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Prognostic counselling in head and neck cancer


- candidate number15239
- NTR NumberNTR4106
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR5-aug-2013
- Secondary IDsNL42154.078.13 METC Rotterdam
- Public TitlePrognostic counselling in head and neck cancer
- Scientific TitleA prospective clinical trial with sequential cohorts on the effect of individualized prognostic counselling on treatment decisions and quality of life in patients with head and neck cancer
- ACRONYM
- hypothesisIn the Netherlands, about 2700 new patients with head and neck squamous cell carcinoma (HNSCC) are diagnosed annually. In the majority of cases, treatment consists of surgery, radiotherapy, chemotherapy and combinations of these modalities. All types of treatment are associated with high morbidity, sometimes compromising vital functions. Accurate counselling for treatment options, survival rates and quality of life is therefore important. Without the knowledge of a reliable individual prognosis, the patient and doctor both will tend to choose treatment according to protocol-based advices by a multidisciplinary team (RWHHT), which is usually the most extensive treatment. Extensive treatment is often associated with major morbidity. While, in patients with a poor prognosis, survival rates will not increase substantially following aggressive treatment. Especially in these patients, the balance between survival and quality of life could be improved by choosing a less aggressive and non-protocol based treatment. Our hypothesis is that a change to individualized prognostic counselling leads to less decisional conflict, less extensive treatment, and an improved quality of life in patients with HNSCC.
- Healt Condition(s) or Problem(s) studiedPrognosis, Quality of life, Education, Head and Neck Squamous Cell Carcinoma
- Inclusion criteriaIn order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Primary squamous cell carcinoma of lip, nasopharynx, oral cavity, oropharynx, larynx or hypopharynx
- Second primary squamous cell carcinoma of lip, nasopharynx, oral cavity, oropharynx, larynx or hypopharynx
- Treatment takes place in the Erasmus MC
- Written informed consent from the patient
- Age >= 18 years
- Exclusion criteriaA potential subject who meets any of the following criteria will be excluded from participation in this study:
- No curative intent based on tumor site and tumor characteristics
- Recurrent tumor
- Simultaneous or synchronic multiple primary HNSCC
- Illiterate patient
- Insufficient knowledge of Dutch language
- Incompetent (due to a.o. mental state) to consider their own treatment choice
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeintervention
- planned startdate 1-okt-2013
- planned closingdate1-nov-2015
- Target number of participants500
- InterventionsThe first cohort receives current prognostic counselling. The next cohort receives individualized prognostic counselling, calculated by OncologIQ, software on the computer.
- Primary outcomeThe fraction of patients who choose not to follow RWHHT advice and therefore receive a non-protocol based treatment
- Secondary outcome- Decisional conflict
- Quality of life
- (Disease-free) survival rates: recurrence of the tumor, death and cause of death.
- TimepointsOutcomes will be measured by obtaining several questionnaires on decisional conflict, shared decision making and quality of life.
- At time of diagnosis of HNSCC patients will answer questionnaires on medical history (ACE27), quality of life (EORTC-QLQ30, EORTC-H&N35, EQ5D) and anxiety (HADS).
- After 1 week, a prognosis and decision consultation will follow. Included patients will answer 2 questionnaires on decisional conflict (Decisional Conflict Scale and Control Preferences Scale).
- 3 months after their treatment included patients will answer questionnaires on Quality of Life (EORTC QLQ 30, EORTC H&N35, EQ5D), on anxiety (HADS) and on decisional regret (Decisional Regret Scale). Patients will also answer a question about the exact therapy they got. The investigator will compare this answer with the medical records to investigate if this therapy was protocol based or not.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD. E.A.C. Dronkers
- CONTACT for SCIENTIFIC QUERIESMD, PHD. R.J. Baatenburg de Jong
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Erasmus Medical Center, Stichting Theia, Noordwijk
- PublicationsN/A
- Brief summaryBackground:
In the Netherlands, about 2700 new patients with head and neck squamous cell carcinoma (HNSCC) are diagnosed annually. In the majority of cases, treatment consists of surgery, radiotherapy, chemotherapy and combinations of these modalities. All types of treatment are associated with high morbidity, sometimes compromising vital functions. Accurate counselling for treatment options, survival rates and quality of life is therefore important. Without the knowledge of a reliable individual prognosis, the patient and doctor both will tend to choose treatment according to protocol-based advices by a multidisciplinary team, which is usually the most extensive treatment. Extensive treatment is often associated with major morbidity. While, in patients with a poor prognosis, survival rates will not increase substantially following aggressive treatment. Especially in these patients, the balance between survival and quality of life could be improved by choosing a less aggressive and non-protocol based treatment. Our hypothesis is that a change to individualized prognostic counselling leads to less decisional conflict, less extensive treatment, and an improved quality of life in patients with HNSCC.

Methods:
In a prospective clinical trial with sequential cohorts we want to investigate the influence of prognostic counselling in patients with HNSCC. For this purpose, the departments of Otorhinolaryngology Head and Neck Surgery of the Erasmus MC and of the Leiden University Medical Center developed during the last decade dedicated software packages incorporating a prognostic model, in which an individualized prognosis for each patient with HNSCC can be calculated (OncologIQ). Besides localisation and TNM-classification of the tumor, patient characteristics such as gender, age, medical history and comorbidity (ACE-27) are taken into account. The outcome of this calculation is expressed in a time-bound percentage (as for example 5-year survival rate), applicable for that specific patient. This prognostic model is internally and externally validated. Newly diagnosed patients with HNSCC at Erasmus MC, with a curative intent, will be included. Prognosis will be communicated using absolute percentages visually supported by graphics. Questionnaires on decisional conflict, quality of life and decisional regret will be taken to measure outcomes.
Conclusion:
In an era of shared decision making, personalized medicine and focus on quality of life, we should not avoid the dialogue between patient and doctor about their prognosis using facts and figures. In our opinion individualized prognostic counselling, using unique patient characteristics, will support informed values based decisions, and therefore will lead to improved communication and quality of life. One should not be afraid of making nonstandard treatment choices in shared decision making when major morbidity or even mortality and a significant decrease in quality of life could be avoided. With the implementation of our innovative prognostic model, OncologIQ, in clinical practice for patients with HNSCC, we aim to improve communication and quality of life: in other words, true personalized medicine.
- Main changes (audit trail)
- RECORD5-aug-2013 - 2-feb-2014


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