Optimising trial methodologies to maximise trial efficiencies: a case study in breast cancer radiotherapy trials
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Background: In an era of falling local relapse rates, the risk-benefit ratio of adjuvant breast radiotherapy requires careful consideration, and the collection of normal tissue effect (NTE) data optimised. For patients at lowest risk of local recurrence, the risk of NTE may outweigh the benefits and radiotherapy can be avoided. Where a component of standard of care is being removed, there is an opportunity to improve patient information provision. Methods: A series of exploratory analyses was conducted within the IMPORT trials to investigate whether patient-reported outcomes (PRO) can be used as primary toxicity endpoints in breast radiotherapy trials as well as determining how PRO change over time and whether baseline characteristics can predict PRO. A patient decision aid (PDA) was developed and tested within PRIMETIME to investigate whether the PDA reduced decisional conflict. Results: Patients reported NTE more frequently than clinician-reported outcomes (CRO) or photographs. Concordance between PRO and CRO or photographs was poor on an individual patient level. However, the results from the comparison of radiotherapy schedules were consistent between PRO and CRO or photographs. Most NTE reduced over time except for breast shrinkage which increased. Baseline predictors of PRO included younger age and larger breast size. Seroma was not associated with worse NTE, but haematoma and smoking were significant risk factors. Decisional conflict scores were low in PRIMETIME and there were no clinically significant reductions after PDA implementation. Around 50% of patients did not use the PDA. Conclusions: PRO can be used as primary toxicity endpoints in breast radiotherapy trials. Baseline predictors of PRO can contribute to the informed consent process for patients considering breast radiotherapy. PRIMETIME-eligible patients at low risk of recurrence displayed low decisional conflict scores and only half used the additional PDA suggesting that standard patient information was sufficient for this patient group.
Breast Cancer - Radiotherapy
Clinical Trials & Statistics Unit
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