Impact of Patient-Reported Outcomes for Symptom Monitoring in Patients Followed for Head and Neck Squamous Cell Carcinoma (HNSCC) (WEBNECK)

Centre Henri Becquerel

Status: Enrolling

Conditions: Head and Neck Squamous Cell Carcinoma HNSCC

Treatments: Other: Remote symptoms moniotring

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07190755

CHB24.06

Details and patient eligibility

About

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.

Enrollment: 192 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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192 participants in 2 patient groups

Standard arm

No Intervention group

Description:

patients will be followed as standard of care

remote symptoms monitoring

Experimental group

Description:

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.

Treatment:

Other: Remote symptoms moniotring