Measuring the functional decline of people with advanced-stage non-small cell lung cancer (NSCLC).

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e19605-e19605
Author(s):  
Linda Denehy ◽  
Andrew Murnane ◽  
Meinir Krishnasamy ◽  
Karla Gough ◽  
Catherine Granger ◽  
...  

e19605 Background: People affected by lung cancer maybe highly symptomatic. This study aimed to quantify changes in physical function and health-related quality of life (HRQoL) in patients with advanced NSCLC. Methods: A prospective cohort study was performed. Patients with stage III and IV NSCLC were recruited within one month of starting treatment and assessed at baseline, 2, 4 and 6 months or until they became too unwell. HRQoL and functional status were measured using the EORTC QLQ-C30, the 6-minute walk test (6MWT) and timed up and go test (TUG). Comparisons between baseline and follow-up assessments were carried out by fitting linear mixed models to each outcome separately. Results: 39 patients (21 male) were included in the analysis; median age of 63 (range 40-80). 59% were receiving treatment with curative intent. 28% had stage 4 disease with 26% deceased by 4 months. Response rates at 2 and 4 months were 71.8% and 53.8% for 6MWT and TUG and 87.2% and 64.1% for EORTC. The mean 6MWT at baseline was significantly lower than predicted for the age, sex and height of the cohort (417.9 versus 550.4 metres, p<0.0005). Significant decline in mean 6MWT distance was seen at 2 (decrease of 42.4m, 95%CI -59.0, -25.7, p<0.0005) and 4 month follow-ups (decrease of 63.6m, 95%CI -85.6, -41.5, p<0.0005) compared to baseline. Significant increases in time taken to complete the TUG were also seen at 2 (increase of 0.76 sec, 95%CI 0.54 – 0.98, p<0.0005) and 4 month follow-ups (increase of 1.01 sec, 95%CI 0.76 – 1.27, p<0.0005) compared with baseline. In contrast, global health status and physical functioning as assessed by the QLQ-C30 showed small but significant decreases at the 2 month follow-up compared to baseline (decrease of 8.04, p=0.01 and decrease of 7.67, p=0.024 respectively), but no significant differences between baseline and the 4 month follow-up. Conclusions: Patients with advanced NSCLC show clinically and statistically significant decrements in physical function at commencement of treatment. This continues to decline rapidly and significantly over time, despite small changes in self-reported HRQoL. The 6MWT demonstrated clinically relevant changes in physical function. Interventions to address this problem are urgently needed.

2019 ◽  
Author(s):  
Duc Ha ◽  
Andrew L. Ries ◽  
Scott M. Lippman ◽  
Mark M. Fuster

AbstractBackgroundLung cancer treatment can lead to negative health consequences. We analyzed the effects of curative-intent lung cancer treatment on functional exercise capacity (EC) and patient-reported outcomes (PROs).MethodsWe performed a prospective-observational cohort study of consecutive patients with stage I-IIIA lung cancer undergoing curative-intent therapy and assessed functional EC [primary outcome, six-minute walk distance (6MWD)], cancer-specific quality of life (QoL) [secondary outcome, European Organization for Research and Treatment of Cancer QoL Questionnaire Core 30 (EORTC-QLQ-C30) summary score], and exploratory outcomes including dyspnea [University of California San Diego Shortness of Breath Questionnaire (UCSD-SOBQ)] and fatigue [Brief Fatigue Inventory (BFI)] symptoms before and at 1 to 3 months post-treatment. We analyzed the time effect of treatment on outcomes using multivariable generalized estimating equations.ResultsIn 35 enrolled participants, treatment was borderline-significantly associated with a clinically-meaningful decline in functional EC [(mean change, 95% CI) 6MWD = −25.4m (−55.3, +4.47), p=0.10], non-significant change in cancer-specific QoL [EORTC-QLQ-C30 summary score = − 3.4 (−9.8, +3.0), p=0.30], and statistically-significant and clinically-meaningful higher dyspnea [UCSD-SOBQ = +13.1 (+5.7, +20.6), p=0.001] and increased fatigue [BFI = +10.0 (+2.9, +17.0), p=0.006].ConclusionsAmong the first prospective analysis of the effect of curative-intent lung cancer treatment on functional EC and PROs, we observed worsening dyspnea and fatigue, and possibly a decline in functional EC but not cancer-specific QoL at 1 to 3 months post-treatment. Interventions to reduce treatment-related morbidities and improve lung cancer survivorship may need to focus on reducing dyspnea, fatigue, and/or improving functional EC.Consent and ApprovalWritten informed consent was obtained from each participant included in this study. All human investigations were performed after approval by the VA San Diego Healthcare System institutional review board and in accord with an assurance filed with and approved by the U.S. Department of Health and Human Services.


