Training caregivers of patients who had surgery for head and neck cancer
Benefit of Paramedical Care in Accompanying Caregivers of Patients That Had Surgery for an Head and Neck Invasive Cancer
This study tests whether special training for caregivers of patients who had head and neck cancer surgery can help them support their loved ones better and make the transition home easier.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 76 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Centre Henri Becquerel Academic / other |
| Locations | 1 site (Rouen) |
| Trial ID | NCT05542706 on ClinicalTrials.gov |
What this trial studies
This study evaluates the impact of paramedical care on caregivers of patients who have undergone surgery for invasive head and neck cancer. While the patient is hospitalized, a paramedical team will provide tailored training to the caregiver to enhance their ability to support the patient’s autonomy and ensure a safe transition home. The study compares outcomes between caregivers receiving this specialized training and those receiving standard care, with the aim of reducing caregiver burden and improving patient quality of life.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 85 diagnosed with non-metastatic head and neck squamous-cell carcinoma requiring curative surgery.
Not a fit: Patients scheduled for surgery after radiotherapy or those with psychological disorders that hinder understanding of the study may not benefit.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life for both patients and their caregivers.
How similar studies have performed: Other studies have shown positive outcomes with caregiver training in similar contexts, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Rouen
- Centre Henri Becquerel — Rouen, France (Recruiting)
Study contacts
- Principal investigator: Yveline David — Centre Henri Becquerel
- Study coordinator: Yveline David
- Email: yveline.david@chb.unicancer.fr
- Phone: +33232082542
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.