C43
Conditions
Interventions
Group 1: Non-interventional cross-sectional mixed-methods studyStudy phase A: quantitative data collection (questionnaire survey) with patients with malignant melanoma and their (informal) caregivers
Sponsors
Universitätsklinikum Hamburg-Eppendorf
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Inclusion criteria – Patients (1) Age = 18 years. (2) Sufficient German language skills to independently complete the assessment instruments. (3) Diagnosis of malignant melanoma. (4) Treatment with at least one immune checkpoint inhibitor (anti-PD-1, anti-CTLA-4, or combination therapy). Inclusion criteria are further differentiated by treatment setting as follows: – Adjuvant setting (ICI completed): Completion of adjuvant ICI therapy at least 1 year ago, no evidence of recurrence since end of therapy. – Advanced setting, ICI completed: No progression or recurrence since initiation of ICI therapy for at least 2 years, therapy completed, no subsequent change of systemic therapy. – Advanced setting, ICI ongoing: Progression-free or stable disease for at least 2 years since initiation of ICI under ongoing ICI therapy, no change of systemic therapy. Inclusion criteria – Caregivers (1) Age = 18 years. (2) Sufficient German language skills. (3) Self-identification as a close person affected by the patient's melanoma diagnosis and treatment. Eligible caregivers include partners, parents, siblings, and adult children. A formal caregiving role is not required. Inclusion criteria – Healthcare professionals (1) Physicians and (study) nurses involved in the treatment or follow-up care of melanoma patients receiving ICI. (2) Working in one of the following specialties: dermato-oncology, psycho-oncology, radiology, rheumatology, or endocrinology.
Exclusion criteria
Exclusion criteria: Exclusion criteria – Patients Recurrence or progression within the last 2 years. Age under 18 years. Insufficient German language skills. Exclusion criteria – Relatives Age under 18 years. Insufficient German language skills.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cross-sectional assessment of bio-psycho-social burden and support needs of long-term melanoma survivors via: WHO-5 (well-being), persistent physical symptoms following ICI therapy (PRO-CTCAE, selected items), fear of recurrence/progression (PA-F-KF), psychological distress (PHQ-4), regret regarding the treatment decision (Decision Regret Scale), and support needs (SCNS-SF34-G). | — |
Secondary
| Measure | Time frame |
|---|---|
| Cross-sectional assessment of support needs of (informal) caregivers (SCNS-P&C-G), quality of life of caregivers (CQOLC), well-being of caregivers (WHO-5), psychological distress of caregivers (PHQ-4), and fear of recurrence/progression in caregivers (PA-F-P-KF). Further secondary, qualitative endpoints comprise the experiences and perspectives of patients, caregivers, and healthcare professionals regarding long-term burden, and in particular regarding underrepresented topics (fertility, sexuality, financial burden, rare long-term side effects) that may occur in the context of ICI therapy, as well as perceived gaps in care. | — |
Countries
Germany
Contacts
Public ContactChiara L. Blomen
Klinik und Poliklinik für Dermatologie und Venerologie, Universitätsklinikum Hamburg-Eppendorf
Outcome results
None listed