Impact of Patient-Reported Outcomes for Symptom Monitoring in Patients Followed for Head and Neck Squamous Cell Carcinoma (HNSCC)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Remote symptoms moniotring.
- Who it may be relevant to
- Registry conditions: Head and Neck Squamous Cell Carcinoma HNSCC. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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
Overview
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.
Interventions
- 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.
Primary outcome measures
- Impact of remote monitoring of symptoms on weight loss [Time frame: 3 months after treatment]
Secondary outcome measures (2)
- Impact of remote symptoms monitoring on global survival [Time frame: 12 month after treatment]
- Impact of remote symptoms monitoring on global survival [Time frame: 18 month after treatment]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
France · 2 centers
- Centre Henri Becquerel — Rouen
- Institut de Cancérologie de Lorraine — Vandœuvre-lès-Nancy
Identifiers
NCT: NCT07190755 · CHB24.06