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

Completed

Conditions: Melanoma
NSCLC en urogenital cancers
10018188
10029107
10040900

Registration Number: NL-OMON48886

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 195

Inclusion Criteria

1. Patient with melanoma, NSCLC or urogenital cancers *2 years since treatment
with at least one cycle of immune checkpoint inhibitor (CTLA-4 inhibitor,
PD(L)-1 inhibitor, or both) within the Department of Medical Oncology or
Pulmonary Oncology of the UMCG.
2. age *18 years at time of immune checkpoint inhibitor treatment
3. all previous or subsequent therapies allowed, including (brain) irradiation,
surgery for metastases, chemotherapy, and targeted therapy provided stable
clinical situation at time of inclusion

Exclusion Criteria

1. switch of systemic therapy or local antitumor intervention (surgery,
radiotherapy) during last 2 months
2. inability to understand or abide to the study protocol
3. debilitating psychiatric illness
4. previous treatment for malignancy other than melanoma (excluding
non-melanoma skin cancer, cervical intra-epithelial neoplasia (CIN) or
carcinoma in situ of breast)

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study endpoint is health-related quality of life (HRQoL) as measured<br /><br>using the EORTC Quality of life questionnaire (QLQ-C30). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameters are possible late effects (neurocognitive<br /><br>dysfunction, endocrine disorders, dermatologic complaints, sexual disorders and<br /><br>infertility, increased cardiovascular risk, and fatigue), physical fitness,<br /><br>psychosocial issues related to work/education, mood disorders (anxiety and<br /><br>depression), patient and treatment-related factors potentially influencing<br /><br>development of late effects, well-being, and quality of life of caregivers.</p><br>