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Trial Title:
Benefit of Paramedical Care in Accompanying Caregivers of Patients That Had Surgery for an Head and Neck Invasive Cancer
NCT ID:
NCT05542706
Condition:
Head and Neck Cancer
Conditions: Official terms:
Head and Neck Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Accompanying caregivers by paramedical team
Description:
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 the enteral
nutrition, prevention of dehydration, pain management.
Arm group label:
Accompanying caregivers by paramedical team
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
85 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Centre Henri Becquerel
Address:
City:
Rouen
Country:
France
Status:
Recruiting
Contact:
Last name:
Yveline David
Phone:
+33232082542
Email:
yveline.david@chb.unicancer.fr
Start date:
October 31, 2022
Completion date:
September 13, 2025
Lead sponsor:
Agency:
Centre Henri Becquerel
Agency class:
Other
Source:
Centre Henri Becquerel
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05542706
