Quality of life in a multicenter phase II trial of metastasectomy for intra- and extra-hepatic metastases from colorectal adenocarcinoma.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e14573-e14573
Author(s):  
Alice Chia-chi Wei ◽  
Pablo Emilio Serrano Aybar ◽  
Sean P. Cleary ◽  
Natalie G. Coburn ◽  
Paul David Greig ◽  
...  

e14573 Background: The combination of intra- and extra-hepatic metastases (IHM and EHM) from colorectal cancer (CRC) has traditionally been considered a contraindication for surgery. Currently there is a growing interest in resecting IHM and EHM. The purpose of this study was to evaluate the health related quality of life (HRQoL) of patients with IHM and EHM from CRC undergoing complete metastasectomy. Methods: Participants with any number of CRC IHM and up to 3 foci of EHM, resectable with RO intent were eligible for the HRQoL component of a Phase-II multi-institutional trial. The effects of therapy on HRQoL were evaluated using: EORTC-QLQ C30, EORTC-LMC21 and FACT-HEP at baseline, prior to surgery and at 4, 8 and 12 months following complete metastasectomy. Results were compared to baseline. >10% mean score change was considered a minimally important clinical difference (MICD). Results: Twenty-five participants were enrolled with a median age: 57 (range: 32-84) years. Protocol surgery was completed in 18/25 (72%) including 11/25 (44%) staged resections. Perioperative morbidity and mortality was 11/25 (44%) and 1/25 (4%), respectively. Median disease-free survival was 6 (range: 0-17) months. 22/25, 88% participants underwent perioperative chemotherapy. EORTC-QLQ C30 Global-HRQoL remained statistically and clinically unchanged compared to baseline at 4 and 8 months but had a MCID decrease at 12 months (mean score change: 15.3) that was not statistically significant. This was associated with a significant decrease in social and role functioning and an increase in fatigue, pain and dyspnea. FACT-Hep score was statistically lower at 4 months post surgery, without reaching a MICD. There was no difference in any of the subscales analyzed in regards to sex, age or the presence of peri-operative complications. Conclusions: Aggressive metastasectomy of multi-site CRC is feasible and safe. Despite disease recurrence in the majority of patients there was no significant deterioration of Global HRQoL as a result of treatment. There was a transient effect on symptoms including fatigue, pain dyspnea and role functioning, which improved by 12 months. Clinical trial information: NCT00606398.

2020 ◽  
Author(s):  
Jeong Hye Kim ◽  
Ju Ri Jung

Abstract Background Esophageal cancer patients experience physical and psychological difficulties after surgery. This study aimed to identify the changes in psychological distress and quality of life in patients with esophageal cancer before surgery to three months after surgery. Methods We enrolled 49 patients who were scheduled to undergo esophageal surgery at a tertiary hospital in Seoul, South Korea in this prospective study. Patients’ psychological distress and quality of life were assessed with the Korean scales HADS, EORTC QLQ-C30, and QLQ-OES18 at the pre-surgery, one-month post-surgery, and three months post-surgery. Results Moderate-to-severe depression was reported in 12.2% of patients at the pre-surgery evaluation, in 57.1% of patients one-month post-surgery, and 8.2% of patients three-months post-surgery. Moderate-to-severe depression was reported in 12.2% of patients at the pre-surgery evaluation, in 63.3% of patients one-month post-surgery, and 16.3% of patients three months post-surgery. Clinically significant, moderate changes (10–20 points) in physical functioning, insomnia, nausea and vomiting, and dyspnea, and significant, large changes (> 20) in role functioning, fatigue, pain, and appetite loss (per EORTC QLQ-C30) were reported from pre-surgery to one-month post-surgery. Clinically significant, moderate changes (10–20 points) in dysphagia and taste problems and a significant, large change (> 20) in eating difficulties (per QLQ-OES18) were reported from pre-surgery to one-month post-surgery. Conclusion One month after esophageal cancer surgery, patients demonstrated severe psychological distress and worsening quality of life.


Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 4111-4111
Author(s):  
Qiufei Ma ◽  
Abigail Bailey ◽  
Neil Milloy ◽  
Jake Butcher ◽  
Ruben G.W Quek ◽  
...  

Abstract Introduction: Diffuse large B-cell lymphoma (DLBCL) is the most common type of aggressive non-Hodgkin's lymphoma (NHL) constituting 30-58% of all NHL (Tilly et al, 2015; Thieblemont et al, 2020). Treatment can include intensive multiagent chemotherapy and other novel therapies which carries risk for toxicities. Despite this, we lack data comprehensively depicting the quality of life of real-world patients with DLBCL, particularly in the modern era with novel therapies. Therefore, we aimed to compare Quality of Life (QoL) to reference populations and assess real-world DLBCL patients across multiple countries and lines of therapy. Methods: Real-world data were drawn from the Adelphi DLBCL Disease Specific Programme™ (DSP), a point-in-time survey of hematologists, hemato-oncologists, oncologists and their patients with DLBCL conducted in France (FR), Germany (DE), Italy (IT), Spain (SP), the United Kingdom (UK) and the United States of America (US) between Jan-May 2021. Patients were asked to voluntarily complete a patient self-completion form (PSC) capturing demographics and QoL data through the use of patient-reported outcome instruments: the European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-C30), EuroQol 5-dimension 5-level questionnaire (EQ-5D-5L), EQ-5D-5L Visual Analogue Scale and Work Productivity and Activity Impairment questionnaire. Bivariate analysis was conducted to compare all cancer and NHL-specific reference values from the EORTC QLQ-C30 manual (Scott et al, 2008) to DLBCL DSP data, and to review QoL across lines of therapy, defined as first line and second line (1L+2L) and third line and above (3L+). Statistical significance level was set at p<.05. If functional scores were lower, when compared to reference values, within the DSP, this was indicative of a worse QoL in patients with DLBCL. For symptomatic scores the opposite was true; should the DSP value be higher, this was indicative of a worse QoL in patients with DLBCL. Results: Data analysis was conducted on 441 patients with DLBCL who completed a PSC (FR: n=80, DE: n=150, IT: n=54, SP: n=43, UK: n=34, US: n=80); at data collection, mean (standard deviation) age was 64.6 (12.39) years, 36% of patients were female, 19% working full- or part-time and 80% were relapsed/refractory, 29% were 3L+. 8%, 24%, 28% and 40% were at Ann Arbor disease stage I, II, III and IV respectively at the time of data collection. When comparing DLBCL DSP values to EORTC QLQ-C30 all cancer reference values for functional scores (Table 1), global health status, physical functioning, role functioning, emotional functioning, cognitive functioning and social functioning were significantly worse than all cancer reference values. In terms of symptoms, DSP values for fatigue, nausea and vomiting, dyspnea, appetite loss and diarrhea were significantly worse than all cancer reference values (Table 2). Results were mixed when comparing with EORTC QLQ-C30 NHL-specific reference values (Table 1) for functional scores; global health status was significantly worse for the DLBCL DSP population, whilst role functioning, cognitive functioning and social functioning were significantly better than NHL reference values. Significantly worse symptom scores were observed in the DLBCL DSP population (Table 2) for nausea and vomiting, pain, dyspnea and diarrhea when compared with the reference values. Functioning scores were significantly worse in 3L+ patients vs 1L+2L for global health status, physical functioning, role functioning, cognitive functioning and social functioning (Table 3). Fatigue, dyspnea and diarrhea symptomatic scores were significantly worse in 3L+ vs 1L+2L patients. Symptom burden was high across all lines of therapy (Table 4). Conclusion: Real-world patients with DLBCL demonstrated significantly worse QoL when compared with a general cancer reference population with respect to all functional scores, as well as fatigue, nausea and vomiting, dyspnea, appetite loss and diarrhea, underscoring the high symptom burden experienced by patients with DLBCL. Patients with DLBCL on 3L+ had significantly worse QoL than those on earlier lines of therapy with respect to global health status, physical functioning, role functioning, cognitive functioning and social functioning, fatigue, dyspnea and diarrhea indicating an unmet need in novel treatment options to help improve QoL in later lines. Figure 1 Figure 1. Disclosures Ma: Regeneron Pharmaceuticals Inc.: Current Employment, Current holder of individual stocks in a privately-held company. Quek: Regeneron Pharmaceuticals Inc.: Current Employment, Current holder of individual stocks in a privately-held company.


