Final validation EORTC Breast Reconstruction Quality of Life module
Research type
Research Study
Full title
Phase 4 - An international field study of the Reliability and Validity of an EORTC breast reconstruction questionnaire to assess quality of life in all types of breast reconstruction
IRAS ID
138294
Contact name
Zoe E Winters
Contact email
Research summary
A recent systematic review suggests the need to develop a breast reconstruction-specific Patient Reported Outcome Measure (PROM) /questionnaire that evaluates the effects of types and timings of breast reconstruction on patients’ health related quality of life (HRQL).
This newly proposed questionnaire should also differentiate the effects of other breast cancer treatments such as radiotherapy and chemotherapy on the results of breast reconstruction (BRR), as well as detecting the impact of breast reconstruction compared to simple mastectomy.
In order to evaluate the effects on patients’ HRQL of the different reconstruction types, we suggested that a BRR module, designed for women with breast cancer, should be developed and used in conjunction with validated PROMS for cancer and specifically breast cancer, respectively such as: the EORTC QLQ-C30, and the EORTC QLQ-BR23.
The first European BRR-specific PROM, the EORTC QLQ-BRR26, has undergone Phases 1 to 3 pre-testing according to the EORTC Quality of Life Group guidelines for module development.
The aim of Phase 4 validation of the EORTC BRR module is to evaluate the clinical discriminant validity between known subgroups of patients undergoing mastectomy with types of immediate and delayed BRRs and adjuvant treatments.
The option of patients’ completing PROMS by either paper or electronically will be given to all study participants. This is a collaboration with the EORTC CHES (Computer Health Evaluation System) team as part of other EORTC PROMS studies using electronic questionnaire completion by patients. This is a previously validated mechanism used in other oncological settings, confirming data protection, user-friendly completion by patients with high compliance levels and effectiveness of data management in large multi centre studies.REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
14/EM/0098
Date of REC Opinion
14 Mar 2014
REC opinion
Further Information Favourable Opinion