The effect of comprehensive counseling by a nurse specialist on depressive symptoms and quality of life: a prospective randomised study in patients with head and neck cancer
Completed
- Conditions
- Head cancer, neck cancer, tumourCancerMalignant neoplasm of other and ill-defined sites
- Registration Number
- ISRCTN06768231
- Lead Sponsor
- niversity Medical Centre Utrecht (UMCU) (Netherlands)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- 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:
2.1. Adequately treated squamous cell or basal cell carcinoma of the skin or in situ carcinoma of the cervix
2.2. Synchronous second squamous cell carcinoma of oral cavity, pharynx or larynx
Which can also be treated with curative intent
3. Ability to complete the questionnaire and expected cooperation of the patient, as reflected by a completed baseline questionnaire
Exclusion Criteria
Does not comply with the above inclusion 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). The CES-D consists of 20 items with a 4-point Likert scale, resulting in a total score ranging from 0 to 60. 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. This questionnaire has been developed for research in the general, non-psychiatric population, it contains 20 items and has been used in Dutch cancer research.
- Secondary Outcome Measures
Name Time Method