Evidence map›Paper›PMID 37819691›Full record

ArticleJMIR research protocols2023

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.

Itske Fraterman, Barbara M Wollersheim, Valentina Tibollo, Savannah Lucia Catherina Glaser, Stephanie Medlock, Ronald Cornet, Matteo Gabetta, Vitali Gisko, Ella Barkan, Nicola di Flora and 18 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in JMIR research protocols, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05827289 (Pilot Study of the eHealth Application 'Cancer Patients Better Life Experience'), which is not on this map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
2.8field-weighted citation impact, top 9% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05827289 naunknown statusnot on this map

Pilot Study of the eHealth Application 'Cancer Patients Better Life Experience'

TypeinterventionalSponsorThe Netherlands Cancer InstituteRan2023 to 2023Enrolled36ConditionsMelanomaArmsCancer Patients Better Life Experience (CAPABLE)
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 12 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

28 authors at 11 institutions in 5 countries.

Itske FratermanDepartment of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute, Amsterdam, Netherlands.ORCID https://orcid.org/0000-0001-7974-8422
Barbara M WollersheimDepartment of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute, Amsterdam, Netherlands.ORCID https://orcid.org/0000-0002-5145-9618
Valentina TibolloLaboratory of Informatics and Systems Engineering for Clinical Research, Istituti Clinici Scientifici Maugeri SpA SB IRCCS, Pavia, Italy.ORCID https://orcid.org/0000-0003-2687-3822
Savannah Lucia Catherina GlaserMedical Informatics, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.ORCID https://orcid.org/0000-0003-0103-079X
Stephanie MedlockMedical Informatics, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.ORCID https://orcid.org/0000-0002-2679-8095
Ronald CornetMedical Informatics, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.ORCID https://orcid.org/0000-0002-1704-5980
Matteo GabettaBIOMERIS SRL, Pavia, Italy.ORCID https://orcid.org/0000-0001-9140-768X
Vitali GiskoBITSENS JSC, Vilnius, Lithuania.ORCID https://orcid.org/0009-0009-3886-7228
Ella BarkanDepartment of Artificial Intelligence for Accelerated Healthcare and Life Sciences Discovery, IBM Research, IBM R&D Laboratories, Haifa, Israel.ORCID https://orcid.org/0000-0001-6521-3873
Nicola di FloraAssociazione Italiana Malati di Cancro, Rome, Italy.ORCID https://orcid.org/0009-0007-7554-5426
David GlasspoolDeontics Ltd, London, United Kingdom.ORCID https://orcid.org/0000-0001-7688-8251
Alexandra KoganDepartment of Information Systems, University of Haifa, Haifa, Israel.ORCID https://orcid.org/0000-0002-5926-1606
Giordano LanzolaDepartment of Electrical, Computer and Biomedical Engineering, University of Pavia, Pavia, Italy.ORCID https://orcid.org/0000-0003-3190-5104
Roy LeizerDepartment of Information Systems, University of Haifa, Haifa, Israel.ORCID https://orcid.org/0009-0000-3149-4427
Henk MalloDepartment of Medical Oncology, Netherlands Cancer Institute-Antoni van Leeuwenhoek, Amsterdam, Netherlands.ORCID https://orcid.org/0000-0001-6555-4942
Manuel OttavianoLife Supporting Technologies, Universidad Politécnica de Madrid, Madrid, Spain.ORCID https://orcid.org/0000-0003-0002-4988
Mor PelegDepartment of Information Systems, University of Haifa, Haifa, Israel.ORCID https://orcid.org/0000-0002-5612-768X
Lonneke V van de Poll-FranseDepartment of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute, Amsterdam, Netherlands.ORCID https://orcid.org/0000-0003-0413-6872
Nicole VeggiottiDepartment of Electrical, Computer and Biomedical Engineering, University of Pavia, Pavia, Italy.ORCID https://orcid.org/0009-0004-5301-8586
Konrad ŚniatałaInstitute of Computing Science, Poznan University of Technology, Poznan, Poland.ORCID https://orcid.org/0000-0003-0746-5399
Szymon WilkInstitute of Computing Science, Poznan University of Technology, Poznan, Poland.ORCID https://orcid.org/0000-0002-7807-454X
Enea ParimbelliDepartment of Electrical, Computer and Biomedical Engineering, University of Pavia, Pavia, Italy.ORCID https://orcid.org/0000-0003-0679-828X
Silvana QuagliniDepartment of Electrical, Computer and Biomedical Engineering, University of Pavia, Pavia, Italy.ORCID https://orcid.org/0000-0002-4288-2561
Mimma RizzoDivision of Medical Oncology, Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari, Bari, Italy.ORCID https://orcid.org/0000-0001-7743-741X
Laura Deborah LocatiDepartment of Internal Medicine and Medical Therapy, University of Pavia, Pavia, Italy.ORCID https://orcid.org/0000-0003-3315-2580
Annelies BoekhoutDepartment of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute, Amsterdam, Netherlands.ORCID https://orcid.org/0000-0003-3637-0655
Lucia SacchiDepartment of Electrical, Computer and Biomedical Engineering, University of Pavia, Pavia, Italy.ORCID https://orcid.org/0000-0002-1390-9825
Sofie WilgenhofDepartment of Medical Oncology, Netherlands Cancer Institute-Antoni van Leeuwenhoek, Amsterdam, Netherlands.ORCID https://orcid.org/0000-0002-3309-4555
University of Pavia · ITThe Netherlands Cancer Institute · NLAmsterdam University Medical Centers · NLUniversity of Haifa · ILPoznań University of Technology · PLAzienda Universitaria Ospedaliera Consorziale - Policlinico Bari · ITIBM Research - Haifa · ILIstituti Clinici Scientifici Maugeri · ITItalian Association for Cancer Research · ITTilburg University · NLUniversidad Politécnica de Madrid · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSince 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.

objectiveIn 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.

methodsThis 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.

resultsStudy inclusion started in April 2023 and is currently ongoing.

conclusionsThis 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 registrationClinicalTrials.gov NCT05827289; https://clinicaltrials.gov/study/NCT05827289. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/49252.

Indexed as

acceptanceadoptioncancerdigital healtheHealthfatigueHRQoLimmune checkpoint inhibitorsimmunotherapyinterventionmelanomamonitoringoncologypatient educationpilot studyQoLquality of lifesymptomsymptoms

Identifiers

PMID37819691
PMCPMC10600650
OpenAlexW4385558439

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.