Clinical trial NCT05542706: Benefit of Paramedical Care in Accompanying Caregivers of Patients That Had Surgery for an Head and Neck Invasive Cancer
Official title: Benefit of Paramedical Care in Accompanying Caregivers of Patients That Had Surgery for an Head and Neck Invasive Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Head and Neck Cancer
Lead sponsor: Centre Henri Becquerel
Sponsor class: OTHER
First posted: 2022-09-15
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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

Primary outcomes:
measure: Comparison of the impact of paramedical care on the caregiving burden between the two groups
timeFrame: At 20 weeks after surgery
Secondary outcomes:
measure: Comparison of the impact of paramedical care on the caregiving burden between the two groups
timeFrame: At 8 weeks after surgery
measure: Comparison of the impact of paramedical care on the caregiving burden between the two groups
timeFrame: At 12 weeks after surgery
measure: Measure of quality of life in the two groups
timeFrame: baseline
measure: Measure of quality of life in the two groups
timeFrame: baseline
measure: Measure of quality of life in the two groups
timeFrame: one week after hospital discharge
measure: Measure of quality of life in the two groups
timeFrame: one week after hospital discharge
measure: Measure of quality of life in the two groups
timeFrame: between 4 and 8 weeks after surgery
measure: Measure of quality of life in the two groups
timeFrame: between 8 and 12 weeks after surgery
measure: Measure of quality of life in the two groups
timeFrame: between 16 and 20 weeks after surgery
measure: Measure of quality of life in the two groups
timeFrame: between 16 and 20 weeks after surgery
Other outcomes:
Locations:
city: Rouen
country: France
facility: Centre Henri Becquerel
Study officials:
affiliation: Centre Henri Becquerel
name: Yveline David
role: PRINCIPAL_INVESTIGATOR
References: