EORTC QoL Thresholds

Section NCT
Category Gynecological tumors / Breast cancer
Subcategory Ovarian cancer, Endometrial cancer
Trial Type Register and supportive Studies
Description for experts Background: Patient-reported outcomes (PROs) are often difficult to interpret for untrained persons. For their use in routine clinical practice, thresholds are needed that simplify the interpretation of the results for users. For one of the world's most frequently used PRO-instruments in the field of oncology (the EORTC QLQ-C30), such threshold values were determined in a previous research project in relation to the clinical significance of the information collected. Such thresholds are not yet available for the entity-specific supplementary modules of the QLQ C30. Objective: To determine thresholds for the clinical importance of PROs for entity-specific EORTC questionnaires. Approach: Questionnaire study. The symptoms/functional limitations of patients and so-called anchor items that record the clinical significance of the symptoms/functional limitations are collected. Conclusion: Threshold values for the clinical significance of a total of 8 EORTC questionnaire modules will be developed. The University Hospital Dresden is involved in determining the threshold values for the QLQ-EN24 (endometrium) and the QLQ-OV28 (ovarian cancer).
Description for laymen Background: Patient-reported outcomes (PROs) are often difficult to interpret for untrained persons. For their use in routine clinical practice, thresholds are needed that simplify the interpretation of the results for users. For one of the world's most frequently used PRO-instruments in the field of oncology (the EORTC QLQ-C30), such threshold values were determined in a previous research project in relation to the clinical significance of the information collected. Such thresholds are not yet available for the entity-specific supplementary modules of the QLQ C30. Objective: To determine thresholds for the clinical importance of PROs for entity-specific EORTC questionnaires. Approach: Questionnaire study. The symptoms/functional limitations of patients and so-called anchor items that record the clinical significance of the symptoms/functional limitations are collected. Conclusion: Threshold values for the clinical significance of a total of 8 EORTC questionnaire modules will be developed. The University Hospital Dresden is involved in determining the threshold values for the QLQ-EN24 (endometrium) and the QLQ-OV28 (ovarian cancer).
JSON Data { "short_title": "EORTC QoL Thresholds", "data_mode": "900", "data_mode_number": "000002336", "official_title": "Establishing thresholds for clinical importance for disease-specific EORTC questionnaire modules", "accrual_state": "running", "therapeutic_value": "nonTherapeutic", "therapieansatz_value": "not_applicable", "therapieintervention_value": "not_applicable", "therapielinie_value": "not_applicable", "ctgov_number": null, "eudract_number": null, "general_contact_email": "martin.eichler@ukdd.de", "general_contact_phone": "+49 351-45819057", "hauptpruefer_dd_name": "Dr. Martin Eichler", "description_laie_de": "Hintergrund: Patientenberichtete Einsch\u00e4tzungen (PRO) liegen h\u00e4ufig in f\u00fcr unge\u00fcbte Personen schwer zu interpretierenden Zahlenangaben vor. F\u00fcr ihren Einsatz in der klinischen Routine bedarf es Schwellenwerte, welche die Interpretation der Ergebnisse f\u00fcr die Nutzenden vereinfachen. F\u00fcr eines der weltweit am h\u00e4ufigsten eingesetzten PRO-Instrumente im Bereich der Onkologie (den EORTC QLQ-C30) wurden solche Schwellenwerte in Bezug auf die klinische Bedeutung der erhobenen Angaben in einem vorhergehenden Forschungsprojekt ermittelt. F\u00fcr die entit\u00e4tsspezifischen erg\u00e4nzenden Module des QLQ C30 liegen solche Schwellenwerte bislang nicht vor.