Grant Number:	5R00CA286967-04 Interpret this number
Primary Investigator:	Harris, Carolyn
Organization:	University Of California, San Francisco
Project Title:	Characterization of the Symptom Experience of Patients with Cutaneous Melanoma Receiving Immune Checkpoint Inhibitor Therapy
Fiscal Year:	2026

The psychological symptom cluster is a common problem that impacts patients receiving cancer treatment and is associated with several negative outcomes, including increased mortality and reduced quality of life. To date, the majority of the research that evaluated for risk factors for the occurrence or increased severity of this cluster has been done in patients receiving chemotherapy, radiation therapy, or aromatase inhibitor therapy. Little is known regarding this cluster in the context of an emerging cancer treatment –immunotherapy. Given that immune checkpoint inhibitor therapy (i.e., a type of immunotherapy) has become the standard of care treatment for patients with stage IIB to IV cutaneous melanoma, characterization of the psychological symptom cluster and its clinical and demographic risk factors in these patients throughout their receipt of this novel therapy is warranted. This research aligns with the National Cancer Institute’s Research Portfolio aim to innovate cancer treatment. This R00 study will employ a longitudinal study design and recruit adult patients with stage IIB through IV cutaneous melanoma prior to the start of their first immune checkpoint inhibitor cycle and will follow them for three additional cycles. The R00 phase aims are to (1) identify symptom clusters in patients with cutaneous melanoma receiving an immune checkpoint inhibitor over time and (2) identify distinct psychological symptom cluster profiles and evaluate for demographic and clinical risk factors associated with a worse cluster profile over time. The proposed R00 project will fill important gaps in our knowledge about the risk factors for a common symptom cluster in patients with cutaneous melanoma receiving immune checkpoint inhibitors. Findings will guide clinical assessment; advise treatment decision making; and inform the development of targeted interventions. In addition, given that immune checkpoint inhibitors for cutaneous melanoma (i.e., nivolumab, pembrolizumab, ipilimumab) have FDA-approved indications for 16 other cancer types, findings from this study will inform research on the symptom experience of patients with other types of cancer who receive these agents.




Study Protocol to Characterize Symptom Experience During Immune Checkpoint Inhibitor Therapy for Cutaneous Melanoma.
Authors: Harris C.S. , Tsai K.K. , Liu L. , Oppegaard K.R. , Cooper B.A. , Paul S.M. , Hubbard E.M. , Levine J.D. , Miaskowski C.A. .
Source: Nursing Research, 2026-06-02 00:00:00.0; , .
EPub date: 2026-06-02 00:00:00.0.
PMID: 42228432
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Associations Between Potassium Channel Genes and the Occurrence of Palpitations in Women Prior to Breast Cancer Surgery.
Authors: Sheng Y. , Fleming M.R. , Harris C.J. , Levine J.D. , Paul S.M. , Carpenter J.S. , Conley Y.P. , Shin J. , Oppegaard K. , Hammer M.J. , et al. .
Source: Seminars In Oncology Nursing, 2025 Dec; 41(6), p. 152039.
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Cytokine-Cytokine Receptor Interaction and Endocytosis are Common Pathways for Symptom Burden and Sickness Behavior Symptoms in Oncology Patients Undergoing Chemotherapy.
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Source: Cancer Medicine, 2025 Nov; 14(21), p. e71328.
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Advancing Global Cancer Symptom Science: Insights and Strategies From the Inaugural Cancer Symptom Science Expert Meeting.
Authors: Colomer-Lahiguera S. , Pozzar R.A. , Harris C.S. , Brant J.M. , Conley Y.P. , Cooley M.E. , Eicher M. , Hinds P.S. , Howell D. , Mitchell S.A. , et al. .
Source: Oncology Nursing Forum, 2025-08-18 00:00:00.0; 52(5), p. 331-350.
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Source: Supportive Care In Cancer : Official Journal Of The Multinational Association Of Supportive Care In Cancer, 2025-03-06 00:00:00.0; 33(4), p. 254.
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Self-reported cancer-related cognitive impairment is associated with perturbed neurotransmission pathways.
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Impact of Multimorbidity on Symptom Burden and Symptom Clusters in Patients Receiving Chemotherapy.
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Associations Between Preoperative Shortness of Breath and Potassium Channels Gene Variations in Women With Breast Cancer.
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Psychological Symptom Cluster Severity Profiles Are Associated With Higher Levels of Stress and Worse Quality of Life in Postmenopausal Women With Breast Cancer.
Authors: Harris C.S. , Conley Y.P. , Rosenzweig M.Q. , Erickson K.I. , Cooper B.A. , Bender C.M. .
Source: Cancer Nursing, 2024-12-02 00:00:00.0; , .
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