires. Non-parametric tests were used for statistical analyses.Results The mean age was 59 years (range 36–81). A majority (61%, n = 33) underwent mastectomy and the rest (n = 19, 45%) breast conservation surgery (BCS). The mean QLQ-C30 score was 68.8 (range 8.3–100) and the mean scores for physical function, role function, emotional function, cognitive function, and social function were 71.4, 81.5, 77.0, 80.2, and 86.4, respectively. The mean scores for body image, sexual functioning, sexual enjoyment, future perspective, systemic therapy, breast symptoms, arm symptoms, and hair loss assessed by the QLQ-BR23 were 76.4, 18.3, 33.3, 73.6, 30.5, 16.2, 23.4 and 32.7, respectively. No significant differences (P > 0.05) were noted in global health status, physical function, role function, emotional function, cognitive function and social function between BCS and mastectomy. QLQ-BR23 body image, sexual functioning, sexual enjoyment and future perspective also did not differ significantly (p > 0.05) between the two groups.Conclusions Sexual functioning and enjoyment, breast and arm symptoms and hair loss contributed to poor QOL while the impact on global health status including physical, social and emotional functions were minimal. Type of surgery did not appear to be associated with QOL. Future studies with a larger sample sizes will be helpful to further study these factors.


Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 1638-1638
Author(s):  
Louise Redder ◽  
Sören Möller ◽  
Anna Thit Johnsen ◽  
Mary Jarden ◽  
Christen lykkegaard Andersen ◽  
...  

Abstract Background: The severe, acute respiratory syndrome, coronavirus 2 (SARS-CoV-2), leading to coronavirus-19 (COVID-19), was detected for the first time in Wuhan, China in December 2019. In general, governments and health authorities have taken precautions during the COVID-19 pandemic to reduce viral spread and protect vulnerable citizens. Patients with multiple myeloma (MM) have an increased risk of being infected with COVID-19 and developing a fatal course due to the MM-related immunodeficiency (Glenthøj, A et al. PMID: 32939853). To some extent, the COVID-19 pandemic has changed standard of care towards extended use of oral regimens and limiting hospital visits (Terpos E et al.PMID: 32444866). We aimed to investigate the quality of life (QoL) of Danish patients with MM during the COVID-19 pandemic. We hypothesized that patients living alone and those under the age of 65 years, as a consequence of the pandemic, would experience impaired QoL due to social isolation and fear of infection with SARS-CoV-2. Methods: The Danish prospective, nation-wide, observational survey "Quality of life in Danish patients with multiple myeloma" (QoL-MM) (Nielsen LK et al. PMID: 30656677) framed our study. In QoL-MM, survey data are obtained at enrolment and subsequently at 12 follow-up time points over a two-year period. The following PRO questionnaires are used; the cancer-generic instrument of European Organisation for Research and Treatment of Cancer Quality of life (EORTC) QLQ-C30 (EORTC QLQ-C30), the Multiple Myeloma module QLQ-MY20 (EORTC QLQ-MY20), the Chemotherapy-Induced Peripheral Neuropathy module (EORTC QLQ-CIPN20) and the Short-form health survey version 2 (SF12v2). In the present study, a subpopulation of the QoL-MM cohort was constructed, based on the response time of the questionnaires. QoL was compared using patient-reported outcome (PRO) data obtained before and during the COVID-19 pandemic at group level. In a Danish context, first wave was defined as April to June 2020 and the second wave as November 2020 to January 2021. The QoL data were analyzed using mixed effects linear regression, with a year-period-interaction. Pre-COVID versus COVID mean domain score difference was considered evident, if the difference was both statistically significant (p-value <0.05) and clinically relevant, using minimal important difference (MID) defined as 0.3 standard deviation of the mean score. Results: The study included 616 patients (63% newly diagnosed and 37% relapsed) with a mean age of 68.2 years (standard deviation, 9.2); 40% were females; 76% were married/cohabiting, and 24% single. Questionnaire completion rates during the investigated periods were between 96% and 97%. In total, 1,685 completed sets of questionnaires were included in the analyses. The patients reported no statistically significant and clinically relevant difference in QoL during the first and second waves of the COVID-19 pandemic, compared to one year earlier, see table 1. When analyzing the subpopulations, we found that patients below 65 years reported improved physical health summaries (p-value 0.016), decreased fatigue (p-value < 0.001), less insomnia (p-value 0.002) and improved role functioning (p-value <0.001) during the first wave, reaching both statistical significance and the threshold of MID. The group of patients living alone reported improved role functioning during the first wave, reaching both statistical significance (p-value <0.001) and the threshold of MID. These findings were not evident during the second wave, see table 1. Conclusion: As a group, Danish patients with MM did not report impaired QoL during the COVID-19 pandemic. In contrary, we observed improvements in some domains in patients below 65 years. Our observations indicate that the patients with MM have felt cared for and in good hands during the first and second waves of the COVID-19 pandemic. However, part of the reason for our finding of no negative impact on QoL by the pandemic could be that the questionnaires used were not developed to capture the impact of the pandemic on QoL. Importantly, our results suggest that QoL data collected in clinical trials during the pandemic allow interpretation without adjusting for the impact of the pandemic. Figure 1 Figure 1. Disclosures Redder: Janssen-Ciliag: Research Funding. Frederiksen: Alexion: Research Funding; Gilead: Research Funding; Abbvie: Research Funding; Janssen Pharmaceuticals: Research Funding; Novartis: Research Funding.


