The EORTC Core Quality-of-Life Questionnaire: Interim Results of an International Field Study
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Aaronson, Neil; Ahmedzai, Sam H; Bullinger, Monika; Crabeels, D.; Estapé, Joan Josep Rotger; Filiberti, A.; Flechtner, Henning; Frick, Ulrich; Hürny, Christoph; Kaasa, S; Klee, M.; Mastilica, Miroslav; Osoba, David; Fausler, P.; Razavi, Darius; Schraub, S; Sullivan, Myrtis; Takeda, Fabiano

doi:10.1201/9781003068648-14

Cited by 27 publications

(4 citation statements)

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“…As a pilot study, size was chosen based on feasibility of recruitment in 1 year. Using Aaronson and colleagues' work on the EORTC, [30,31] n = 40 provides 80% power to detect an improvement of 20.4 points in Global QOL in intervention group at 12 weeks (relative to control arm) with a significance level of 0.05 using a two-sided two sample t test.…”

Section: Study Setting and Participantsmentioning

confidence: 99%

“Randomized trial of physical activity on quality of life and lung cancer biomarkers in patients with advanced stage lung cancer: a pilot study”

Bade

Gan²,

Li³

et al. 2021

BMC Cancer

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Background Lung cancer survivors need more options to improve quality of life (QoL). It is unclear to what extent patients with advanced stage disease are willing to participate in home-based physical activity (PA) and if these interventions improve QoL. The goal of our study was to determine interest in participating in our 3-month home-based walking regimen in patients with advanced stage lung cancer. We used a randomized design to evaluate for potential benefit in PA and patient-reported outcomes. Methods We performed an open-label, 1:1 randomized trial in 40 patients with stage III/IV non-small cell lung cancer (NSCLC) evaluating enrollment rate, PA, QoL, dyspnea, depression, and biomarkers. Compared to usual care (UC), the intervention group (IG) received an accelerometer, in-person teaching session, and gain-framed text messages for 12 weeks. Results We enrolled 56% (40/71) of eligible patients. Participants were on average 65 years and enrolled 1.9 years from diagnosis. Most patients were women (75%), and receiving treatment (85%) for stage IV (73%) adenocarcinoma (83%). A minority of patients were employed part-time or full time (38%). Both groups reported low baseline PA (IG mean 37 (Standard deviation (SD) 46) vs UC 59 (SD 56) minutes/week; p = 0.25). The IG increased PA more than UC (mean change IG + 123 (SD 212) vs UC + 35 (SD 103) minutes/week; p = 0.051)). Step count in the IG was not statistically different between baseline (4707 step/day), week 6 (5605; p = 0.16), and week 12 (4606 steps/day; p = 0.87). The intervention improved EORTC role functioning domain (17 points; p = 0.022) with borderline improvement in dyspnea (− 13 points; p = 0.051) compared to UC. In patients with two blood samples (25%), we observed a significant increase in soluble PD-1 (219.8 (SD 54.5) pg/mL; p < 0.001). Conclusions Our pilot trial using a 3-month, home-based, mobile health intervention enrolled over half of eligible patients with stage III and IV NSCLC. The intervention increased PA, and may improve several aspects of QoL. We also identified potential biomarker changes relevant to lung cancer biology. Future research should use a larger sample to examine the effect of exercise on cancer biomarkers, which may mediate the association between PA and QoL. Clinical trial registration Clinicaltrials.gov (NCT03352245).

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Section: Study Setting and Participantsmentioning

confidence: 99%

“Randomized trial of physical activity on quality of life and lung cancer biomarkers in patients with advanced stage lung cancer: a pilot study”

Bade

Gan²,

Li³

et al. 2021

BMC Cancer

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“…The secondary objectives are 1 to study the feasibility of this experimental management system in terms of patient identification (recruitment rate) and patient acceptability (non-inclusion rate) 2 ; to study the acceptability of this experimental management system by the patient’s referring GP 3 ; to identify the consistency of the care pathway in terms of the place of care with that initially planned in the experimental group 4 ; to compare the two management modalities in terms of patient satisfaction 5 ; to compare the two management modalities in terms of patient quality of life 6 ; to quantify the burden on the informal caregiver in both patient groups and 7 to evaluate the medical and economic consequences of the two patient management strategies using a cost-effectiveness analysis.…”

