The introduction of immune checkpoint inhibitors (ICIs) for the treatment of patients with stages IIB to IV cutaneous melanoma resulted in dramatic improvements in mortality rates for this common form of cancer. With this rapid shift in treatment, significant gaps in knowledge exist regarding the impact of ICIs on patients' symptom experiences. An in-depth characterization of inter-individual differences in patients' symptom experiences will fill this knowledge gap and assist with the early detection of ICI toxicity; guide symptom management; inform treatment decision making; and refine ICI-symptom instrument development. Furthermore, given the limited knowledge in this area, the identification of demographic, clinical, environmental, and molecular risk factors associated with a worse symptom experience is warranted. This is a longitudinal, prospective study evaluating the symptoms that immune checkpoint inhibitors may cause in patients with cutaneous melanoma.
Adults ≥18 years of age
Able to speak and read English
Diagnosed with stage IIB, III, or IV cutaneous melanoma
Participants who are scheduled to receive >=1 immune checkpoint inhibitor at University of California San Francisco medical center locations. Participants on targeted therapies (e.g., BRAF or mitogen-activated extracellular signal-regulated kinase (MEK) inhibitors) will be eligible.
Participants will be excluded if they are unable to complete study requirements.
Adult participants with stage IIB, III, or IV cutaneous melanoma who will receive ≥ 1 immune checkpoint inhibitor therapy as part of treatment for cutaneous melanoma.
Cohort
Prospective
Blood Sample
Procedure/SurgeryBlood samples will be collected
Health Related Quality of Life Questionnaires (HRQoL)
Other interventionParticipants may be given HRQoLs during the course of data collection
Medical Chart Review
Other interventionParticipants will undergo medical charts review during the course of data collection
Frequency of symptoms reported over time
Evaluations of symptoms over time will be assessed via calculating the occurrence rates and means and standard deviations for the severity and distress ratings for all 53 symptoms and determine the most common, severe, and distressing symptoms over time.
Number of distinct symptom profiles identified
Latent class analysis will be used to identify subgroups of patients with distinct symptom occurrence profiles separately at each time point. Only symptoms that occurred in ≥20% of patients will used in the latent class analysis.
Number of risk factors identified with worse symptom profile over time.
Associations among the latent symptom occurrence profiles in demographic, clinical, environmental, and molecular characteristics along with financial toxicity, quality of life, and cancer-related distress will be evaluated using parametric and non-parametric methods to identify risk factors associated with a worse symptom profile over time.
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University of California, San Francisco
Lead sponsor
National Cancer Institute (NCI)
Collaborator
