Health-related quality of life (HRQoL) in advanced endometrial cancer (aEC) patients (pts) treated with lenvatinib plus pembrolizumab or treatment of physician’s choice (TPC).

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 5570-5570
Author(s):  
Domenica Lorusso ◽  
Nicoletta Colombo ◽  
Antonio Casado Herraez ◽  
Alessandro Santin ◽  
Emeline Colomba ◽  
...  
Keyword(s):  
Compliance Rate ◽  
Primary Analysis ◽  
Meaningful Improvement ◽  
Treatment Groups ◽  
Related Quality ◽  
Eortc Qlq C30 ◽  
Health Related ◽  
Eortc Qlq

5570 Background: In Study 309/KEYNOTE-775, lenvatinib + pembrolizumab (L+P) demonstrated significant and clinically meaningful improvement in OS, PFS, and ORR compared with TPC in aEC pts following prior platinum-based systemic therapy. Given the medical complexity/age of EC pts, QoL analyses are critical, but often under-reported. We present results of pt-reported HRQoL for Study 309/KEYNOTE-775. Methods: Pts were randomized 1:1 to receive lenvatinib 20 mg QD PO + pembrolizumab 200 mg IV Q3W (n=411) or TPC (n=416; doxorubicin 60 mg/m2 IV Q3W or paclitaxel 80 mg/m2 IV QW, 3 wks on/1 wk off). Pt-reported HRQoL was assessed at cycle 1 day 1, day 1 of each subsequent cycle and at time of discontinuation using EORTC QLQ-C30, its EC module QLQ-EN24, and EQ-5D-5L in treated pts who had ≥1 HRQoL assessment available. Higher scores indicate better functioning/QoL (EORTC QLQ-C30, EQ-5D-5L) or worse symptom severity (QLQ-EN24). Changes in EORTC QLQ-C30 global health status (GHS)/QoL was a secondary endpoint. This was analyzed from baseline to the latest timepoint at which overall completion was ≥60% and overall compliance was ≥80%, using constrained longitudinal data analysis; other HRQoL analyses were exploratory. Results: Completion and compliance rates of EORTC QLQ-C30 were >95% in both groups at baseline. Primary analysis was conducted at wk 12 as completion rate was 80% for L+P and 62% for TPC; compliance rate was 93% for L+P and 87% for TPC. Baseline GHS/QoL scores were similar between the L+P group and TPC group: mean (SD) of 65.74 (21.87) vs 65.69 (22.71), respectively. Over 12 wks of follow-up, pts in both groups had slight decreases in GHS/QoL. Similar decreases were observed for pts receiving L+P vs TPC: -5.97 (95% CI: -8.36, -3.58) vs -6.98 (95% CI: -9.63, -4.33). The between-group difference in least-squares (LS) mean score change from baseline to wk 12 for L+P vs TPC was 1.01 points (95% CI: -2.28, 4.31). Over time, QoL scores were generally similar across treatments. Results were similar for other HRQoL endpoints (Table). Conclusions: No significant differences were observed in HRQoL scores between treatment groups. With no standard treatment approach following failure of platinum-based therapy, these data along with previously reported efficacy and safety findings from Study 309/KEYNOTE-775 further support that L+P has an overall favorable benefit/risk profile compared to chemotherapy. Clinical trial information: NCT03517449. [Table: see text]

KEYNOTE-629: Health-related quality of life (HRQoL) with pembrolizumab (pembro) in patients (pts) with locally advanced (LA) or recurrent or metastatic (R/M) cutaneous squamous cell carcinoma (cSCC).

