Ignite Creation Date:
2024-05-06 @ 5:54 PM
Last Modification Date:
2024-10-26 @ 2:38 PM
Study NCT ID:
NCT05479682
Status:
COMPLETED
Last Update Posted:
2023-05-09
First Post:
2022-07-26
Brief Title:
Investigating the Equivalence of the EORTC QLQ-C30 and the QLQ-F17
Sponsor:
University Hospital Regensburg
Organization:
University Hospital Regensburg
Study Overview
Official Title:
Investigating the Equivalence of the EORTC QLQ-C30 and the QLQ-F17
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The EORTC QLQ-C30 a patient-reported outcome measure PROM that is available in 110 different languages has been used in thousands of clinical cancer trials worldwide The QLQ-C30 is composed of six functioning scales including a measure for global quality of life three symptom scales and six single items
Researchers and regulatory bodies came up with the idea to construct a shortened EORTC questionnaire that solely consists of functioning scales and to use additional symptom items according to the side effect profile of the specific medication under investigation
This shortened form termed QLQ-F17 includes the Physical Functioning PF Role Functioning RF Emotional Functioning EF Cognitive Functioning CF and Social Functioning SF scales as well as the Global Health StatusQuality of Life QL scale in their original wording This functioning questionnaire can be amended with symptom-specific items taken from the EORTC item library This method provides a flexible and economic testing strategy that fits the demands of regulators and users in industry and academia
It is an open question however whether the QLQ-F17 is equivalent to the QLQ-C30 in terms of measurement properties Based on empirical research on response biases and order effects one might argue that elimination of the symptoms between RF and CF-Dyspnea DY Pain PA Fatigue FA Insomnia SL Appetite AP NauseaVomiting NV Constipation CO and Diarrhea DI-and of the Financial difficulties FI item between SF and QL may alter the manner in which subsequent items are completed
Thus from a methodological point of view it is essential to confirm the psychometric properties of the QLQ-F17 and to present evidence that scale values derived from the QLQ-F17 are equivalent to those of the QLQ-C30 Only in the case of equivalence may studies using either of the two basic questionnaires be compared directly The present project is designed to address this research question
This is an international multicenter survey study that will include respondents with cancer from Australia Finland France Germany Italy Poland Romania Spain Sweden and United Kingdom A randomized cross-over design will be applied enabling between-patients as well as within-patients comparisons of the QLQ-C30 and the QLQ-F17 One group of respondents will first fill in the QLQ-C30 followed by the QLQ-F17 the other group will start with the QLQ-F17 followed by the QLQ-C30
A sample size of 1500 cancer patients is sufficient to get precise estimates with narrow confidence intervals regarding item and scale-level agreement Thresholds and margins to be used for the analyses in this study will be consented by a statistical advisory group Reliability and psychometric properties can also be precisely estimated with a sample of this size The present study is based on the hypothesis that the QLQ-F17 and the QLQ-C30 questionnaires are equivalent
Researchers and regulatory bodies came up with the idea to construct a shortened EORTC questionnaire that solely consists of functioning scales and to use additional symptom items according to the side effect profile of the specific medication under investigation
This shortened form termed QLQ-F17 includes the Physical Functioning PF Role Functioning RF Emotional Functioning EF Cognitive Functioning CF and Social Functioning SF scales as well as the Global Health StatusQuality of Life QL scale in their original wording This functioning questionnaire can be amended with symptom-specific items taken from the EORTC item library This method provides a flexible and economic testing strategy that fits the demands of regulators and users in industry and academia
It is an open question however whether the QLQ-F17 is equivalent to the QLQ-C30 in terms of measurement properties Based on empirical research on response biases and order effects one might argue that elimination of the symptoms between RF and CF-Dyspnea DY Pain PA Fatigue FA Insomnia SL Appetite AP NauseaVomiting NV Constipation CO and Diarrhea DI-and of the Financial difficulties FI item between SF and QL may alter the manner in which subsequent items are completed
Thus from a methodological point of view it is essential to confirm the psychometric properties of the QLQ-F17 and to present evidence that scale values derived from the QLQ-F17 are equivalent to those of the QLQ-C30 Only in the case of equivalence may studies using either of the two basic questionnaires be compared directly The present project is designed to address this research question
This is an international multicenter survey study that will include respondents with cancer from Australia Finland France Germany Italy Poland Romania Spain Sweden and United Kingdom A randomized cross-over design will be applied enabling between-patients as well as within-patients comparisons of the QLQ-C30 and the QLQ-F17 One group of respondents will first fill in the QLQ-C30 followed by the QLQ-F17 the other group will start with the QLQ-F17 followed by the QLQ-C30
A sample size of 1500 cancer patients is sufficient to get precise estimates with narrow confidence intervals regarding item and scale-level agreement Thresholds and margins to be used for the analyses in this study will be consented by a statistical advisory group Reliability and psychometric properties can also be precisely estimated with a sample of this size The present study is based on the hypothesis that the QLQ-F17 and the QLQ-C30 questionnaires are equivalent
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None