'Cancer Patients Better Life Experience'

NCT ID: NCT05827289

Last Updated: 2023-07-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-15
• Study Completion Date: 2023-12-31

Brief Summary

The purpose of this study is to compare health-related quality of life, specifically fatigue, in melanoma patients treated with immunotherapy who use or do not use a patient-centered mobile coaching and monitoring system (CAPABLE). It is expected that by using the CAPABLE eHealth tool, patients' fatigue worsens less significantly (10 points) in the first 3 months follow-up than observed in usual care.

Detailed Description

This is a prospectively enrolling, explorative cohort study in melanoma patients, eligible for or on treatment with ICI therapy. The explorative cohort receives the CAPABLE smartphone application and a multi-sensorial smartwatch. Patients will be asked to use the system for minimum of three to maximum of six months after enrolment. Questionnaires on health-related quality of life (such as fatigue) and user experience will be administered to the patients on baseline/before start treatment (T0), three months (T1) and six months (T2). Results of this interventional study will be compared with a historical cohort consisting of melanoma patients (P20MEL; NL75996.031.20) with the same inclusion criteria as this study population, but receiving standard care (e.g. without the CAPABLE app).

Conditions

Melanoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

CAPABLE cohort

Group that receives the CAPABLE application during treatment

Group Type: EXPERIMENTAL

Cancer Patients Better Life Experience (CAPABLE)

Intervention Type: DEVICE

The CAPABLE system serves three main goals for the patient: symptom monitoring, information needs fulfilment and interventions to improve mental- and physical wellbeing. These are available to the patient as a smartphone application that is connected to a smartwatch to monitor activity, blood pressure, sleep and heart rate. Patients are able to report symptoms experienced from the treatment and are eligible to do interventions such as mindfulness or yoga. Patients will receive the CAPABLE application and smartwatch for a minimum 3 to a maximum of 6 months after start treatment.

Interventions

Cancer Patients Better Life Experience (CAPABLE)

The CAPABLE system serves three main goals for the patient: symptom monitoring, information needs fulfilment and interventions to improve mental- and physical wellbeing. These are available to the patient as a smartphone application that is connected to a smartwatch to monitor activity, blood pressure, sleep and heart rate. Patients are able to report symptoms experienced from the treatment and are eligible to do interventions such as mindfulness or yoga. Patients will receive the CAPABLE application and smartwatch for a minimum 3 to a maximum of 6 months after start treatment.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• >18 years of age
• Sufficient understanding of the Dutch language
• Participants or their caregiver can use a smartphone (upon patient's consent)
• Histologically confirmed stage III or IV melanoma who receive treatment with immune checkpoint-inhibitors, according to the clinical guidelines.

Exclusion Criteria

• Included in a clinical trial
• >12 months on active treatment

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pavia

OTHER

Sponsor Role: collaborator

University of Haifa

OTHER

Sponsor Role: collaborator

Biomeris s.r.l.

UNKNOWN

Sponsor Role: collaborator

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER

Sponsor Role: collaborator

IBM Research

UNKNOWN

Sponsor Role: collaborator

Bitsens JSC

UNKNOWN

Sponsor Role: collaborator

Poznań University of Technology

UNKNOWN

Sponsor Role: collaborator

Instituti Clinici Scientifici Maugeri

UNKNOWN

Sponsor Role: collaborator

Deontics LTD

UNKNOWN

Sponsor Role: collaborator

Associazione Italiana Malati di Cancro

UNKNOWN

Sponsor Role: collaborator

Universidad Politecnica de Madrid

OTHER

Sponsor Role: collaborator

The Netherlands Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Netherlands Cancer Institute

Amsterdam, North Holland, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Itske Fraterman, MSc

Role: CONTACT

i.fraterman@nki.nl

+31205122036

Facility Contacts

Itske Fraterman

Role: primary

i.fraterman@nki.nl

+31205122036

References

Fraterman I, Wollersheim BM, Tibollo V, Glaser SLC, Medlock S, 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 LD, Boekhout A, 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 Oct 11;12:e49252. doi: 10.2196/49252.

Reference Type: DERIVED

PMID: 37819691 (View on PubMed)

Other Identifiers

NL81970.000.22

Identifier Type: OTHER

Identifier Source: secondary_id

P22BLE

Identifier Type: -

Identifier Source: org_study_id