Metastatic malignant melanoma

Gender Neutral
Type Module
Testing Phase I / II - in development
Principal investigator(s)
Lonneke van de Poll-Franse
Eindhoven, Netherlands
Study coordinator(s)
Marieke van Leeuwen
The Netherlands Cancer Institute
, Mees Diederik Egeler
The Netherlands Cancer Institute
Amsterdam, Netherlands

Project summary

The introduction of immunotherapy and targeted therapy has substantially improved the clinical outcomes of stage III (local metastases) and IV melanoma (distant metastases) patients. However, these treatments present their unique combination of potential (immune-related) adverse events (irAEs) that might affect the patients’ health-related quality of life (HRQOL). A validated questionnaire that adequately covers these issues does currently not exist. Therefore, this study aims to develop an HRQOL questionnaire for patients with advanced melanoma.


Since the last meeting, we finalized the literature review on the topic and interviewed 18 healthcare professionals. We have created the initial issue list based on the literature review results and updated it based on the results of the healthcare professional interviews.


Future plans

Expected completion of the future steps of the project:

1) Patient interviews
June 2022

2) Conversion issues to items: September 2022

3) Pre-testing and psychometric property evaluation
February 2024

4) Phase 4: To be determined


Planning to initiate the patient interviews for the project a.s.a.p.



For patients

Not that long ago, people diagnosed with advanced skin cancer had relatively little chance to survive their disease. But, through impressive research, new therapies have been created that have improved these odds. Therefore, these new treatments have become the new standard to treat people with advanced skin cancer. However, as these treatments are new, we do not fully understand what physical, mental, and emotional issues these people can experience from their disease and treatment. We are therefore creating a questionnaire that will help us measure this.