Quality of Life OutcomesQOL-DR-NEUROMANCT06844461
Quality of Life and Decisional Regret in Patients Affected by Acoustic Neuroma
An observational study of Quality of Life Outcomes and Acoustic Schwannoma, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
Italian translation and validation study of two different questionnaire (VSQOL and DRS) about quality of life in patient with acoustic schwannoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quality of Life Outcomes, Acoustic Schwannoma
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 20 Jan 2024to 30 Apr 2025
- How long will I take part?
- 4 Months
- Phase
- Observational
- 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
Study population: Patients enrolled at the outpatient clinic of an Otolaryngology and Audiology Unit and Neurosurgery Unit of two third level university hospitals in Northern Italy with acoustic neuroma diagnosis between 01/01/2000 and 31/10/2022.
Who may be able to join
- Patient with sporadic acoustic neuroma in follow-up with wait and scan protocol or treated with microsurgical resection with any approach
Who cannot join
- Patient with NF2
- Patient previuosly treated with RT in the head and neck district
- Patient with pre-treatment facial palsy ipsi and controlateral
- Patient non native italian speakers
- Patient with major mental illness already existing before the acoustic neuroma diagnosis
- Patient with neurological issues such as chronic migraine or postural instability already existing before the acoustic neuroma diagnosis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Irccs Aou Bologna
Bologna, 40138
Cecilia Botti, +39 0512143266, cecilia.botti@aosp.bo.it
Cecilia Botti, ENT specialist
About this study
Italian translation and validation study of two different questionnaire (VSQOL and DRS) about quality of life in patient with acoustic schwannoma.
- Conditions
- Quality of Life Outcomes, Acoustic Schwannoma
- Medical subject headings
- Neuroma, Acoustic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Wait-and-scan cohort | Clinico-radiological follow-up with annual brain MRI to detect increase of volume and size of the tumor | |
| Surgery cohort | Surgical cohort with tumor excision through any possible approach to lateral skull base |
What is being measured
The primary outcome is the main question the study is designed to answer.
VSQOL-It
Self evaluation of quality of life in patient diagnosed with sporadic acoustic neuroma. It is composed of 40 questions, of which 37 are built on a Likert scale from 1 to 5, where 1 indicates strong disagreement and 5 indicates strong agreement, and 3 with 3 possible answers. The questions relate to 8 domains: Hearing Problems, Postural Instability and Imbalance, Pain, Discomfort, and Tinnitus, Facial or Ocular Issues, Impact on Physical, Emotional, and Social Well-being, Difficulties with Thinking and Memory, Satisfaction or Regret, Impact on Work Activity.
The score of questions 1 to 33 is reversed, so that a higher score indicates a favorable health status or better quality of life. The scores for questions 1 to 33 are linearly transformed onto a scale from 0 to 100, where 0 indicates poor quality of life and 100 indicates ideal quality of life. The overall score of the index is calculated as the average of the scores of the first six domains, excluding SatisfactionRegret domain
Measured: From the surgery to the enrollment time (6 months post-treatment) for surgical group. At baseline at enrollment for wait-and-scan group
DRS-It
Decisional regret scale to evaluate any regret about the therapeutic choice both in wait-and-scan cohort and surgical cohort. The score ranges from 0 (no regret) to 100 (complete regret). Patients with more than 25pts are considered to have moderate/high regret
Measured: From the surgery to the enrollment time (6 months post-treatment) for surgical group. At baseline at enrollment for wait-and-scan group
Secondary outcomes (2)
PANQOL
Specific quality of life questionnaire in patient with acoustic neuroma composed of 26 questions built on a Likert scale from 1 to 5, where 1 indicates strong disagreement and 5 indicates strong agreement. The questions relate to 7 domains: Hearing (4 questions), Balance (6 questions), Facial Function (3 questions), Energy (6 questions), Anxiety (4 questions), General Health Status (2 questions), and Pain (1 question).
The score for each domain is calculated as the average of the responses to the questions assigned to it and is linearly transformed onto a scale from 0 to 100, where 0 indicates poor quality of life and 100 indicates ideal quality of life. The overall score of the scale is calculated as the average of the scores of the individual domains.
Measured: From the surgery to the enrollment time (6 months post-treatment) for surgical group. At baseline at enrollment for wait-and-scan group
DASS-21 Questionnaire
Psychometric self-evaluation of depression, anxiety and stress during the study period. 21 items-questionnaire about depression, anxiety and stress during the study period. Each subscale presents a singular score from 0 to 42. Higher scores corresponds to worse emotional outcome.
