Study Protocol to Characterize Symptom Experience During Immune Checkpoint Inhibitor Therapy for Cutaneous Melanoma

Area of Science:

• Oncology
• Immunology
• Patient-Reported Outcomes

Background:

• Immune checkpoint inhibitors (ICIs) have improved survival for advanced cutaneous melanoma.
• However, knowledge gaps exist regarding the impact of ICIs on patient symptom experiences.
• Understanding inter-individual differences in symptoms is crucial for managing toxicity and guiding treatment.

Purpose of the Study:

• To describe the occurrence, severity, and distress of 53 symptoms across four ICI cycles in advanced melanoma patients.
• To identify symptom clusters, patient subgroups with distinct symptom profiles, and associated risk factors.
• To evaluate differences in demographic, clinical characteristics, cancer-related stress, financial toxicity, and quality of life (QOL) among symptom profiles.

Main Methods:

• Longitudinal descriptive study of 300 adults with stage IIB-IV cutaneous melanoma starting ICIs.
• Symptom data collected using a modified Memorial Symptom Assessment Scale prior to each of four ICI cycles.
• Exploratory factor analysis and latent class/profile analysis used to identify symptom clusters and patient subgroups.

Main Results:

• Participant recruitment is ongoing, with completion expected in June 2027.
• Detailed results on symptom occurrence, severity, distress, and cluster analysis will be available upon study completion.

Conclusions:

• This research will elucidate inter-individual differences in symptom experiences and risk factors for advanced melanoma patients receiving ICIs.
• Findings will inform clinical assessment, monitoring of high-risk patients, and future research in biomarker discovery and intervention development.