Validation of brief symptom indexes among patients with recurrent or metastatic squamous cell carcinoma of the head and neck: A trial of the ECOG‐ACRIN Cancer Research Group (E1302)

BACKGROUND: Patients with advanced head and neck cancer have identified pain, fatigue, and difficulties swallowing, breathing, and communicating as high‐priority disease‐related symptoms. The Functional Assessment of Cancer Therapy‐Head and Neck Symptom Index‐10 (FHNSI‐10) assesses these symptoms. We sought to validate the FHNSI‐10, another brief symptom index (FHNSI‐7), and individual symptom endpoints representing these high‐rated priority disease symptoms among patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN). METHODS: Patients (N = 239) were enrolled in a phase III randomized clinical trial (E1302) and completed the FHNSI‐10 at multiple time points. We assessed the internal consistencies and test–retest reliabilities of the FHNSI‐10 and FHNSI‐7 scores, and the known‐groups validity, predictive criterion validity, and responsiveness‐to‐change of the symptom indexes and individual symptom endpoint scores. RESULTS: The FHNSI‐10 and FHNSI‐7 indexes showed satisfactory internal consistencies (Cronbach's alpha coefficient range 0.60‐0.75) and acceptable test–retest reliabilities (intraclass correlation coefficients = 0.75 and 0.74, respectively). The FHNSI‐10, FHNSI‐7, and the pain, fatigue, swallowing, and breathing symptom scores showed evidence of known‐groups validity by performance status at baseline. The FHNSI‐10, FHNSI‐7, and the pain, fatigue, and breathing symptom scores at baseline showed evidence of predictive criterion validity for overall survival, but not time‐to‐progression (TTP). Changes in the symptom indexes and individual symptom scores were not associated with changes in performance status over 4 weeks, though most patients had stable performance status. CONCLUSIONS: There is initial evidence of validity for the FHNSI‐10 and FHNSI‐7 indexes and selected individual symptom endpoints as brief disease‐related symptom assessments for patients with recurrent or metastatic SCCHN.