Trial Comparing Different Follow-up Strategies
- Conditions
- Head and Neck Cancer
- Interventions
- Procedure: Deintensified follow up schedule without imagingProcedure: Conventional follow up schedule with imaging
- Registration Number
- NCT05388136
- Lead Sponsor
- Insel Gruppe AG, University Hospital Bern
- Brief Summary
There is an ongoing debate about the optimal duration, frequency and extent of follow-up (FU) after treatment with curative intent (aimed at complete cure) in patients with head and neck cancer (HNC). The present study aims to answer these questions and thus provide a scientifically sound, evidence-based basis for the current debate. The aim is to develop a more personalized follow-up strategy with patient involvement. The study contains an internal pilot phase and a main phase.
Pilot phase, started in Oct 2022:
Sample size: 20 participants Duration: 2 years (12 months recruitment, 12 months FU) Planned First-Participant-In: Oct 2022 Planned Last-Participant-Out: Oct/2024
Main study, not yet started awaiting for funding :
Sample size: 550 participants Estimated duration: 8 years (recruitment period: 3 years, FU period: 5 years) Planned First-Participant-In: Q4/2023 Planned Last-Participant-Out: Q4/2031
- Detailed Description
The study will be conducted in a two-arm design, with a control group receiving conventional aftercare and a group receiving less intensive, individualized aftercare. Patients in both groups will be strongly sensitized or trained to the symptoms of cancer recurrence or second tumor. Assignment to one of the two groups is randomized. The study starts with a internal pilot phase of one year aiming to proof the feasibility of recruitment and participant's adherence to the randomized FU scheme. When the pilot phase proved feasibility showed positive result, we will conduct the main study which lasts 5 years for all participants.
For the control group (standard follow-up), medical check-ups are performed at 3-monthly intervals in the first 3 years after completion of therapy, then 4 - 6-monthly until completion of the follow-up period after 5 years. In addition, imaging is scheduled 12 and 24 months after the end of therapy. In addition, imaging examinations (magnetic resonance imaging or computed tomography) are scheduled 6 and 18 months after study inclusion. For active and former smokers, a CT scan of the lungs is scheduled at 30, 42, and 54 months.
In the experimental group (individualized, deintensified follow-up), medical examinations are scheduled only every six months from the beginning and there are no fixed appointments for imaging. In the latter follow-up strategy, the focus is more on the symptoms of the patients.
In the study, participants in both groups document their symptoms monthly in a patient reported-outcome (PRO) questionnaire with possible signs of disease indicating a recurrence of head and neck cancer or a new secondary tumor. For the pilot study, a paper PRO will be used, while in the main study a electronic PRO is planned. In the less intensive, individualized follow-up strategy, the answers to the symptom questionnaires are checked monthly and, depending on the severity and development of the symptoms, a warning is given and a timely follow-up appointment is organized. During this appointment, it will be decided if additional examinations such as imaging and/or tissue sampling are necessary. This means that fewer examinations are not necessarily performed overall, but at times when there is an increased likelihood that a clinically relevant finding will also be found.
Disease progression will be monitored for 5 years.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 550
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Individualized Deintensified Arm Deintensified follow up schedule without imaging Individualized de-intensified FU entailing less frequent clinical exams and no routine imaging (11 visits including visit at randomization) without any routinely planned imaging during 5 years of FU. PRO with rating scale is to be completed monthly by the participant. The PRO result will trigger an alert to the participant and to the site in conditions indicating possible REC/SPM. In case of possible (recurrence or secondary primary malignancy) REC/SPM, an 'open urgent appointment' will be arranged for the participant by the participating centers' team within 2 weeks. Control Arm Conventional follow up schedule with imaging Conventional (standard) FU entails frequent clinical exams and routine imaging (17 visits including a visit at randomization, plus 4 or 7 imaging depending on smoking habits of the participant) during 5 years of FU. PRO with rating scale is to be completed monthly by the participant, but no alert will be generated and the participating center will not arrange urgent appointment, except in case of self-referral for any reasons.
- Primary Outcome Measures
Name Time Method Death from any cause Up to 5 years Death from any cause is defined as the time interval between the date of randomization and the date of death up to 5 years i.e. patients who are not known to have died will be censored at the date of the last time point at which they were known to be alive (quantified by the 5-year RMST).
- Secondary Outcome Measures
Name Time Method Compliance with scheduled follow up assessments Up to 5 years Defined as percentage of scheduled follow up visits attended
Number of in-person visits triggered by the recommendation of the PRO Up to 5 years Death from any cancer Up to 5 years Time to cancer-specific death
Death from head and neck cancer Up to 5 years Time to HNC-specific death
First biopsy-proven REC or SPM Up to 5 years Based on participating centers' assessment according to the Union for International Cancer Control (UICC)/ tumor, nodes, metastasis (TNM) 8th ed.
Head and neck cancer-specific health-related QoL Up to 5 years As assessed every 6 months over 5 years by means of the European Organisation for Research and Treatment of Cancer, Head and Neck Cancer Module (EORTC QLQ-HN43), a scale of 1 - 4 are used to assess each condition and a higher scores mean a worse outcome
Fear of Recurrence (REC) Up to 5 years Assessed by a rating scale (0 - 4) question within the PRO questionnaire, and a higher scores mean a worse outcome
Head and neck caner-specific healthcare utilization Up to 5 years Defined as any regular and emergency visits to any physician, hospitalizations and treatments for HNC-related reasons
General health-related Quality of Life (QoL) Up to 5 years As assessed every 6 months over 5 years by means of the European Organisation for Research and Treatment of Cancer, Core Quality of Life of Cancer Patients (EORTC QLQ-C30)a scale of 1 - 4 are used to assess each condition and a higher scores mean a worse outcome
Number of regularly scheduled in-person visits Up to 5 years Number of self-referral in-person visits Up to 5 years Number of any in-person visits Up to 5 years
Trial Locations
- Locations (3)
Inselspital, University Hospital Bern
🇨🇭Bern, Switzerland
Universitätsspital Zürich, Klinik für Ohren-, Nasen-, Hals- und Gesichtschirurgie
🇨🇭Zürich, Switzerland
Luzerner Kantonsspital, Klinik für Hals-,Nasen-,Ohren-und Gesichtschirurgie
🇨🇭Lucerne, Switzerland