Quality of life, cognitive function, and physical fitness of patients surviving more than 2 years after immune checkpoint inhibitor therapy

Tremendous anti-tumor effects have been achieved using immune checkpoint
inhibitors for melanoma, NSCLC and urogenital cancers with long lasting
responses of more than 2 years in a substantial subgroup of patients. However,
we are still largely unaware of the health-related quality of life of these
patients. We should carefully and thoroughly assess the long-term burden of
disease and treatment toxicity. We need this information to guide follow-up and
implement intervention strategies to improve quality of life.

Primary Objective:
- to investigate health-related quality of life (HRQoL) of patients surviving 2
years or more after the first cycle of an immune checkpoint inhibitor for
melanoma or NSCLC.

Secondary Objectives:
- to assess neurocognitive function, endocrine function, cardiovascular risk,
physical fitness, mood disorders, sexual problems, work participation in
patients surviving 2 years or more after the first cycle of immune checkpoint
inhibitor;
- to assess quality of life of the caregivers of these patients.

Observational cross-sectional study.

Participation in the study will include one study visit of approximately 2.5
hours. If possible, the study visit will be combined with a regular follow-up
visit. Vena puncture is the only invasive procedure, with low risk of adverse
effects. Blood will be drawn after an overnight fast. To minimize the duration
of the visit, patients will be offered to fill out the questionnaires at home.
Individual adverse test results will be reported to a participants* treating
physician (oncologist and GP) to enable treatment or follow-up as indicated.
The results of the full study group will be used to guide future interventions
and support for patients treated with immune checkpoint inhibitors.