Eortc MoBilE Device (EMBED)
ConditionDiagnosis of Cancer
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorEuropean Organisation for Research and Treatment of Cancer - EORTC
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of cancer
Age≥18
Starting a first or new anticancer treatment within one month following enrolment
Literacy in the target language
Disqualifiers
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.
Trial population
Adult cancer patients prior to the start of a new treatment without restrictions related to gender, cancer site or cancer stage.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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
General feasibility index (GFI)
Time frame
baseline assessment week, week 4, week 8, week 12 and overallSecondary outcomes
1
To assess the compliance with the Patient Reported Outcome remote assessment
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.
Time frame
baseline and weeks 4, 8 and 122
To assess the compliance with the physical activity remote assessment
Wearable wear-time rate will be determined for each assessment period (baseline week and weeks 4, 8 and 12) as the proportion of patients with a successful wearable assessment divided by the total number of patients participating to the study at that time point. A wearable assessment will be successful if it was worn for at least 4 days out of 7 for \>10 hours per day. NOTE: for the following point another outcome measure needs to be added, differentiating between end-of-study user experience and interviews
Time frame
baseline assessment week, week 4, week 8, week 12 and overall3
To assess the patients' user experience related to the Patient Reported Outcome and physical activity remote assessment
User experience (quantitative): Mean score to end-of-study user experience as assessed by a customized questionnaire at week 12. User experience (qualitative): Summary qualitative results of the post-study (within one month following week 12) interviews' verbatim as assessed through a thematic analysis.
Time frame
Within 1 month after Week 12Locations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: