Difficulties with Measuring the Patient's Perspective in Non Hodgkin's Lymphoma - a Review of Patient Reported Outcome Measures

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 4703-4703
Author(s):  
Jyotsna Mehta ◽  
Florence Joulain ◽  
Peter C Trask ◽  
Bonnie Teschendorf
Keyword(s):  
Quality Of Life ◽  
Clinical Trials ◽  
Clinical Benefit ◽  
Cell Lymphoma ◽  
B Cell Lymphoma ◽  
Medical Attention ◽  
Eortc Qlq C30 ◽  
Eortc Qlq ◽  
Pro Instruments

Abstract Abstract 4703 Aims: Patients with NHL present with a classic array of symptoms reflecting the origin of the cancer itself. Symptoms include painless swelling of lymph nodes, increased sensitivity to alcohol, weight loss which can be substantial, persistent fever, soaking night sweats, itchy skin, coughing, difficulty breathing, chest or upper back pain and persistent weakness and tiredness. The severity of symptoms alters the patient's perception of quality of life, their capacity to perform usual activities, and results in seeking medical attention. Due to profound symptoms, it is critical to use excellent measurement tools to record change and demonstrate clinical benefit in trials. The objective of the study was to describe and assess the PRO instruments used in lymphoma, summarize PROs used in ongoing clinical trials, identify gaps in existing PRO measures and evaluate the potential for labeling when using these measures for patient self-report in advanced NHL, particularly as it relates to selecting and implementing PROs. Methods: An in depth literature review was conducted. Elsevier and Medline databases were consulted using Embase platform. Studies were included if they were: published from 01/01–12/11, in English, and included terms related to lymphoma disease and PROs. A thorough review of abstracts was performed. Studies where PRO instruments were used and/or psychometric validation was performed were included. References for selected articles were used to identify other relevant sources. Clinical trials.gov was also used to search for lymphoma trials from 2001–2011. Results: Of 1278 hits, 17 articles met the search criteria. 7 PRO instruments were reported or used in NHL: 2 lymphoma specific questionnaires FACT-Lym (Functional Assessment of Cancer Therapy-Lymphoma module), FACT FLymSI-18 (FACT-Lymphoma Symptom Index), 5 cancer-specific instruments (EORTC-QLQ-C30, FACT-G, CARES (Cancer Rehabilitation Evaluation System), CARES-SF, QOL-CS (Quality of Life-Cancer Survivors), IOC (Impact Of Cancer scale). The 2 most widely used PROs were FACT-Lym and the EORTC QLQ C30. PRO instruments have been included in ongoing phase 2 and 3 clinical trials (Table 1) as secondary endpoints, including 2 in Diffuse Large B-cell lymphoma (DLBCL), 4 in Follicular lymphoma (FL), and 1 each in indolent NHL or mantle cell lymphoma (MCL). EORTC QLQ C30 was the most common instrument followed by FACT-Lym. No specific labeling claims were found in labels made to date for NHL related compounds to FDA or EMA. Conclusions: While there are some lymphoma specific measures, most ongoing trials are using only cancer specific instruments such as EORTC QLQ C30. Several instruments contain only general cancer related symptoms, but not NHL specific symptoms. To more completely understand the burden of disease and treatment effects with NHL through the eyes of patients, evaluation of existing instruments as well as potential instrument development/modification may be warranted. NHL symptom-specific measures could demonstrate therapeutic effectiveness, enhance our understanding of the impact of NHL and provide more evidence of clinical benefit for developing treatments. Disclosures: Mehta: Sanofi: Employment. Joulain:Sanofi: Employment, Equity Ownership. Trask:Sanofi: Employment.

scholarly journals Effect of lisocabtagene maraleucel on HRQoL and symptom severity in relapsed/refractory large B-cell lymphoma

2021 ◽  
Vol 5 (8) ◽  
pp. 2245-2255
Author(s):  
Donald L. Patrick ◽  
Annette Powers ◽  
Monika Parisi Jun ◽  
Yeonhee Kim ◽  
Jacob Garcia ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Cell Lymphoma ◽  
B Cell Lymphoma ◽  
Meaningful Improvement ◽  
Large B Cell Lymphoma ◽  
Car T ◽  
Eortc Qlq C30 ◽  
Eortc Qlq ◽  
Large B Cell