Measured: From the surgery to the enrollment time (6 months post-treatment) for surgical group. At baseline at enrollment for wait-and-scan group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start20 Jan 2024
- Primary completion20 Apr 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of Life OutcomesStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 4 Months
Sponsor and investigators
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06844461
- Sponsor's protocol ID
- QOL-DR-NEUROMA
- Acronym
- QOL-DR-NEUROMA
- Status last verified
- Dec 2024
- First submitted
- 28 Jan 2025
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life and Decisional Regret in Patients Affected by Acoustic Neuroma
- ClinicalTrials.gov ID
- NCT06844461
- Acronym / sponsor ID
- QOL-DR-NEUROMA / QOL-DR-NEUROMA
- Conditions
- Quality of Life Outcomes, Acoustic Schwannoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 20 Jan 2024 (actual)
- Primary completion
- 20 Apr 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 25 Feb 2025 (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.
Italian translation and validation study of two different questionnaire (VSQOL and DRS) about quality of life in patient with acoustic schwannoma.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 4 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wait-and-scan cohort | – | –Clinico-radiological follow-up with annual brain MRI to detect increase of volume and size of the tumor |
| Surgery cohort | – | –Surgical cohort with tumor excision through any possible approach to lateral skull base |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients enrolled at the outpatient clinic of an Otolaryngology and Audiology Unit and Neurosurgery Unit of two third level university hospitals in Northern Italy with acoustic neuroma diagnosis between 01/01/2000 and 31/10/2022.
Key inclusion criteria (1 listed)
- Patient with sporadic acoustic neuroma in follow-up with wait and scan protocol or treated with microsurgical resection with any approach
Key exclusion criteria (6 listed)
- Patient with NF2
- Patient previuosly treated with RT in the head and neck district
- Patient with pre-treatment facial palsy ipsi and controlateral
- Patient non native italian speakers
- Patient with major mental illness already existing before the acoustic neuroma diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
VSQOL-It
Time frame: From the surgery to the enrollment time (6 months post-treatment) for surgical group. At baseline at enrollment for wait-and-scan group
Self evaluation of quality of life in patient diagnosed with sporadic acoustic neuroma. It is composed of 40 questions, of which 37 are built on a Likert scale from 1 to 5, where 1 indicates strong disagreement and 5 indicates strong agreement, and 3 with 3 possible answers. The questions relate to 8 domains: Hearing Problems, Postural Instability and Imbalance, Pain, Discomfort, and Tinnitus, Facial or Ocular Issues, Impact on Physical, Emotional, and Social Well-being, Difficulties with Thinking and Memory, Satisfaction or Regret, Impact on Work Activity. The score of questions 1 to 33 is reversed, so that a higher score indicates a favorable health status or better quality of life. The scores for questions 1 to 33 are linearly transformed onto a scale from 0 to 100, where 0 indicates poor quality of life and 100 indicates ideal quality of life. The overall score of the index is calculated as the average of the scores of the first six domains, excluding SatisfactionRegret domain
DRS-It
Time frame: From the surgery to the enrollment time (6 months post-treatment) for surgical group. At baseline at enrollment for wait-and-scan group
Decisional regret scale to evaluate any regret about the therapeutic choice both in wait-and-scan cohort and surgical cohort. The score ranges from 0 (no regret) to 100 (complete regret). Patients with more than 25pts are considered to have moderate/high regret
2 secondary outcomes
PANQOL
Time frame: From the surgery to the enrollment time (6 months post-treatment) for surgical group. At baseline at enrollment for wait-and-scan group
DASS-21 Questionnaire
Time frame: From the surgery to the enrollment time (6 months post-treatment) for surgical group. At baseline at enrollment for wait-and-scan group
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 25 Feb 2025.
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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?
An observational study of Quality of Life Outcomes and Acoustic Schwannoma, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna 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 1 inclusion and 6 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 25 Feb 2025. 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?
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 Cecilia Botti, ENT Specialist (+39 0512143266, cecilia.botti@aosp.bo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VSQOL-It (time frame: From the surgery to the enrollment time (6 months post-treatment) for surgical group. At baseline at enrollment for wait-and-scan group). The study lists 2 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 25 Feb 2025.