Outcomes toolbox for head and neck cancer research

Area of Science:

• Oncology
• Clinical Trials
• Patient-Reported Outcomes

Background:

• Head and neck cancer research traditionally prioritized tumor control.
• Improving survival highlights the need to address profound and enduring treatment side-effects.
• Clinical trials increasingly require patient-reported and functional outcomes.

Purpose of the Study:

• To identify validated and feasible instruments for assessing patient-reported and functional outcomes in head and neck cancer clinical trials.
• To establish a standardized set of measures for widespread application in multicenter trials.

Main Methods:

• A subcommittee of the Previously Untreated, Locally Advanced (PULA) Task Force was convened.
• Literature review and expert opinion were used to identify key areas of concern.
• Instruments were evaluated for validity, feasibility, and clinical acceptance.

Main Results:

• Eighteen main areas of concern in head and neck cancer were identified.
• Recommended measures suitable for multicenter clinical trials were proposed for each area.
• The recommendations prioritized instruments with strong validity, feasibility, and clinical acceptance.

Conclusions:

• Validated instruments are available for most head and neck cancer concerns.
• Gaps in measurement tools necessitate further development.
• Harmonizing outcome measurement across future clinical trials is crucial.