Technology-enabled data collection is a rapidly-developing field in routine clinical practice and within clinical trials. This has primarily two strands i) collecting data directly from patients via electronic patient-reported outcomes (ePRO) using technology-based user friendly solutions such as smartphone apps [1], and ii) emerging opportunities for trials to link with routinely-collected NHS data. Whilst the merits of the goal are obvious, achieving that goal is challenging for multiple reasons. These include governance / data access issues and difficulties with collection of recurrence data from routine sources for cancer clinical trials. In addition, the ePRO is not always user-friendly or deemed cost effective or sufficiently inclusive for the trial-specific patient population and/or type of data being requested.
Outcomes relevant to breast cancer radiotherapy trials
As for any medical treatment, radiotherapy for breast cancer has to balance clinical benefit in terms of treating the cancer against minimising treatment-related adverse effects. Hence important outcomes in breast cancer radiotherapy trials include disease-related efficacy outcomes, i.e. recurrence and survival, as well as radiotherapy-related adverse effects. These radiotherapy adverse effects are usually termed “normal tissue effects” (NTE) as they relate to the healthy normal tissues that may receive some radiation dose when the area around where the tumour site is treated. These normal tissue effects can occur in the short-term (during and shortly after radiotherapy) and tend to resolve quickly, but long-term effects can occur up to many years following radiotherapy. Although rates of these so-called late normal tissue effects have declined following developments in radiotherapy techniques, they remain prevalent (around 25% may experience a moderate/marked adverse effect in the treated breast by 5 years following radiotherapy), and can be permanent (e.g. breast shrinkage), potentially having a long-term impact on patients. Severe radiotherapy-related adverse effects such as cardiac or lung disease are rare, but clearly clinically important. In the era of very low disease event rates (around 2% of patients experience a recurrence of the cancer in their breast within 5 years) it is even more imperative to minimise treatment-related adverse effects, and hence appropriate measurement of these effects within clinical trials is essential.
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