Spots Global Cancer Trial Database for Trial Comparing Different Follow-up Strategies

Study Description

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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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