Total LaryngectomyNCT04491487
Pre-operative Counselling in Laryngectomized Patients
A study testing pre-operative counselling in people with Total Laryngectomy, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
The investigators aim to verify the effects of pre-operative Speech-Language Pathology (SLP) counselling on patients undergoing total laryngectomy in terms of levels of distress, post-traumatic stress symptoms, anxious-depressive symptoms, acquisition and acceptance of the new voice. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Total Laryngectomy
- What is being tested?
- pre-operative counselling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2020to 1 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 18 years and over;
- patients waiting for TL and primary TEP;
- patients able and willing to provide written informed consent.
Who cannot join
- positive history for psychiatric or psychological disorders,
- neurological disorders,
- ineligibility for voice prosthesis rehabilitation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Pre-operative Speech-Language Pathology Counselling in Patients Undergoing to Total Laryngectomy: a Randomized Clinical Trial
The investigators aim to verify the effects of pre-operative Speech-Language Pathology (SLP) counselling on patients undergoing total laryngectomy in terms of levels of distress, post-traumatic stress symptoms, anxious-depressive symptoms, acquisition and acceptance of the new voice.
This is a randomized controlled trial (RCT) of patients undergoing total laryngectomy and primary tracheoesophageal puncture. Patients will be randomized into two groups: an Experimental group that will receive a pre-operative SLP counselling session and a Control group that will not receive it. The investigators will administer a structured interview and three questionnaires: the Impact of Event Scale - Revised (IES-R), the Psychological Distress Inventory (PDI), the Hospital Anxiety and Depression Scale (HADS). The data will be collected between the 5th and 7th day after surgery (T0), 1-month (T1) and 3-months (T2) after being discharged from hospital.
- Conditions
- Total Laryngectomy
- Being tested
- pre-operative counselling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pre-operative counsellingOther
pre-operative Speech-Language Pathology (SLP) counselling before Total Laryngectomy
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Not described Receives: Other: pre-operative counselling |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of Event Scale-revised
presence of post-traumatic symptoms
Measured: Between the fifth and seventh post-operative day (T0)
Impact of Event Scale-revised
presence of post-traumatic symptoms
Measured: one month after being discharged from hospital (T1)
Impact of Event Scale-revised
presence of post-traumatic symptoms
Measured: three months after being discharged from hospital (T2)
Secondary outcomes (6)
Psychological Distress Inventory
psychological distress levels
Measured: Between the fifth and seventh post-operative day (T0)
Psychological Distress Inventory
psychological distress levels
Measured: one month after being discharged from hospital (T1)
Psychological Distress Inventory
psychological distress levels
Measured: three months after being discharged from hospital (T2)
Hospital Anxiety and Depression Scale
anxiety and depression levels
Measured: Between the fifth and seventh post-operative day (T0)
Hospital Anxiety and Depression Scale
anxiety and depression levels
Measured: one month after being discharged from hospital (T1)
Hospital Anxiety and Depression Scale
anxiety and depression levels
Measured: three months after being discharged from hospital (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2020
- Study start1 Sep 2020
- Primary completion2 Feb 2021
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total LaryngectomyStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LONGOBARDI YLENIA, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- Longobardi, Principal investigator, Otolaryngology department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04491487
- Sponsor's protocol ID
- 3347
- Status last verified
- Feb 2023
- First submitted
- 22 Jul 2020
- Last updated
- 17 Feb 2023
- 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 17 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pre-operative Speech-Language Pathology Counselling in Patients Undergoing to Total Laryngectomy: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04491487
- Acronym / sponsor ID
- 3347
- Conditions
- Total Laryngectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 2 Feb 2021 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 29 Jul 2020 (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.
The investigators aim to verify the effects of pre-operative Speech-Language Pathology (SLP) counselling on patients undergoing total laryngectomy in terms of levels of distress, post-traumatic stress symptoms, anxious-depressive symptoms, acquisition and acceptance of the new voice.
This is a randomized controlled trial (RCT) of patients undergoing total laryngectomy and primary tracheoesophageal puncture. Patients will be randomized into two groups: an Experimental group that will receive a pre-operative SLP counselling session and a Control group that will not receive it. The investigators will administer a structured interview and three questionnaires: the Impact of Event Scale - Revised (IES-R), the Psychological Distress Inventory (PDI), the Hospital Anxiety and Depression Scale (HADS). The data will be collected between the 5th and 7th day after surgery (T0), 1-month (T1) and 3-months (T2) after being discharged from hospital.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: pre-operative counselling |
| Control group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age 18 years and over;
- patients waiting for TL and primary TEP;
- patients able and willing to provide written informed consent.
Key exclusion criteria (3 listed)
- positive history for psychiatric or psychological disorders,
- neurological disorders,
- ineligibility for voice prosthesis rehabilitation.
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 |
|---|---|---|
| pre-operative counsellingpre-operative Speech-Language Pathology (SLP) counselling before Total Laryngectomy | Other | Experimental group |
Primary outcome
Impact of Event Scale-revised
Time frame: Between the fifth and seventh post-operative day (T0)
presence of post-traumatic symptoms
Impact of Event Scale-revised
Time frame: one month after being discharged from hospital (T1)
presence of post-traumatic symptoms
Impact of Event Scale-revised
Time frame: three months after being discharged from hospital (T2)
presence of post-traumatic symptoms
6 secondary outcomes
Psychological Distress Inventory
Time frame: Between the fifth and seventh post-operative day (T0)
Psychological Distress Inventory
Time frame: one month after being discharged from hospital (T1)
Psychological Distress Inventory
Time frame: three months after being discharged from hospital (T2)
Hospital Anxiety and Depression Scale
Time frame: Between the fifth and seventh post-operative day (T0)
Hospital Anxiety and Depression Scale
Time frame: one month after being discharged from hospital (T1)
Hospital Anxiety and Depression Scale
Time frame: three months after being discharged from hospital (T2)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2023.
- Individual participant dataSharing planned: No
Related trials for Total Laryngectomy
Not yet recruitingPhase 2
Early Feeding TL Trial
Total Laryngectomy
RecruitingObservational study
Gender Disparities in Voice Outcomes After Tracheoesophageal Puncture in Total Laryngectomy Patients (UC Davis)
Speech Disorders, Speech Dysfunction
Recruiting
Correlation Between Personnality Traits and Ability to Learn Oroesophageal Voice
Laryngectomy, Total Pharyngo-laryngectomy
Active, not recruiting
Mechanical and Sensorial Training in the Olfactive Rehabilitation of Patients With Total Laryngectomy
Cognitive Aging, Hyposmia
Recruiting
FRENCH THERAPEUTIC EDUCATION PROGRAM AIMING TO IMPROVE LARYNGECTOMIZED PATIENTS' AND THEIR FAMILY CAREGIVER'S QUALITY OF LIFE
Patients With Total Laryngectomy and Their Close Relatives
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.
Longobardi principal investigator
Otolaryngology department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pre-operative counselling in people with Total Laryngectomy, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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 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: finished, as of the sponsor's last update on 17 Feb 2023. 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Impact of Event Scale-revised (time frame: Between the fifth and seventh post-operative day (T0)). The study lists 3 primary outcomes in all. 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 17 Feb 2023; AzTrials last refreshed its copy on 6 Nov 2026.