Abstract CD19-directed chimeric antigen receptor (CAR) T-cell therapy has shown efficacy as a third-line or later treatment in patients with relapsed/refractory large B-cell lymphoma (LBCL). Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire, we evaluated the impact of CAR T-cell treatment with lisocabtagene maraleucel (liso-cel) on health-related quality of life (HRQoL) and symptoms in patients with relapsed/refractory LBCL in the ongoing, open-label, nonrandomized TRANSCEND NHL 001 trial. Clinically meaningful improvement was observed in EORTC QLQ-C30 scores for global health status/QoL, based on a minimally important difference of 10 points at 2 to 18 months after liso-cel infusion. There were no clinically meaningful changes in physical functioning and pain, whereas clinically meaningful improvements were observed in fatigue at 2, 12, and 18 months. The proportion of patients with clinically meaningful improvement in global health status/QoL was generally higher for treatment responders than for nonresponders. A trend toward decreased mean EQ-5D-5L index scores was observed at 1 month after liso-cel infusion, followed by subsequent increases through 18 months. Mean EQ-5D-5L visual analog scale scores increased from 2 through 18 months. In summary, patients with relapsed/refractory LBCL treated with liso-cel had early, sustained, and clinically meaningful improvements in HRQoL and symptoms that correlated with antitumor activity. This study was registered at www.clinicaltrials.gov as #NCT02631044.

Assessment of Quality of Life, Psychological Distress, and Alexithymia in Patients with Cutaneous Lymphoma.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 5540-5540
Author(s):  
Francesca Sampogna ◽  
Marina Frontani ◽  
Giannandrea Baliva ◽  
Giuseppe Lombardo ◽  
Cristina Di Pietro D Stat ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Psychological Distress ◽  
Cell Lymphoma ◽  
B Cell Lymphoma ◽  
Cutaneous Lymphoma ◽  
Cutaneous Lymphomas ◽  
Eortc Qlq C30 ◽  
Eortc Qlq ◽  
Tas 20

Abstract Cutaneous lymphoma is a visible cutaneous malignancy, which especially in the more severe forms may have a profound effect on patients lives. The aim of this study was to evaluate quality of life (QoL), psychological distress, and alexithymia in patients with cutaneous lymphoma referring to a dermatological hospital, and to correlate these results with clinical parameters. QoL was evaluated with the Skindex-29, that measures QoL in skin conditions on three scale (symptoms, emotions, and functioning), and the EORTC QLQ-C30, that assesses the QoL of cancer patients. Presence of minor non-psychotic psychiatric disorders was assessed using the GHQ-12, defining as case patients scoring 4 or more; alexithymia was evaluated using the TAS-20 questionnaire. In our ongoing study, we analysed data from the first 66 patients. Of them, 67% were men, the mean age was 58 years (range: 26–85y), and there were 15 patients (23%) with cutaneous B-cell lymphoma (CTBL), and 51 with T-cell lymphoma (CTCL), 6 of them with Sézary Syndrome. In our population, 31.3% of patients were GHQ-cases, 18.6% had alexithymia, and another 22% possible alexithymia. Dermatology-specific QoL was particularly impaired in the symptoms and the emotions scales. QoL was always significantly more impaired in patients with CTCL than in those with CBCL. Also, the prevalence of GHQ-cases was higher (35% in CTCL vs 13% in CBCL), as well as the prevalence of people with alexithymia (48% vs 20%). Skindex-29 and TAS-20 scores significantly correlated with the T stage of lymphoma (i.e., the higher the stage, the lower the QoL and the higher the prevalence of alexithymia). The evaluation of quality of life and psychological problems in patients with cutaneous lymphomas may help clinicians to better manage the disease and its burden on patients life. Also, the relation between quality of life impairment and clinical variables may give important information on the course of the disease as well as the possible effect of treatment.

scholarly journals Establishing anchor-based minimally important differences (MID) with the EORTC quality-of-life measures: a meta-analysis protocol

BMJ Open ◽  
2018 ◽  
Vol 8 (1) ◽  
pp. e019117 ◽  
Author(s):  
Zebedee Jammbe Musoro ◽  
Jean-Francois Hamel ◽  
Divine Ewane Ediebah ◽  
Kim Cocks ◽  
Madeleine T King ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trials ◽  
Patient Data ◽  
Disease Stage ◽  
Healthcare Intervention ◽  
Life Questionnaire ◽  
Eortc Qlq C30 ◽  
Eortc Qlq ◽  
Eortc Quality

