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Trial Title:
'Cancer Patients Better Life Experience'
NCT ID:
NCT05827289
Condition:
Melanoma
Conditions: Official terms:
Melanoma
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Screening
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Cancer Patients Better Life Experience (CAPABLE)
Description:
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.
Arm group label:
CAPABLE cohort
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).
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Netherlands Cancer Institute
Address:
City:
Amsterdam
Zip:
1066CX
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Itske Fraterman
Phone:
+31205122036
Email:
i.fraterman@nki.nl
Start date:
April 15, 2023
Completion date:
December 31, 2023
Lead sponsor:
Agency:
The Netherlands Cancer Institute
Agency class:
Other
Collaborator:
Agency:
University of Pavia
Agency class:
Other
Collaborator:
Agency:
University of Haifa
Agency class:
Other
Collaborator:
Agency:
Biomeris s.r.l.
Agency class:
Other
Collaborator:
Agency:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Agency class:
Other
Collaborator:
Agency:
IBM Research
Agency class:
Other
Collaborator:
Agency:
Bitsens JSC
Agency class:
Other
Collaborator:
Agency:
Poznań University of Technology
Agency class:
Other
Collaborator:
Agency:
Instituti Clinici Scientifici Maugeri
Agency class:
Other
Collaborator:
Agency:
Deontics LTD
Agency class:
Other
Collaborator:
Agency:
Associazione Italiana Malati di Cancro
Agency class:
Other
Collaborator:
Agency:
Universidad Politecnica de Madrid
Agency class:
Other
Source:
The Netherlands Cancer Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05827289
