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

NCT ID: NCT07190755

Last Updated: 2025-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

192 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-15

Study Completion Date

2030-06-01

Brief Summary

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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.

Detailed Description

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Conditions

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Head and Neck Squamous Cell Carcinoma HNSCC

Keywords

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head and neck squamous cell carcinoma symptoms monitoring web monitoring

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Standard arm

patients will be followed as standard of care

Group Type NO_INTERVENTION

No interventions assigned to this group

remote symptoms monitoring

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.

Group Type EXPERIMENTAL

Remote symptoms moniotring

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Resilience

INDUSTRY

Sponsor Role collaborator

Centre Henri Becquerel

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sebastien Thureau, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Centre Henri Becquerel

Locations

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Centre Henri Becquerel

Rouen, , France

Site Status RECRUITING

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, , France

Site Status NOT_YET_RECRUITING

Countries

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France

Central Contacts

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Sebastien Thureau, MD,PhD

Role: CONTACT

Phone: +33232082992

Email: [email protected]

Doriane Richard, PhD

Role: CONTACT

Phone: +33232082985

Email: [email protected]

Facility Contacts

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Sébastien Thureau, MD, PhD

Role: primary

Jean-Christophe Faivre, MD

Role: primary

Other Identifiers

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CHB24.06

Identifier Type: -

Identifier Source: org_study_id