The Prognostic Significance of Patient-Reported Outcomes in Cancer Clinical Trials

2008 ◽  
Vol 26 (8) ◽  
pp. 1355-1363 ◽  
Author(s):  
Carolyn C. Gotay ◽  
Crissy T. Kawamoto ◽  
Andrew Bottomley ◽  
Fabio Efficace
Keyword(s):  
Quality Of Life ◽  
Clinical Trials ◽  
Patient Reported Outcomes ◽  
Prognostic Significance ◽  
Cancer Clinical Trials ◽  
Life Questionnaire ◽  
European Organization ◽  
Patient Reported ◽  
The Impact

Purpose Patient-reported outcomes (PROs), routinely collected as a part of cancer clinical trials, have been linked with survival in numerous clinical studies, but a comprehensive critical review has not been reported. This study systematically assessed the impact of PROs on patient survival after a cancer diagnosis within the context of clinical trials. Design Cancer clinical trials that assessed baseline PROs and mortality were identified through MEDLINE (through December 2006) supplemented by the Cochrane database, American Society of Clinical Oncology/European Society for Medical Oncology abstracts and hand searches. Inclusion criteria were publication in English language and use of multivariate analyses of PROs that controlled for one or more clinical factors. Two raters reviewed each study, abstracted data, and assessed study quality; two additional raters verified abstractions. Results In 36 of 39 studies (N = 13,874), at least one PRO was significantly associated with survival (P < .05) in multivariate analysis, with varying effect sizes. Studies of lung (n = 12) and breast cancer (n = 8) were most prevalent. The most commonly assessed PRO was quality of life, measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 in 56% of studies. Clinical variables adjusted for included performance status (PS), treatment arm, stage, weight loss, and serum markers. Results indicated that PROs provide distinct prognostic information beyond standard clinical measures in cancer clinical trials. Conclusion PROs might be considered for stratification purposes in future trials, as they were often better predictors of survival than PS. Studies are needed to determine whether interventions that improve PROs also increase survival and to identify explanatory mechanisms through which PROs relate to survival.

scholarly journals Quality of life trajectories during the first three years after diagnosis of breast cancer: the NEON-BC study

2019 ◽  
Author(s):  
Luisa Lopes-Conceição ◽  
Mariana Brandão ◽  
Natália Araújo ◽  
Milton Severo ◽  
Teresa Dias ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Sleep Quality ◽  
Patient Reported Outcomes ◽  
Life Questionnaire ◽  
European Organization ◽  
Life Trajectories ◽  
Patient Reported ◽  
Anxiety Depression

Abstract Background We aimed to identify and characterize quality of life trajectories up to 3 years after breast cancer diagnosis. Methods A total of 460 patients were evaluated at baseline (before treatments), and after 1- and 3-years. Patient-reported outcomes, including quality of life (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30, QLQ-C30), anxiety, depression and sleep quality, were assessed in all evaluations. Model-based clustering was used to identify quality of life trajectories. Results We identified four trajectories without intersection during 3 years. The two trajectories characterized by better quality of life depicted relatively stable scores; in the other trajectories, quality of life worsened until 1 year, though in one of them the score at 3 years improved. Sociodemographic and clinical characteristics at baseline did not differ between trajectories, except for mastectomy, which was higher in the worst trajectory. Anxiety, depression and poor sleep quality increased from the best to the worst trajectory. Conclusions The type of surgery and the variation of other patient-reported outcomes were associated with the course of quality of life over 3 years. More research to understand the heterogeneity of individual trajectories within these major patterns of variation is needed.

How Accurate Is Clinician Reporting of Chemotherapy Adverse Effects? A Comparison With Patient-Reported Symptoms From the Quality-of-Life Questionnaire C30

2004 ◽  
Vol 22 (17) ◽  
pp. 3485-3490 ◽  
Author(s):  
Erik K. Fromme ◽  
Kristine M. Eilers ◽  
Motomi Mori ◽  
Yi-Ching Hsieh ◽  
Tomasz M. Beer
Keyword(s):  
Quality Of Life ◽  
Clinical Trials ◽  
Adverse Event ◽  
Adverse Effects ◽  
Adverse Events ◽  
Life Questionnaire ◽  
European Organization ◽  
Quality Of Life Questionnaire ◽  
Patient Reported

