Health-related quality of life in women with breast cancer: a review of measures

Background To identify and describe the breast cancer–specific health-related quality of life (HRQoL) instruments with evidence of validation in the breast cancer population for potential use in patients treated for breast cancer (excluding surgery). Methods We conducted a systematic literature review using PubMed, Embase, and PsycINFO databases to identify articles that contain psychometric properties of HRQoL instruments used in patients with breast cancer. Relevant literature from January 1, 2009, to August 19, 2019, was searched. Articles published in English that reported psychometric properties (reliability, validity) of HRQoL instruments were identified. Results The database search yielded 613 unique records; 131 full-text articles were reviewed; 80 articles presented psychometric data for instruments used in breast cancer (including generic measures). This article reviews the 33 full articles describing psychometric properties of breast cancer-specific HRQoL instruments: EORTC QLQ-C30, EORTC QLQ-BR23, FACT-B, FBSI, NFBSI-16, YW-BCI36, BCSS, QuEST-Br, QLICP-BR, INA-BCHRQoL, and two newly developed unnamed measures, one by Deshpande and colleagues (for use in India) and one by Vanlemmens and colleagues (for use among young women and their partners). The articles that described the EORTC QLQ-C30, QLQ-BR23, and FACT-B centered on validating translations, providing additional support for content validity, and demonstrating acceptability of electronic patient-reported outcome administration. Psychometric properties of the measures were acceptable. Several new measures have been developed in Asia with an emphasis on development on cultural relevance/sensitivity. Others focused on specific populations (i.e., young women with breast cancer). Conclusions Historically, there have been limited options for validated measures to assess HRQoL of patients with breast cancer. A number of new measures have been developed and validated, offering promising options for assessing HRQoL in this patient population. This review supports the reliability and validity of the EORTC QLQ-C30 and FACT-B; new translations and electronic versions of these measures further support their use for this population.

KHẢO SÁT CHẤT LƯỢNG CUỘC SỐNG CỦA NGƯỜI BỆNH UNG THƯ PHỔI KHÔNG TẾ BÀO NHỎ TRƯỚC VÀ SAU XẠ TRỊ TẠI KHOA XẠ LỒNG NGỰC, BỆNH VIỆN K

Mục tiêu :Khảo sát chất lượng cuộc sống của người bệnh ung thư phổi không tế bào nhỏ (UTPKTBN) trước và sau xạ trị tại khoa Xạ Lồng ngực, Bệnh viện K. Đối tượng, phương pháp :105 người bệnh được chẩn đoán là Ung thư nguyên phát tại phổi giai đoạn III điều trị tia xạ. Sử dụng thang điểm Bộ câu hỏi EORTC QLQ-C30 để khảo sát chất lượng cuộc sống của người bệnh tại 2 thời điểm trước và sau xạ trị. Kết quả: Trước xạ trị điểm trung bình CLCS cao nhất thuộc về lĩnh vực “Chức năng cảm xúc” với 72,8 điểm, xếp thứ hai là “Chức năng nhận thức” đạt 72,0 điểm, còn thấp nhất là lĩnh vực “Chức năng hoạt động” 31,7 điểm. Sau xạ trị điểm trung bình về lĩnh vực chức năng lần lượt là: nhận thức (77,2), cảm xúc (76,7), xã hội (71,8), thể chất (67,1), hoạt động (31,2). Chất lượng cuộc sống chung ở mức trung bình cả 2 thời điểm nghiên cứu là 54,0 điểm. Lĩnh vực triệu chứng của người bệnh UTPKTBN giai đoạn III kể cả trước và sau xạ trị có điểm trung bình lần lượt là: mệt mỏi (68,2; 65,8), đau (54,4; 43,6), chán ăn (53,0; 50,2), mất ngủ (52,5; 28,5) và khó thở (31,7; 25,9). Các triệu chứng buồn nôn, táo bón và tiêu chảy ít gặp với điểm trung bình dưới 20 điểm cả 2 thời điểm. Vấn đề khó khăn tài chính của đối tượng nghiên cứu có điểm ở mức trung bình (60,4; 63,8). Kết luận: Với nhóm đối tượng nghiên cứu thì vấn đề chức năng của người bệnh tốt, vấn đề về sức khỏe ở mức độ trung bình.