Section: Methods and Analysismentioning

confidence: 99%

“…These questionnaires are of two types. Patient questionnaires will comprise Quality of Life Assessment Questionnaire: QLQ-C30,6 CREDO satisfaction questionnaire (online supplemental appendix 2) and Activities of Daily Living Assessment Questionnaires (ADL and IADL) 7 8. Questionnaires for the informal caregiver (if applicable) will include Burden Assessment Questionnaire (Zarit Burden interview),9 and a questionnaire concerning the time spent by the informal caregiver, over the past week, to assist in the performance of the activities of daily living described in the ADL and IADL questionnaires (online supplemental appendix 3).…”

Section: Methods and Analysismentioning

confidence: 99%

Study protocol of the CREDO randomised controlled trial: evaluation of a structured return home consultation for patients suffering from metastaticcancer

et al. 2023

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IntroductionPatients suffering from cancer are often managed by multiple health professionals. General practitioners with specific skills in oncology could facilitate care coordination between hospital and general practice in the management of these patients. To explore this hypothesis, we run a randomised clinical trial, called ‘Concertation de REtour à DOmicile, CREDO’. The main objective is to explore the effectiveness of a ‘return home’ consultation compared with standard care. The number of unscheduled visits to care centres is used to evaluate the effectiveness of the treatment.Methods and analysisCREDO is a multicentre, randomised, open-label, prospective trial. It takes place in two specialised cancer care centres in southern France (Occitania region). Patient inclusion criteria are: be over 18 years old; be treated with a first cycle of metastatic chemotherapy in a specialised cancer care centre; have a metastatic solid cancer and be returning home after treatment. Patients are randomised in two arms: standard-arm (conventional management) or intervention-arm (CREDO management). In the intervention arm, a ‘return home’ consultation is carried out in three steps. First, the investigating GP (GP with specific skills in oncology) from the specialised care centre collects information about the patient and patient’s management choices. Then, the investigating GP conducts an interview with the patient’s referring GP to quickly communicate and discuss information about the patient. Finally, the investigating GP summarises these exchanges and transmits this information to the care centres chosen by the patient.All the patients are followed for 1 year.Statistical and medicoeconomic analysis are planned.Ethics and disseminationThis clinical trial is registered under ClinicalTrials.gov identifier and was approved by the ethics committee of South-Western French Committee for the Protection of Persons (number: 2016-A01587-44) and from the French National Drug Safety Agency (ANSM, number: 2016111500034).An international publication of the final results and conference presentations will be planned.Trial registration numberNCT02857400.

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“…Demonstrating a PROM's content validity involves generating qualitative evidence from patients that the questionnaire framework and items are appropriate and comprehensive relative to its intended measurement concept, population and context of use [5]. During development, the QLQ-C30's conceptual framework and items were based on oncologist and researcher consensus [4,6], before undergoing validity and reliability testing with patients [7]. However, since initial development, more detailed guidelines and standards have been established for demonstrating PROMs' content validity, focussing on patient input to inform measurement concepts and acceptability of item and instruction wording [8e11].…”

Section: Introductionmentioning

confidence: 99%

Content validity of the EORTC quality of life questionnaire QLQ-C30 for use in cancer

Cocks

Wells

Johnson

et al. 2023

European Journal of Cancer

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The EORTC Core Quality-of-Life Questionnaire: Interim Results of an International Field Study *

Cited by 27 publications

References 0 publications

“Randomized trial of physical activity on quality of life and lung cancer biomarkers in patients with advanced stage lung cancer: a pilot study”

“Randomized trial of physical activity on quality of life and lung cancer biomarkers in patients with advanced stage lung cancer: a pilot study”

Study protocol of the CREDO randomised controlled trial: evaluation of a structured return home consultation for patients suffering from metastaticcancer

Content validity of the EORTC quality of life questionnaire QLQ-C30 for use in cancer

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