Optimising study design and analysis in breast cancer trials to capture and understand impact of diverse patient experiences
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Embargo End Date
2026-08-25
ICR Authors
Authors
Ng, S
Document Type
Thesis or Dissertation
Date
2026-02-25
Date Accepted
Abstract
This thesis explores how clinical trials for breast cancer can be designed and analysed in ways that more meaningfully reflect the lived experiences of patients. While traditional endpoints such as recurrence-free survival and treatment-related physical toxicity remain central to evaluating efficacy, they offer an incomplete picture of patient quality of life. Through a series of exploratory studies, this thesis demonstrates the importance of integrating broader outcomes, such as financial toxicity and gaps in caregiving responsibilities, into the clinical trial framework.Chapters 2 and 3 present findings from the CASCARA study, a UK pilot survey exploring financial, psychosocial, and caregiving challenges among individuals affected by breast cancer. Results show that financial strain, unmet supportive care needs, and caregiving burdens are prevalent among UK individuals; and physical, emotional and financial quality of life were associated with each other. Chapter 4 presents long-term patient-reported outcomes (PROs) from the IMPORT HIGH trial, identifying 5 year trends of adverse events (AEs) and highlighting baseline AE predictors including age and anxiety. Chapter 5 identifies financial, logistical, and informational barriers that may deter participation in a proton beam therapy trial (PARABLE). Chapter 6 examines predictors of PRO attrition across two large radiotherapy trials (IMPORT HIGH and IMPORT LOW), revealing that deprivation, mental health, and social factors influence long-term data completeness—raising concerns about the generalisability of trial findings.Together, these studies highlight the need for more inclusive, patient-centred trial designs and for routine integration of non-traditional outcomes into breast cancer research. The thesis concludes by offering methodological, clinical, and policy recommendations, emphasising that modern cancer trials should not only focus on survivorship but also improve the quality of life for all patients equitably.
Citation
2026
DOI
Source Title
Publisher
Institute of Cancer Research (University Of London)
ISSN
eISSN
Collections
Research Team
Clin Trials & Stats Unit