Psychometric testing of the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx) subscale in a longitudinal study of cancer patients treated with chemotherapy.

BACKGROUND: The aim of this study was to evaluate the psychometric properties of the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx) subscale in a longitudinal study of cancer patients treated with chemotherapy. METHODS: Patients were assessed with the FACT/GOG-Ntx subscale, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Chemotherapy-Induced Peripheral Neuropathy Scale 20 (EORTC QLQ-CIPN20), National Cancer Institute -Common Terminology Criteria for Adverse Events (NCI-CTCAE), and light touch test using 10 g monofilament for up to ten assessment points from baseline (prior to initiation of first chemotherapy), after the end of each cycle (up to 6 cycles, 3 weeks per cycle), and at 6, 9, and 12 months after starting chemotherapy. Psychometric analyses included internal consistency reliability, convergent validity, factorial validity, sensitivity to change and responsiveness (minimal clinically important difference, MCID). RESULTS: Cronbach's alpha coefficients of the FACT/GOG-Ntx subscale were 0.82-0.89 across assessment points. The subscale strongly correlated with the EORTC QLQ-CIPN20 (r = 0.79-0.93) but low-to-moderately correlated with the NCI-CTCAE sensory (rs = 0.23-0.45) and motor items (rs = 0.15-0.50) as well as the monofilament test (rs = 0.23-0.47). The hypothesized 4-factor structure of the FACT/GOG-Ntx subscale was not confirmed at assessment points (χ2/df = 2.26-8.50; all P < 0.001). The subscale exhibited small-to-moderate sensitivity to change (r = 0.17-0.37). The MCIDs were between 1.38 and 3.68. CONCLUSION: The FACT/GOG-Ntx subscale has satisfactory reliability, validity, sensitivity to change and responsiveness to evaluate CIPN in cancer patients. Future research is needed to explore the factorial structure of the FACT/GOG-Ntx subscale as the published four-factor structure was not supported in this study.

Docetaxel-Induced Peripheral Neuropathy in Breast Cancer Patients Treated with Adjuvant or Neo-Adjuvant Chemotherapy.

BACKGROUND: Docetaxel-induced peripheral neuropathy (PN) is typically manifested as sensory and motor neuropathy. This study aimed to investigate the incidence, duration, and risk factors of sensory and motor PN and their impact on health-related quality of life (HRQOL) among breast cancer (BC) patients during the first year since starting docetaxel-based chemotherapy. METHODS: We reported a secondary analysis of longitudinal data on docetaxel-induced PN and HRQOL among 127 BC patients. RESULTS: Cumulative incidence rates of motor and sensory PN were 31.5 and 21.3%, while the median durations of motor and sensory PN were 6 and 13 weeks. A consistently significant risk factor for both PNs was a cumulative docetaxel dose of >300 mg/m2. A significant interaction between sensory PN and time was found for physical and social functioning, while a significant motor PN and time interaction effect was identified for physical functioning only. CONCLUSIONS: Motor PN was more common than sensory PN in BC patients treated with docetaxel. Both types of PN had a significant impact on physical functioning.