Otorhinolaryngologic NeoplasmsPAKO-HDJNCT06512662
Support Pathway for ENT Cancer Patients in a Support Care Day Hospital
A study testing Consultations with paramedics in people with Otorhinolaryngologic Neoplasms, run by Clinique Pasteur Lanroze at 1 site in France.
Trial summary
Cancers of the upper respiratory / digestive tract are a major public health problem, ranking 5th among the most common cancers. Surgery plays a central role in the recommended treatments for this type of pathology. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Otorhinolaryngologic Neoplasms
- What is being tested?
- Consultations with paramedics
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 8 Oct 2024to 31 Mar 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient undergoing surgery for VADS cancer requiring at least one night's post-operative hospitalisation
- Understanding of spoken and written French
- Patient covered by a social security scheme
Who cannot join
- Protected patient under a protective measure or legal safeguard
- Pregnant or breast-feeding patients
- Patients suffering from major cognitive disorders
- Patients with major anxiety disorders prior to the onset of cancer
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Clinique Pasteur Lanroze
Brest, 29000
Anthony Monnier, +33 2 98 31 33 51, amonnier@chp-brest.bzh
About this study
Official title: Support Pathway for ENT Cancer Patients in a Support Care Day Hospital Single-centre Prospective Randomised Interventional Study
Cancers of the upper respiratory / digestive tract are a major public health problem, ranking 5th among the most common cancers. Surgery plays a central role in the recommended treatments for this type of pathology. The surgical procedure and its after-effects can be anxiety-provoking and have a major psychological, physical and social impact on patients over the long term.
Our institution's standard protocol is based on a pre-operative supportive care day hospital. The aim of this study is to compare our current care pathway with a more extensive interdisciplinary care pathway focused on patients' needs, in order to reduce anxiety and improve the quality of life of patients undergoing surgery for cancers of the upper respiratory / digestive tract.
Our aim is to use a prospective single-centre interventional study to assess the impact of adding three post-operative day hospitals to the existing care pathway in terms of reducing anxiety and improving the quality of life of patients undergoing surgery.
- Conditions
- Otorhinolaryngologic Neoplasms
- Being tested
- Consultations with paramedics
- Keywords
- surgery, quality of life, anxiety, supportive care
- Medical subject headings
- Otorhinolaryngologic Neoplasms, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Consultations with paramedicsProcedure or surgery
Patients of experimental arm will beneficiate of supplemental consultations with paramedics intervenants at 1 month, 3 months and 6 months after surgery :
- dietetician
- speech therapist
- psychologist
- advanced practice nurse
During these consultations, several scales will be performed to assess the patient's condition (anxiety, nutritional status, psychological condition, speech therapy status).
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| Supportive care | Experimental | Not described Receives: Procedure: Consultations with paramedics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety
Anxiety evaluation by State Trait Anxiety Inventory (STAI) scale. It is a psychological inventory consisting of 40 self-report items on a 4-point Likert scale. The STAI measures two types of anxiety - state anxiety and trait anxiety. Higher scores are positively correlated with higher levels of anxiety.
Measured: 1 month ; 3 months ; 6 months
Secondary outcomes (7)
Quality of life evaluation
Quality of life will be evaluated by EORTC C30. The EORTC quality of life questionnaire (QLQ) is an integrated system for assessing the health-related quality of life (QoL) of cancer patients participating in international clinical trials.
Measured: 1 month ; 3 months ; 6 months
pain evaluation
Pain will be assessed using a visual analogue scale from 0 (no pain) to 10 (worst pain imaginable).
Measured: 1 month ; 3 months ; 6 months
Toxic behaviour (tobacco and alcohol) evaluation
Tobacco (number of cigarettes per day) and alcohol (number of units per day) consumption will be evaluated by questioning the patient.
Measured: 1 month ; 3 months ; 6 months
Weight status evaluation
Weight statut will be determined by calculating the body mass index (BMI) and the percentage of loss weight.
Measured: 1 month ; 3 months ; 6 months
nutritional status evaluation
Nutritional status will be evaluated using SEFI (simple evaluation of food intake) scale. This scale is a Likert scale to assess the portion eaten at mealtimes, from 0 ("I haven't eaten anything") to 10 ('I have eaten everything").
