It's A Kind Of Magic! The Unexpected Impact of a Systematic In-Patient Controlled Clinical Trial on Patient Well-Being

Abstract

Breast cancer is the most common malignancy for women in New Zealand, the majority receiving radiation therapy as part of their treatment regimen. Radiation-induced skin toxicities occur in a large proportion of patients yet currently there is no standard treatment for them, practice largely being based on historical and anecdotal evidence. As radiation therapy techniques become increasingly complex and practice focuses on the greater good of the patient, some crossing of professional boundaries will occur. In a first for New Zealand, we instigated radiation therapist (RT)-led on-treatment review clinics for breast cancer patients which saw us step into an area that is traditionally considered the domain of medics. This led to clinical trials, initiated and managed by RTs, aimed at providing the authentication for our emerging evidence-based practice. One trial in particular had significant ramifications for our practice. The randomised controlled multi-centre trial compared the efficacy of silicon foam dressing with the standard treatment of aqueous cream. A total of 104 patients were enrolled, the majority receiving 50Gy in 25 fractions. Toxicities were assessed three times a week using the Radiation-Induced Skin Reaction Scale with patients doubling as their own controls to eliminate confounding patient and treatment-related factors. The trial endpoint was moist desquamation (MD). Statistical analysis, using ANOVA design of repeated measurement of paired patches together with the non-parametric Wilcoxon signed rank test, clearly demonstrated a significant toxicity decrease (42%; p<0.001). An intriguing incongruity emerged when the percentage of our patients progressing to MD - 14% control; 0% trial area - was compared with those from other centres - 44% control; 24% trial area. Analysis of this disparity resulted in a substantial change in our practice, allowing us to capitalise on these enhanced patient outcomes. Further research examining the correlation between the levels of holistic care afforded to patients and the intensity of reactions experienced/observed is also underway.