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 9546-9546
Author(s):  
Åse Bratland ◽  
Eva Muñoz-Couselo ◽  
Laurent Mortier ◽  
Osama Roshdy ◽  
Rene Gonzalez ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Locally Advanced ◽  
Point Change ◽  
Related Quality ◽  
Eortc Qlq C30 ◽  
Health Related ◽  
Vas Scores ◽  
Eortc Qlq

9546 Background: KEYNOTE-629 is a single-arm phase 2 study of pembro for cSCC. At second interim analysis (IA), pembro had robust and durable antitumor activity and manageable safety in LA and R/M cohorts. At first IA, pembro maintained HRQoL in the R/M cohort; LA was not analyzed because of ongoing accrual. HRQoL of pts with LA or R/M cSCC at second IA (database cutoff July 29, 2020; additional 15-mo follow-up since IA1 for the R/M cohort) is shown. Methods: Pts with LA or R/M cSCC received pembro 200 mg IV Q3W for ≤35 cycles. HRQoL was a prespecified exploratory end point assessed using EORTC QLQ-30 and EuroQol EQ-5D-5L instruments administered at baseline, wk 3, and wk 6; then Q6W through y 1; then Q9W until treatment end/discontinuation; and at the 30-day safety follow-up. HRQoL was analyzed in pts who received ≥1 pembro dose and completed baseline and ≥1 postbaseline HRQoL assessments. Mean change from baseline in EORTC QLQ-C30 global health status (GHS)/quality of life (QoL), physical functioning (PF), and EQ-5D-5L visual analog scale (VAS) scores were evaluated at wk 12 to ensure adequate completion rate and through last pt visit at wk 75 for EORTC QLQ-C30 GHS/QoL and PF scores. HRQoL was categorized as improved or deteriorated based on ≥10-point change in EORTC QLQ-C30 scores (considered clinically meaningful). Results: The HRQoL analysis population for LA had 47 pts for EORTC QLQ-C30 and EQ-5D-5L; the R/M cohort had 99 pts for EORTC QLQ-C30 and 100 for EQ-5D-5L. At wk 12, compliance rates were >75% for LA and >80% for R/M cohorts for EORTC QLQ-C30 and EQ-5D-5L. Mean change from baseline to wk 12 was minimal for EORTC QLQ-C30 GHS/QoL, PF, and EQ-5D-5L VAS scores for both cohorts (Table). Mean change from baseline in EORTC QLQ-C30 GHS/QoL and PF scores remained stable over 48 wk in the LA cohort (75-wk data unavailable) and over 75 wk in the R/M cohort. Most pts had improved or stable EORTC QLQ-C30 GHS/QoL and PF scores relative to baseline during follow-up. Conclusions: HRQoL was generally maintained with pembro in LA and R/M cSCC cohorts and was not negatively impacted by tumor progression or AEs. Clinical trial information: NCT03284424. [Table: see text]

scholarly journals Cocreated Smartphone App to Improve the Quality of Life of Adolescents and Young Adults with Cancer (Kr�ftv�rket): Protocol for a Quantitative and Qualitative Evaluation (Preprint)

2018 ◽  
Author(s):  
Abbey Elsbernd ◽  
Maiken Hjerming ◽  
Camilla Visler ◽  
Lisa Lyngsie Hjalgrim ◽  
Carsten Utoft Niemann ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Young Adults ◽  
Adolescents And Young Adults ◽  
Pilot Test ◽  
Related Quality ◽  
Eortc Qlq C30 ◽  
Health Related ◽  
Eortc Qlq