2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e20576-e20576
Author(s):  
C. Coens ◽  
F. Martinelli ◽  
C. Quinten ◽  
C. S. Cleeland ◽  
E. Greimel ◽  
...  

e20576 Background: Increasingly randomized controlled trials in cancer research include Health-related Quality of Life (HRQoL) alongside traditional biomedical outcome measures. The majority of these trials focus on a general cancer HRQoL measure. The objective of this meta-analysis was to identify which HRQoL indicators influence a patient's overall quality of life, in order to better understand the changes in such a generic scale. Methods: Retrospective pooling of 29 European Organisation for Research and Treatment of Cancer (EORTC) clinical trials, among 10 cancer sites, yielded baseline EORTC QLQ-C30 data for a total of 6,739 patients. A cluster analysis, using Ward's method, was performed to determine how the 15 HRQoL indicators, and the Global Health scale (GH) in particular, cluster overall and by cancer characteristics. Cronbach's alpha coefficient (α) was used to measure internal consistency. Dendrograms of the HRQoL indicators were plotted for each cancer type. Results: Three main clusters emerged: a physical function related cluster (physical functioning, role functioning, fatigue and pain, α = 0.83), a psychological function related cluster (emotional functioning, cognitive functioning and insomnia, α = 0.64) and a gastrointestinal cluster (nausea and vomiting and appetite loss, α = 0.68). The GH scale was found to be part of the physical function cluster in the overall dataset (α = 0.85). This result was reproduced for both metastatic and non-metastatic patients. When looking across the 10 different cancer sites, the GH scale was mainly linked with a physical component in brain, head and neck, lung, melanoma, ovarian, pancreatic and prostate cancer. However, in breast and testicular cancer, GH was more strongly associated with the emotional scales. Conclusions: This study shows that the GH scale of the EORTC QLQ-C30 is most strongly linked with a patient's physical status. This result is consistent across stage of disease and most cancer sites. The different results seen in patients with breast and testicular cancer deserve additional investigation. No significant financial relationships to disclose.


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 9546-9546
Author(s):  
Åse Bratland ◽  
Eva Muñoz-Couselo ◽  
Laurent Mortier ◽  
Osama Roshdy ◽  
Rene Gonzalez ◽  
...  

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]


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 5570-5570
Author(s):  
Domenica Lorusso ◽  
Nicoletta Colombo ◽  
Antonio Casado Herraez ◽  
Alessandro Santin ◽  
Emeline Colomba ◽  
...  

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]


2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 7607-7607
Author(s):  
Divine Ewane Ediebah ◽  
Corneel Coens ◽  
Efstathios Zikos ◽  
Chantal Quinten ◽  
Jolie Ringash ◽  
...  

