Quality of LifeNCT06086119
Quality of Life and Voice Perception in Patients Laryngoctomized Phonatory Wearers
An observational study of Quality of Life and Larynx Cancer, run by Regina Elena Cancer Institute at 1 site in Italy.
Trial summary
Prospective, multicenter observational study involving patients who will undergo total laryngectomy surgery and placement of phonatory prosthesis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quality of Life, Larynx Cancer
- What is being tested?
- to assess the voice perception of the patient undergoing phonatory prosthesis placement surgery by evaluating the optimal score (>30) in terms of VHI.
- How many people
- 31 participants
- Where
- 1 siteItaly
- Study dates
- 4 May 2021to 4 May 2024
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Prospective, multicenter observational study involving patients who will undergo total laryngectomy surgery and placement of phonatory prosthesis.
Who may be able to join
- Patients who will undergo laryngeal demolition surgery, total laryngectomy, who agree to phonatory prosthesis placement
- Patients who have undergone previous total laryngectomy surgery and intend to undergo placement of phonatory prosthesis.
- Age > 18 years
- Written informed consent
Who cannot join
- Patients who have not undergone demolitive surgical treatment by total laryngectomy or who do not accept the placement of phonatory prosthesis.
- Patients who are unable to complete questionnaires/follow the rehabilitation pathway
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
"Regina Elena" National Cancer Institute
Rome, 00144
Raul Pellini, MD, ND, raul.pellini@ifo.it
About this study
Prospective, multicenter observational study involving patients who will undergo total laryngectomy surgery and placement of phonatory prosthesis.
- Conditions
- Quality of Life, Larynx Cancer
- Being tested
- to assess the voice perception of the patient undergoing phonatory prosthesis placement surgery by evaluating the optimal score (>30) in terms of VHI.
- Medical subject headings
- Laryngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
to assess the voice perception of the patient undergoing phonatory prosthesis placement surgery by evaluating the optimal score (>30) in terms of VHI.Diagnostic test
Prospective, multicenter observational study involving patients who will undergo total laryngectomy surgery and placement of phonatory prosthesis
| Study group | Role | What they receive |
|---|---|---|
| Patients who will be subjected to total laryngectomy and placement of voice prosthesis | Prospective, multicenter observational study involving patients who will be subjected to total laryngectomy and placement of voice prosthesis.Evaluate the patient's quality of life and voice perception underwent surgery for the placement of a voice prosthesis, through the administration of validated quality of life questionnaires: EORTC QLQ - H\&N35; EORTC QLQ -C30, V-RQOL, VHI, SECEL3,4 Receives: Diagnostic Test: to assess the voice perception of the patient undergoing phonatory prosthesis placement surgery by evaluating the optimal score (>30) in terms of VHI. |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluate the patient's quality of life and voice perception underwent surgery for the placement of a voice prosthesis
Evaluate the perception of the voice of the patient undergoing surgery of voice prosthesis positioning, evaluating the optimal score (>30) in terms of VHI.
To calculate the sample size we based our estimate on the percentage of patients not undergoing voice prosthesis with a VHI score greater than 30 (Good Score). Such percentage is approximately 35%, a figure reported in the literature. Assuming a difference of 25% in terms of percentage of patients undergoing voice prosthesis who have a VHI score greater than 30 (60%) to ensure a power (1-β) equal to 80% and an α error of 5%, it will be necessary to enlist a total of 31 patients with the required requirements. Descriptive statistics will be calculated for all variables of interest. The associations will come evaluated using Fisher's exact test. Differences between subgroups will be assessed using the Mann-Whitney U test. All statistical analyzes were conducted using SPSS statistical software (version 21.0)
Measured: Enlistment period: 2 years Total duration of the study: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2023
- Study start4 May 2021
- Primary completion15 Oct 2022
- Study completion4 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 31 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regina Elena Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- San Giovanni Addolorata Hospital, Azienda Policlinico Umberto I
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06086119
- Sponsor's protocol ID
- RS1497/21
- Status last verified
- Jun 2023
- First submitted
- 29 Mar 2023
- Last updated
- 17 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life and Voice Perception in Patients Laryngoctomized Phonatory Wearers
- ClinicalTrials.gov ID
- NCT06086119
- Acronym / sponsor ID
- RS1497/21
- Conditions
- Quality of Life, Larynx Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- Regina Elena Cancer InstituteUniversity, hospital or other
- Collaborators
- San Giovanni Addolorata Hospital, Azienda Policlinico Umberto I
- Study start
- 4 May 2021 (actual)
- Primary completion
- 15 Oct 2022 (actual)
- Study completion
- 4 May 2024 (estimated)
- First posted
- 17 Oct 2023 (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.
Prospective, multicenter observational study involving patients who will undergo total laryngectomy surgery and placement of phonatory prosthesis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who will be subjected to total laryngectomy and placement of voice prosthesis | – | Diagnostic Test: to assess the voice perception of the patient undergoing phonatory prosthesis placement surgery by evaluating the optimal score (>30) in terms of VHI.Prospective, multicenter observational study involving patients who will be subjected to total laryngectomy and placement of voice prosthesis.Evaluate the patient's quality of life and voice perception underwent surgery for the placement of a voice prosthesis, through the administration of validated quality of life questionnaires: EORTC QLQ - H\&N35; EORTC QLQ -C30, V-RQOL, VHI, SECEL3,4 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Prospective, multicenter observational study involving patients who will undergo total laryngectomy surgery and placement of phonatory prosthesis.
Key inclusion criteria (4 listed)
- Patients who will undergo laryngeal demolition surgery, total laryngectomy, who agree to phonatory prosthesis placement
- Patients who have undergone previous total laryngectomy surgery and intend to undergo placement of phonatory prosthesis.
- Age > 18 years
- Written informed consent
Key exclusion criteria (2 listed)
- Patients who have not undergone demolitive surgical treatment by total laryngectomy or who do not accept the placement of phonatory prosthesis.
- Patients who are unable to complete questionnaires/follow the rehabilitation pathway
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 |
|---|---|---|
| to assess the voice perception of the patient undergoing phonatory prosthesis placement surgery by evaluating the optimal score (>30) in terms of VHI.Prospective, multicenter observational study involving patients who will undergo total laryngectomy surgery and placement of phonatory prosthesis | Diagnostic test | Patients who will be subjected to total laryngectomy and placement of voice prosthesis |
Primary outcome
evaluate the patient's quality of life and voice perception underwent surgery for the placement of a voice prosthesis
Time frame: Enlistment period: 2 years Total duration of the study: 36 months
Evaluate the perception of the voice of the patient undergoing surgery of voice prosthesis positioning, evaluating the optimal score (>30) in terms of VHI. To calculate the sample size we based our estimate on the percentage of patients not undergoing voice prosthesis with a VHI score greater than 30 (Good Score). Such percentage is approximately 35%, a figure reported in the literature. Assuming a difference of 25% in terms of percentage of patients undergoing voice prosthesis who have a VHI score greater than 30 (60%) to ensure a power (1-β) equal to 80% and an α error of 5%, it will be necessary to enlist a total of 31 patients with the required requirements. Descriptive statistics will be calculated for all variables of interest. The associations will come evaluated using Fisher's exact test. Differences between subgroups will be assessed using the Mann-Whitney U test. All statistical analyzes were conducted using SPSS statistical software (version 21.0)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2023.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Life and Larynx Cancer, run by Regina Elena Cancer Institute 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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 17 Oct 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluate the patient's quality of life and voice perception underwent surgery for the placement of a voice prosthesis (time frame: Enlistment period: 2 years Total duration of the study: 36 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 17 Oct 2023.