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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorCentre Henri Becquerel

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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,

Disqualifiers

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),

Trial design

Design model

Parallel

Treatments tested in this trial

  • Remote symptoms moniotring

    Other intervention

    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.

Treatment groups

192 Participants
are divided into 2 treatment groups
Group A: Standard armNo intervention 0 interventions
Group B: remote symptoms monitoringExperimental treatment 1 intervention

Trial outcomes

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

Time frame
3 months after treatment

Secondary outcomes

1

Impact of remote symptoms monitoring on global survival

Time beetween inclusion and death for any cause

Time frame
12 month after treatment
2

Impact of remote symptoms monitoring on global survival

Time beetween inclusion and death for any cause

Time frame
18 month after treatment

Other outcomes

Sponsors and contacts

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