Actively Recruiting
Impact of Patient-Reported Outcomes for Symptom Monitoring in Patients Followed for Curative Treatment of Head and Neck Squamous Cell Carcinoma With Radiotherapy or Chemoradiotherapy
Led by Centre Henri Becquerel · Updated on 2025-12-30
192
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
C
Centre Henri Becquerel
Lead Sponsor
R
Resilience
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the impact of remote symptom monitoring on patients with Head and Neck Squamous Cell Carcinoma (HNSCC) who are receiving curative radiotherapy or chemoradiotherapy. The study aims to see if digital tools can help detect problems early and reduce the proportion of patients experiencing at least 5% weight loss within three months after treatment. This approach may help improve care by addressing symptoms before they worsen. Participants will be randomly assigned to one of two groups. One group receives standard care without additional monitoring. The other group uses Resilience PRO, a mobile phone app that regularly asks about symptoms and sends alerts to the care team when important issues arise. This allows timely adjustments to treatment and support. The study will continue to monitor survival at 12 and 18 months after treatment. Throughout the study, participants will be followed for symptom reporting, weight changes, and survival outcomes. The research team will collect data via the app and standard clinical visits. The main measure is the impact of remote monitoring on weight loss three months after treatment. Secondary measures include survival rates up to 18 months. The total participation period extends at least 18 months with ongoing evaluation of health status and treatment effects.
CONDITIONS
Brief Title
Impact of Patient-Reported Outcomes for Symptom Monitoring in Patients Followed for Head and Neck Squamous Cell Carcinoma (HNSCC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient aged over 18 and under 75 years with WHO score less than 2
- Treated for localized head and neck squamous cell carcinoma with curative radiotherapy or chemoradiotherapy
- Signed the informed consent form
- Affiliated with or beneficiary of a social protection scheme
- Access to a smartphone or the internet
You will not qualify if you...
- History of other cancer less than 2 years ago or progressive disease
- History of ear, nose, and throat radiotherapy
- Pregnant or breastfeeding women
- Adults under guardianship, curatorship, or judicial protection
- Participation in another therapeutic study
- Inability to understand the study or comply with its requirements (language, psychological, geographical issues)
- Blindness preventing use of the telemonitoring app
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of radiotherapy or chemoradiotherapy treatment
Participants receive curative radiotherapy or chemoradiotherapy for localized head and neck squamous cell carcinoma. Those in the intervention group use a mobile app to report symptoms remotely for timely care adjustments.
Regular visits as part of standard care; symptom reporting via mobile app as applicable
Duration - Up to 18 months after treatment
Participants are monitored for impact of symptom monitoring on weight loss and survival after treatment completion.
Follow-up visits as per standard care schedule
Trial Site Locations
Total: 2 locations
1
Centre Henri Becquerel
Rouen, France
Actively Recruiting
2
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, France
Not Yet Recruiting
Research Team
S
Sebastien Thureau, MD,PhD
D
Doriane Richard, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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