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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-A00687-36 | Other Identifier | national identifier |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Accompanying caregivers by paramedical team | Experimental |
| |
| No dedicated accompanying by medical team | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Accompanying caregivers by paramedical team | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of the impact of paramedical care on the caregiving burden between the two groups | Via Zarit Burden Interview | At 20 weeks after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of the impact of paramedical care on the caregiving burden between the two groups | Via Zarit Burden Interview | At 8 weeks after surgery |
| Comparison of the impact of paramedical care on the caregiving burden between the two groups |
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Inclusion Criteria Patients :
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yveline David | Contact | +33232082542 | yveline.david@chb.unicancer.fr | |
| Doriane Richard | Contact | +33232082985 | doriane.richard@chb.unicancer.fr |
| Name | Affiliation | Role |
|---|---|---|
| Yveline David | Centre Henri Becquerel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Henri Becquerel | Recruiting | Rouen | France |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
Via Zarit Burden Interview
| At 12 weeks after surgery |
| Measure of quality of life in the two groups | WHOQOL-26 | baseline |
| Measure of quality of life in the two groups | QLQ-H&N35 | baseline |
| Measure of quality of life in the two groups | QLQ-H&N35 | one week after hospital discharge |
| Measure of quality of life in the two groups | WHOQOL-26 | one week after hospital discharge |
| Measure of quality of life in the two groups | QLQ-H&N35 | between 4 and 8 weeks after surgery |
| Measure of quality of life in the two groups | WHOQOL-26 | between 8 and 12 weeks after surgery |
| Measure of quality of life in the two groups | WHOQOL-26 | between 16 and 20 weeks after surgery |
| Measure of quality of life in the two groups | Via QLQ-H&N35 | between 16 and 20 weeks after surgery |