The effect of comprehensive counseling by a nurse specialist on depressive symptoms and quality of life: A prospective randomized study in patients with head and neck cancer.
Recruiting
- Conditions
- - Comprehensive counseling by a nurse specialist (intervention group)- care as usual (control group)
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 154
Inclusion Criteria
1. Patients with squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx, receiving treatment with surgery and/or radiotherapy with curative intent;
2. No previous or synchronous malignancies, with the exception of:
adequately treated squamous cell or basal cell carcinoma of the skin or in situ carcinoma of the cervix
synchronous second squamous cell carcinoma of oral cavity, pharynx or larynx which can also be treated with curative intent;
Exclusion Criteria
No further exclusion criteria.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Depression will be measured with the Center for Epidemiological Studies-Depression Scale (CES-D) (Radloff 1977, Bouma 1988, Hanewald 1992). The CES-D consists of 20 items with a 4 point Likert scale, resulting in a total score ranging from 0 to 60 (Bouma 1988). A high score reflects a high level of depression. A cut-off point of 16 can be used, patients with a score of 16 or more being classified as being a possible case of depression. <br />This questionnaire has been developed for research in the general, non-psychiatric population, it contains 20 items and has been used in Duch cancer research (Komproe 1995, de Graeff 2000, de Leeuw 2000)
- Secondary Outcome Measures
Name Time Method