2019 ◽  
Vol 11 (1) ◽  
pp. 9-18
Author(s):  
Abdul Wakhid ◽  
Ana Puji Astuti ◽  
Maya Kurnia Dewi

Logoterapi merupakan terapi untuk menemukan makna positif dibalik sebuah kejadian yang tidak diharapkan. Logoterapi dilaksanakan secara individu maupun berkelompok dalam bentuk konseling dan berorientasi pada pencarian makna hidup individu. Tujuan logoterapi meningkatkan makna pengalaman hidup individu yang diarahkan kepada pengambilan keputusan yang bertanggung jawab. Penelitian ini dilakukan dengan menggunakan rancangan pre-experiment dengan metode pre and post test group, artinya pengumpulan data dilakukan terhadap responden untuk membandingkan kualitas hidup sebelum dan sesudah dilakukan intervensi. Teknik pengambilan sampel dilakukan dengan metode total sampling yaitu pengambilan seluruh sampel dengan tetap memperhatikan kriteria yang telah ditetapkan. Jumlah pasien yang menjalani hemodialisis di RSUD Ungaran sebanyak 21 orang dan di RSUD Ambarawa sebanyak 25 pasien. Analisis data dilakukan dengan menggunakan uji t test dependent. Hasil penelitian didapatkan bahwa dari 46 responden didapatkan rata-rata skor kualitas hidup pasien yang mejalani hemodialisis sebesar 60.22 dengan skor terrendah 55 dan skor tertinggi 69. Bahwa dari 46 responden didapatkan rata-rata skor kualitas hidup pasien yang mejalani hemodialisis sebesar 88.72 dengan skor terrendah 79 dan skor tertinggi 103. Hasil uji statistik dengan uji t test dependent diketahui ada pengaruh logoterapi terhadap kemampuan memaknai hidup pada klien yang menjalani hemodialisis di RSUD Kabupaten Semarang (p value: 0,0001). Saran perlunya peningkatan kemampuan perawat dalam memberikan layanan kesehatan termasuk pemberian atau pemanduan penemuan makna hidup bagi pasien hemodialysis, agar selain dengan hemodialysis, ada faktor internal dari pasien yang dapat dijadikan sebagai motivasi untuk sembuh dari penyakit.   Kata Kunci: Logoterapi, kualitas hidup   IMPROVE THE QUALITY OF LIFE OF PATIENTS WITH RENAL FAILURE WHO UNDERWENT HEMODIALYSIS   ABSTRACT Logotherapy is a therapy to discover the positive meaning behind an unexpected event. Logotherapy is carried out individually or in groups in the form of counseling and oriented to the search for the meaning of individual life. This study aims to improve the quality of life of patients with renal failure who underwent hemodialysis. This research was conducted by using pre-experiment with pre-post test study. The sampling technique was done by the convenience sampling. The number of patients undergoing hemodialysis as many as 46 respondents. Data analysis was done by using test t test dependent. The result showed that from 46 respondents got the mean of quality of life of patients who had hemodialysis 60.22 with lowest score 55 and highest score 69. Whereas from 46 respondents got the mean score of life quality of patients who had hemodialysis 88.72 with score the lowest score 79 and the highest score 103. The result of statistical test with t test dependent is known there is influence of logoterapi to the ability of meaningful life on client who undergo hemodialysis at Semarang Regency hospitals (p value: 0.0001). Advice on the need to improve the nurse's ability to provide health services, including the provision or guidance of the discovery of the meaning of life for hemodialysis patients, in addition to hemodialysis, there are internal factors of the patient that can be used as a motivation to recover from illness.   Keywords: Logotherapy, quality of life, kidney failure.  


