DeintensiF: Standard versus individualized deintensified follow-up after curative treatment in head and neck cancer: protocol of a randomized pilot study.

Background: Around 70% of head and neck cancer (HNC) cases are diagnosed in an advanced stage. Improvements in treatment have led to a cure rate of up to 80-90% for early-stage and 40-50% for advanced-stage disease. However, routine follow-up involves social and financial burdens, including frequent imaging associated with radiation exposure and costs. Currently, there is no consensus on the follow-up strategy after HNC treatment, and no conclusive evidence shows a survival advantage for routine follow-up over symptom-driven self-referrals. The DeintensiF study aims to provide robust evidence, comparing standard follow-up with a tailored deintensified approach. Additionally, it seeks to explore whether early detection of recurrence/second primary malignancy in asymptomatic patients impacts survival and quality of life. The pilot phase aims to assess feasibility of patients' recruitment and adherence to the assigned follow-up strategy and patient-reported outcomes (PROs) questionnaire in the first 2 years.

Methods: This randomized-controlled, multicenter, open-label, pilot study has the goal to randomize a minimum of 16 patients across three Swiss sites into two arms within 1 year. The Experimental Arm A: scheduled clinical exams every 6 months and monthly PRO with evaluation and possibility to alert for open urgent appointments; and the Control Arm B: regular visits every 3 months for the first 2 years and less frequent thereafter plus multiple scheduled imaging appointments for head and neck magnet resonance imaging (MRI) and computed tomography (CT) with contrast and chest CT scans. Patients' motivation for participation or not will be explored by additional questionnaire before randomization. The primary objective during the pilot phase is to evaluate the feasibility of recruiting and randomizing patients with complete remission 6 months after treatment of head and neck squamous cell carcinoma to a deintensified and to a conventional follow-up. The secondary objective is to assess adherence to the two different follow-up strategies.

Discussion: If feasible, the DeintensiF pilot study will expand from the recruited patients (detailed in the "Methods" section) to a larger cohort of advanced HNC cases in the main trial, integrating electronic PRO tailored follow-up care. This approach aims to reshape follow-up practices, enhancing patient-centered strategies and outcomes in head and neck oncology.

Trial-registration: ClinicalTrials.gov (NCT05388136); Swiss National Clinical Trial Portal (SNCTP000005198).