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Accepted for/Published in: JMIR Research Protocols

Date Submitted: May 24, 2023
Date Accepted: Aug 3, 2023

The final, peer-reviewed published version of this preprint can be found here:

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

Fraterman I, Wollersheim BM, Tibollo V, Glaser SL, Medlock SK, Cornet R, Gabetta M, Gisko V, Barkan E, di Flora N, Glasspool D, Kogan A, Lanzola G, Leizer R, Mallo H, Ottaviano M, Peleg M, van de Poll-Franse LV, Veggiotti N, Sniatala K, Wilk S, Parimbelli E, Quaglini S, Rizzo M, Locati L, Boekhout AH, Sacchi L, Wilgenhof S

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

JMIR Res Protoc 2023;12:e49252

DOI: 10.2196/49252

PMID: 37819691

PMCID: 10600650

An eHealth application (CAPABLE) providing symptom monitoring, well-being interventions and educational material for melanoma patients treated with immune-checkpoint inhibitors: A study protocol for an exploratory intervention trial

  • Itske Fraterman; 
  • Barbara M. Wollersheim; 
  • Valentina Tibollo; 
  • Savannah L.C. Glaser; 
  • Stephanie K. 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 Sniatala; 
  • Szymon Wilk; 
  • Enea Parimbelli; 
  • Silvana Quaglini; 
  • Mimma Rizzo; 
  • Laura Locati; 
  • Annelies H. Boekhout; 
  • Lucia Sacchi; 
  • Sofie Wilgenhof

ABSTRACT

Background:

Since treatment with immune-checkpoint inhibitors (ICIs) is becoming standard therapy for high-risk and advanced-melanoma patients, an increasing number of patients experience treatment-related adverse events such as fatigue. Until now, studies have demonstrated the benefits of using eHealth tools in providing either symptom monitoring or interventions to reduce treatment-related symptoms like fatigue. However, an eHealth tool that facilitates the combination of both symptom monitoring and symptom management is still needed.

Objective:

In this pilot study, we will explore the use of the Cancer Patients Better Life Experience (CAPABLE) application in providing symptom monitoring, education and wellbeing interventions, on health-related quality of life (HRQoL) outcomes such as fatigue and physical functioning, as well as patients’ acceptance of using a system like CAPABLE.

Methods:

This prospective, exploratory pilot study will examine changes in fatigue over time in 36 patients with stage III/IV melanoma during treatment with ICI using the CAPABLE intervention (a smartphone application and a multi-sensorial smartwatch). This cohort will be compared to a prospectively collected cohort of melanoma patients treated with standard ICI therapy. The CAPABLE application and smartwatch will be used for a minimum of three and a maximum of six months. The primary endpoint in this study is the change in fatigue between baseline, 3 and 6 months after start of treatment. Secondary endpoints include other 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 the CAPABLE system in melanoma patients during treatment with ICI. This study will be the first to provide a system developed in collaboration with patients and clinicians that includes symptom monitoring, information provision and wellbeing interventions in one eHealth tool. The Medical Ethics Committee NedMec (Amsterdam, The Netherlands) granted ethical approval for this study under reference number 22-981/NL81970.000.22. Clinical Trial: Trial registration number: NCT05827289


 Citation

Please cite as:

Fraterman I, Wollersheim BM, Tibollo V, Glaser SL, Medlock SK, Cornet R, Gabetta M, Gisko V, Barkan E, di Flora N, Glasspool D, Kogan A, Lanzola G, Leizer R, Mallo H, Ottaviano M, Peleg M, van de Poll-Franse LV, Veggiotti N, Sniatala K, Wilk S, Parimbelli E, Quaglini S, Rizzo M, Locati L, Boekhout AH, Sacchi L, Wilgenhof S

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

JMIR Res Protoc 2023;12:e49252

DOI: 10.2196/49252

PMID: 37819691

PMCID: 10600650

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© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.