NCT05542706 Benefit of Paramedical Care in Accompanying Caregivers of Patients That Had Surgery for an Head and Neck Invasive Cancer
| NCT ID | NCT05542706 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Henri Becquerel |
| Condition | Head and Neck Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 76 participants |
| Start Date | 2022-10-31 |
| Primary Completion | 2026-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 76 participants in total. It began in 2022-10-31 with a primary completion date of 2026-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Yveline David
PRINCIPAL INVESTIGATOR
Centre Henri Becquerel
Frequently Asked Questions
Who can join the NCT05542706 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Head and Neck Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05542706 currently recruiting?
Yes, NCT05542706 is actively recruiting participants. Contact the research team at yveline.david@chb.unicancer.fr for enrollment information.
Where is the NCT05542706 trial being conducted?
This trial is being conducted at Rouen, France.
Who is sponsoring the NCT05542706 clinical trial?
NCT05542706 is sponsored by Centre Henri Becquerel. The principal investigator is Yveline David at Centre Henri Becquerel. The trial plans to enroll 76 participants.
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