TY - JOUR
T1 - Measuring Therapy-Induced Peripheral Neuropathy
T2 - Preliminary Development and Validation of the Treatment-Induced Neuropathy Assessment Scale
AU - Mendoza, Tito R.
AU - Wang, Xin Shelley
AU - Williams, Loretta A.
AU - Shi, Qiuling
AU - Vichaya, Elisabeth G.
AU - Dougherty, Patrick M.
AU - Thomas, Sheeba K.
AU - Yucel, Emre
AU - Bastida, Christel C.
AU - Woodruff, Jeanie F.
AU - Cleeland, Charles S.
N1 - Funding Information:
The data collection for this project was supported by awards from the National Cancer Institute to C.S.C., including NCI R01 CA026582 and NCI P01 CA124787 , and by an AstraZeneca Center of Excellence grant. The development of the Treatment-Induced Neuropathy Assessment Scale was supported by a grant from Genentech to C.S.C. P.M.D. is supported by NIH grant R01 NS046606 and the H.E.B. Professorship in Cancer Research. All research at The University of Texas MD Anderson Cancer Center is supported in part by the institution's Cancer Center Support Grant, NCI P30 016672 . The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Cancer Institute, the National Institutes of Health, or the other sponsors. The sponsors played no role in the study design; in the collection, analysis and interpretation of data; in the writing of the report; or in the decision to submit the article for publication. The authors report no conflicts of interest in this work.
Publisher Copyright:
© 2015 American Pain Society.
PY - 2015/10/1
Y1 - 2015/10/1
N2 - Various sensory and motor effects are associated with cancer treatment-induced peripheral neuropathy. The current method for capturing the multifaceted nature of neuropathy includes a combination of objective tests, clinician evaluation, and subjective patient report, an approach that is often not logistically feasible, especially for multisite trials. We report the performance of a brief yet comprehensive, easily administered measure, the Treatment-Induced Neuropathy Assessment Scale (TNAS), for assessing the severity and course of neuropathy across various cancer treatments. Data were derived from 4 longitudinal or cross-sectional patient cohorts (N = 573). Patients with multiple myeloma treated primarily with bortezomib and patients with colorectal cancer receiving oxaliplatin evaluated candidate items. Cognitive debriefing showed that all items were easy to understand, and this preliminary TNAS demonstrated reliability, validity, and sensitivity. Numbness/tingling was the most severe item, regardless of therapeutic agent. Although numbness and general pain were moderately correlated, patients perceived them as distinct. Most TNAS items were more severe at follow-up, demonstrating the sensitivity of the instrument to accumulating dose. The TNAS will be refined with further patient input, with final psychometric evaluation conducted in a new patient sample receiving treatments known to be associated with peripheral neuropathy. The nonpainful component of neuropathy may be more disabling than the pain component. Perspective Our data suggest that the nonpainful components of neuropathy may be more disabling than the pain component during cancer treatment. Here we report data on sensory and motor symptoms reported by patients receiving neurotoxic cancer therapy, and we detail the development of a neuropathy assessment scale that follows regulatory guidance for patient-reported outcomes.
AB - Various sensory and motor effects are associated with cancer treatment-induced peripheral neuropathy. The current method for capturing the multifaceted nature of neuropathy includes a combination of objective tests, clinician evaluation, and subjective patient report, an approach that is often not logistically feasible, especially for multisite trials. We report the performance of a brief yet comprehensive, easily administered measure, the Treatment-Induced Neuropathy Assessment Scale (TNAS), for assessing the severity and course of neuropathy across various cancer treatments. Data were derived from 4 longitudinal or cross-sectional patient cohorts (N = 573). Patients with multiple myeloma treated primarily with bortezomib and patients with colorectal cancer receiving oxaliplatin evaluated candidate items. Cognitive debriefing showed that all items were easy to understand, and this preliminary TNAS demonstrated reliability, validity, and sensitivity. Numbness/tingling was the most severe item, regardless of therapeutic agent. Although numbness and general pain were moderately correlated, patients perceived them as distinct. Most TNAS items were more severe at follow-up, demonstrating the sensitivity of the instrument to accumulating dose. The TNAS will be refined with further patient input, with final psychometric evaluation conducted in a new patient sample receiving treatments known to be associated with peripheral neuropathy. The nonpainful component of neuropathy may be more disabling than the pain component. Perspective Our data suggest that the nonpainful components of neuropathy may be more disabling than the pain component during cancer treatment. Here we report data on sensory and motor symptoms reported by patients receiving neurotoxic cancer therapy, and we detail the development of a neuropathy assessment scale that follows regulatory guidance for patient-reported outcomes.
KW - Key words Neuropathy
KW - colorectal cancer
KW - multiple myeloma
KW - patient-reported outcomes
KW - validation
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U2 - 10.1016/j.jpain.2015.07.002
DO - 10.1016/j.jpain.2015.07.002
M3 - Article
AN - SCOPUS:84942829616
SN - 1526-5900
VL - 16
SP - 1032
EP - 1043
JO - Journal of Pain
JF - Journal of Pain
IS - 10
ER -