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

Head and Neck Cancer Clinical Trial

— AIDORL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05542706
• Other study ID #: CHB22.01
• Secondary ID: 2022-A00687-36
• Status: Recruiting
• Phase: N/A
• Start date: October 31, 2022
• Est. completion date: September 13, 2025

Study information

• Verified date: September 2022
• Source: Centre Henri Becquerel
• Contact: Yveline David
• Phone: +33232082542
• Email: yveline.david[@]chb.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 76
• Est. completion date: September 13, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

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.

Locations

Country	Name	City	State
France	Centre Henri Becquerel	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
Centre Henri Becquerel

Country where clinical trial is conducted

France, 

Outcome

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