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Towards personalised follow-up care in ovarian cancer using online remote PROMs monitoring: a study protocol of a feasibility trial

Por: Aarts · J. W. M. · Oudbier · S. J. · Van Muilekom · M. M. · Röling · P. · Tromp · J. · Smeulers · M. · van Lonkhuijzen · L. R.
Introduction

Ovarian cancer patients often experience persistent symptoms such as fatigue and pain, impacting their quality of life. Current follow-up care, focused primarily on recurrence detection, may not adequately address these symptoms and can be burdensome. This study evaluates the feasibility of remote monitoring using patient-reported outcome measures (PROMs) and measurements of weight and abdominal circumference as an alternative to standard hospital visits. We aim to assess feasibility (ie, usability and satisfaction) of this approach and identify implementation barriers and facilitators.

Methods and analysis

This study is a single-centre longitudinal observational pilot that uses both qualitative and quantitative data to evaluate the feasibility of an innovative remote monitoring system for ovarian cancer follow-up care (Controle op Afstand, CopA). It is accessible to both healthcare professionals in the electronic health record and patients through the patient portal. Instead of 3-monthly in-hospital visits, patients are invited to complete regular surveys assessing PROMS about symptoms and quality of life and home measurements of weight and abdominal circumference. Feasibility will be assessed by (1) analysing patient and healthcare professional (HCP) experiences with CopA with the Measurement Instrument for Determinants of Innovations questionnaire for HCPs, and the ‘Experienced Usability and Satisfaction with Self-monitoring in the Home Setting’ questionnaire for patients, (2) investigating implementation barriers and facilitators using qualitative method and (3) performing a process evaluation of the intervention, assessing components such as reach, fidelity and compliance, time to response and number of (tele)consultations during the study period. Quantitative data will be analysed using descriptive statistics. Qualitative data will be analysed using thematic analysis.

Ethics and dissemination

This study was reviewed by the Ethics Committee of the Amsterdam University Medical Centre (METC 2022.0256) and exempted it from further review as this study was not subject to the Dutch Medical Research Involving Human Subject Act. Results will be disseminated via peer-reviewed open-access publications, scientific conferences and targeted communication to patient organisations, healthcare providers and the wider public.

UNIversity students LIFEstyle behaviours and Mental health cohort (UNILIFE-M): study protocol of a multicentre, prospective cohort study

Por: Schuch · F. B. · Waclawoscky · A. · Tornquist · D. · Oyeyemi · A. L. · Sadarangani · K. P. · Takano · K. · Teychenne · M. · Balanza-Martinez · V. · ONeil · A. · Romain · A. J. · McGrath · A. · Alselmi · A. · Andrade-Lima · A. · Zanetti · A. C. G. · Trompetero-Gonzalez · A.-C. · Heiss
Introduction

Students enrolling in higher education often adopt lifestyles linked to worse mental health, potentially contributing to the peak age onset of mental health problems in early adulthood. However, extensive research is limited by focusing on single lifestyle behaviours, including single time points, within limited cultural contexts, and focusing on a limited set of mental health symptoms.

Methods and analysis

The UNIversity students’ LIFEstyle behaviours and Mental health cohort (UNILIFE-M) is a prospective worldwide cohort study aiming to investigate the associations between students’ lifestyle behaviours and mental health symptoms during their college years. The UNILIFE-M will gather self-reported data through an online survey on mental health symptoms (ie, depression, anxiety, mania, sleep problems, substance abuse, inattention/hyperactivity and obsessive/compulsive thoughts/behaviours) and lifestyle behaviours (ie, diet, physical activity, substance use, stress management, social support, restorative sleep, environment and sedentary behaviour) over 3.5 years. Participants of 69 universities from 28 countries (300 per site) will be assessed at university admission in the 2023 and/or the 2024 academic year and followed up for 1, 2 and 3.5 years.

Ethics and dissemination

The study was first approved at a national level in Brazil (CAE:63025822.8.1001.5346). Study sites outside Brazil obtained additional ethics approval from their institutions using the main approval. Results from the UNILIFE-M cohort will be disseminated through scientific publications, presentations at scientific meetings, press releases, the general media and social media.

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