Evidence map›Paper›PMID 40380278›Full record

ArticlePilot and feasibility studies2025

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

M Mueller, M Visini, S A Mueller, T Stadler, G P Rajan, G B Morand, S-L Hool, D H Schanne, P Balermpas, A Limacher and 4 more

Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Pilot and feasibility studies, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05388136 (Multicenter Randomized Trial Comparing an Individualized De-intensified and Conventional Follow-up Strategy After Curative Treatment in Head and Neck Cancer), which is not on this map. Not yet cited in PubMed.

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1 · What the graph read from it

What it found

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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05388136 naterminatednot on this map

Multicenter Randomized Trial Comparing an Individualized De-intensified and Conventional Follow-up Strategy After Curative Treatment in Head and Neck Cancer

TypeinterventionalSponsorInsel Gruppe AG, University Hospital BernRan2022 to 2025Enrolled30ConditionsHead and Neck CancerArmsConventional follow up schedule with imaging, Deintensified follow up schedule without imaging
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

M Mueller *Department of Otorhinolaryngology, Head and Neck Surgery, Inselspital, Bern University Hospital and University of Bern, Bern, Switzerland.
M Visini *Department of Otorhinolaryngology, Head and Neck Surgery, Inselspital, Bern University Hospital and University of Bern, Bern, Switzerland.
S A Mueller *Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital Zurich and University of Zurich, Zurich, Switzerland.
T StadlerDepartment of Otorhinolaryngology, Head and Neck Surgery, University Hospital Zurich and University of Zurich, Zurich, Switzerland.
G P RajanDepartment of Otorhinolaryngology, Head and Neck Surgery, Lucerne Cantonal Hospital, Lucerne, Switzerland.
G B MorandDepartment of Otorhinolaryngology, Head and Neck Surgery, University Hospital Zurich and University of Zurich, Zurich, Switzerland.
S-L HoolDepartment of Otorhinolaryngology, Head and Neck Surgery, Inselspital, Bern University Hospital and University of Bern, Bern, Switzerland.
D H SchanneDepartment of Radiation-Oncology, Inselspital, Bern University Hospital and University of Bern, Bern, Switzerland.
P BalermpasDepartment of Radiation-Oncology, University Hospital Zurich and University of Zurich, Zurich, Switzerland.
A LimacherDepartment of Clinical Research, University of Bern, Bern, Switzerland.
S ChanDepartment of Clinical Research, University of Bern, Bern, Switzerland.
S Trelle *Department of Clinical Research, University of Bern, Bern, Switzerland.
O Elicin *Department of Radiation-Oncology, Inselspital, Bern University Hospital and University of Bern, Bern, Switzerland.
R Giger *Department of Otorhinolaryngology, Head and Neck Surgery, Inselspital, Bern University Hospital and University of Bern, Bern, Switzerland. roland.giger@insel.ch.ORCID http://orcid.org/0000-0002-5574-3210

Funding

Swiss Cancer Research Foundation HS R-4356-11-2017
6 · The paper itself

Abstract

backgroundAround 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.

methodsThis 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).

Indexed as

Follow-up studiesHead and neck neoplasmsLocalNeoplasm recurrencePatient-reported outcome measuresPrecision medicineRecurrenceSquamous cell carcinoma of head and neck

Identifiers

PMID40380278
PMCPMC12083109

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.