Clinical trial NCT05827289: 'Cancer Patients Better Life Experience'
Official title: Pilot Study of the eHealth Application 'Cancer Patients Better Life Experience'
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Melanoma
Lead sponsor: The Netherlands Cancer Institute
Sponsor class: OTHER
Collaborators: name: University of Pavia
name: University of Haifa
name: Biomeris s.r.l.
name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: IBM Research
name: Bitsens JSC
name: Poznań University of Technology
name: Instituti Clinici Scientifici Maugeri
name: Deontics LTD
name: Associazione Italiana Malati di Cancro
name: Universidad Politecnica de Madrid
First posted: 2023-04-25
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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).

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

Primary outcomes:
measure: Change in fatigue between baseline and 3 and 6 months, as measured by fatigue symptom scale of The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-core 30 (EORTC QLQ-C30)
timeFrame: Baseline, month 3, month 6
Secondary outcomes:
measure: Change in health-related quality of life and QALY's between baseline and 3 and 6 months, as measured by The EuroQoL-5D (EQ-5D-5L).
timeFrame: Baseline, month 3, month 6
measure: Change in health-related quality of life and physical symptoms between baseline and 3 and 6 months, as measured by the EORTC QLQ-C30
timeFrame: Baseline, month 3, month 6
measure: Change in melanoma specific quality of life between baseline and 3 and 6 months, as measured by the FACT-M
timeFrame: Baseline, month 3, month 6
measure: Change in patient reported immunotherapy-related toxicity between baseline and 3 and 6 months, as measured by a self-developed questionnaire using EORTC item bank items
timeFrame: Baseline, month 3, month 6
measure: Change in psychological distress between baseline and 6 months, as measured by the Hospital Anxiety and Depression Scale (HADS).
timeFrame: Baseline, month 6
measure: Change in information satisfaction/needs between baseline and 6 months, as measured by the EORTC QLQ-INFO25
timeFrame: Baseline, month 6
measure: Recruitment rate
timeFrame: Through study completion, an average of 6 months
measure: Patient compliance
timeFrame: Through study completion, an average of 6 months
measure: Usability/user experience as measured by The System Usability Scale (SUS)
timeFrame: Baseline
measure: Usability/user experience as measured by PAtient Trust Assessment Tool (PATAT)
timeFrame: Month 3
measure: Usability/user experience as measured by the User Version of the Mobile Application Rating Scale (uMARS)
timeFrame: Month 6
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Netherlands Cancer Institute
state: North Holland
Study officials:
References: