C43
Conditions
Interventions
Group 1: Patients with stage III melanoma after complete resection who received adjuvant immunotherapy. Within the study, health-related quality of life is assessed once using standardized questionnai
Sponsors
Heidelberg Universitätsklinikum
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Adult patients (= 18 years) capable of providing informed consent Histologically confirmed stage III melanoma Initial diagnosis of the primary melanoma prior to 2021 Complete surgical resection of the melanoma Ability to complete the questionnaire independently Written informed consent for study participation
Exclusion criteria
Exclusion criteria: Ongoing systemic therapy due to disease progression Presence of another active malignancy requiring systemic treatment Physical or cognitive impairment preventing completion of the questionnaire Insufficient German language skills to complete the questionnaire Patients unable to provide informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome: Health-related quality of life in long-term survivors with stage III melanoma: What: Total score of the standardized questionnaire Functional Assessment of Cancer Therapy – Immune Checkpoint Modulator (FACT-ICM) and its subscales (physical, social, emotional, functional well-being, and immunotherapy-specific module). When: Single assessment at the time of study participation (cross-sectional assessment). How: Patient-reported outcome using a standardized questionnaire (FACT-ICM), collected electronically (online) or paper-based. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Current self-reported health status What: Visual analogue scale (VAS) When: single assessment at the time of survey How: patient self-report 2. Type of adjuvant therapy What: immunotherapy, targeted therapy, or no adjuvant therapy When: retrospective (from medical records) How: extracted from routine clinical data 3. Type and severity of treatment-related adverse events What: occurrence, type, and severity of previous and ongoing adverse events When: retrospective (during treatment and follow-up period) How: extracted from medical records 4. Presence of chronic or persistent adverse events What: long-term treatment-related adverse effects When: at time of data collection How: derived from medical records and, if applicable, patient report | — |
Countries
Germany
Contacts
Public ContactSusanne Dugas-Breit
Heidelberg Universitätsklinikum
Outcome results
None listed