OBJECTIVES: To understand the patient experience of squamous cell carcinoma of the head and neck (SCCHN) and guide selection of relevant measurement concepts for clinical trials. Patient reported outcome (PRO) instruments (EORTC QLQ-C30 and H&N-35) were also assessed for their suitability in this population. METHODS: A literature review and clinician interviews were conducted to inform in-depth semi-structured telephone interviews with patients who had received treatment in the past 12 months for metastatic and/or recurrent SCCHN. Interview transcripts were analysed thematically in ATLAS.ti v7; patient quotes were coded to identify concepts and themes to develop a conceptual model of SCCHN experience. RESULTS:  Thirteen patients were interviewed (77% male, aged 35-84); the majority diagnosed for >1 year. Patients reported few symptoms pre-diagnosis; commonly a neck lump/swelling (n=7) and/or difficulty swallowing (n=3). Treatment generally comprised of surgery and chemotherapy and/or radiotherapy. Key side effects included pain (n=8), fatigue (n=8), and weight loss (n=8). These impaired health-related quality of life (HRQoL) including work (n=6), socializing (n=7), and emotional wellbeing (n=11). Tumour location, surgery and radiation particularly affected difficulty speaking (n=7) and difficulty eating/drinking (n=9). This was most severe in patients who had a feeding tube in-situ. Patients generally found the QLQ-C30 and H&N-35 content to be understandable and conceptually relevant; some additions were suggested including excessive mucous production and neuropathic symptoms. Patient data generally corroborated with the clinician interview and the literature review findings. CONCLUSIONS: SCCHN diagnosis, symptoms, and treatment impacts patients’ physical functioning, emotional wellbeing, and overall HRQoL. PRO instruments included in clinical trials should assess the effect of novel therapies on fatigue, pain and oral problems including swallowing. The QLQ-C30 and H&N-35 appeared generally relevant and suitable to capture symptoms and impacts associated with SCCHN. However, some items could be amended/added to ensure conceptual comprehensiveness.