Background: Since treatment with immune checkpoint inhibitors (ICIs) is becoming standard therapy for patients with high-risk and advanced melanoma, an increasing number of patients experience treatment-related adverse events such as fatigue. Until now, studies have demonstrated the benefits of using eHealth tools to provide either symptom monitoring or interventions to reduce treatment-related symptoms such as fatigue. However, an eHealth tool that facilitates the combination of both symptom monitoring and symptom management in patients with melanoma treated with ICIs is still needed.
Objective: In this pilot study, we will explore the use of the CAPABLE (Cancer Patients Better Life Experience) app in providing symptom monitoring, education, and well-being interventions on health-related quality of life (HRQoL) outcomes such as fatigue and physical functioning, as well as patients' acceptance and usability of using CAPABLE.
Methods: This prospective, exploratory pilot study will examine changes in fatigue over time in 36 patients with stage III or IV melanoma during treatment with ICI using CAPABLE (a smartphone app and multisensory smartwatch). This cohort will be compared to a prospectively collected cohort of patients with melanoma treated with standard ICI therapy. CAPABLE will be used for a minimum of 3 and a maximum of 6 months. The primary endpoint in this study is the change in fatigue between baseline and 3 and 6 months after the start of treatment. Secondary end points include HRQoL outcomes, usability, and feasibility parameters.
Results: Study inclusion started in April 2023 and is currently ongoing.
Conclusions: This pilot study will explore the effect, usability, and feasibility of CAPABLE in patients with melanoma during treatment with ICI. Adding the CAPABLE system to active treatment is hypothesized to decrease fatigue in patients with high-risk and advanced melanoma during treatment with ICIs compared to a control group receiving standard care. The Medical Ethics Committee NedMec (Amsterdam, The Netherlands) granted ethical approval for this study (reference number 22-981/NL81970.000.22).
Trial registration: ClinicalTrials.gov NCT05827289; https://clinicaltrials.gov/study/NCT05827289.
International registered report identifier (irrid): DERR1-10.2196/49252.
Keywords: HRQoL; QoL; acceptance; adoption; cancer; digital health; eHealth; fatigue; immune checkpoint inhibitors; immunotherapy; intervention; melanoma; monitoring; oncology; patient education; pilot study; quality of life; symptom; symptoms.
©Itske Fraterman, Barbara M Wollersheim, Valentina Tibollo, Savannah Lucia Catherina Glaser, Stephanie Medlock, Ronald Cornet, Matteo Gabetta, Vitali Gisko, Ella Barkan, Nicola di Flora, David Glasspool, Alexandra Kogan, Giordano Lanzola, Roy Leizer, Henk Mallo, Manuel Ottaviano, Mor Peleg, Lonneke V van de Poll-Franse, Nicole Veggiotti, Konrad Śniatała, Szymon Wilk, Enea Parimbelli, Silvana Quaglini, Mimma Rizzo, Laura Deborah Locati, Annelies Boekhout, Lucia Sacchi, Sofie Wilgenhof. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 11.10.2023.