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NCT Number: NCT07190755

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

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.

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Key information

Conditions

Head and Neck Squamous Cell Carcinoma HNSCC Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Squamous Cell Carcinoma of Head and Neck

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Henri Becquerel, Rouen, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Remote symptoms moniotring

Other

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.

Primary outcomes

  1. Impact of remote monitoring of symptoms on weight loss

    Time frame: 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 outcomes

  1. Impact of remote symptoms monitoring on global survival

    Time frame: 12 month after treatment

    Time beetween inclusion and death for any cause

  2. Impact of remote symptoms monitoring on global survival

    Time frame: 18 month after treatment

    Time beetween inclusion and death for any cause

Study contacts

Contact information is provided by the study sponsor or research team.

Doriane Richard, PhD

CONTACT

[email protected]

+33232082985

Sebastien Thureau, MD,PhD

CONTACT

[email protected]

+33232082992

Sponsors and collaborators

Lead sponsor

Centre Henri Becquerel

Other

Collaborators

  • Resilience

Registry information

Official study title

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

Acronym: WEBNECK

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Sep 24, 2025
Registry last updated
Dec 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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