Purpose Adverse events in chemotherapy clinical trials are assessed and reported by clinicians, yet clinician accuracy in assessing symptoms has been questioned. We compared patient reporting of eight symptoms using a validated instrument, the European Organization for the Research and Treatment of Cancer Quality-of-Life Questionnaire C30 (QLQ-C30 or QLQ) with physicians' reporting of the same symptoms in the study's adverse events log. Patients and Methods Thirty-seven men with metastatic, androgen-independent prostate cancer enrolled onto a phase II trial of weekly calcitriol and docetaxel completed the QLQ every 4 weeks for up to 28 weeks. A patient-reported symptom was defined as an increase in a QLQ symptom score by at least 10 points (0 to 100 scale), sustained for at least 4 weeks. A physician-reported symptom was considered present if it was ever documented in the adverse event log. Results Forty-nine (new or worsened) symptoms were detected by both physician and QLQ, 48 symptoms were detected by the physician alone, and 55 symptoms were detected by the QLQ alone. They agreed on the absence of a symptom in 102 instances of 254 possible opportunities. Their uncorrected agreement was 59.4%, but Cohen's κ, a coefficient of agreement that corrects for chance, was 0.15, indicating only slight agreement. Using the QLQ as the standard, overall physician sensitivity and specificity was 47% and 68%, respectively, although it varied considerably among symptoms. Conclusion Even in a tightly controlled clinical trial, physician reporting was neither sensitive nor specific in detecting common chemotherapy adverse effects. Tools for collecting patient-reported adverse event data in chemotherapy clinical trials should be developed.

Quality of Life and Patient-Reported Outcomes in Endometrial Cancer Clinical Trials

2014 ◽  
Vol 24 (9) ◽  
pp. 1693-1699 ◽  
Author(s):  
Florence Joly ◽  
Jessica McAlpine ◽  
Remi Nout ◽  
Elisabeth Åvall-Lundqvist ◽  
Emad Shash ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trials ◽  
Endometrial Cancer ◽  
Patient Reported Outcomes ◽  
Cancer Clinical Trials ◽  
Patient Reported

Patient-Reported Outcomes After Hepatic Resection of Colorectal Cancer Metastases

2012 ◽  
Vol 30 (12) ◽  
pp. 1364-1370 ◽  
Author(s):  
Jonathan R. Rees ◽  
Jane M. Blazeby ◽  
Peter Fayers ◽  
Elizabeth A. Friend ◽  
Fenella K.S. Welsh ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Liver Metastases ◽  
Hepatic Resection ◽  
Patient Reported Outcomes ◽  
Hepatic Metastases ◽  
Life Questionnaire ◽  
Quality Of Life Questionnaire ◽  
Patient Reported ◽  
The Impact

Purpose Hepatic resection of colorectal carcinoma (CRC) liver metastases is increasing, but evidence for the impact of surgery on patient-reported outcomes (PROs) is limited. This study aimed to describe comprehensively the impact of liver surgery for CRC hepatic metastases on PROs. Patients and Methods Consecutive patients selected for hepatic resection completed the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire–C30 and Quality of Life Questionnaire–Liver Metastases C21 before and 3, 6, and 12 months after surgery. For functional scales, mean scores with 95% CIs were calculated at each time point, with differences in scores of at least 10 points considered clinically significant. Responses to symptom scales and items were categorized as minimal or severe. Proportions and 95% CIs for each symptom category were calculated. Results Hepatic surgery was planned in 241 patients but abandoned in nine because of unresectable disease. There were two postoperative deaths, 58 complications (25.2%), and 32 patients (14.9%) with disease recurrence. Questionnaire compliance was excellent (> 95% at all time points). After surgery, most functional aspects of health decreased, and the proportions of patients with severe symptoms increased; role function deteriorated significantly, and 30% of patients reported severe activity/vigor problems. Functional scales recovered by 6 months and were maintained at 1 year. Postoperative symptoms returned to baseline levels at 12 months, but 32.1% of patients reported severe problems with sexual dysfunction and 11.9% with abdominal pain. Conclusion These findings provide new evidence regarding outcomes of liver resection for CRC metastases. It is recommended that patients be reassured that surgery has a minimal and short-lived detrimental impact on health.