\r\nZielsetzung: Ermittlung von Schwellenwerten f\u00fcr die klinische Bedeutung der PRO f\u00fcr entit\u00e4tsspezifische EORTC-Frageb\u00f6gen. \r\nVorgehensweise: Fragebogenstudie. Erhoben werden die Symptome/ Funktionseinschr\u00e4nkungen von Patienten und sogenannte Anchoritems welche die klinische Bedeutung der Symptome/ Funktionseinschr\u00e4nkungen erfassen. \r\nSchlussfolgerung: Entwickelt werden Schwellenwerte f\u00fcr die klinische Bedeutung von insgesamt 8 EORTC-Fragebogenmodulen. Das Universit\u00e4tsklinikum Dresden beteiligt sich an der Ermittlung der Schwellenwerte f\u00fcr den QLQ-EN24 (Endometrium) und den QLQ-OV28 (Eierstockkrebs).", "description_laie_en": "Background: Patient-reported outcomes (PROs) are often difficult to interpret for untrained persons. For their use in routine clinical practice, thresholds are needed that simplify the interpretation of the results for users. For one of the world's most frequently used PRO-instruments in the field of oncology (the EORTC QLQ-C30), such threshold values were determined in a previous research project in relation to the clinical significance of the information collected. Such thresholds are not yet available for the entity-specific supplementary modules of the QLQ C30.\r\nObjective: To determine thresholds for the clinical importance of PROs for entity-specific EORTC questionnaires. \r\nApproach: Questionnaire study. The symptoms/functional limitations of patients and so-called anchor items that record the clinical significance of the symptoms/functional limitations are collected. \r\nConclusion: Threshold values for the clinical significance of a total of 8 EORTC questionnaire modules will be developed. The University Hospital Dresden is involved in determining the threshold values for the QLQ-EN24 (endometrium) and the QLQ-OV28 (ovarian cancer).", "description_expert_de": "Hintergrund: Patientenberichtete Einsch\u00e4tzungen (PRO) liegen h\u00e4ufig in f\u00fcr unge\u00fcbte Personen schwer zu interpretierenden Zahlenangaben vor. F\u00fcr ihren Einsatz in der klinischen Routine bedarf es Schwellenwerte, welche die Interpretation der Ergebnisse f\u00fcr die Nutzenden vereinfachen. F\u00fcr eines der weltweit am h\u00e4ufigsten eingesetzten PRO-Instrumente im Bereich der Onkologie (den EORTC QLQ-C30) wurden solche Schwellenwerte in Bezug auf die klinische Bedeutung der erhobenen Angaben in einem vorhergehenden Forschungsprojekt ermittelt. F\u00fcr die entit\u00e4tsspezifischen erg\u00e4nzenden Module des QLQ C30 liegen solche Schwellenwerte bislang nicht vor.\r\nZielsetzung: Ermittlung von Schwellenwerten f\u00fcr die klinische Bedeutung der PRO f\u00fcr entit\u00e4tsspezifische EORTC-Frageb\u00f6gen. \r\nVorgehensweise: Fragebogenstudie. Erhoben werden die Symptome/ Funktionseinschr\u00e4nkungen von Patienten und sogenannte Anchoritems welche die klinische Bedeutung der Symptome/ Funktionseinschr\u00e4nkungen erfassen. \r\nSchlussfolgerung: Entwickelt werden Schwellenwerte f\u00fcr die klinische Bedeutung von insgesamt 8 EORTC-Fragebogenmodulen. Das Universit\u00e4tsklinikum Dresden beteiligt sich an der Ermittlung der Schwellenwerte f\u00fcr den QLQ-EN24 (Endometrium) und den QLQ-OV28 (Eierstockkrebs).", "description_expert_en": "Background: Patient-reported outcomes (PROs) are often difficult to interpret for untrained persons. For their use in routine clinical practice, thresholds are needed that simplify the interpretation of the results for users. For one of the world's most frequently used PRO-instruments in the field of oncology (the EORTC QLQ-C30), such threshold values were determined in a previous research project in relation to the clinical significance of the information collected. Such thresholds are not yet available for the entity-specific supplementary modules of the QLQ C30.\r\nObjective: To determine thresholds for the clinical importance of PROs for entity-specific EORTC questionnaires. \r\nApproach: Questionnaire study. The symptoms/functional limitations of patients and so-called anchor items that record the clinical significance of the symptoms/functional limitations are collected. \r\nConclusion: Threshold values for the clinical significance of a total of 8 EORTC questionnaire modules will be developed. The University Hospital Dresden is involved in determining the threshold values for the QLQ-EN24 (endometrium) and the QLQ-OV28 (ovarian cancer).", "rechtsgrundlage_value": "BO", "phase_amg_value": null, "main_cat_id": 3, "sub_cat_id": 20 }
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Short name 900-000002336