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

Centre Henri Becquerel

Status

Enrolling

Conditions

Head and Neck Cancer

Treatments

Other: Accompanying caregivers by paramedical team

Study type

Interventional

Funder types

Other

Identifiers

NCT05542706

2022-A00687-36 (Other Identifier)

CHB22.01

Details and patient eligibility

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.

Enrollment

76 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria Patients :

Age between 18 and 85 years old
ECOG ≤ 2
Patient diagnosed with an head and neck squamous-cell carcinoma, stage T2-T4/N+, non-metastatic, localised at larynx, pharynx, oropharynx, oral cavity or maxillary, needing curative surgery, with indication of radiotherapy after surgery, in accordance to decision of the regular multidisciplinary meetings in cancerology
No ongoing measure of corrective justice for the patient
Informed consent form signed
Patient covered by health system

Exclusion Criteria:

Patient scheduled for surgery after radiotherapy or for surgery on site already irradiated
Patient or caregiver that do not agree to participate in the study (the pair patient-caregiver is needed)
History of psychological or sensorial disorder or anomaly that can prevent the patient from understanding the conditions for study participation