DeintensiF: Trial Comparing Different Follow-up Strategies
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 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. 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Control Arm 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. |
Procedure: Conventional follow up schedule with imaging
Frequent of follow up visit and imaging
|
| Experimental: Individualized Deintensified Arm 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. |
Procedure: Deintensified follow up schedule without imaging
Less intense follow up visit without imaging
|
Outcome Measures
Primary Outcome Measures
- 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
- Death from head and neck cancer [Up to 5 years]
Time to HNC-specific death
- Death from any cancer [Up to 5 years]
Time to cancer-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.
- 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
- 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
- Compliance with scheduled follow up assessments [Up to 5 years]
Defined as percentage of scheduled follow up visits attended
- Number of regularly scheduled in-person visits [Up to 5 years]
- Number of in-person visits triggered by the recommendation of the PRO [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]
- 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
Other Outcome Measures
- Type and grading of specific treatment-related adverse events and outcome [Up to 5 years]
- Characteristics of REC/ secondary primary malignancy (SPM) [Up to 5 years]
Diagnostic modalities that lead to detection of REC/SPM, incidence, site, stage, and whether it is amenable to curatively-intended salvage therapy
- Adherence to electronical signs/symptom monitoring and visits that are triggered by the PRO [Up to 5 years]
Defined as the number of PRO questionnaires that were completed and the number of follow up visits that were triggered by the PRO in which the participant attended
Eligibility Criteria
Criteria
Inclusion Criteria:
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Histopathologically proven invasive Head and Neck Squamous Cell Carcinoma (HNSCC) of the oral cavity, oropharynx, hypopharynx or larynx
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≥18 years of age
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In non-surgically treated HNSCC: clinical/radiological stage II-IV (excluding M1) according to the UICC / TNM 8th ed.
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In surgically treated HNSCC: pathological stage II-IV (excluding M1) according to the UICC / TNM 8th ed.
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Treatment with curative intent, regardless of treatment modality (mono- or multimodal), and FU planned at the participating study center.
Remark: Patients with several synchronous HNSCC, all treated with curative intent and all in complete remission are eligible
• Radiological confirmation of complete remission of disease and no SPM from the 3rd to 6th month after treatment for all stages (minimal demanded imaging: head and neck (H&N) MRI or H&N CT scan and CT scan covering chest to pelvis (with contrast if not contraindicated); or preferable whole-body 18FDG-PET/CT or positron emission tomography (PET)/MRI for patients with ≥T3 and/or N+).
Note: Patients with positive or equivocal imaging/clinical findings are allowed if the tumor is ruled out with negative biopsies.
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Clinical confirmation of complete remission of disease through H&N examination including endoscopy of the pharynx and larynx at the time of enrolment, that is 6 months (+/- 4 weeks) after the last HNSCC treatment
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Agreement for long term FU (5 years) and all visits are to be performed at the participating center
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Written informed consent, signed by the patient and the investigator
Exclusion Criteria:
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Initial clinical stage I and/or M1 HNSCC (according to the UICC / TNM 8th ed.)
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Nasopharyngeal cancer and carcinoma of unknown primary
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Any other previously treated HNC (including parotid and thyroid gland cancer) except for curatively and adequately treated carcinoma in-situ, basal cell carcinoma and locally confined T1 squamous cell carcinoma of the skin without any sign of tumor recurrence at the time of screening
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Any other malignancy within the last 5 years except for curatively and adequately treated basal cell carcinoma, locally confined T1 squamous cell carcinoma of the skin, low-risk prostate cancer, carcinoma in-situ of the skin or uterine cervix without any sign of tumor recurrence at the time of screening
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Participation in another study entailing regular medical exams by Ear Nose Throat (ENT) specialists or persons involved in the oncological treatment, or regular imaging
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Pregnant or breastfeeding women
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Presence of any conditions that potentially hampering compliance with the study protocol and FU schedule at the participating center
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Inselspital, University Hospital bern | Bern | Switzerland | 3010 |
Sponsors and Collaborators
- University Hospital Inselspital, Berne
- University of Bern
Investigators
- Principal Investigator: Roland Giger, Dr. med., Inselspital, University Hospital Bern
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1685 DeintensiF