Clinical trial · Interventional
'Cancer Patients Better Life Experience'
Pilot Study of the eHealth Application 'Cancer Patients Better Life Experience'
NCT05827289CI-TRIAL-00067829CAPABLEunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cancer Patients Better Life Experience (CAPABLE) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CAPABLE cohort
- description
- Group that receives the CAPABLE application during treatment
- interventionNames
- Device: Cancer Patients Better Life Experience (CAPABLE)
Primary outcomes (1)
- 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
- description
- Fatigue is measured on a score from 0-100, the lower the score the less fatigue a patient has
Secondary outcomes (11)
- 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).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDFraterman 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. PMID 37819691