2003 ◽  
Vol 17 (3) ◽  
pp. 257-262 ◽  
Author(s):  
Kiki Pistevou-Gombaki ◽  
Nikos Eleftheriadis ◽  
Georgios A Plataniotis ◽  
Ioannis Sofroniadis ◽  
Vassilis E Kouloulias

2009 ◽  
Vol 7 (3) ◽  
pp. 289-297 ◽  
Author(s):  
Gunn E. Grande ◽  
Morag C. Farquhar ◽  
Stephen I.G. Barclay ◽  
Christopher J. Todd

AbstractObjective:Self-reported health-related quality of life (HRQoL) is an important predictor of survival alongside clinical variables and physicians' prediction. This study assessed whether better prediction is achieved using generic (SF-36) HRQoL measures or cancer-specific (EORTC QLQ-C30) measures that include symptoms.Method:Fifty-four lung and 46 colorectal patients comprised the sample. Ninety-four died before study conclusion. EORTC QLQ-C30 and SF-36 scores and demographic and clinical information were collected at baseline. Follow-up was 5 years. Deaths were flagged by the Office of National Statistics. Cox regression survival analyses were conducted. Surviving cases were censored in the analysis.Results:Univariate analyses showed that survival was significantly associated with better EORTC QLQ-C30 physical functioning, role functioning, and global health and less dyspnea and appetite loss. For the SF-36, survival was significantly associated with better emotional role functioning, general health, energy/vitality, and social functioning. The SF-36 summary score for mental health was significantly related to better survival, whereas the SF-36 summary score for physical health was not. In the multivariate analysis, only the SF-36 mental health summary score remained an independent, significant predictor, mainly due to considerable intercorrelations between HRQoL scales. However, models combining the SF-36 mental health summary score with diagnosis explained a similar amount of variance (12%–13%) as models combining diagnosis with single scale SF-36 Energy/Vitality or EORTC QLQ-C30 Appetite Loss.Significance of results:HRQoL contributes significantly to prediction of survival. Generic measures are at least as useful as disease-specific measures including symptoms. Intercorrelations between HRQoL variables and between HRQoL and clinical variables makes it difficult to identify prime predictors. We need to identify variables that are as independent of each other as possible to maximize predictive power and produce more consistent results.


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.


Author(s):  
Albert Tuca Rodríguez ◽  
Miguel Núñez Viejo ◽  
Pablo Maradey ◽  
Jaume Canal-Sotelo ◽  
Plácido Guardia Mancilla ◽  
...  

Abstract Purpose The main aim of the study was to assess the impact of individualized management of breakthrough cancer pain (BTcP) on quality of life (QoL) of patients with advanced cancer in clinical practice. Methods A prospective, observational, multicenter study was conducted in patients with advanced cancer that were assisted by palliative care units. QoL was assessed with the EORTC QLQ-C30 questionnaire at baseline (V0) and after 28 days (V28) of individualized BTcP therapy. Data on background pain, BTcP, comorbidities, and frailty were also recorded. Results Ninety-three patients completed the study. Intensity, duration, and number of BTcP episodes were reduced (p < 0.001) at V28 with individualized therapy. Transmucosal fentanyl was used in 93.8% of patients, mainly by sublingual route. Fentanyl titration was initiated at low doses (78.3% of patients received doses of 67 μg, 100 μg, or 133 μg) according to physician evaluation. At V28, mean perception of global health status had increased from 31.1 to 53.1 (p < 0.001). All scales of EORTC QLQ-C30 significantly improved (p < 0.001) except physical functioning, diarrhea, and financial difficulties. Pain scale improved from 73.6 ± 22.6 to 35.7 ± 22.3 (p < 0.001). Moreover, 85.9% of patients reported pain improvement. Probability of no ≥ 25% improvement in QoL was significantly higher in patients ≥ 65 years old (OR 1.39; 95% CI 1.001–1.079) and patients hospitalized at baseline (OR 4.126; 95% CI 1.227–13.873). Conclusion Individualized BTcP therapy improved QoL of patients with advanced cancer. Transmucosal fentanyl at low doses was the most used drug. Trial registration This study was registered at ClinicalTrials.gov database (NCT02840500) on July 19, 2016.


