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

Not Applicable

Recruiting

• Conditions: Head and Neck Cancer
• Interventions: Other: Accompanying caregivers by paramedical team

• Registration Number: NCT05542706
• Lead Sponsor: Centre Henri Becquerel

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-09
• Study First Submitted: 2022-09-09
• Study First Submitted QC: 2022-09-13
• Study First Posted: 2022-09-15
• Study Start: 2022-10-31
• Last Update Submitted: 2022-12-22
• Last Update Posted: 2022-12-23
• Primary Completion: 2025-01-31
• Study Completion: 2025-09-13

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Accompanying caregivers by paramedical team	Accompanying caregivers by paramedical team	-

Primary Outcome Measures

Name	Time	Method
Comparison of the impact of paramedical care on the caregiving burden between the two groups	At 20 weeks after surgery	Via Zarit Burden Interview

Secondary Outcome Measures

Name	Time	Method
Comparison of the impact of paramedical care on the caregiving burden between the two groups	At 12 weeks after surgery	Via Zarit Burden Interview
Measure of quality of life in the two groups	between 16 and 20 weeks after surgery	Via QLQ-H\&N35

Trial Locations

Locations (1)

Centre Henri Becquerel; 🇫🇷 Rouen, France