No registrations found.
ID
Source
Brief title
Health condition
Melanoma (stage III/IV)
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome will be assessed by use of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-core 30 (EORTC QLQ-C30). The EORTC QLQ-C30 is a self-reported questionnaire, specifically developed for patients with cancer who are receiving cancer treatment. The EORTC-QLQ- C30 is widely accepted and validated in clinical studies.
Secondary outcome
- Melanoma (surgery) specific symptoms (Functional Assessment of Cancer Therapy- Melanoma; FACT-M)
- Sociodemographic data
- Anxiety and depression (Hospital Anxiety and Depression Scale; HADS)
- Worry about cancer (Cancer Worry Scale; CWS)
- Immunotherapy-related discomforts
- Sexual health (EORTC sexuality questionnaire)
- Work ability
- Quality-adjusted life years (QUALYs) by means of the 5 level EuroQoL-5D
- Cognitive status (Amsterdam Cognition Scan)
Background summary
The introduction of checkpoint inhibitors (immunotherapy) has improved clinical outcomes of stage III and IV melanoma patients substantially. These treatments have led to long-term benefit or even cure for the patients, but there is still insufficient data on the effects of these treatments on health-related quality of life (HRQoL). Therefore, in this study we will explore HRQoL (by means of a questionnaire) and patients’ cognitive functioning (by means of an online cognition scan) after active treatment with immunotherapy, surgery or a combination of both.
Study objective
No hypothesis due to the explorative character of the study
Study design
in this cohort study, a single questionnaire and cognition scan will take place >2 years of active treatment.
Intervention
not applicable
Inclusion criteria
In order to participate in this study, patients have to be:
- At least 18 years of age
- Actively treated for melanoma by use of immunotherapy, surgery or a combination.
- Willing to fill in one questionnaire and perform one online cognition test.
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Insufficient understanding of the Dutch or English language
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9198 |
| Other | METC AVL : METCP20OPC |