IntroductionAs patient assessment of health-related quality of life (HRQOL) in cancer clinical trials has increased over the years, so has the need to attach meaningful interpretations to differences in HRQOL scores between groups and changes within groups. Determining what represents a minimally important difference (MID) in HRQOL scores is useful to clinicians, patients and researchers, and can be used as a benchmark for assessing the success of a healthcare intervention. Our objective is to provide an evidence-based protocol to determine MIDs for the European Organisation for Research and Treatment for Cancer Quality of life Questionnaire core 30 (EORTC QLQ-C30). We will mainly focus on MID estimation for group-level comparisons. Responder thresholds for individual-level change will also be estimated.Methods and analysisData will be derived from published phase II and III EORTC trials that used the QLQ-C30 instrument, covering several cancer sites. We will use individual patient data to estimate MIDs for different cancer sites separately. Focus is on anchor-based methods. Anchors will be selected per disease site from available data. A disease-oriented and methodological panel will provide independent guidance on anchor selection. We aim to construct multiple clinical anchors per QLQ-C30 scale and also to compare with several anchor-based methods. The effects of covariates, for example, gender, age, disease stage and so on, will also be investigated. We will examine how our estimated MIDs compare with previously published guidelines, hence further contributing to robust MID guidelines for the EORTC QLQ-C30.Ethics and disseminationAll patient data originate from completed clinical trials with mandatory written informed consent, approved by local ethical committees. Our findings will be presented at scientific conferences, disseminated via peer-reviewed publications and also compiled in a MID ‘blue book’ which will be made available online on the EORTC Quality of Life Group website as a free guideline document.

Health-related quality of life (HRQOL) burden in patients with relapsed/refractory diffuse large B-cell lymphoma (RR-DLBCL) and non-Hodgkin’s lymphoma (RR-NHL).

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e20070-e20070
Author(s):  
Vincent Lin ◽  
Bhagyashree Oak ◽  
Julia Snider ◽  
Josh Epstein
Keyword(s):  
Quality Of Life ◽  
Literature Review ◽  
B Cell Lymphoma ◽  
Health Utility ◽  
Current Standard ◽  
Sf 36 ◽  
Patient Reported ◽  
Eortc Qlq C30 ◽  
Eortc Qlq

e20070 Background: CAR T therapy is being investigated as 2nd line therapy in RR-DLBCL. To evaluate its impact on patients’ HRQOL, it is essential to understand the HRQOL of patients receiving current standard of care (SOC) therapy for DLBCL and NHL patients. Methods: A systematic literature review (SLR) of studies reporting HRQOL in RR-DLBCL patients was conducted in March 2019 (updated to include RR-NHL in May 2019) using EMBASE, MEDLINE, Cochrane (all from 2007), Northern Light and International Society for Quality of Life Research abstracts (both from 2017). A targeted literature review (TLR) for untreated or 1st line patients was conducted in July 2019 using PubMed. Search terms included diseases, lines of therapy and patient-reported outcome (PRO) measures. Abstracts and publications were screened for eligibility and data were extracted. Results: Of the 977 publications screened for the SLR, 26 met the inclusion criteria. Another 18 studies were included from the TLR. The most commonly used PRO measures were the SF-36 (10 studies), EORTC QLQ-C30 and FACT-Lym (8 studies each). The EORTC QLQ-C30 showed statistically significant or clinically meaningful changes in a greater number of domains (86%) than the FACT-Lym (75%) and SF-36 (62%). Additional results in table. Conclusions: While research is limited, RR-DLBCL patients receiving current SOC therapy report decreases in HRQOL and health utility. Further research is needed on how existing and future therapies may affect HRQOL among RR-DLBCL patients. [Table: see text]

scholarly journals Minimally important differences for the EORTC QLQ-C30 in prostate cancer clinical trials

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Eva M. Gamper ◽  
Jammbe Z. Musoro ◽  
Corneel Coens ◽  
Jean-Jacques Stelmes ◽  
Claudette Falato ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Prostate Cancer ◽  
Clinical Trials ◽  
Group Differences ◽  
Life Questionnaire ◽  
Change Over Time ◽  
Eortc Qlq C30 ◽  
Eortc Qlq ◽  
Over Time

Abstract Background The aim of the study was to estimate the minimally important difference (MID) for interpreting group-level change over time, both within a group and between groups, for the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) scores in patients with prostate cancer. Methods We used data from two published EORTC trials. Clinical anchors were selected by strength of correlations with QLQ-C30 scales. In addition, clinicians’ input was obtained with regard to plausibility of the selected anchors. The mean change method was applied for interpreting change over time within a group of patients and linear regression models were fitted to estimate MIDs for between-group differences in change over time. Distribution-based estimates were also evaluated. Results Two clinical anchors were eligible for MID estimation; performance status and the CTCAE diarrhoea domain. MIDs were developed for 7 scales (physical functioning, role functioning, social functioning, pain, fatigue, global quality of life, diarrhoea) and varied by scale and direction (improvement vs deterioration). Within-group MIDs ranged from 4 to 14 points for improvement and − 13 to − 5 points for deterioration and MIDs for between-group differences in change scores ranged from 3 to 13 for improvement and − 10 to − 5 for deterioration. Conclusions Our findings aid the meaningful interpretation of changes on a set of EORTC QLQ-C30 scale scores over time, both within and between groups, and for performing more accurate sample size calculations for clinical trials in prostate cancer.

