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Abstract: Cancers in the head and neck often lead to disability in basic functions, including speech and swallowing. Restoration of these functional impairments is the main treatment goals in managing patients affected by head and neck cancer. Historically, expert stakeholders including clinicians and researchers determine the outcomes measured. Increasingly, it is now believed that these conventional outcomes measures do not provide all the information needed to fully capture treatment effects. Incorporation of patient perspectives, or patient-reported outcomes (PRO), in functional outcome measures has been gaining increasing prominence in the reconstructive literature. The objective of this study was to create and validate the first instrument to measure the main functional areas of concern of the head and neck oncology patient. This was a four-phase qualitative study. In Phases I and II, function domains of importance were identified using open-ended questioning of head and neck cancer patients and grounded theory. The itemized PRO (i.e., Head and Neck Research Network-33) was created in Phase III with expert and patient input. In the final phase, patients completed the Head and Neck Research Network-33 (HNRN-33) as well as completed modified barium swallow testing, speech intelligibility (SI) testing, MD Anderson Dysphagia Inventory, and the European Organization for Research and Treatment of Cancer (EORTC) quality of life head and neck questionnaire in order to perform criterion validity testing. The HNRN-33 correlated strongly with assessments of swallowing (0.77, -0.73, and -0.60). Similarly, strong correlations were observed between the HNRN-33 and assessments of speech (-0.64, 0.61, and 0.55). Assessments of dry mouth and chewing domains correlated moderately to strong, with observed r values of -0.54 and -0.45, respectively. A factor analysis was also performed using multi-institutional data. The factor loading values for the domains of swallowing, speech, dry mouth, and chewing were all observed to be greater than 0.3 with p-values < 0.001. The mean factor loading values for the items relating to swallowing and speech were 0.71 and 0.76, respectively. The mean factor loading values for the items relating to dry mouth and chewing were 0.71 and 0.77, respectively. These values represent very strong loading values between the individual items and their respective domains. The HNRN-33 is the first validated patient-reported outcome instrument designed to assess functional outcomes in head and neck oncology patients and could serve as a single comprehensive measure for functional outcomes. Future research may entail attempting to validate the HNRN-33 as a screening tool for functional assessment in head and neck cancer patients.