Author(s):  
Golnaz Azami ◽  
Soh Kim Lam ◽  
Sazlina Shariff-Ghazali ◽  
Salmiah Mohd Said ◽  
Sanaz Aazami ◽  
...  

Objective: Type 2 diabetes mellitus (T2DM) is a chronic condition that requires consistent medical care to help control glycemic indices. Diabetes self-management is found to be essential for optimal glycemic control. This study aimed to investigate the predictors of diabetes self-management in adult with T2DM. Materials and Methods: A cross-sectional study was conducted. A purposive sample of 142 adults with T2DM attended an outpatient endocrine clinic in an academic hospital in Ilam, Iran was invited to participate in this study from September to October 2016. The data were collected using a combination of validated questionnaires and the blood sample. IBM SPSS software version 22 used to conduct the analysis. Hierarchical linear regression analysis with the stepwise method was used to explore the predictors of diabetes self-management.  Results: The mean age of participants was 54.2 ± (11.8) years. The mean duration of diabetes was 8.9 ± (7.4). Hierarchical linear regression analysis determined that self-management behaviors had positive relationship with efficacy expectation (B= 0.445, P-value< 0.01), quality of life (B= 0.222, P-value= 0.02), and has a negative relationship with HbA1c (B= -0.194, P-value= 0.01).  Conclusion: The result of our study indicate that better diabetes self-management behaviors can be predicted by higher efficacy expectation, the better quality of life and lower HbA1c levels. Future interventions should focus on enhancing efficacy expectation, quality of life and optimizing glycemic control to improve self-management of diabetes.


Author(s):  
Seyed Saeed Mazloomy Mahmoodabad ◽  
Nahid Ardian ◽  
Hadi Eslami

Background: One of the factors influencing the level of general health and quality of life of individuals, is the level of social support that people enjoy. Given the importance of general health, quality of life and the amount of social support and their relationship with the level of physical activity in young people in Yazd province counties were studied. Methods: The study population of this descriptive, cross-sectional study consisted of 15- to 29-year-old people. Given the study population, sample size was calculated for the counties Yazd, Mehriz, Ardakan and Meybod separately. Methods: A total of 1533 people were selected by cluster sampling, and a person aged 15-29 years from each family completed the questionnaire. The questionnaire used, in addition to demographic questions, included three sections general health questionnaire (GHQ-28), Multidimensional Scale of Perceived Social Support, and World Health Organization Quality Of Life Brief (WHOQOL-BREF). The data were analyzed by SPSS18, nonparametric statistical tests and Pearson's correlation. Results: The mean general health score of youth was 30.82 (9.56) and the mean scores of their quality of life and social support were 38.32 (8.67) and 42.64 (7.73), respectively. Mental health, quality of life and social support were significantly associated with education level (P-value ≤ 0.001). The quality of life of young athletes was higher than that of young non-athletes (P-value ≤ 0.001). General health and social support were higher in women than in men (P-value ≤ 0.001). Conclusion: The general health level of Yazd youth is higher than the cut-off point and not optimal, but based on social and cultural conditions in this province, the levels of social support and quality of life were found to be satisfactory. Planning to increase the level of vitality and exercise in different fields can be an opportunity to improve the general health of young people.


