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

Обзор

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.

Вмешательства

• Другое 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

Первичные конечные точки

• Comparison of the impact of paramedical care on the caregiving burden between the two groups [Срок оценки: At 20 weeks after surgery]

Вторичные конечные точки (10)

• Comparison of the impact of paramedical care on the caregiving burden between the two groups [Срок оценки: At 8 weeks after surgery]
• Comparison of the impact of paramedical care on the caregiving burden between the two groups [Срок оценки: At 12 weeks after surgery]
• Measure of quality of life in the two groups [Срок оценки: baseline]
• Measure of quality of life in the two groups [Срок оценки: baseline]
• Measure of quality of life in the two groups [Срок оценки: one week after hospital discharge]
• Measure of quality of life in the two groups [Срок оценки: one week after hospital discharge]
• Measure of quality of life in the two groups [Срок оценки: between 4 and 8 weeks after surgery]
• Measure of quality of life in the two groups [Срок оценки: between 8 and 12 weeks after surgery]
• Measure of quality of life in the two groups [Срок оценки: between 16 and 20 weeks after surgery]
• Measure of quality of life in the two groups [Срок оценки: between 16 and 20 weeks after surgery]

Критерии участия

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Франция · 1 центр

• Centre Henri Becquerel — Rouen

Идентификаторы

NCT: NCT05542706 · CHB22.01 · 2022-A00687-36

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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