Phase 4 International study of the EORTC Breast Reconstruction (BRR) Questionnaire
EORTC and NIHR CRN portfolio: 16639
Primary aim: To establish the psychometric validity of a European PROM (Patient Reported Outcome Measure) for women
undergoing mastectomy and breast reconstruction (BRR) following breast cancer.
Eligibility:
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Invasive breast cancer and Ductal Cancer in Situ (DCIS) requiring mastectomy
Neo-adjuvant chemotherapy or endocrine treatment
Recommended Post-Mastectomy Radiotherapy (PMRT)
Completion mastectomy (within 6 months) for microscopic margin clearance
Previous mastectomy (within 12 to 60 months) with no metastases
Able and willing to complete the questionnaires
No previous patient participation in earlier questionnaire development
Implant only (with or without Acellular Dermal Matrix (ADM) assisted technique)
BRR involving a dissected donor site (back, abdomen, buttock or thigh).
Study Design: NRES Ethics approved (14/EM/0098) observational study comprising a prospective cohort (260 patients) and a crosssectional cohort (100 patients). The prospective cohort will complete a pre-operative or baseline questionnaire (before
mastectomy and BRR) and one post-operative questionnaire at 6months after the final stage BRR. The cross-sectional cohort will
complete the post-operative questionnaire at any time point in the preceding 12-60 months after ‘final’ BRR. This group will also
complete a second questionnaire 3 weeks later. A debriefing questionnaire will be given to all women.
Prospective Cohort: 260 patients
Pre-operative assessment (Baseline):
Completion of EORTC QLQ-C30, QLQ-BR23
and BRR15 questionnaire
Post-operative assessment (6 months post
BRR):
Completion of EORTC QLQ-C30, QLQ-BR23
and BRR24 questionnaire + Debrief Q.
Cross-sectional Cohort: 100 patients
Time point 1: Completion of EORTC QLQ-C30,
QLQ-BR23 and BRR24 questionnaire
Time point 2 (test-retest reliability) - 3 weeks after
time point 1: Completion of EORTC QLQ-C30,
QLQ-BR23 and BRR24 questionnaire + Debrief Q.
Patients will be given the “choice” to complete the questionnaires using the Computer-based Health
Evaluation System (CHES), which allows web-based Patient Reported Outcomes (PRO) data
collection versus the pen paper completion.
CHES will also be used to record clinical data through Case Report Forms.
Each centre will need to provide a touch screen tablet or PC for patients to use.
30 Collaborating centres: European (Austria: 2 centres, Italy: 2 centres, France: 2 centres, Sweden, Germany), UK
(17 centres); International (Australia: 3 centres, New Zealand, Brazil).
Chief Investigator: Dr. Zoë Ellen Winters (Bristol), PhD FRCS FCS
Sponsor: University of Bristol, School of Clinical Sciences, Learning and Research Building, Level 2, Southmead Hospital, BS10 5NB
NIHR portfolio adopted and funded by the European Organisation for Research and Treatment of Cancer; Quality of Life Group; Avenue E. Mounier 83/11,
1200 Brussels, Belgium.
For further information please contact Dr Zoe Winters on 0117 323 5304 or email: zoe.winters@bris.ac.uk
Dr. Maryam Afzal (Research Administrator) on 0117 323 5438 or email: maryam.afzal@bristol.ac.uk
PI Poster
14.08.2014
Version 3.0