Patient reported outcomes in high risk and advanced melanoma patients

Recruiting

• Conditions: Kwaliteit van leven; Quality of life; 10040900

• Registration Number: NL-OMON51119
• Lead Sponsor: Antoni van Leeuwenhoek Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

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
<p>Primary outcome is to assess HRQoL. This will be assessed with The European<br /><br>Organization for Research and Treatment of Cancer Quality of Life<br /><br>Questionnaire-Core 30 (EORTC QLQ-C30). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes are collected through different questionnaires:<br /><br>sociodemographic questions, the Functional Assessment of Cancer Therapy -<br /><br>Melanoma (FACT-M), the Hospital Anxiety and Depression Scale (HADS), the Cancer<br /><br>Worry Scale (CWS), the immunotherapy-specific questtionaire, 4 questions about<br /><br>sexual health (EORTC sexuality module), the work-ability index (WAI)<br /><br>questionnaire, the 5-level EuroQoL-5D (EQ-5D-5L) and patients' perceptions of<br /><br>received information (QLQ-INFO25). </p><br>