2021 ◽  
pp. 0272989X2110035
Author(s):  
Dennis A. Revicki ◽  
Madeleine T. King ◽  
Rosalie Viney ◽  
A. Simon Pickard ◽  
Rebecca Mercieca-Bebber ◽  
...  

Background The EORTC QLU-C10D is a multiattribute utility measure derived from the cancer-specific quality-of-life questionnaire, the EORTC QLQ-C30. The QLU-C10D contains 10 dimensions (physical, role, social and emotional functioning, pain, fatigue, sleep, appetite, nausea, bowel problems). The objective of this study was to develop a United States value set for the QLU-C10D. Methods A US online panel was quota recruited to achieve a representative sample for sex, age (≥18 y), race, and ethnicity. Respondents undertook a discrete choice experiment, each completing 16 choice-pairs, randomly assigned from a total of 960 choice-pairs. Each pair included 2 QLU-C10D health states and duration. Data were analyzed using conditional logistic regression, parameterized to fit the quality-adjusted life-year framework. Utility weights were calculated as the ratio of each dimension-level coefficient to the coefficient for life expectancy. Results A total of 2480 panel members opted in, 2333 (94%) completed at least 1 choice-pair, and 2273 (92%) completed all choice-pairs. Within dimensions, weights were generally monotonic. Physical functioning, role functioning, and pain were associated with the largest utility weights. Cancer-specific dimensions, such as nausea and bowel problems, were associated with moderate utility decrements, as were general issues such as problems with emotional functioning and social functioning. Sleep problems and fatigue were associated with smaller utility decrements. The value of the worst health state was 0.032, which was slightly greater than 0 (equivalent to being dead). Conclusions This study provides the US-specific value set for the QLU-C10D. These estimated health state scores, based on responses to the EORTC QLQ-C30 questionnaire, can be used to evaluate the cost-utility of oncology treatments.


2004 ◽  
Vol 22 (2) ◽  
pp. 354-360 ◽  
Author(s):  
Philippe Rauch ◽  
Joelle Miny ◽  
Thierry Conroy ◽  
Lionel Neyton ◽  
Francis Guillemin

Purpose To identify factors affecting the quality of life (QoL) of disease-free survivors of rectal cancer. Patients and Methods One hundred twenty-one patients in complete remission more than 2 years after diagnosis were asked to complete three QoL questionnaires: the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30; its colorectal module, QLQ-CR38; and the Duke generic instrument. Results Patients reported less pain (P = .002) than did controls drawn from the general population. EORTC QLQ-C30 physical scores were also higher among rectal cancer survivors than in the general Norwegian or German population (P = .0005 and P = .002, respectively). Unexpectedly, stoma patients reported better social functioning than did nonstoma patients (P = .005), with less anxiety (P = .008) and higher self-esteem (P = .0002). In the present authors' experience, the QLQ-CR38 does not discriminate between these groups. Residual abdominal or pelvic pain and constipation had the most negative influence on QoL. Conclusion QoL is high among rectal cancer survivors, including stoma patients. Simultaneous use of several QoL questionnaires appears to have value in follow-up and in monitoring the effects of therapy. The impact of residual pain and constipation on long-term QoL should be considered when establishing a treatment regimen.


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