About this trial
The use of digital strategies to systematically monitor patients' symptoms in clinical settings allows problems to be detected at an early stage before they worsen or lead to complications. In this study, the hypothesis is that the proportion of patients with a weight loss of at least 5% between before radiotherapy/radiochemotherapy and 3 months after treatment would be lower with optimised care thanks to remote monitoring using a medical telemonitoring solution in oncology.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient aged over 18 and under 75 years WHO score < 2,
Treated for localised heand and neck cancer of the squamous cell carcinoma type for which curative treatment has been chosen and receiving radiotherapy or radio-chemotherapy exclusively or as an adjuvant with the aim of cure
Having signed the informed consent form,
Affiliated with or beneficiary of a social protection scheme,
Disqualifiers
History of other neoplastic disease less than 2 years ago or progressive disease,
History of ENT radiotherapy,
Pregnant or breastfeeding women,
Protected adults (under guardianship, curatorship or judicial protection),
Trial design
Parallel
Treatments tested in this trial
Remote symptoms moniotring
Other interventionParticipants in the intervention arm will use Resilience PRO, a mobile phone application regularly asking participants about their symptoms. For clinically important symptoms, an alert is sent to the care team that can incorporate that information to timely adjust the care of the participants.
Treatment groups
Trial outcomes
Primary outcomes
Impact of remote monitoring of symptoms on weight loss
Proportion of patients with at least a 5% reduction in weight 3 months after treatment compared to the consultation at the start of radiotherapy or radiochemotherapy
Secondary outcomes
Impact of remote symptoms monitoring on global survival
Time beetween inclusion and death for any cause
Impact of remote symptoms monitoring on global survival
Time beetween inclusion and death for any cause
Sponsors and contacts
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Centre Henri Becquerel
Lead sponsor
Resilience
Collaborator