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

Impact of Patient-Reported Outcomes for Symptom Monitoring in Patients Followed for Curative Treatment of Head and Neck Squamous Cell Carcinoma (HNSCC) With Radiotherapy or Chemoradiotherapy

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.

Study Overview

• Status: Recruiting
• Conditions: Head and Neck Squamous Cell Carcinoma HNSCC
• Intervention / Treatment: Other: Remote symptoms moniotring

• Study Type: Interventional
• Enrollment (Estimated): 192
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Doriane Richard, PhD; Phone Number: +33232082985; Email: doriane.richard@chb.unicancer.fr
• Study Contact Backup: Name: Sebastien Thureau, MD,PhD; Phone Number: +33232082992; Email: sebastien.thureau@chb.unicancer.fr

Study Locations

• France
  • Rouen, France
    • Recruiting
    • Centre Henri Becquerel
    • Contact: Sébastien Thureau, MD, PhD; Phone Number: +33232082992; Email: sebastien.thureau@chb.unicancer.fr
  • Vandœuvre-lès-Nancy, France
    • Not yet recruiting
    • Institut de Cancérologie de Lorraine
    • Contact: Jean-Christophe Faivre, MD; Phone Number: +33383598349; Email: jc.faivre@nancy.unicancer.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard arm; patients will be followed as standard of care
Experimental: remote symptoms monitoring; 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.	Other: Remote 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 months after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact of remote symptoms monitoring on global survival	Time beetween inclusion and death for any cause	12 month after treatment
Impact of remote symptoms monitoring on global survival	Time beetween inclusion and death for any cause	18 month after treatment

Collaborators and Investigators

• Sponsor: Centre Henri Becquerel
• Collaborators: Resilience
• Investigators: Principal Investigator: Sebastien Thureau, MD,PhD, Centre Henri Becquerel

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2025
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): June 1, 2030

Study Registration Dates

• First Submitted: September 17, 2025
• First Submitted That Met QC Criteria: September 17, 2025
• First Posted (Estimated): September 24, 2025

Study Record Updates

• Last Update Posted (Actual): December 30, 2025
• Last Update Submitted That Met QC Criteria: December 29, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: head and neck squamous cell carcinoma; symptoms monitoring; web monitoring
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Head and Neck Neoplasms; Neoplasms, Glandular and Epithelial; Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
• Other Study ID Numbers: CHB24.06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No