Advanced Practice Providers' Role in Intimacy in Advanced Cancer Patients.

The primary objectives of early phase clinical trials are to determine the safety, tolerability, and recommended doses of an investigational agent for patients with advanced cancer. Although these advances in cancer treatment have resulted in patients living longer, patients often experience psychological side effects that may affect sexual health and intimacy. It is estimated that cancer and its subsequent treatments affect the sexual health and intimacy of 40% to 100% of this patient population. Patients with advanced cancer who have undergone numerous treatments may be impacted negatively, not only physically (such as being disfigured by surgical resection) but also emotionally in relationship aspects with their intimate partners. Health-care providers who treat patients with advanced cancer enrolled in early phase clinical trials tend to focus primarily on treatment, physical side effects, and symptom management. Advanced practice providers (APPs) are accustomed to performing comprehensive physical examinations on patients; however, research indicates that intimacy and sexuality are most often excluded in discussions with patients with advanced cancer. The purpose of the article is to increase awareness of the need to address intimacy and sexuality in this patient population and to encourage APPs to make this a part of their everyday practice.

Management of Adverse Events in Early Clinical Trials by Advanced Practice Providers in the Outpatient Setting: The University of Texas MD Anderson Cancer Center Experience.

Background: Advanced practice providers (APPs) play important roles in enrolling, educating, and caring for patients in clinical trials. However, much remains unknown about the role of APPs in managing adverse events (AEs) in early (phase I to II) clinical trials. In this study, we assessed the outpatient management of grade 3 to 4 AEs by APPs in early trials and characterized the workflow of our APP Phase I to II Fast Track (FT) Clinic. Patients and Methods: We retrospectively reviewed records of patients with advanced or metastatic solid tumors enrolled in phase I to II clinical trials who were seen by APPs from September 2017 to August 2018 in the APP phase I to II FT clinic in the Department of Investigational Cancer Therapeutics. Results: A total of 808 patients enrolled in 159 clinical trials were seen in 2,697 visits (median 3 visits per patient; range 1-28) by 10 APPs. Treatment was interrupted in 6.9% of visits, and grade 3 to 4 AEs were seen in 5.4% of visits; however, patients from 1.4% of visits were sent to the emergency center (EC) and/or admitted. Patients referred to the EC and/or admitted were more likely to have baseline hypoalbuminemia, high lactate dehydrogenase, and poor Eastern Cooperative Oncology Group performance status (i.e., ECOG > 1; p < .001). There were no associations between EC referral and gender, APP years of experience, or type of treatment. Conclusions: The APP Phase I to II FT Clinic has an important role in the management of AEs by APPs in early clinical trials in the outpatient setting, potentially avoiding EC visits and admissions.

Occurrence of Type 1 Diabetes in A Patient Enrolled in An Immunotherapy Combination Phase 1 Clinical Trial: A Case Study.

Advances in cancer immunotherapy treatments have shown promising results in patients with metastatic malignancy who have been refractory to prior treatments. Immune checkpoint inhibitors such as pembrolizumab in combination with other systemic agents may unleash immune-related adverse events (irAEs). Immunotherapy-induced Type 1 diabetes is rare; however, if left undiagnosed, it may cause life-threatening metabolic endocrinopathies. Advanced practice registered nurses are in a unique position to recognize and identify this irAE and in doing so can provide pathways for early diagnosis and treatments, thus leading to improved clinical and patient outcomes.