Benefit of Paramedical Care in Accompanying Caregivers of Patients That Had Surgery for an Head and Neck Invasive Cancer (AIDORL)
Primary Purpose
Head and Neck Cancer
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Accompanying caregivers by paramedical team
Sponsored by
About this trial
This is an interventional supportive care trial for Head and Neck Cancer
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
Sites / Locations
- Centre Henri BecquerelRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Accompanying caregivers by paramedical team
No dedicated accompanying by medical team
Arm Description
Outcomes
Primary Outcome Measures
Comparison of the impact of paramedical care on the caregiving burden between the two groups
Via Zarit Burden Interview
Secondary Outcome Measures
Comparison of the impact of paramedical care on the caregiving burden between the two groups
Via Zarit Burden Interview
Comparison of the impact of paramedical care on the caregiving burden between the two groups
Via Zarit Burden Interview
Measure of quality of life in the two groups
WHOQOL-26
Measure of quality of life in the two groups
QLQ-H&N35
Measure of quality of life in the two groups
QLQ-H&N35
Measure of quality of life in the two groups
WHOQOL-26
Measure of quality of life in the two groups
QLQ-H&N35
Measure of quality of life in the two groups
WHOQOL-26
Measure of quality of life in the two groups
WHOQOL-26
Measure of quality of life in the two groups
Via QLQ-H&N35
Full Information
NCT ID
NCT05542706
First Posted
September 9, 2022
Last Updated
December 22, 2022
Sponsor
Centre Henri Becquerel
1. Study Identification
Unique Protocol Identification Number
NCT05542706
Brief Title
Benefit of Paramedical Care in Accompanying Caregivers of Patients That Had Surgery for an Head and Neck Invasive Cancer
Acronym
AIDORL
Official Title
Benefit of Paramedical Care in Accompanying Caregivers of Patients That Had Surgery for an Head and Neck Invasive Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 31, 2022 (Actual)
Primary Completion Date
January 31, 2025 (Anticipated)
Study Completion Date
September 13, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Henri Becquerel
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
76 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Accompanying caregivers by paramedical team
Arm Type
Experimental
Arm Title
No dedicated accompanying by medical team
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Accompanying caregivers by paramedical team
Intervention 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.
Primary Outcome Measure Information:
Title
Comparison of the impact of paramedical care on the caregiving burden between the two groups
Description
Via Zarit Burden Interview
Time Frame
At 20 weeks after surgery
Secondary Outcome Measure Information:
Title
Comparison of the impact of paramedical care on the caregiving burden between the two groups
Description
Via Zarit Burden Interview
Time Frame
At 8 weeks after surgery
Title
Comparison of the impact of paramedical care on the caregiving burden between the two groups
Description
Via Zarit Burden Interview
Time Frame
At 12 weeks after surgery
Title
Measure of quality of life in the two groups
Description
WHOQOL-26
Time Frame
baseline
Title
Measure of quality of life in the two groups
Description
QLQ-H&N35
Time Frame
baseline
Title
Measure of quality of life in the two groups
Description
QLQ-H&N35
Time Frame
one week after hospital discharge
Title
Measure of quality of life in the two groups
Description
WHOQOL-26
Time Frame
one week after hospital discharge
Title
Measure of quality of life in the two groups
Description
QLQ-H&N35
Time Frame
between 4 and 8 weeks after surgery
Title
Measure of quality of life in the two groups
Description
WHOQOL-26
Time Frame
between 8 and 12 weeks after surgery
Title
Measure of quality of life in the two groups
Description
WHOQOL-26
Time Frame
between 16 and 20 weeks after surgery
Title
Measure of quality of life in the two groups
Description
Via QLQ-H&N35
Time Frame
between 16 and 20 weeks after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yveline David
Phone
+33232082542
Email
yveline.david@chb.unicancer.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Doriane Richard
Phone
+33232082985
Email
doriane.richard@chb.unicancer.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yveline David
Organizational Affiliation
Centre Henri Becquerel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Henri Becquerel
City
Rouen
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yveline David
Phone
+33232082542
Email
yveline.david@chb.unicancer.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Benefit of Paramedical Care in Accompanying Caregivers of Patients That Had Surgery for an Head and Neck Invasive Cancer
We'll reach out to this number within 24 hrs