Grant Number:	1K08CA237619-01A1 Interpret this number
Primary Investigator:	Lopez-Olivo, Maria De Los Angeles
Organization:	University Of Tx Md Anderson Can Ctr
Project Title:	Improving Decision-Making in Patients with Resectable Melanoma and Pre-Existing Autoimmune Disease Considering Immune Checkpoint Inhibition
Fiscal Year:	2020

PROJECT ABSTRACT Shared decision-making is a process aimed at helping health care providers and their patients make informed health decisions. During this process, information is exchanged (patients inform doctors about their health issues and preferences and health care providers inform patients about options for treatment), and options that will ultimately lead to a decision regarding management are clarified. Regarding cancer treatment decisions, patients often have other comorbidities, which can result in increased treatment-related toxicity or decreased benefits because of competing risk of other diseases. These concerns make decision-making both emotionally and cognitively difficult. One such difficult decision is whether to use immunotherapy as adjuvant therapy— specifically, immune checkpoint inhibitors—in patients with resectable melanoma and pre-existing autoimmune disease. Checkpoint inhibitors can cause adverse events due to immune-mediated tissue damage, termed immune-related adverse events. In patients with cancer and pre-existing autoimmune disease, immune checkpoint inhibition is possible but is associated with an increase incidence of adverse events and flares. Thus, this treatment requires cautious monitoring. Optimal treatment decisions require careful consideration of harms and benefits as well as the likelihood of recurrence. The overall goal of this proposed study is to develop and test an individualized shared decision- making tool for patients with resectable melanoma and pre-existing autoimmune disease that can be used with providers to improve the decision-making regarding initiation of adjuvant treatment with immune checkpoint inhibitors. Such tools have yet to be developed. This career development award will provide the principal investigator with protected time to become a decision scientist with an interest in shared decision-making by patients with cancer and comorbid conditions. The specific aims of her research proposal are to evaluate the benefits and risks of immune checkpoint inhibitors in patients with resectable melanoma and pre-existing autoimmune disease considering stage, survival, expected rates of toxicity, and flares; 2) to develop a multicomponent shared decision-making tool for cancer patients with RA considering treatment with immune checkpoint inhibitors; and 3) evaluate the tool which will be appropriate for low-literacy populations, and will be tailored to patients' individual characteristics. To achieve her career goals, the principal investigator has assembled a multidisciplinary team of experts in the fields of interest and is proposing a comprehensive training program.

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