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

• Sponsor: Centre Henri Becquerel (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05542706
• Collaborator: (none)
• Enrollment: 76
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 36
• Patients Per Site Per Month: 2.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Cancer	Other: Accompanying caregivers by paramedical team	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 76 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Benefit of Paramedical Care in Accompanying Caregivers of Patients That Had Surgery for an Head and Neck Invasive Cancer
• Anticipated Study Start Date: Sep 13, 2022
• Anticipated Primary Completion Date: Jan 31, 2025
• Anticipated Study Completion Date: Sep 13, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. Comparison of the impact of paramedical care on the caregiving burden between the two groups [At 8 weeks after surgery]

   Via Zarit Burden Interview

2. Comparison of the impact of paramedical care on the caregiving burden between the two groups [At 12 weeks after surgery]

   Via Zarit Burden Interview

3. Measure of quality of life in the two groups [baseline]

   WHOQOL-26

4. Measure of quality of life in the two groups [baseline]

   QLQ-H&N35

5. Measure of quality of life in the two groups [one week after hospital discharge]

   QLQ-H&N35

6. Measure of quality of life in the two groups [one week after hospital discharge]

   WHOQOL-26

7. Measure of quality of life in the two groups [between 4 and 8 weeks after surgery]

   QLQ-H&N35

8. Measure of quality of life in the two groups [between 8 and 12 weeks after surgery]

   WHOQOL-26

9. Measure of quality of life in the two groups [between 16 and 20 weeks after surgery]

   WHOQOL-26

10. Measure of quality of life in the two groups [between 16 and 20 weeks after surgery]

    Via QLQ-H&N35

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre Henri Becquerel	Rouen		France

Sponsors and Collaborators

• Centre Henri Becquerel

Investigators

• Principal Investigator: Yveline David, Centre Henri Becquerel

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Henri Becquerel
• ClinicalTrials.gov Identifier: NCT05542706
• Other Study ID Numbers: CHB22.01; 2022-A00687-36
• First Posted: Sep 15, 2022
• Last Update Posted: Sep 15, 2022
• Last Verified: Sep 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Head and Neck Neoplasms

Study Results

No Results Posted as of Sep 15, 2022