7607 Background: Over 60 cancer clinical trials have shown that baseline health-related quality of life (HRQoL) scores are prognostic for patient survival. Few studies have investigated the added value of change in HRQoL scores. Our aim was to investigate if change in HRQoL scores from baseline over time is also associated with survival. Methods: We analyzed data from an EORTC 3-arm randomized clinical trial (RCT) in advanced non-small-cell lung cancer (NSCLC) patients, comparing gemcitabine+cisplatin, versus paclitaxel+gemcitabine, versus standard arm paclitaxel+cisplatin. HRQoL was measured in 394 patients using the EORTC QLQ-C30 at baseline and after each chemotherapy cycle. The prognostic significance of sex, age and WHO performance status (0-1 vs. 2) and the 15 QLQ-C30 subscales were assessed with Cox proportional hazard models stratified for treatment (level of significance 0.05). Changes in HRQoL scores from baseline to each chemotherapy cycle assessment were categorized as “improved”, “stable” and “worsened” using a threshold of 10 points difference. Due to expected attrition, the analysis was limited to changes from baseline up to cycle 3. Results: There were 248 patients in cycle 1, 212 in cycle 2 and 196 in cycle 3. We performed analyses separately using data at cycle 1, cycle 2, and cycle 3. In all analyses, HRQoL in various subscales and socio-demographic and clinical variables (physical functioning (hazard ratio [HR] 0.91, 95% CI 0.85-0.98; p=0.0103), pain (1.11, 1.05-1.17; p= 0.0004), age (0.98, 0.97-1.00, p=0.0413) and WHO performance status (1.77, 1.09-2.89; p=0.0218) at cycle 1; pain (1.11, 1.03-1.20; p=0.0016), age (0.98, 0.96-1.00; p=0.0217) and sex (0.63, 0.42-0.95; p=0.0081) at cycle 2; and role functioning (0.93, 0.88-1.00; p=0.0128) and age (0.98, 0.96-1.00; p=0.0081) at cycle 3) predicted survival; however, change in HRQoL was only an independent predictor for improvement at cycle 1. Conclusions: Our findings suggest that change from baseline over time in HRQoL, as measured on subscales of the EORTC QLQ-C30, contains added prognostic value for survival independent of baseline HRQoL scores. Further work is needed to assess the robustness and sensitivity of these findings.


2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 9575-9575
Author(s):  
Paul K. Paik ◽  
Leora Horn ◽  
Dariusz M. Kowalski ◽  
Jyoti D. Patel ◽  
Frank Griesinger ◽  
...  

9575 Background: In the phase II VISION study (NCT02864992) tepotinib had promising efficacy (response rate of 40–50% & median duration of response >1 y) and tolerable safety in pts with advanced NSCLC with METex14 skipping (3–4% of NSCLC), who are typically elderly with poor prognosis. Pt reported outcomes (PROs) of HRQoL are described here. Methods: Pts with advanced NSCLC positive for METex14 skipping by tissue or liquid biopsy received oral tepotinib 500 mg once daily; PROs were assessed using QLQ-LC13 (lung cancer symptoms), EORTC QLQ-C30 (Global health status [GHS] & 5 functional scales), and EQ-5D-5L (VAS). Questionnaires were completed at baseline (BL) and every 6 weeks (Wk); results were scored from 0–100 (minimal clinically important difference [MCID] ≥10 points). Mean change from BL was analyzed at Wk 12 (predefined analyses). Results: By 19 Jul 19 cut-off, 130 pts across treatment lines were enrolled (median age 74.2 y), with PROs available for 129. Questionnaire completion rates were 90.1% at Wk 12. Symptom burden at BL was moderate for advanced NSCLC; mean change from BL for PROs are shown in the table (better functioning: lower QLQ-LC13 or higher QLQ-C30 scores). For the QLQ-LC13 symptoms, mean changes from BL indicated a meaningful improvement in coughing, with a median time to improvement (2.8 months) paralleling the onset of objective response (within first 3 months), and a numerical improvement in dyspnea (–2.3 at Wk 12) and chest pain (–4.2 at Wk 12). QLQ-C30 values remained stable over treatment as did EQ-5D-5L scores (higher=better): mean (standard deviation, SD) change from BL score (60 [20.4]) was 6 (18.6) at Wk 6 and 5 (20.9) at Wk 12. Conclusions: In this first analysis of PROs in pts with advanced NSCLC with METex14 skipping with a moderate symptom burden, treatment with tepotinib led to a clinically meaningful improvement in coughing symptoms, while maintaining HRQoL. Coupled with the efficacy and safety profile, the predefined HRQoL analysis from the VISION study supports tepotinib as a promising treatment option for this elderly population with METex14+ NSCLC. Clinical trial information: NCT02864992 . [Table: see text]