2020 ◽  
Vol 10 (1) ◽  
pp. 253-265
Author(s):  
Mahmuddin Mahmuddin ◽  
Dhian Ririn Lestari ◽  
Ichsan Rizani

 Latar Belakang: Kanker payudara adalah keganasan sel yang menyerang payudara dan merupakan penyebab kematian kedua pada wanita. Frekuensi kemoterapi menimbulkan gangguan pada fungsi dan gejala kanker payudara yang dapat mempengaruhi kualitas hidup. Kualitas hidup merupakan keadaan yang menyatakan kepuasan batin dan kenyamanan hidup seseorang. Tujuan: Penelitian ini bertujuan untuk mengetahui hubungan lama menjalani kemoterapi dengan kualitas hidup penderita kanker payudara di RSUD Ulin Banjarmasin Metode: Penelitian ini merupakan penelitian analitik dengan pendekatan cross sectional menggunakan accidental sampling didapatkan 47 responden, penilaian kualitas hidup menggunakan European Organization of Research and Treatment of Cancer (EORTC) BR23. Uji Analisa menggunakan korelasi spearman. Hasil: Hasil rata-rata lama penderita menjalani kemoterapi sebanyak 4,53 kali  dan rata-rata kualitas hidup penderita kanker payudara berada di 65, 5% . Kesimpulan: dari Hasil analisis didapatkan ada hubungan antara lama menjalani kemoterapi dengan kualitas hidup penderita kanker payudara di RSUD Ulin Banjarmasin (P Value=0,000,01) dengan arah hubungan positif yakni semakin lama menjalani kemoterapi semakin tinggi nilai kualitas hidup penderita kanker payudara. Kualitas hidup yang paling tinggi dilihat dari function scale adalah sexs enjoyment yakni 72,0  sedangkan dari symptom scale   adalah side effect dengan skor 582,6 Kata kunci : kanker payudara, kemoterapi, kualitas hidup.Long Relationship Undergo Chemotherapy with Quality of Life of Breast Cancer Patients in Ulin Hospital BanjarmasinAbstractBackground: Breast cancer is a malignancy cells that attack breast and it is also the second leading cause of death among women. Frequency of chemotherapy may have detrimental function and symptom can make affect for patient’s quality of life. Quality of life is defined as condition to which individual reports inner satisfaction and comfort in life. Aim:The study to identify correlation between duration of chemotherapy and quality of life in patients with breast cancer RSUD Ulin Banjarmasin Method: This Research use Analitic Method with  design was cross sectional and involved 47 patients, all of whom were selected through accidental sampling. European Organization of Research and Treatment of Cancer (EORTC) BR23 was applied to measure patient’s quality of life. Anlyssis test using spearman correlation. Result: The mean of chemotherapy duration among participants was 4.53 times and the mean of QoL of patients with breast cancer was 73.31%. Conclusion: The analysis revealed a significant correlation between duration of chemotherapy and quality of life in patients with breast cancer in Ulin public hospital of Banjarmasin (p value = 0.000.01) with positive direction of association indicating that the longer the duration of make increase the score life quality of patients with breast cancer. The highest quality of life seen from the function scale is sex enjoyment, namely 72.0 while the symptom scale   is a side effect with a score of 582.6. Key words: breast cancer, chemotherapy, quality of life 


2019 ◽  
Vol 2 (3) ◽  
pp. 123-127
Author(s):  
Ismayani

IL-5 is an important role cytokine on the RA. IL-5 has an important role on eosinophils. ARIA-WHO made classification of RA based on how long the clinical symptoms and the impact on quality of life. The aim of this study was to know the classification of RA with IL-5 on RA study. This study used a cross-sectional method with 39 samples. The examination of IL-5 used ELISA. The highest classification of RA was medium-severe persistent of 43.58% with the mean value IL-5 was 56.25 pg/ml. Based on the test of Kruskal Wallis, it was obtained p-value = 0.664. Conclusion: There was no significant relation between classification RA and IL-5.  


