Incorporating the Patient Voice in Sarcoma Research: How Can We Assess Health-Related Quality of Life in This Heterogeneous Group of Patients? A Study Protocol
Abstract
:Simple Summary
Abstract
1. Introduction
2. Methods and Analysis
2.1. Study Design and Setting
2.2. Patient and Public Involvement
2.3. Eligibility Criteria
2.4. Data Collection
2.4.1. Literature Review
2.4.2. Part A: Interviews
2.4.3. Part B: Review Issue-List
2.5. Recruitment
2.6. Case Report Forms
2.7. Questionnaires
2.7.1. EORTC-Quality of Life Questionnaire (EORTC QLQ-C30)
2.7.2. EORTC-QLQ-Head and Neck Module (EORTC QLQ-H&N43)
2.7.3. EORTC-QLQ-Endometrial Cancer Module (EORTC QLQ-EN24)
2.8. Objectives
2.9. Sample Size Calculation
2.10. Statistical Analysis
2.11. Missing Data
3. Conclusions
Supplementary Materials
Author Contributions
Funding
Acknowledgments
Conflicts of Interest
References
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Stratification by Disease Stage, Subtype and Treatment | Extremities | Axial Skeleton (Including Pelvic Bones) | Head and Neck (Including Scalp) | Thoracic (Including Breast) | Retroperitoneal and Intra-Abdominal | Pelvic Organs Including Urogenital | Total |
---|---|---|---|---|---|---|---|
Phase 1a | |||||||
Localized | |||||||
Bone | |||||||
SU | 4 | 2 | 2 | - a | - | - | |
SU + RT | 4 | 4 | - | 74 | |||
SU(+RT) + ST | 4 | 4 | - | ||||
Soft tissue | |||||||
SU | 2 | - | 2 | 6 | 6 | 10 | |
SU+RT | 8 | - | 2 | 4 | 4 | - | |
Metastatic/local relapse | 80 | ||||||
Bone | |||||||
Local treatment (+ST) | 4 | 2 | 2 | - a | - | - | |
ST | 6 | 8 | 8 | - | - | ||
Soft tissue | |||||||
Local treatment (+ST) | 2 | - | - | - | - | - | |
ST | 6 | - | 8 | 8 | 8 | ||
BSC | 2 | - | 2 | 2 | 2 | 2 | 10 |
Total | |||||||
Per location | 154 | ||||||
Per treatment | |||||||
SU only: | 34 | ||||||
SU + RT: | 26 | ||||||
SU + RT + ST: | 14 | ||||||
Surgery total: | 74 | ||||||
RT total: | 42 | 20 | 32 | 20 | 20 | 20 | 40 |
ST only: | 60 | ||||||
ST total: | 74 | ||||||
Local: | 10 | ||||||
Per subtype | |||||||
Bone: | 54 | ||||||
Soft tissue: | 100 | ||||||
Phase 1b | |||||||
Localized | |||||||
Bone | |||||||
SU | 20 | 4 | 5 | - a | - | - | |
SU + RT | 20 | 8 | - | ||||
SU(+RT) + ST | 20 | 8 | - | 235 | |||
Soft tissue | |||||||
SU | 10 | - | 4 | 12 | 24 | 20 | |
SU + RT | 40 | - | 4 | 8 | 16 | - | |
SU(+RT) + ST | - | - | 12 | - | - | - | |
Metastatic/local relapse | |||||||
Bone | |||||||
Local treatment (+ST) | 20 | 4 | 4 | - a | - | - | |
ST | 30 | 16 | 16 | - | - | 240 | |
Soft tissue | |||||||
Local treatment (+ST) | 10 | - | - | - | - | - | |
ST | 30 | - | 16 | 16 | 32 | 16 | |
BSC | 10 | - | 4 | 4 | 8 | 4 | 30 |
Total | |||||||
Per location | 210 | 40 | 65 | 40 | 80 | 40 | 475 |
Per treatment | |||||||
SU only: | 99 | ||||||
SU + RT: | 96 | ||||||
SU + RT + ST: | 40 | ||||||
Surgery total: | 235 | ||||||
RT total: | 136 | ||||||
ST only: | 172 | ||||||
ST total: | 212 | ||||||
Local: | 38 | ||||||
Per subtype | |||||||
Bone: | 175 | ||||||
Soft tissue: | 300 |
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den Hollander, D.; Fiore, M.; Martin-Broto, J.; Kasper, B.; Casado Herraez, A.; Kulis, D.; Nixon, I.; Sodergren, S.C.; Eichler, M.; van Houdt, W.J.; et al. Incorporating the Patient Voice in Sarcoma Research: How Can We Assess Health-Related Quality of Life in This Heterogeneous Group of Patients? A Study Protocol. Cancers 2021, 13, 1. https://doi.org/10.3390/cancers13010001
den Hollander D, Fiore M, Martin-Broto J, Kasper B, Casado Herraez A, Kulis D, Nixon I, Sodergren SC, Eichler M, van Houdt WJ, et al. Incorporating the Patient Voice in Sarcoma Research: How Can We Assess Health-Related Quality of Life in This Heterogeneous Group of Patients? A Study Protocol. Cancers. 2021; 13(1):1. https://doi.org/10.3390/cancers13010001
Chicago/Turabian Styleden Hollander, Dide, Marco Fiore, Javier Martin-Broto, Bernd Kasper, Antonio Casado Herraez, Dagmara Kulis, Ioanna Nixon, Samantha C. Sodergren, Martin Eichler, Winan J. van Houdt, and et al. 2021. "Incorporating the Patient Voice in Sarcoma Research: How Can We Assess Health-Related Quality of Life in This Heterogeneous Group of Patients? A Study Protocol" Cancers 13, no. 1: 1. https://doi.org/10.3390/cancers13010001