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

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.

Study Overview

• Status: Recruiting
• Conditions: Head and Neck Cancer
• Intervention / Treatment: Other: Accompanying caregivers by paramedical team

• Study Type: Interventional
• Enrollment (Estimated): 76
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yveline David; Phone Number: +33232082542; Email: yveline.david@chb.unicancer.fr
• Study Contact Backup: Name: Doriane Richard; Phone Number: +33232082985; Email: doriane.richard@chb.unicancer.fr

Study Locations

• France
  • Rouen, France
    • Recruiting
    • Centre Henri Becquerel
    • Contact: Yveline David; Phone Number: +33232082542; Email: yveline.david@chb.unicancer.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Accompanying caregivers by paramedical team	Other: Accompanying caregivers by paramedical team; At each study visit (baseline, one week after hospital discharge, 4-8 weeks after surgery, 8-12 weeks after surgery and 16-20 weeks after surgery), the paramedical team have a dedicated meeting with the caregiver of the patient (at hospital or remote) and teach them the care procedures needed in accompanying the patient and the evaluate the learning progress. The training is adapted to each caregiver, according to his/her motivation and his/her ability. The goal is to have the training regarding the enteral nutrition, prevention of dehydration, pain management.
No Intervention: No dedicated accompanying by medical team

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of the impact of paramedical care on the caregiving burden between the two groups	Via Zarit Burden Interview	At 20 weeks after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of the impact of paramedical care on the caregiving burden between the two groups	Via Zarit Burden Interview	At 8 weeks after surgery
Comparison of the impact of paramedical care on the caregiving burden between the two groups	Via Zarit Burden Interview	At 12 weeks after surgery
Measure of quality of life in the two groups	WHOQOL-26	baseline
Measure of quality of life in the two groups	QLQ-H&N35	baseline
Measure of quality of life in the two groups	QLQ-H&N35	one week after hospital discharge
Measure of quality of life in the two groups	WHOQOL-26	one week after hospital discharge
Measure of quality of life in the two groups	QLQ-H&N35	between 4 and 8 weeks after surgery
Measure of quality of life in the two groups	WHOQOL-26	between 8 and 12 weeks after surgery
Measure of quality of life in the two groups	WHOQOL-26	between 16 and 20 weeks after surgery
Measure of quality of life in the two groups	Via QLQ-H&N35	between 16 and 20 weeks after surgery

Collaborators and Investigators

• Sponsor: Centre Henri Becquerel
• Investigators: Principal Investigator: Yveline David, Centre Henri Becquerel

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2022
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2027

Study Registration Dates

• First Submitted: September 9, 2022
• First Submitted That Met QC Criteria: September 13, 2022
• First Posted (Actual): September 15, 2022

Study Record Updates

• Last Update Posted (Estimated): January 2, 2026
• Last Update Submitted That Met QC Criteria: December 29, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Head and Neck Neoplasms
• Other Study ID Numbers: CHB22.01; 2022-A00687-36 (Other Identifier: national identifier)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No