Head and Neck CancerAIDORLNCT05542706
Benefit of Paramedical Care in Accompanying Caregivers of Patients That Had Surgery for an Head and Neck Invasive Cancer
A study testing Accompanying caregivers by paramedical team in people with Head and Neck Cancer, run by Centre Henri Becquerel at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Accompanying caregivers by paramedical team
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteFrance
- Study dates
- 31 Oct 2022to 31 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Head and Neck Cancer
- Being tested
- Accompanying caregivers by paramedical team
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accompanying caregivers by paramedical teamOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Accompanying caregivers by paramedical team | Experimental | Not described Receives: Other: Accompanying caregivers by paramedical team |
| No dedicated accompanying by medical team | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the impact of paramedical care on the caregiving burden between the two groups
Via Zarit Burden Interview
Measured: At 20 weeks after surgery
Secondary outcomes (10)
Comparison of the impact of paramedical care on the caregiving burden between the two groups
Via Zarit Burden Interview
Measured: At 8 weeks after surgery
Comparison of the impact of paramedical care on the caregiving burden between the two groups
Via Zarit Burden Interview
Measured: At 12 weeks after surgery
Measure of quality of life in the two groups
WHOQOL-26
Measured: baseline
Measure of quality of life in the two groups
QLQ-H\&N35
Measured: baseline
Measure of quality of life in the two groups
QLQ-H\&N35
Measured: one week after hospital discharge
Measure of quality of life in the two groups
WHOQOL-26
Measured: one week after hospital discharge
Measure of quality of life in the two groups
QLQ-H\&N35
Measured: between 4 and 8 weeks after surgery
Measure of quality of life in the two groups
WHOQOL-26
Measured: between 8 and 12 weeks after surgery
Measure of quality of life in the two groups
WHOQOL-26
Measured: between 16 and 20 weeks after surgery
Measure of quality of life in the two groups
Via QLQ-H\&N35
Measured: between 16 and 20 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2022
- Study start31 Oct 2022
- Primary completion30 Oct 2026
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Henri Becquerel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yveline David, Principal investigator, Centre Henri Becquerel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05542706
- Sponsor's protocol ID
- CHB22.01
- Other IDs
- 2022-A00687-36
- Acronym
- AIDORL
- Status last verified
- Nov 2026
- First submitted
- 9 Sep 2022
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefit of Paramedical Care in Accompanying Caregivers of Patients That Had Surgery for an Head and Neck Invasive Cancer
- ClinicalTrials.gov ID
- NCT05542706
- Acronym / sponsor ID
- AIDORL / CHB22.01
- Conditions
- Head and Neck Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Centre Henri BecquerelUniversity, hospital or other
- Study start
- 31 Oct 2022 (actual)
- Primary completion
- 30 Oct 2026 (actual)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 15 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Accompanying caregivers by paramedical team | Experimental | Other: Accompanying caregivers by paramedical team |
| No dedicated accompanying by medical team | No intervention | – |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Accompanying caregivers by paramedical teamAt 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. | Other | Accompanying caregivers by paramedical team |
Primary outcome
Comparison of the impact of paramedical care on the caregiving burden between the two groups
Time frame: At 20 weeks after surgery
Via Zarit Burden Interview
10 secondary outcomes
Comparison of the impact of paramedical care on the caregiving burden between the two groups
Time frame: At 8 weeks after surgery
Comparison of the impact of paramedical care on the caregiving burden between the two groups
Time frame: At 12 weeks after surgery
Measure of quality of life in the two groups
Time frame: baseline
Measure of quality of life in the two groups
Time frame: baseline
Measure of quality of life in the two groups
Time frame: one week after hospital discharge
Measure of quality of life in the two groups
Time frame: one week after hospital discharge
Measure of quality of life in the two groups
Time frame: between 4 and 8 weeks after surgery
Measure of quality of life in the two groups
Time frame: between 8 and 12 weeks after surgery
Measure of quality of life in the two groups
Time frame: between 16 and 20 weeks after surgery
Measure of quality of life in the two groups
Time frame: between 16 and 20 weeks after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yveline David principal investigator
Centre Henri Becquerel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Accompanying caregivers by paramedical team in people with Head and Neck Cancer, run by Centre Henri Becquerel at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the impact of paramedical care on the caregiving burden between the two groups (time frame: At 20 weeks after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.