Patient reported outcomes in high risk and advanced melanoma patients
Recruiting
- Conditions
- High-risk (resectable stage III) or advanced (stage IV and unresectable stage III) melanoma
- Registration Number
- NL-OMON20229
- Lead Sponsor
- one, investigator initiated
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 300
Inclusion Criteria
Adults of 18 years and older; Melanoma patients indicated to receive treatment with immune checkpoint-inhibitors, according to the clinical guidelines; Written informed consent to participate in the study.
Exclusion Criteria
Insufficient understanding of the Dutch or English language; Inclusion in experimental clinical trials
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary outcome is to assess HRQoL. This will be assessed with The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30).
- Secondary Outcome Measures
Name Time Method Secondary outcomes are collected through different questionnaires: sociodemographic questions, the Functional Assessment of Cancer Therapy - Melanoma (FACT-M), the Hospital Anxiety and Depression Scale (HADS), the Cancer Worry Scale (CWS), the immunotherapy-specific questtionaire, 4 questions about sexual health (EORTC sexuality module), the work-ability index (WAI) questionnaire, the 5-level EuroQoL-5D (EQ-5D-5L) and patients' perceptions of received information (QLQ-INFO25).