scholarly journals Smartphone Sensors for Monitoring Cancer-Related Quality of Life: App Design, EORTC QLQ-C30 Mapping and Feasibility Study in Healthy Subjects

2019 ◽  
Vol 16 (3) ◽  
pp. 461 ◽  
Author(s):  
Sabina Asensio-Cuesta ◽  
Ángel Sánchez-García ◽  
J. Alberto Conejero ◽  
Carlos Saez ◽  
Alejandro Rivero-Rodriguez ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trials ◽  
Life Questionnaire ◽  
European Organization ◽  
Daily Monitoring ◽  
Phone Calls ◽  
Related Quality ◽  
Eortc Qlq C30 ◽  
Eortc Qlq

Quality of life (QoL) indicators are now being adopted as clinical outcomes in clinical trials on cancer treatments. Technology-free daily monitoring of patients is complicated, time-consuming and expensive due to the need for vast amounts of resources and personnel. The alternative method of using the patients’ own phones could reduce the burden of continuous monitoring of cancer patients in clinical trials. This paper proposes monitoring the patients’ QoL by gathering data from their own phones. We considered that the continuous multiparametric acquisition of movement, location, phone calls, conversations and data use could be employed to simultaneously monitor their physical, psychological, social and environmental aspects. An open access phone app was developed (Human Dynamics Reporting Service (HDRS)) to implement this approach. We here propose a novel mapping between the standardized QoL items for these patients, the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and define HDRS monitoring indicators. A pilot study with university volunteers verified the plausibility of detecting human activity indicators directly related to QoL.

scholarly journals Quality of life patients treated with rituximab intravenous versus subcutaneous in B-cell lymphomas: results from outpatient Hematooncology Clinic in Lodz

Oncoreview ◽  
2021 ◽  
Author(s):  
Magdalena Witkowska ◽  
Sonia Witkowska ◽  
Marika Klimczak ◽  
Anna Frydecka ◽  
Michał Witkowski ◽  
...  
Keyword(s):  
Quality Of Life ◽  
B Cell ◽  
B Cell Lymphoma ◽  
Well Being ◽  
Eortc Qlq C30 ◽  
Eortc Qlq ◽  
Nonhodgkin Lymphoma ◽  
First Time ◽  
Better Than

Introduction: Nowadays, rituximab is available both as intravenous (IV) and subcutaneous (SC) formulations. The aim of this study is to compare quality of life (QOL) of patients treated in Hematooncology Clinic in Lodz with B-cell nonHodgkin lymphoma (B-NHL) treated with rituximab IV and SC.   Material and Methods: In 50 adult patients with B-NHL diagnosis we assessed QOL by three different questionnaries (EORTC QLQ-C30, FACT/ GOG-NTx and EQ-5D). We compared it between patients treated with rituximab IV and SC.   Results: In comparison of general condition in EQ-5D-3L and EORTC QLQ-C30 questionnaire patients treated with rituximab SC felt statistically better than with IV administration (p<0.01). In SC group general health was evaluated for 72 while in IV for only 58,1. According to FACT/GOG-NTx questionnaire SC group had significantly better physical well-being. In SC group we observed statistically more complete responses (CR) 21 (88%) versus 17 (65%) in IV group. Moreover, trend was observed in emotional well-being in favor of SC treatment.   Discussion: In our study we observed for the first time in the literature statistical difference in frequency of vomiting, nausea, and lack of appetite mentioned from our patients in questionnarie. It is very important that this findings were not published in any other study comparing SC and IV route od administration. Also looking at economic side of SC administration, this type of dosing. As a result it should be preferred form for B-cell lymphoma patients.

scholarly journals Psychometric validation of the Moroccan version of the EORTC QLQ-C30 in colorectal Cancer patients: cross-sectional study and systematic literature review

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Yacir El Alami ◽  
Hajar Essangri ◽  
Mohammed Anass Majbar ◽  
Saber Boutayeb ◽  
Said Benamr ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Colorectal Cancer ◽  
Discriminant Validity ◽  
Cross Sectional Study ◽  
Cross Sectional ◽  
Related Quality ◽  
Eortc Qlq C30 ◽  
Eortc Qlq ◽  
Colorectal Cancer Patients

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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