Health-related quality of life among cervical cancer patients at Kenyatta National Hospital

Background Previous study showed that health-related quality of life (HRQoL) was adversely affected during treatment of cervical cancer, with a worsening global score. Therefore, this study aimed to determine the HRQoL of cervical cancer patients at Kenyatta National Hospital. Methods A cross-sectional study design was employed among cervical cancer patients. All eligible consecutive samples of 103 cervical cancer patients were included in the study. Following consent, patients were interviewed using The European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire 30 (EORTC QLQ-30) and Cervical Cancer Module CX24 (EORTC QLQ-CX24). The data were entered and analyzed using the SPSS version 20.0 software. Univariate and multivariate binary logistic regression analysis was employed to investigate the predictors of HRQoL. A p-value of ≤ 0.05 was considered statistically significant. Results The majority (69%) of the patients had a poor overall quality of life while 31% of study participants had a good quality of life. Patients with early-stage disease were 7.3 times (AOR = 7.3, 95% CI = 2.4–21.7, p = 0.000) more likely to have a good HRQoL than patients with advanced-stage disease. Patients with no comorbidities were 3.1 times (COR = 3.1, 95% CI = 1.1–9.1, p = 0.037) more likely to have a good HRQoL than patients with comorbidities. Conclusion The overall HRQoL among cervical cancer patients was poor in the setting. Advanced stage of disease and presence of comorbidities were the significant predictors of poor quality of life.

FIVE YEARS SURVIVAL AND QUALITY OF LIFE AFTER RADICAL NEPHRECTOMY: A DESCRIPTIVE SINGLE CENTER STUDY

Objective: This study aims to evaluate five years of survival rate, and quality of life of the patient after radical nephrectomy in our center. Material & Methods: This descriptive longitudinal study included thirty patients who were diagnosed as having renal mass in the Urology division H. Adam Malik General Hospital between January 2014 and December 2015. All patients were completely followed-up for 5 years or the patient died during the observation. We used a translated and validated Indonesian written European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) questionnaire to assess the patient’s quality of life. Results: Overall 5-years survival of kidney tumor patients was 100%, 66.67%, 50%, 8.33%, respectively for stage 1 to 4. We found a sharp decrease in the cumulative survival rate of stage IV group in the first 24 months compared to the first 12 months, from 66.67% to 25%. This pattern of decrease was not found in the other group of stage. Overall, the quality of life of patients has increased in the first three years postoperatively and decreased in the two years afterward. These fluctuations consistently occur in all groups. All of the groups had reached the maximum quality of life at the third year postoperatively. Conclusion: Stage I renal cell carcinoma patient shown the best five-years survival rate and quality of life among others. The quality of life for all groups inclined for the first three years after surgery and decline consistently afterward. These findings are in accordance with many studies that have been published previously.

Two-year quality of life after robot-assisted radical prostatectomy according to pentafecta criteria and cancer of the prostate risk assessment (CAPRA-S)

The quality of life (QoL) of men with optimal outcomes after robot-assisted radical prostatectomy (RARP) is largely unexplored. Thus we assessed meaningful changes of QoL measured with the EORTC QLQ-C30 24 months after RARP according to postsurgical Cancer of the Prostate Risk Assessment score (CAPRA-S) and pentafecta criteria. 2871 prostate cancer (PCa) patients with completed EORTC QLQ-C30 were stratified according to CAPRA-S, pentafecta (erectile function recovery, urinary continence recovery, biochemical-recurrence-free survival (BFS), negative surgical margins) and 90-day Clavien–Dindo-complications (CDC) ≤ 3a. Multivariable logistic regression analyses (LRM) aimed to predict improvement of EORTC QoL. Mean preoperative QoL values did not significantly differ between CAPRA-S low- (LR) vs. high-risk (HR, 75.7 vs. 75.2; p = 0.7) and pentafecta vs. non-pentafecta groups (75.6 vs. 75.2; p = 0.6). After RARP, stable QoL rates for CAPRA-S LR vs. HR and pentafecta were 30, 26 and 30%, respectively. Corresponding improved QoL rates were 44, 32 and 47%. In LRM, CAPRA-S and pentafecta criteria were independent predictors of improved QoL. We conclude that most favourable combined outcomes after RARP might confer stable or even improved QoL but up to one third of patients might experience deterioration. This warrants further investigation how to capture the underlying cause and to address and potentially solve these perceived negative effects despite successful RARP.

