Cutaneous Melanoma, Cutaneous Melanoma by AJCC V7 Stage, Cutaneous Melanoma, Stage III, Cutaneous Melanoma, Stage IV
Conditions
Keywords
Toxicity
Brief summary
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.
Detailed description
PRIMARY OBJECTIVES: 1. Evaluate for changes over time in the patients' symptom experience, 2. Identify distinct symptom profiles over time. 3. Evaluate for demographic, clinical, environmental, and molecular risk factors associated with a worse profile. OUTLINE: Participants receiving ICI outside the scope of this study as part of usual care will have a chart review from the first cycle of non-investigational treatment for up to 4 cycles. Participants may complete symptom and health-related quality of life questionnaires during the course of the study, and blood samples will be obtained at regular clinic visits.
Interventions
PROCEDUREBlood Sample
Blood samples will be collected
Participants may be given HRQoLs during the course of data collection
OTHERMedical Chart Review
Participants will undergo medical charts review during the course of data collection
Sponsors
National Cancer Institute (NCI)
University of California, San Francisco
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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. * Provide written informed consent to participate in this study. * Participants with stage IIB or higher cutaneous melanoma
Exclusion criteria
* Participants will be excluded if they are unable to complete study requirements.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of symptoms reported over time | Up to 5 months | 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 | Up to 5 months | 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. | Up to 5 months | 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. |
Countries
United States
Contacts
Primary ContactErin Hubbard, MPH
Backup ContactCarolyn Harris, PhD, RN
Outcome results
None listed