NCT05542706Active, not recruiting
Benefit of Paramedical Care in Accompanying Caregivers of Patients That Had Surgery for an Head and Neck Invasive Cancer
Source: ClinicalTrials.gov · Last updated 4 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 48 (actual)
- First submitted
- 9 Sept 2022
- Start date
- 31 Oct 2022
- Primary completion date
- 30 Oct 2026
- Lead sponsor
- Centre Henri Becquerel
- Diseases
- Head and neck cancer
- NCT number
- NCT05542706
What you commit to
- Study type: Interventional
- Participants enrolled: 48
- From 31 Oct 2022 to the primary completion date, 30 Oct 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient scheduled for surgery after radiotherapy or for surgery on site already irradiated
Other illness
- History of psychological or sensorial disorder or anomaly that can prevent the patient from understanding the conditions for study participation
Other
- Patient or caregiver that do not agree to participate in the study (the pair patient-caregiver is needed)
Who the study is looking for
- 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
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Henri Becquerel Coordinator of this site? Confirm its status | Rouen | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.