etherlands Quality of Life and Biomedical Cohort Studies_Head and Neck Cancer
Recruiting
- Conditions
- head and neck cancerhead and neck neoplasm10038666
- Registration Number
- NL-OMON50452
- Lead Sponsor
- Vrije Universiteit Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 1478
Inclusion Criteria
Newly diagnosed head and neck cancer patients
Exclusion Criteria
malignancies of the salivary glands, nasopharyngeal malignancies, lymphoma,
skin malignancies, thyroid cancer; patients unable to understand the questions
or test instructions; no informed consent and severe psychiatric co-morbidities
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>1) To describe the long term course of QoL from diagnosis to 5 years follow-up<br /><br>or death in newly-diagnosed HNC patients and their caregivers and to identify<br /><br>cancer-related, personal, genetic, biological, psychobehavioural, physical,<br /><br>lifestyle-related, and social determinants of QoL.</p><br>
- Secondary Outcome Measures
Name Time Method <p>2) To determine the association between QoL and survival adjusted for relevant<br /><br>cancer-related, personal, genetic, biological, psychobehavioural,<br /><br>lifestyle-related, and social factors.<br /><br>3) To build predictive models for long term QoL and survival of cancer patients.<br /><br>4) To prospectively examine patients* and their caregivers' supportive care<br /><br>needs in all phases of the disease and the association with the long-term<br /><br>course of QoL.<br /><br>5) To establish a large QoL database and biobank of tissue specimen, DNA, RNA,<br /><br>serum plasma, saliva and oral rinse, with integrated clinical information.</p><br>