Outcomes toolbox for head and neck cancer research

Background. Clinical research in head and neck cancer traditionally focused on tumor control. As survival improves, it is increasingly recognized that the side-effects of multimodality treatment can be profound and enduring. Thus, clinical trials require patient-reported and functional outcomes. Methods. A subcommittee of the Previously Untreated, Locally Advanced (PULA) Task Force of the Head and Neck Steering Committee of the Coordinating Centre for Clinical Trials at the National Cancer Institute (NCI) was convened to identify a set of instruments suitable for widespread application in the conduct of clinical trials for head and neck cancer. Results. Based on existing literature and expert opinion, 18 main areas of concern were identified. For each, measures suitable for use in multicenter clinical trials were recommended on the basis of validity, feasibility, and clinical acceptance. Conclusion. Suitable instruments exist for most head and neck cancer concerns, but gaps require further development. Future efforts should be made to harmonize measurement across trials.