Measured: 1 month ; 3 months ; 6 months
swallowing assessment
Swallowing is measured by Deglutition Handicap Index (DHI). It is a questionnaire with 30 questions (10 physical, 10 functional, 10 emotional) with a Likert scale from "never" to "always".
Measured: 1 month ; 3 months ; 6 months
vocal status assessment
Vocal status is measured by Vocal Handicap Index (VHI). It is a questionnaire with 30 questions with a Likert scale from "never" to "always".
Measured: 1 month ; 3 months ; 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start8 Oct 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Otorhinolaryngologic NeoplasmsStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinique Pasteur Lanroze
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06512662
- Sponsor's protocol ID
- 2023-18-CPL
- Acronym
- PAKO-HDJ
- Status last verified
- Mar 2026
- First submitted
- 16 Jul 2024
- Last updated
- 6 Apr 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 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Support Pathway for ENT Cancer Patients in a Support Care Day Hospital Single-centre Prospective Randomised Interventional Study
- ClinicalTrials.gov ID
- NCT06512662
- Acronym / sponsor ID
- PAKO-HDJ / 2023-18-CPL
- Conditions
- Otorhinolaryngologic Neoplasms
- Keywords
- surgery, quality of life, anxiety, supportive care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Clinique Pasteur LanrozeUniversity, hospital or other
- Study start
- 8 Oct 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 22 Jul 2024 (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.
Cancers of the upper respiratory / digestive tract are a major public health problem, ranking 5th among the most common cancers. Surgery plays a central role in the recommended treatments for this type of pathology. The surgical procedure and its after-effects can be anxiety-provoking and have a major psychological, physical and social impact on patients over the long term.
Our institution's standard protocol is based on a pre-operative supportive care day hospital. The aim of this study is to compare our current care pathway with a more extensive interdisciplinary care pathway focused on patients' needs, in order to reduce anxiety and improve the quality of life of patients undergoing surgery for cancers of the upper respiratory / digestive tract.
Our aim is to use a prospective single-centre interventional study to assess the impact of adding three post-operative day hospitals to the existing care pathway in terms of reducing anxiety and improving the quality of life of patients undergoing surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| Supportive care | Experimental | Procedure: Consultations with paramedics |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patient undergoing surgery for VADS cancer requiring at least one night's post-operative hospitalisation
- Understanding of spoken and written French
- Patient covered by a social security scheme
Key exclusion criteria (4 listed)
- Protected patient under a protective measure or legal safeguard
- Pregnant or breast-feeding patients
- Patients suffering from major cognitive disorders
- Patients with major anxiety disorders prior to the onset of cancer
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 |
|---|---|---|
| Consultations with paramedicsPatients of experimental arm will beneficiate of supplemental consultations with paramedics intervenants at 1 month, 3 months and 6 months after surgery : * dietetician * speech therapist * psychologist * advanced practice nurse During these consultations, several scales will be performed to assess the patient's condition (anxiety, nutritional status, psychological condition, speech therapy status). | Procedure or surgery | Supportive care |
Primary outcome
Anxiety
Time frame: 1 month ; 3 months ; 6 months
Anxiety evaluation by State Trait Anxiety Inventory (STAI) scale. It is a psychological inventory consisting of 40 self-report items on a 4-point Likert scale. The STAI measures two types of anxiety - state anxiety and trait anxiety. Higher scores are positively correlated with higher levels of anxiety.
7 secondary outcomes
Quality of life evaluation
Time frame: 1 month ; 3 months ; 6 months
pain evaluation
Time frame: 1 month ; 3 months ; 6 months
Toxic behaviour (tobacco and alcohol) evaluation
Time frame: 1 month ; 3 months ; 6 months
Weight status evaluation
Time frame: 1 month ; 3 months ; 6 months
nutritional status evaluation
Time frame: 1 month ; 3 months ; 6 months
swallowing assessment
Time frame: 1 month ; 3 months ; 6 months
vocal status assessment
Time frame: 1 month ; 3 months ; 6 months
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 6 Apr 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Consultations with paramedics in people with Otorhinolaryngologic Neoplasms, run by Clinique Pasteur Lanroze 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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 6 Apr 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?
Contact Camille Vuarin, APN (+33 2 98 34 20 31 ext. 552031, cvuarin@chp-brest.bzh), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety (time frame: 1 month ; 3 months ; 6 months). 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 6 Apr 2026.