Head and Neck Squamous Cell Carcinoma HNSCC
Conditions
Keywords
head and neck squamous cell carcinoma, symptoms monitoring, web monitoring
Brief summary
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.
Interventions
OTHERRemote symptoms moniotring
Participants 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.
Sponsors
Resilience
Centre Henri Becquerel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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, * Access to a smartphone or the internet,
Exclusion criteria
* 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), * Patients participating in a therapeutic study, * Patients unable to understand the study for any reason or to comply with the constraints of the trial (language, psychological or geographical issues, etc.), patients with blindness preventing the use of the medical telemonitoring solution in oncology.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Impact of remote monitoring of symptoms on weight loss | 3 months after treatment | 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
| Measure | Time frame | Description |
|---|---|---|
| Impact of remote symptoms monitoring on global survival | 12 month after treatment | Time beetween inclusion and death for any cause |
Countries
France
Contacts
Primary ContactSebastien Thureau, MD,PhD
Backup ContactDoriane Richard, PhD
Outcome results
None listed