Date of Award
Doctor of Philosophy in Nursing (PhD)
Meagan Whisenant, PhD
Constance Johnson, PhD
Hussein Tawbi, M.D.
Xin Shelley Wang, M.D.
Background: Immune checkpoint inhibitors (ICIs) are novel therapeutic agents utilized in the management of advanced melanoma. Though generally well-tolerated, patients receiving ICIs experience treatment-related toxicities at varying onset and intensity. Assessment and evaluation of these toxicities and their impact on a quality of life is essential to comprehensive cancer care. Patient-reported outcomes (PRO) contribute vital data to a clinical assessment, supporting clinicians in their ability to improve outcomes. To date, there is no melanoma-specific or ICI-specific PRO measure of symptom burden available.
Purpose: The purpose of this study was to describe the symptom experience from the patient's perspective and how it relates to the quality of life among patients undergoing ICIs for advanced melanoma across the treatment trajectory. In addition, this study assessed the concordance between symptoms communicated to clinicians during a follow-up visit and those reported via PRO instruments.
Methods: This was a cross-sectional, mixed-methods evaluation of the symptom experience of patients with advanced melanoma within their first year of ICI therapy. Participants completed two PRO instruments: the FACT-M and a modified version of the MDASI. The clinical review of systems was captured from the electronic health record following the visit in which the PRO instruments were completed to assess degree of matching. A subset of participants completed semi-structured, qualitative interviews to enrich the quantitative data. Interpretive description informed the inductive and iterative analysis approach.
Results: All 60 participants reported at least one symptom on the PRO instruments. Most commonly reported on the modified MDASI were lack of energy (N=43, 72%), fatigue (n=42, 71%), feeling drowsy (n=35, 60%), joint stiffness/soreness (n=34, 57%), disturbed sleep (n=33, 56%), dry mouth (n=32, 53%), and itching (n=30, 50%). Most commonly reported on the FACT-M were fatigue (n=49, 82%), lack of energy (n=46, 77%), worry that the disease would get worse (n=38, 63%), worry about dying (n=32, 54%), and feeling sad (n=32, 54%). More than 50% of participants reported interference with working (n=32, 53%) and general activity (n=33, 55%). Participants reported three or more symptoms on the PRO instruments when compared to the number of symptoms documented in the clinician ROS in the EHR. The participants (n=19) who completed the qualitative interviews had a heterogenous experience of ICI and melanoma-related symptoms. The most commonly reported symptoms in qualitative interviews included distress (n= 16, 84%), fatigue (n=13, 68%), and rash (n=10, 53%). Uncertainty was a pervasive theme (n=13, 68%), despite the majority having positive thoughts about ICI therapy (n=11, 58%) and expectations of the success of therapy (n=10, 53%).
Conclusion: The physical and emotional burden of a melanoma diagnosis and related therapy and the uncertainty of outcomes are common themes described by patients. Communication surrounding the diagnosis, prognosis, treatment options, and outcomes needs to be clear and acknowledge that there are unknowns. Providers may benefit from utilizing a validated PRO instrument to evaluate and understand patients' symptom experiences while undergoing ICI therapy. Further research is needed to finalize a melanoma ICI-specific instrument.
Jackson-Carroll, Natalie, "Symptom Experience of Patients with Advanced Melanoma Undergoing Immune Checkpoint Inhibitor Therapy" (2023). Dissertations (Open Access). 66.
melanoma, patient-reported outcome measures, quality of life, immune-checkpoint inhibitor, oncology