BACKGROUND Adolescents and young adults with cancer face significant challenges during the course of their medical treatment and recovery from illness. Many adolescents and young adults struggle with long-term complications in the physical, psychosocial, economic, and academic domains. Mobile health (mHealth) interventions provide an innovative platform for delivering supportive care, particularly through the utilization of apps on smartphones and tablets. To create a successful mHealth intervention for adolescents and young adults, youth input and feedback is essential. The process of cocreation, in which the target app user has a direct role in dictating design and function, was utilized to create the prototype smartphone app for adolescents and young adults with cancer, “Kræftværket.” OBJECTIVE The objective of this paper is to describe the protocol for the evaluation of the Kræftværket app, a prototype app designed via cocreation, to support and improve health-related quality of life for adolescents and young adults with cancer. METHODS The Kræftværket app has three primary features, (1) a symptom and activity diary, (2) a supportive communication network between app users, and (3) a “one-stop shop” information bank with practical information as well as links to patient organizations and other resources. The app will be evaluated in two phases, a pilot test and an implementation test. In the pilot test, the app will be launched to a test group of 20 adolescents and young adults aged 15 to 29 years, selected for equal representation amongst age group and treatment status. Patients will be allowed to utilize the app over the course of six weeks and will complete a baseline and follow-up European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) health-related quality of life inventory. In addition, participant focus group interviews will be conducted according to a semistructured interview guide. Resulting data will be analyzed using thematic analysis. Results and appropriate analysis from both the qualitative and quantitative branches of the pilot test will be discussed amongst the research group, and appropriate changes based on user feedback will be made to the app before the final project phase. In the implementation test, the app will be provided and utilized by a sample of 50 adolescents and young adults aged 15-29 years selected for equal representation amongst gender, age group, diagnosis, and treatment status over the course of 3 months. Participants will be asked to complete a baseline and follow-up EORTC QLQ-C30 HRQoL inventory. RESULTS Pilot testing is expected to take place in February 2018, and implementation testing is expected to begin May 2018. CONCLUSIONS It is the hope that Kræftværket app will serve as a beneficial and easily utilized product. The process of evaluating the app and its effect on quality of life will address the absence of evidence-based mHealth interventions, and attempt to validate new approaches to benefitting adolescents and young adult oncology patients in the digital world. REGISTERED REPORT IDENTIFIER RR1-10.2196/10098

scholarly journals Randomized Trial Assessing the Impact of Routine Assessment of Health-Related Quality of Life in Patients with Head and Neck Cancer

Cancers ◽  
2021 ◽  
Vol 13 (15) ◽  
pp. 3826
Author(s):  
Oumar Billa ◽  
Franck Bonnetain ◽  
Jérôme Chamois ◽  
Angeline Ligey ◽  
Valérie Ganansia ◽  
...  
Keyword(s):  
Head And Neck ◽  
Satisfaction With Care ◽  
Related Quality ◽  
Eortc Qlq C30 ◽  
Health Related ◽  
Eortc Qlq ◽  
The Impact ◽  
Routine Assessment ◽  
Eq Vas

The impact of routine assessment of health-related quality of life (HRQoL) on satisfaction with care and the HRQoL of patients with head and neck cancer (HNC) treated with radiotherapy was assessed. Patients with HNC were randomly assigned to two arms, with stratification on sex, cancer localization, and stage of the disease. In the intervention arm, the patients completed the EORTC QLQ-C30 and EORTC QLQ-H&N35 questionnaires first before randomization, then before each medical appointment during radiotherapy (7 weeks), and then every 3 months until 1 year and at 2 years thereafter. In the control arm, the EORTC QLQ-C30 and EORTC QLQ-H&N35 questionnaires were completed before randomization and at 1 year and 2 years thereafter. The primary endpoint was mean change in HRQoL at score at 2 years from baseline assessed by EQ VAS from the EuroQol questionnaire. The secondary endpoint was mean change in satisfaction with care at 2 years from baseline assessed by QLQ-SAT32. Two hundred patients with head and neck cancers were involved in this study (mean age, 58.83 years (range, 36.56–87.89)), of whom 100 were assigned to the intervention arm and 100 to the control arm. Patients in the intervention arm were reported to have a statistically significant increase in EQ VAS at 2 years (p < 0.0001) and exceeded the minimal clinically important difference (mean change at 2 years from baseline = 10.46). In the two arms, mean differences between arms were not statistically significant, but minimal clinically important differences in favor of the intervention arm were found for EQ VAS (mean change difference (MD) = 5.84), satisfaction with care, in particular waiting times (MD = 10.85) and satisfaction with accessibility (MD = 6.52). Routine assessment of HRQoL improves HRQoL and satisfaction with care for patients with HNC treated with radiotherapy.

scholarly journals The course of peripheral neuropathy and its association with health-related quality of life among colorectal cancer patients

