Metastatic malignant melanoma

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

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.

 

Potential uses for this questionnaire:

  1. To assess the quality of life of metastatic melanoma patients in clinical trials.
  2. To identify (specific) quality of life issues that metastatic melanoma patients might face.

Achievements

1. Protocol for project written
2.Local ethical approval obtained
3. Finalizing phase 1A
4. Setting up EORTC contracts with local collaborators.

 

Finalizing Phase 1A, setting up EORTC contract with local collaborators for the projects, and obtaining ethics approval from collaborating sites

Future plans

Expected completion of the project’s phases:

Phase 1A: September 2021

Phase 1B-1D: September 2022

Phase 2: February 2023

Phase 3A-3B: September 2024

Phase 4: To be determined

 

Note:

If you are interested to collaborate in this project, please send an email to m.egeler@nki.nl

For patients

Not that long ago, people diagnosed with advanced skin cancer had relatively little chance to survive their disease. However, through impressive research, new therapies have been created that improve these odds. With more people showing long-term survival, the way it affects their lifestyle becomes more interesting. How does having advanced skin cancer affect their lives, their mental health, their physical wellbeing? What issues do they experience from their disease, from their treatment, and how long do these issues last? This study aims to answer these questions and ultimately create a questionnaire that will serve as a compass to see:
1) What issues patients with advanced skin cancer face, and 2) what we as health care professionals can do to address these issues and improve their lives.