No registrations found.
ID
Source
Brief title
Health condition
High-risk (resectable stage III) or advanced (stage IV and unresectable stage III) melanoma
Sponsors and support
Intervention
Outcome measures
Primary outcome
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
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).
Background summary
Still little is known about the long term effect of the different immunotherapies on psychosocial outcomes in high risk melanoma and advanced melanoma survivors. Collecting patient-reported outcomes (PROs) and health-related quality of life (HRQoL) data is important for understanding the short term and long term impact of melanoma itself and the treatment with ICIs on quality of life outcomes in melanoma patients. Therefore, in this study prospectively enrolling, monocenter cohort study in melanoma patients eligible for undergoing ICI treatment, we want to do more research into patient reported outcomes, what is necessary to identify personal care needs and contribute to the development of appropriate supportive care to optimize melanoma patients’ wellbeing and HRQoL. Study outcomes will be obtained via PRO questionnaires. Primary outcome is to assess short- and long-term HRQoL in high risk and advanced melanoma patients treated with immune checkpoint-inhibitors. Secondary outcomes are to describe short- and long-term anxiety and depression; fear of cancer recurrence; melanoma-specific HRQoL; symptoms and work ability in high risk and advanced melanoma patients treated with immune checkpoint-inhibitors.
Study objective
No hypothesis due to the explorative character of the study
Study design
11 questionnaires distributed over 5 years (baseline, first year FU every 3 months, year two and three of FU every 6 months, year four and five of FU yearly.
Intervention
N/A
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
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 | NL9498 |
| Other | METC Stichting Nederlands Kanker Instituut - Het Antoni van Leeuwenhoek Ziekenhuis : METCP20MEL |