No hypothesis due to the explorative character of the study
ID
Bron
Verkorte titel
Aandoening
High-risk (resectable stage III) or advanced (stage IV and unresectable stage III) melanoma
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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).
Achtergrond van het onderzoek
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.
Doel van het onderzoek
No hypothesis due to the explorative character of the study
Onderzoeksopzet
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.
Onderzoeksproduct en/of interventie
N/A
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Insufficient understanding of the Dutch or English language; Inclusion in experimental clinical trials
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL9498 |
Ander register | METC Stichting Nederlands Kanker Instituut - Het Antoni van Leeuwenhoek Ziekenhuis : METCP20MEL |