2020 ◽  
Author(s):  
Cynthia S. Bonhof ◽  
Lonneke V. van de Poll-Franse ◽  
Dareczka K. Wasowicz ◽  
Laurens V. Beerepoot ◽  
Gerard Vreugdenhil ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Colorectal Cancer ◽  
Peripheral Neuropathy ◽  
Health Related Quality ◽  
Related Quality ◽  
Health Related ◽  
Eortc Qlq ◽  
The Impact

Abstract Purpose To gain more insight into the course of chemotherapy-induced peripheral neuropathy (CIPN) and its impact on health-related quality of life (HRQoL) in a population-based sample of colorectal cancer (CRC) patients up to 2 years after diagnosis. Methods All newly diagnosed CRC patients from four hospitals in the Netherlands were eligible for participation in an ongoing prospective cohort study. Patients (n = 340) completed questions on CIPN (EORTC QLQ-CIPN20) and HRQoL (EORTC QLQ-C30) before initial treatment (baseline) and 1 and 2 years after diagnosis. Results Among chemotherapy-treated patients (n = 105), a high sensory peripheral neuropathy (SPN) level was reported by 57% of patients at 1 year, and 47% at 2-year follow-up, whereas a high motor peripheral neuropathy (MPN) level was reported by 47% and 28%, at years 1 and 2, respectively. Linear mixed model analyses showed that SPN and MPN symptoms significantly increased from baseline to 1-year follow-up and did not return to baseline level after 2 years. Patients with a high SPN or MPN level reported a worse global quality of life and a worse physical, role, emotional, cognitive, and social functioning compared with those with a low SPN or MPN level. Conclusions Future studies should focus on understanding the mechanisms underlying CIPN so targeted interventions can be developed to reduce the impact of CIPN on patient’s lives. Implications for cancer survivors Patients need to be informed of both CIPN and the impact on HRQoL.

scholarly journals Reliability and validity of Amharic version of EORTC QLQ-C30 and QLQ-BR23 modules for assessing health-related quality of life among breast cancer patients in Ethiopia

2019 ◽  
Vol 17 (1) ◽  
Author(s):  
Diriba Alemayehu Gadisa ◽  
Esayas Tadesse Gebremariam ◽  
Getnet Yimer Ali
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Cancer Patients ◽  
Health Related Quality ◽  
Breast Cancer Patients ◽  
Related Quality ◽  
Eortc Qlq C30 ◽  
Health Related ◽  
Eortc Qlq

Abstract Background Breast cancer is the most common cancer among women and it affects quality of life of those women. So far, the two most frequently used tools for assessing health related quality of life in breast cancer patients, EORTC QLQ-C30 and EORTC QLQ-BR23 modules, were not validated in Ethiopia. Hence, the present study aimed to assess the psychometric properties of the tools among Ethiopian breast cancer patients. Methods Institutional based longitudinal study was conducted from January 1 to May 1, 2017 GC at only nationwide oncology center, Tikur Anbessa Specialized Hospital (TASH), Addis Ababa, Ethiopia. A total of 146 patients who visited the facility during that period, with no missing quality of life data, were selected for analysis. The psychometric properties of the EORTC QLQ-C30 and EORTC QLQ-BR23 were evaluated in terms of reliability, convergent, divergent, construct and clinical validity using SPSS version 22. Results Satisfactory internal consistency reliability (Cronbach’s α coefficients > 0.7) was confirmed, except for cognitive function (α = 0.516) of EORTC QLQ-C30 and body image (α = 0.510) of EORTC QLQ-BR23. Multiple-trait scaling analysis demonstrated a good convergent and divergent validity. No scaling errors were observed. Most items in EORTC QLQ-BR23 possessed a weak or no correlation with its own dimension in EORTC QLQ-C30 (r < 0.4) except with some of symptom scales. A statistically significant chemotherapy induced quality of life scores changes (P ≤ 0.05) were observed in all dimensions of both instruments between baseline and the end of first cycle chemotherapy, except for body image (P = 0.985) and sexual enjoyment (P = 0.817) of EORTC QLQ-BR23, indicating clinical validity. Conclusion Amharic version of the EORTC QLQ-C30 and EORTC QLQ-BR23 modules are valid and adequately reliable tool and can be used for clinical and epidemiological cancer researches to study the health related quality of life (HRQoL) of women with breast cancer in Ethiopia.

