melanoma skincancer
Conditions
Interventions
None listed
Sponsors
Antoni van Leeuwenhoek Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: * >18 years of age * Sufficient understanding of the Dutch language * Participants or their caregiver can use a smartphone (upon patient*s consent) * Histologically confirmed melanoma (high-risk resectable stage III and stage IV and unresectable stage III) patients indicated to receive treatment with immune checkpoint-inhibitors, according to the clinical guidelines.
Exclusion criteria
Exclusion criteria: Included in experimental clinical trial (with medication)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study parameters are the fatigue symptom scale 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 and is the most common quality of life instrument used in melanoma studies. | — |
Secondary
| Measure | Time frame |
|---|---|
| Feasibility • Recruitment rate: number of included patients relative to the number of invited patients: recruitment rate will be calculated by the percentage of included patients compared to the total number of eligible patients contacted. An overall recruitment rate of 36 patients will be considered feasible. • Patient compliance to the system will be evaluated by system interaction and data from the CAPABLE operational logs: o Users* interactions logs; o Component interaction data; o Recommendations and messages generated by the system for the clinician and patient. • Patient retainment: number of patients finishing the study: Patient retainment will be calculated as the number of patients retained in the study for the full first three months as a percentage of the number of patients who started the study Additional patient-reported outcomes (PROMs) Secondary study parameters include outcomes of questionnaires regarding health-related quality of life outcomes, anxiety and depression, melanoma-specific HRQoL, immune-related adverse events and information needs in high risk and advanced melanoma patients treated with immune checkpoint-inhibitors. * The EuroQoL-5D (EQ-5D-5L). The EQ-5D is a standardised 5-level, 5-dimensional multi-attribute utility questionnaire that measures mobility, self-care, usual activities, pain/discomfort and anxiety/depression, using a five dimension scale. This questionnaire is currently being used in the hospital according to clinical practice. * Of the FACT-M, we use the Melanoma Subscale and the Melanoma Surgery Subscale, items specific to quality of life in melanoma patients. High scores show a high quality of life. Testing has shown that the FACT-M is a reliable and valid instrument to assess quality of life in patients with melanoma. This questionnaire is currently used in the hospital according to clinical practice. * Psychological distress will be assessed with the Hospital Anxiety and Depression Sca | — |
Countries
Netherlands
Outcome results
None listed