Quality of Life of Emirati Women With Breast Cancer

Background: This study examined the quality of life of Emirati women with breast cancer (BC).Methods: This study was a population-based study of a random sample of 250 Emirati women with BC. Quality of life (QoL) was assessed using the European Organization for Research and Treatment of Cancer Quality of Life Cancer-Specific version (EORTC QLQ-C30, v.3.0) and the EORTC QoL Breast Cancer-Specific version (EORTC QLQ-BR23) translated into Arabic.Results: The mean age and median age of the 250 participants were 53.4 (SD ±11.3) and 52 years, respectively.Participants had a mean global health score of 74.73 (SD ±18.25), with a minimum of 16.67, indicating a good level of wellbeing.On the QLQ-C30, the Emirati women seemed to perform well on the functional scales but poorly on the symptom scales. While social functioning scored the highest (82.33 ±28.38) among the functional scales, emotional functioning scored the lowest (68.43 ±30.02). The most worrying symptom was sleep disturbance (47.87±38.46), followed by fatigue (38.18±30.31) and pain (29.13±28.01). Financial impact scored the lowest, indicating that most women did not have financial issues related to their cancer.On the QLQ-BR23, we found that participants performed above average to very good on the functional scales but poorly on the symptom scales. While sexual functioning scored the highest (86.07±22.61) among the functional scales, future perspective scored the lowest (50.80±37.92). The most worrying symptom was upset by hair loss (61.01±37.35), followed by arm symptoms (33.73±28.08).Conclusions: Emirati BC survivors reported good QoL overall. The most bothersome symptoms were sleep disturbance, fatigue, pain, hair loss and arm symptoms. Emirati women scored average on all functional scales, which indicates mediocre functioning, but high on the symptom scales, which indicates worse symptoms. Factors associated with a decline in the domains of QoL included age, income, education, metastases, mastectomy, and lymph node dissection. Recommendations to address these issues are discussed.Trial Registration: NA

Statistical analysis plan for the Dual mTorc Inhibition in advanCed/recurrent Epithelial ovarian, fallopian tube or primary peritoneal cancer (of clear cell, endometrioid and high-grade serous type, and carcinosarcoma) trial (DICE)

Background Treatment for ovarian cancer includes platinum-based chemotherapy, but many women become resistant to chemotherapy, becoming platinum-resistant. Standard of care for these women is weekly paclitaxel chemotherapy, but cancers can often become paclitaxel resistant. TAK228, an investigational dual TORC1/2 inhibitor, is an oral therapy that can be added to standard treatment. The DICE trial is a phase II international multicentre, parallel-group, superiority clinical trial with 1:1, open label randomisation which has the aim of investigating the effectiveness of TAK228 plus weekly paclitaxel. The planned sample size is 124 women (62 per treatment arm) with platinum-resistant ovarian cancer. Objective To outline the planned analyses for DICE in a statistical analysis plan (SAP) before database hard lock and the start of analysis. This ensures that bias is minimised during the analysis phase. Results This SAP provides detailed descriptions of the analysis principles and statistical procedures for analysing primary and secondary outcomes of the trial. The primary outcome is overall progression-free survival (PFS). Secondary outcomes include progression-free survival (PFS) at 24 weeks, overall response rate (ORR), duration of response (DoR), time to progression (TTP), clinical benefit rate (CBR) at 4 months, Cancer Antigen 125 (CA125) response according to Gynaecological Cancer Intergroup (GCIG) criteria, overall survival (OS), safety and tolerability as assessed by adverse events and the quality-of-life questionnaires (EORTC QLQ-C30 and EORTC QLQ-OV28). This detailed description includes significance levels, sensitivity analyses and compliance analysis. Discussion The DICE trial will determine whether the addition of TAK228 to weekly paclitaxel chemotherapy shows a statistically significant improvement to participant’s progression free and overall survival and that the adverse events (AEs) and quality of life (QoL) are not significantly worse than the standard treatment. The study commenced recruitment in September 2018. An interim analysis was performed in early 2021, the results of which advised continuation of the trial. The study recruitment is ongoing and is due to complete by the end of 2021. Trial registration ClinicalTrials.govNCT03648489. Registered on 27 August 2018

Influência dos Cânceres Gástrico e Hematológico na Qualidade de Vida e na Funcionalidade de Pacientes Oncológicos

Introdução: O câncer é uma doença complexa, sendo a segunda maior causa de morte no Brasil e no mundo, com uma média de 9,8 milhões de óbitos ao ano. Objetivo: Verificar a influência do tipo de câncer, gástrico ou hematológico, na qualidade de vida e na funcionalidade dos indivíduos. Método: Trata-se de um estudo clínico, transversal, analítico e de abordagem quantitativa. Utilizaram-se na coleta de dados uma ficha com dados demográficos, antropométricos, habituais e da doença, o Quality of Life Questionnaire-Core30 da European Organization for Research and Treatment of Cancer (EORTC QLQ-C30) e a Escala de Performance de Karnofsky (KPS). Resultados: Foram avaliados 29 pacientes no total; destes, 19 pacientes com câncer hematológico (Grupo A) e dez com câncer gástrico (Grupo B). A correlação entre idade, EORTC QLQ-C30 e KPS foi positiva entre a idade e os sintomas (r=,571, p=0,011) e a idade e a somatória total do EORTC QLQ-C30 (r=,548, p=0,015); e negativa entre a KPS e os sintomas (r=-,495, p=0,031) e a KPS e a somatória total do EORTC QLQ-C30 (r=,-580, p=0,009) no grupo A. No grupo B, não foi observada nenhuma correlação entre essas variáveis. Conclusão: Pacientes com câncer hematológico e câncer gástrico apresentam redução da qualidade de vida, sendo observada uma diminuição da funcionalidade nos pacientes com câncer hematológico quando comparado ao câncer gástrico. A redução da função nesses indivíduos pode estar diretamente relacionada com a idade e os sintomas físicos apresentados.

Minimal important differences of EORTC QLQ-C30 for metastatic breast cancer patients: Results from a randomized clinical trial

Purpose To establish minimal important differences (MIDs) for the European Organisation for Research and Treatment for Cancer Quality of life Questionnaire core 30 (EORTC QLQ-C30) in patients with metastatic breast cancer. Methods The dataset was obtained from the SELECT BC-CONFIRM randomized clinical trial. Anchors obtained from patients (transition items) and clinicians (performance status) were used for anchor-based methods. Anchors obtained through 6 months after starting treatment were used for this analysis. Correlation coefficients of anchor and change in QLQ-C30 and effect size were used to qualify for estimating MIDs. Mean change method and generalized estimating equation were applied to estimate MIDs. Distribution-based methods were used for comparison. Results We analyzed a dataset of 154 metastatic breast cancer patients. MIDs were estimated in 8 of 15 scales of QLQ-C30. Estimated MIDs for within-group improvement varied from 7 to 15 and those for deterioration varied from − 7 to − 17. Estimated MIDs for between-group improvement varied from 5 to 11 and those for deterioration varied from − 5 to − 8 across QLQ-C30 scales. Patient-reported anchors were more susceptible to early changes in health status than clinician-reported anchors. Conclusion We provided the MIDs of the QLQ-C30 using both patient- and clinicians-reported anchors measured in a randomized trial of Japanese patients with metastatic breast cancer. We recommend patient-reported anchors for anchor-based estimation of MID. Our results can aid patients and clinicians, as well as researchers, in the interpretation of QLQ-C30.

Compression Therapy for HIV-Associated Kaposi Sarcoma Leg Lymphedema: Results of the Kenyan Improvised Compression for Kaposi Sarcoma Randomized Controlled Trial

PURPOSE Evaluate the effectiveness of compression while receiving chemotherapy compared with chemotherapy alone in the treatment of HIV-associated Kaposi sarcoma (KS) lymphedema. METHODS A randomized controlled trial was conducted in a single oncology clinic in western Kenya ( NCT03404297 ). A computer-generated randomization schedule was used to allocate treatment arms. Randomized block design was used for stratification by lymphedema stage. Participants were HIV positive adults age ≥ 18 years on antiretroviral therapy with biopsy-proven KS associated with leg lymphedema and being initiated on chemotherapy. The intervention was 10 weeks of weekly clinic-based application of two-component paste compression bandages. The primary outcome was change in the Lower Extremity Lymphedema Index (LELI) score from week 0 to week 14. The secondary outcomes were change in the Lymphedema Quality of Life measure (LYMQOL) and change in the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 score from week 0 to week 14. Blinded outcome assessments were conducted. RESULTS Of 30 participants randomly assigned, 25 eligible patients (chemotherapy [control], n = 13; compression plus chemotherapy [intervention], n = 12) returned at week 14. Change in LELI, LYMQOL, and EORTC QLQ-C30 scores between week 14 and week 0 did not significantly differ by arm. The mean (standard deviation) change in LELI score was –25.9 (34.6) for the control arm compared with –13.3 (29.5) for the intervention arm, P = .340. The difference (95% CI) in the change in LELI score was –12.6 (–39.3 to 14.1). CONCLUSION Future studies evaluating a 14-week change in LELI for KS lymphedema should assume a standard deviation of approximately 30. Lessons learned from this pilot trial should inform the development of a larger, multicenter trial to evaluate the effectiveness of compression for KS lymphedema.