scholarly journals The impact of sociodemographic factors on quality of life and functional impairment in patients treated of oropharyngeal carcinoma

2019 ◽  
Vol 76 (6) ◽  
pp. 598-606
Author(s):  
Jovica Milovanovic ◽  
Dragoslava Andrejic ◽  
Ana Jotic ◽  
Vojko Djukic ◽  
Oliver Toskovic ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Oropharyngeal Cancer ◽  
Oropharyngeal Carcinoma ◽  
Life Questionnaire ◽  
European Organization ◽  
Quality Of Life Questionnaire ◽  
Hpv Status ◽  
Eortc Qlq ◽  
The Impact

Backround/Aim. Considering the distinct increase in the incidence of oropharyngeal cancer over oral cavity cancers and changing epidemiology with human papilloma virus (HPV) infection emerging as an important risk factor, there is a need to establish better treatment choices in specific groups of patients with oropharyngeal cancer. The aim of this study was to assess the quality of life (QOL) and functional performance and the impact of different demographical data, stage of disease, and treatment type on these parameters in patients with oropharyngeal cancer with successfully achieved locoregional control a year after the treatment. Methods. Study included 87 patients who underwent QOL and functional impairment assessment 12 to 14 months after finished oncological treatment with the following questionnaires: the European Organization for Research and Treatment of Cancer Quality-of Life-Questionnaire-C30 (EORTC QLQ-C30), European Organization for Research and Treatment of Cancer Quality of- Life Questionnaire-Head and Neck 35 (EORTC QLQ-H&N35) and The Karnofsky Performance Scale (KPS). Results. Specific groups of patients had significantly different post-treatment QOL scores. The factors associated with the worse QOL scores were female gender, not being in a partnership, level of education and HPV status. Conclusion. Clinicians should consider socioeconomic factors and HPV status in planning the recovery after treatment of patients with oropharyngeal carcinoma. Gender, education level and employment are the variables that form a certain risk profiles associated with the lower QOL.

Quality of Life of Patients with Head and Neck Cancer Receiving Cetuximab, Fluorouracil, Cisplatin Comparing to Cetuximab, Fluorouracil, Cisplatin and Docetaxel within the CEFCID Trial

2021 ◽  
Author(s):  
Ute Goerling ◽  
Thomas Gauler ◽  
Andreas Dietz ◽  
Viktor Grünwald ◽  
Stephan Knipping ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Head And Neck Cancer ◽  
Head And Neck ◽  
Neck Cancer ◽  
Treatment Time ◽  
Life Questionnaire ◽  
European Organization ◽  
Global Quality Of Life ◽  
The Impact

Introduction: CeFCiD was a multicenter phase II study comparing the efficacy of cetuximab, 5-flourouracil, cisplatin with the same regimen adding docetaxel in recurrent/metastatic head and neck cancer. The primary analysis trial did not demonstrate survival benefit from therapy intensification in first-line recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN). The current analysis of the trial assessed the impact of treatment on quality of life (QoL). Methods: The European Organization for Research and Treatment of Cancer Quality of life Questionnaire QLQ-C30 and the tumor specific module for head and neck cancer (QLQ-H&N35) were used to assess QoL at baseline (visit 1), after 2 (visit 3), 4 (visit 5), and 6 (visit 7) cycles of chemotherapy. Results: Of 180 patients included in this study, 86 patients (47.8%) completed the questionnaires at baseline. Considering selected scores over treatment time, there was no difference in global quality of life, dyspnea, swallowing and speech between the treatment arms in the course. For fatigue a significant increase from baseline to visit 3 (p=0.02), visit 5 (p=0.002), and to visit 7 (p=0.003) was observed for patients receiving docetaxel (D), cisplatin or carboplatin (P), 5-FU (F) and cetuximab (C). At the end of chemotherapy the manifestation of fatigue was similar compared in the two treatment arms. Discussion/Conclusion: Therapy intensification not adversely affect selected scores of QoL of patients with recurrent and/or metastatic SCCHN. Nevertheless, fatigue seems to be pronounced in patients treated with docetaxel.

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