Clinical trial · Observational
Eortc MoBilE Device (EMBED)
Eortc MoBilE Device (EMBED) - Implementation of Smart Devices for the Assessment of Quality of Life, Patient Reported Outcomes (PROs) and Physical Functioning and Activity in EORTC Clinical Trials: A Feasibility Study.
- 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)
This study is a longitudinal observational study that will investigate the feasibility of using mobile devices for the assessment of HRQoL and physical activity in adult cancer patients undergoing treatment. Patients will complete a set of patient reported outcome measures (PROMs), and wear a smartwatch (min. 10 hours per day for one week), at baseline, and at weeks 4, 8 and 12 after treatment start.
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 |
|---|---|---|---|
| Diagnosis of Cancer | Malignant Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Assessing the general feasibility of implementing mobile devices for the assessment of HRQoL and PA over a period of 12 weeks in cancer patients undergoing treatment, identifying its major human and operational factors
- timeFrame
- baseline assessment week, week 4, week 8, week 12 and overall
- description
- General feasibility index (GFI)
Secondary outcomes (3)
- measure
- To assess the compliance with the Patient Reported Outcome remote assessment
- timeFrame
- baseline and weeks 4, 8 and 12
- description
- PROM completion rate will be determined for each assessment point (baseline and weeks 4, 8 and 12) as the proportion of patients with a successful PRO assessment divided by the total number of patients participating to the study at that time point.
- measure
- To assess the compliance with the physical activity remote assessment
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of cancer * Age≥18 * Starting a first or new anticancer treatment within one month following enrolment * Literacy in the target language * Ability to understand and fill out questionnaires * Ability to operate a smartphone * In possession of a smartphone allowing for an internet connection and willing to use this device to submit data * Written informed consent * Life expectancy\>3 months Exclusion Criteria: * Exclusively receiving palliative care * Start of cancer-related treatment \< 1 week from time of screening * Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed and discussed with the patient before enrolment in this study.
References
Publications (0)
Data not yet available