Health-Related Quality of Life As a Survival Predictor for Patients With Localized Head and Neck Cancer Treated With Radiation Therapy

2009 ◽  
Vol 27 (18) ◽  
pp. 2970-2976 ◽  
Author(s):  
François Meyer ◽  
André Fortin ◽  
Michel Gélinas ◽  
Abdenour Nabid ◽  
François Brochet ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Radiation Therapy ◽  
Head And Neck ◽  
Prognostic Value ◽  
Health Related Quality ◽  
Related Quality ◽  
Eortc Qlq C30 ◽  
Health Related ◽  
Eortc Qlq

Purpose To assess the added prognostic value for overall survival (OS) of baseline health-related quality of life (HRQOL) and of early changes in HRQOL among patients with localized head and neck cancer (HNC) treated with radiation therapy. Patients and Methods All 540 patients with HNC who participated in a randomized trial completed two HRQOL instruments before radiation therapy: the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) and the Head and Neck Radiotherapy Questionnaire. Six months after the end of radiation therapy, 497 trial participants again completed the two HRQOL instruments. During the follow-up, 179 deaths were observed. Multivariate Cox proportional hazards models were used to test whether HRQOL variables, baseline and change, provided additional prognostic value beyond recognized prognostic factors. Results The baseline EORTC QLQ-C30 physical functioning (PF) score was an independent predictor of OS. The hazard ratio (HR) associated with a 10-point increment in baseline PF was 0.87 (95% CI, 0.81 to 0.94). In multivariate models, the change in HRQOL was significantly associated with OS for most HRQOL dimensions. Among these, PF change was the strongest predictor. The magnitude of the association between PF change and survival decreased over time. At 1 year, the HR associated with a positive PF change of 10 points was 0.75 (95% CI, 0.68 to 0.83). After PF is taken into account, no other HRQOL variable was associated with survival. Conclusion Our findings indicate that both baseline PF and PF change provide added prognostic value for OS beyond established predictors in patients with HNC. Assessing HRQOL could help better predict survival of cancer patients.

scholarly journals Health-related quality of life assessed by the EORTC QLQ-C30 questionnaire in the general slovenian population

2017 ◽  
Vol 51 (3) ◽  
pp. 342-350 ◽  
Author(s):  
Vaneja Velenik ◽  
Ajra Secerov-Ermenc ◽  
Jasna But-Hadzic ◽  
Vesna Zadnik
Keyword(s):  
Quality Of Life ◽  
Health Related Quality ◽  
Linear Regression Models ◽  
Slovenian Population ◽  
Related Quality ◽  
Eortc Qlq C30 ◽  
Health Related ◽  
Eortc Qlq ◽  
The Impact

Abstract Background The aim of our study was to obtain reference data of the EORTC QLQ-C30 quality of life dimensions for the general Slovenian population. We intend to provide the researchers and clinicians in our country with the expected mean health-related quality of life (HRQL) scores for distinctive socio-demographic population groups. Methods The EORTC QLQ-C30 questionnaire supplemented by a socio-demographic inquiry was mailed or distributed to 1,685 randomly selected individuals in the Slovenian population aged 18 – 90. Answers from 1,231 subjects representing socio-demographic diversity of the Slovenian population were collected and transformed into EORTC dimensions and symptoms. The impact of socio-demographic features on HRQL scores was assessed by multiple linear regression models. Results Gender, age and self-rated social class are the important confounders in the quality of life scores in our population. Men reported better quality of life on the majority of the specific scales and, at the same time, reported fewer symptoms. There was no gender-specific difference in cognitive functioning. The mean scores were consistently lower with age in both sexes. Conclusions This is the first study to report the normative EORTC QLQ-C30 scores for one of the south-eastern European populations. The reported expected mean scores allow Slovenian oncologists to estimate what the quality of life in cancer patients would be, had they not been ill. As they are derived by common methodology, our results can easily be included in any further international comparisons or in the calculation of European summarized HRQL scores.

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