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

NCT07190755 | Recruiting

• 1 other identifier: CHB24.06
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 2

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.

Conditions

Head and Neck Squamous Cell Carcinoma HNSCC

Keywords

head and neck squamous cell carcinoma; symptoms monitoring; web monitoring

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Impact of remote symptoms monitoring on global survival

  12 month after treatment

• Impact of remote symptoms monitoring on global survival

  18 month after treatment

Study Arms (2)

Standard arm

NO INTERVENTION

patients will be followed as standard of care

remote symptoms monitoring

EXPERIMENTAL

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

Interventions

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.

remote symptoms monitoring

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Henri Becquerel: lead
• Resilience: collaborator

Study Sites (2)

Centre Henri Becquerel

Rouen, France

RECRUITING

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, France

NOT YET RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

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

Study Officials

• Sebastien Thureau, MD,PhD

  Centre Henri Becquerel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sebastien Thureau, MD,PhD

CONTACT

+33232082992; sebastien.thureau@chb.unicancer.fr

Doriane Richard, PhD

CONTACT

+33232082985; doriane.richard@chb.unicancer.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2025
• First Posted: September 24, 2025
• Study Start: October 15, 2025
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): June 1, 2030
• Last Updated: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)