QJM ◽  
2020 ◽  
Vol 113 (Supplement_1) ◽  
Author(s):  
S A Abdelwahab ◽  
A S Tawfik ◽  
N A Mosalam ◽  
E M E Ghazy

Abstract Background Lung cancer is the most commonly diagnosed cancer worldwide for both sexes. There are 1.8 million new cases in 2012 (12.9% of the total), 58% of which occurred in the less developed regions. The disease remains the most common cancer in men worldwide (1.2 million, 16.7% of the total) and the most common causes of cancer deaths worldwide for both sexes, estimated to be responsible for nearly one in five (1.59 million deaths, 19.4% of the total) Aim of the Work are to evaluate the effect of platinum-based chemotherapy combinations as a first line treatment on health related quality of life (HRQOL) in advanced NSCLC Egyptian patients and to assess tumor’s response to treatment and treatment toxicity. Patients and Methods A prospective, single arm clinical study, to evaluate the effect of palliative chemotherapy on advanced NSCLC patient’s health related quality of life before starting chemotherapy and after 3 cycles of treatment, patient’s response to treatment and toxicity related to treatment. Results 61 patients completed the EORTC QLQ-C30 and the QLQ-LC13 for the evaluation of HRQoL before the 1st cycle of chemotherapy. Started with 70 patients, 9 were excluded during the study (because of a change in the chemotherapy protocol or because of treatment discontinuation during the following cycles of chemotherapy. Conclusion The present study explored self-reported quality of life in advanced NSCLC patients receiving chemotherapy, Aiming for a better understanding of how chemotherapy influences HRQoL. The importance of patient perception of their own health regarding the complexity of cancer, which is a disease that affects every dimension of life and the way in which individuals perceive the environment, the diagnosis, and the therapy. Therefore, the combination of periodic quality of life assessments and clinical practice should be more extensively.


2018 ◽  
Author(s):  
Abbey Elsbernd ◽  
Maiken Hjerming ◽  
Camilla Visler ◽  
Lisa Lyngsie Hjalgrim ◽  
Carsten Utoft Niemann ◽  
...  

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


BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Yacir El Alami ◽  
Hajar Essangri ◽  
Mohammed Anass Majbar ◽  
Saber Boutayeb ◽  
Said Benamr ◽  
...  

Abstract Background Health-related quality of life is mainly impacted by colorectal cancer which justified the major importance addressed to the development and validation of assessment questionnaires. We aimed to assess the validity and reliability of the Moroccan Arabic Dialectal version of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (QLQ-C30) in patients with colorectal cancer. Methods We conducted a cross-sectional study using the Moroccan version of the EORTC QLQ-C30 on colorectal cancer patients from the National Oncology Institute of Rabat, in the period from February 2015 to June 2017. The QLQ-C30 was administered to 120 patients. Statistical analysis included reliability, convergent, and discriminant validity as well as known-groups comparisons. Results In total, 120 patients with colorectal cancer were included in the study with 38 (32%) patients diagnosed with colon cancers. Eighty-two patients (68%) had rectal cancer, among which 29 (24%) patients with a stoma. The mean age of diagnosis was 54 years (+/− 13.3). The reliability and validity of the Arabic dialectal Moroccan version of the EORTC QLQ-C30 were satisfactory. [Cronbach’s alpha (α =0.74)]. All items accomplished the criteria for convergent and discriminant validity except for question number 5, which did not complete the minimum required correlation with its own scale (physical functioning). Patients with rectal cancer presented with bad Global health status and quality of life (GHS/QOL), emotional functioning as well as higher fatigue symptoms compared to patients with colon cancer. The difference between patients with and without stoma was significant for diarrhea and financial difficulty. Conclusions The Moroccan Arabic Dialectal version of the QLQ-C30 is a valid and reliable measure of health-related quality of life (HRQOL) in patients with colorectal cancer.


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