TY  - JOUR
AU  - Fraterman, Itske
AU  - Wollersheim, Barbara M
AU  - Tibollo, Valentina
AU  - Glaser, Savannah Lucia Catherina
AU  - Medlock, Stephanie
AU  - Cornet, Ronald
AU  - Gabetta, Matteo
AU  - Gisko, Vitali
AU  - Barkan, Ella
AU  - di Flora, Nicola
AU  - Glasspool, David
AU  - Kogan, Alexandra
AU  - Lanzola, Giordano
AU  - Leizer, Roy
AU  - Mallo, Henk
AU  - Ottaviano, Manuel
AU  - Peleg, Mor
AU  - van de Poll-Franse, Lonneke V
AU  - Veggiotti, Nicole
AU  - Śniatała, Konrad
AU  - Wilk, Szymon
AU  - Parimbelli, Enea
AU  - Quaglini, Silvana
AU  - Rizzo, Mimma
AU  - Locati, Laura Deborah
AU  - Boekhout, Annelies
AU  - Sacchi, Lucia
AU  - Wilgenhof, Sofie
PY  - 2023
DA  - 2023/10/11
TI  - An eHealth App (CAPABLE) Providing Symptom Monitoring, Well-Being Interventions, and Educational Material for Patients With Melanoma Treated With Immune Checkpoint Inhibitors: Protocol for an Exploratory Intervention Trial
JO  - JMIR Res Protoc
SP  - e49252
VL  - 12
KW  - eHealth
KW  - melanoma
KW  - fatigue
KW  - quality of life
KW  - intervention
KW  - pilot study
KW  - QoL
KW  - cancer
KW  - oncology
KW  - HRQoL
KW  - symptom
KW  - symptoms
KW  - monitoring
KW  - adoption
KW  - acceptance
KW  - patient education
KW  - digital health
KW  - immune checkpoint inhibitors
KW  - immunotherapy
AB  - 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 
SN  - 1929-0748
UR  - https://www.researchprotocols.org/2023/1/e49252
UR  - https://doi.org/10.2196/49252
UR  - http://www.ncbi.nlm.nih.gov/pubmed/37819691
DO  - 10.2196/49252
ID  - info:doi/10.2196/49252
ER  -