1. 159 Patient-oriented, individualized follow-up in head and neck cancer (DeIntensiF randomized trial NCT05388136)

Purpose/Objective
Approximately 70% of head and neck cancer (HNC) patients present with locoregionally advanced disease. The curative rate for early disease is 80-95%; for advanced tumors, locoregional recurrence rate remains at about 50-60% despite advances in treatment, and 20-30% will have distant metastases. Further, patients will develop a second primary malignancy (SPM) with a rate of 2-4% per year.
Follow-up (FU) is important to detect recurrence (REC) and SPM at an early stage, to enable effective salvagetherapy, manage treatment-related sequelae, and provide functional rehabilitation and psychosocial support.
In the absence of high-level evidence, there is no clear international consensus in FU regimens. There are only retrospective studies addressing this topic, mostly showing no difference in overall survival between patients with REC detected during routine FU and symptom-driven self-referral visits. The value of imaging is also subject of debate. Moreover, many of the hitherto published studies did not include the logistical, psychological and financial consequences and the relevant cost evaluations in today's healthcare systems facing increasing financial pressure.
We propose a large multicenter, randomized prospective trial in HNC patients with complete remission 6 months after curative treatment to compare two FU schemes differing in frequency of scheduled clinical examinations and imaging. We hypothesize that implementing an individualized de-intensified FU with active patient involvement does not differ from a conventional regular FU in terms of death from any cause up to 5 years (=primary endpoint). We also hypothesize that symptom-driven self-referral FU visits have a higher diagnostic yield in detection of REC/SPM than regular scheduled clinical and radiological examinations. Consequently, we assume that fewer scheduled exams in well-instructed patients will not lead to worse outcome. The secondary objectives are the comparison of death from HNC and any cancer, detection of first REC/SPM, health-related quality of life, fear of recurrence, compliance with FU assessments, number of visits and HNC-specific health-care utilization.
The objective of the herein presented Pilot 1 study was to assess the feasibility of patients’ recruitment, motivation for trial participation and compliance in completing a monthly, paper-based symptoms’ monitoring (patient-reported outcome [PRO], symptom tracker). This Pilot is supported by Swiss Cancer Research.