Actively Recruiting

Phase Not Applicable
Age: 18Years - 85Years
All Genders
NCT05542706

Benefit of Paramedical Care in Accompanying Caregivers of Patients That Had Surgery for an Head and Neck Invasive Cancer

Led by Centre Henri Becquerel · Updated on 2026-01-02

76

Participants Needed

1

Research Sites

260 weeks

Total Duration

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AI-Summary

What this Trial Is About

Head and Neck invasive cancer usually requires surgery that is associated with modifications of the body structure of patient regarding breathing, eating and communication. These modifications are correlated with an important loss of autonomy in patients. During the study, while the patient is hospitalised after the surgery, the paramedical team will train the caregiver of the patient from experimental group a new dimension of autonomy in order to assure a safe return home. The level of learning depends on each caregiver and patient; therefore, an adapted training is provided. This study evaluates the impact of paramedical care in accompanying caregivers of patients that had surgery for an ENT invasive cancer, by comparing the experimental group (paramedical care) to the standard group (standard care). The hypothesis of the study is that a benefit will be seen in the experimental group, by reducing the caregiver burden, improving the quality of life of patients and lowering the rate of hospitalisations and prolonged hospitalisations in these patients.

CONDITIONS

Official Title

Benefit of Paramedical Care in Accompanying Caregivers of Patients That Had Surgery for an Head and Neck Invasive Cancer

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 85 years old
  • ECOG performance status of 2 or less
  • Diagnosed with localized, non-metastatic head and neck squamous-cell carcinoma (stage T2-T4/N+)
  • Cancer located at larynx, pharynx, oropharynx, oral cavity, or maxillary requiring curative surgery
  • Indication for radiotherapy after surgery based on multidisciplinary tumor board decision
  • No ongoing legal corrective measures for the patient
  • Signed informed consent form
  • Patient covered by the health system
Not Eligible

You will not qualify if you...

  • Scheduled for surgery after prior radiotherapy or surgery on previously irradiated site
  • Patient or caregiver unwilling to participate (both needed for study)
  • History of psychological or sensory disorder or anomaly preventing understanding of study conditions

AI-Screening

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Trial Site Locations

Total: 1 location

1

Centre Henri Becquerel

Rouen, France

Actively Recruiting

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Research Team

Y

Yveline David

CONTACT

D

Doriane Richard

CONTACT

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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