Eortc MoBilE Device (EMBED)

Rationale:

The EORTC currently does not have experience in implementing mobile devices for the remote assessment of Health-Related Quality of Life (HRQoL) and Physical Activity (PA) in cancer clinical trials. The feasibility and logistics related to such assessment methodologies might be challenging in many regards. To anticipate these challenges, a first-hand experience in the conduct of a study involving the implementation of mobile devices in cancer clinical settings appears as the most efficient approach. The current study aims at building the first blocks of an implementation strategy for the incorporation of HRQoL and PA measurements into the world of digital health and remote assessment in cancer patients and to prepare the EORTC and the Quality of Life Group (QLG) to face the emergence of these new technologies in the field of cancer clinical trials.

Objective(s):

Main objective: • 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 Secondary objectives: • Assessing the patients' compliance with the PRO assessments • Assessing the patients' compliance with the wearable passive assessments • Assessing the patients' and health care providers' (HCPs) experience related to the protocol Exploratory objectives: • Exploring the association between feasibility and user experience and patients' individual characteristics • Exploring the association between device-reported PA data (wearable) and HRQoL, self-reported PA and patient individual characteristics .

Study design:

A longitudinal observational study to investigate the feasibility of using mobile devices for the assessment of HRQoL and PA level in adult cancer patients undergoing treatment will be performed. Patients will be invited to complete a set of patient reported outcome measures (PROMs) at study inclusion, at the end of baseline week (a 1-week period following inclusion into the study, which should fall within 1 month prior to the start of treatment) and end of weeks 4, 8 and 12 and to wear a smartwatch (min. 10 hours per day) for a week at baseline and during weeks 4, 8, 12. At the end of the study (end of week 12), a subsample of patients (20%) will be invited to participate to semistructured interviews which will occur within within one month following the 12-week follow-up assessment. Study duration Study accrual is expected to last 24 months. Each patient will be followed for 12 to 16 weeks (depending on time between baseline and treatment start). Total study duration is therefore 2 years and 4 months from first patient enrolled. End of study End of study will be declared when all enrolled patients have completed their end of study assessment (which is expected to occur 12 to 16 weeks after last patient enrolled) and the study database is mature for all prespecified analyses.

Number of patients:

The study is powered to ensure the recruitment of a representative sample of cancer patients for the assessment of the feasibility and user experience related to the patient reported outcomes and wearable follow-up. We considered that a final sample of 100 patients with completed follow-up information would satisfy this criterion. According to literature \[1\], cancer patients' compliance to such protocols varies between 73% and 92%. Taking a conservative approach, we estimated that the recruitment of 137 patients would yield a minimum of 100 patients with completed follow-up (i.e., N=137x\[73/100\]=100.01).

Study population:

Adult cancer patients prior to the start of a new treatment without restrictions related to gender, cancer site or cancer stage. Recruitment will be stratified by recruitment sites and monitored twice a year by the study steering committee. Main 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 Main exclusion criteria • Exclusively receiving palliative care

Statistical analyses:

Feasibility and user experience mean levels: • Analyses of variance (ANOVAs) with pairwise comparisons will be conducted for weekly compliance with PRO and wearable passive assessments to evaluate potential burden effects experienced by the patients over time (baseline vs week 4; baseline vs week 8; baseline vs week 12; week 4 vs week 8; week 4 vs week 12; week 8 vs week 12). • Mean score to the user experience questionnaire will be examined.

Quality of Life:

Quality of life will be assessed 4 times over the duration of the study (end of baseline, week 4, week 8 \& week 12) using the following measures: • EORTC QLQ-C30 (30 items) • EORTC CAT Core Pain, Fatigue and Physical Functioning (10 items)

• To assess the compliance with the Patient Reported Outcome remote assessment [Срок оценки: baseline and weeks 4, 8 and 12]
• To assess the compliance with the physical activity remote assessment [Срок оценки: baseline assessment week, week 4, week 8, week 12 and overall]
• To assess the patients' user experience related to the Patient Reported Outcome and physical activity remote assessment [Срок оценки: Within 1 month after Week 12]