2021 ◽  
pp. 65-66
Author(s):  
Krishnendu Maiti ◽  
Kundan Kumar ◽  
Dilip Kumar Pal

OBJECTIVE: To compare the impact of catheter size 14 French vs 12 French on quality of life of patients using Clean intermittent selfcatheterization. SUBJECTInclusion criteria patients using CISC for neurogenic (DSD) bladder, hypo contractile bladder. Exclusion criteria patient with urethral stricture, history of urethral, bladder, or prostate surgery, pediatric patients. METHODS: It was a comparative, observational, study which comprised of total 40 patients diagnosed with neurogenic bladder (detrusor sphincter dyssynergia), hypo contractile bladder, out of which 20 patients were given 12french catheter and 20 patients were given 14 French catheters as per coin randomization method. The patients were assessed for quality of life by using WHO QoL-BREF. T- test was utilised to compare the mean. p<o.05 was taken to be statistically signicant. RESULTS: In physical domain the mean score was higher in patients using 12 French catheter (56.01) compared with patients using 14 French catheter (55.1) but difference was statistically insignicant with p-value (0.688). In Psychological domain the mean score was higher in patients using 12 French catheters (63.90) compared with patients using 14 French catheters (63.30) with p-value (0.793). In Social relationships domain the mean score was higher in patients using 14 French catheters (62.20) compared with patients using 12 French catheters (61.55) but difference was statistically insignicant with p-value (0.855). similarly in the social relationships domain the mean score was higher in patients using 14 French catheter (58.65) compared with patients using 12 French catheter (58.53) with p-value 0.935. CONCLUSION: Higher score in physical and psychological domain implies less pain, greater treatment compliance and improving the patient's QoL, but higher score observed in physical and psychological domain was statistically insignicant. Based on above study we concluded that there was no signicant difference in quality of life of patients using 12 French or 14 French for CISC.


Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 3309-3309 ◽  
Author(s):  
Heinz Ludwig ◽  
Philippe Moreau ◽  
Meletios A Dimopoulos ◽  
Maria-Victoria Mateos ◽  
Martin F Kaiser ◽  
...  

Abstract Introduction: The randomized, phase 3 study ENDEAVOR (NCT01568866; N=929) demonstrated a clinically meaningful and statistically significant improvement in progression-free survival for patients with relapsed or refractory multiple myeloma who were treated with carfilzomib and dexamethasone (Kd) versus bortezomib and dexamethasone (Vd; median, 18.7 vs 9.4 months; hazard ratio: 0.53; 95% confidence interval [CI]: 0.44-0.65; P<0.0001) (Dimopoulos et al. Lancet Oncol. 2016;17:27−38). Patient-reported outcomes (PROs) were included as exploratory endpoints in the ENDEAVOR study. Here, we present results of a prespecified analysis of health-related quality of life (HR-QoL) in the ENDEAVOR trial. Methods: HR-QoL was assessed by 3 validated instruments: the European Organization of Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30-item questionnaire (QLQ-C30), the EORTC Quality of Life Questionnaire-multiple myeloma specific 20-item module (QLQ-MY20), and the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx) "Additional Concerns" neurotoxicity subscale. These instruments were assessed prior to treatment administration on day 1 of cycle 1, and then every 28 days until disease progression, withdrawal of consent, or commencement of other nonstudy anticancer treatment. Due to differing treatment cycle lengths, the PRO assessments coincided across groups every 12 weeks. The primary PRO hypothesis was superiority of Kd over Vd for the Global Health Status/Quality of Life (GHS/QoL) scale of the QLQ-C30. Seven further subscales were prespecified from the QLQ-C30 (fatigue, nausea/vomiting, pain, physical functioning, role functioning) and the QLQ-MY20 (disease symptoms, side effects of treatment). PRO subscales were compared between groups using a restricted maximum likelihood-based mixed model for repeated measures (MMRM). Two sensitivity analyses were performed for the GHS/QoL scale to evaluate the robustness of the MMRM to missing data. Clinical interpretation for the EORTC QLQ-C30 subscales was guided by pre-specifying minimum important differences (MIDs) based on evidence-based guidelines (5 points for the GHS/QoL scale). For the QLQ-MY20 subscales, the standard error of measurement was used as a proxy for the MID. The proportion of patients who had improved (≥5 points) from baseline on the GHS scale was summarized at each coinciding time point. Results: Baseline completion of the QLQ-C30 questionnaire was similar between groups (Kd, 87.7%; Vd, 84.3%). Compliance was high when calculated for all patients expected to provide a questionnaire at each time point (ie, alive and on-study), ranging from 73.1% to 93.9%. Median duration on study treatment was 40 weeks and 27 weeks for Kd and Vd patients, respectively. Using the MMRM model, Kd was associated with statistically significantly higher GHS/QoL scores compared with Vd (p<0.0001). However, the overall treatment difference point estimate of 3.5 (95% CI, 2.0-5.1) did not reach the pre-defined MID. When including the treatment by time interaction (p=0.28) to estimate the treatment difference at timepoints where HR-QoL assessments coincided with day 1 of a cycle, the point estimates increased over time, with the differences at week 60 and 72 reaching clinical significance (5.4 and 5.8, respectively) (Figure). Results from the two sensitivity analyses confirmed findings from the MMRM analysis. Statistically significant benefits were observed in favor of the Kd group for fatigue (P=0.04), pain (P=0.02), side effects (P<0.0001) and NTx subscales (p=0.0002), although these differences did not meet MID thresholds. The proportion of patients reaching a ≥5 point improvement in the GHS scale was numerically higher in the Kd group up to week 48, although the difference between the groups did not reach statistical significance. Conclusions: This analysis of PROs in the ENDEAVOR study demonstrated that Kd was statistically superior to Vd on the QLQ-C30 GHS/QoL scale, with clinically meaningful differences observed at later timepoints but not on average overall. For patients remaining on longer term treatment, the clinical benefits of Kd compared with Vd were associated with better GHS/QOL. Although not meeting MID thresholds, statistically significant benefits were also observed in favor of the Kd group for other aspects of HR-QoL. Disclosures Ludwig: Janssen: Speakers Bureau; BMS: Speakers Bureau; Takeda: Research Funding, Speakers Bureau; Amgen: Research Funding, Speakers Bureau. Moreau:Amgen: Honoraria; Celgene: Honoraria; Takeda: Honoraria; Janssen: Honoraria; BMS: Honoraria; Novartis: Honoraria. Dimopoulos:Amgen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Genesis: Consultancy, Honoraria; Celgene: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Novartis: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Janssen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees. Mateos:Janssen: Honoraria, Membership on an entity's Board of Directors or advisory committees; Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees; Amgen: Honoraria, Membership on an entity's Board of Directors or advisory committees; Takeda: Honoraria, Membership on an entity's Board of Directors or advisory committees; BMS: Honoraria, Membership on an entity's Board of Directors or advisory committees; Glicomimetics: Honoraria, Membership on an entity's Board of Directors or advisory committees. Kaiser:BMS: Consultancy, Other: Travel Support; Takeda: Consultancy, Other: Travel Support; Amgen: Consultancy, Honoraria; Janssen: Consultancy, Honoraria; Celgene: Consultancy, Honoraria, Research Funding; Chugai: Consultancy. Feng:Amgen: Employment, Equity Ownership. Cocks:Amgen: Consultancy; Celgene: Consultancy; BMS: Consultancy; Endomag: Consultancy. Buchanan:Amgen: Employment, Equity Ownership. Weisel:BMS: Consultancy, Honoraria; Novartis: Honoraria; Takeda: Consultancy, Honoraria; Amgen: Consultancy, Honoraria; Onyx: Consultancy; Janssen: Consultancy, Honoraria, Research Funding; Celgene: Consultancy, Honoraria, Research Funding.


2017 ◽  
Vol 39 (1) ◽  
pp. 57 ◽  
Author(s):  
Sabrina Nunes Garcia ◽  
Raquel De Castro Figueiredo Pereira Coelho ◽  
Pamella Naiana Dias dos Santos ◽  
Mariluci Alves Maftum ◽  
Maria De Fátima Mantovani ◽  
...  

The objective of this study was to investigate the impairment of social and emotional functions, body image and future perspective in women with breast cancer undergoing chemotherapeutic treatment. This is a longitudinal research conducted from October 2012 to October 2013 at the chemotherapy unit of a private institution of Oncology located in Curitiba, PR, Brazil. Sociodemographic and clinical questionnaires were applied, Quality of Life Questionnaire Core 30 e Quality of Life Questionnaire – Breast Cancer Module, to 48 women subjected for the first time to chemotherapy, in three different stages of the treatment. Analysis with Friedman`s, Spearman and Kruskal-Wallis nonparametric tests was performed. Changes were observed in social function and body image, which compromised quality of life significantly. Results can subsidize the planning of and adjustments to the care provided to these women by considering the perception about the impact of therapy on QL and their perspectives. 


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