A 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.
Recruiting
- Conditions
- plaveiselcelcarcinoom van het hoofd-hals gebiedhead and neck squamous cell carcinoma10027655
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 400
Inclusion 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
Curative intent
Follow-up takes place in the Erasmus MC
Written informed consent from the patient
Exclusion Criteria
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>* A significant reduction of decisional conflict in the intervention group.</p><br>
- Secondary Outcome Measures
Name Time Method <p>* Fraction of patients who choose not to follow RWHHT advice and therefore<br /><br>receive a non-protocol based treatment in the intervention group.<br /><br>* Quality of life: level of quality of life, specified on head and neck cancer,<br /><br>anxiety and/or distress.<br /><br>* (Disease-free) survival rates: recurrence of the tumor, death and cause of<br /><br>death<br /><br>* Socio-economic status: highest level of education, current profession and<br /><br>postal code of the home address</p><br>