Chemotherapy Nail Toxicity: Questionnaire Development
Research type
Research Study
Full title
Taxane Chemotherapy and Nail Toxicity in women with Breast Cancer, Stage One: Questionnaire Development
IRAS ID
143424
Contact name
Audrey Morrison
Contact email
Research summary
Nail changes associated with chemotherapy are under reported in terms of incidence and severity (Minisini et al, 2003). Taxane chemotherapy improves clinical response however, it results in more nail toxicity changes. Nail toxicity may vary in appearance, severity and function. Nail toxicity is currently assessed using the Common Toxicty Criteria for Adverse Events (CTCAE) version 3.0. However, this tool has previously been criticised for being insufficient for accurate reporting of type and grades of adverse effects (Chen et al, 2012). Anecdotal reports from clinical practice suggest an increasing impact on quality of life in patients with chemotherapy-induced nail changes and there is little research to support the management of this problem. Before we can investigate potential interventions that may address these problems, we need to develop more rigorous, sensitive outcome measures that capture not only physical nail changes but also the emotional, functional and psychological impact on the patient.
The NToX-G12 (Nail Assessment Scale) and the NToX-QoL (Patient Quality of Life Questionnaire) were originally developed by members of staff at the Beatson Cancer Centre and the University of Glasgow. To obtain content validity these novel tools were then reviewed by ten external 'expert' specialists involved clinically and/or academically in Oncology. The review panel consisted of 'experts' from medicine, nursing, podiatry, psychology and radiography.
We are now seeking approval to assess these two new outcome measures with clinicians and patients in actual breast cancer clinics. This application is for permission to assess:
1. face validity, intra-relater and inter-relater reliability of the 'NToX-G12' (Nail Assessment Scale) with healthcare professionals.
2. face validity, and intra-rater reliability for the 'NToX-QoL' (Patient Quality of Life Questionnaire) with breast cancer patients receiving Taxane-based chemotherapy treatment.REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
14/YH/1142
Date of REC Opinion
1 Sep 2014
REC opinion
Further Information Favourable Opinion