Quality of Life and Decisional Regret in Patients Affected by Acoustic Neuroma

NCT06844461 | Recruiting

• 1 other identifier: QOL-DR-NEUROMA
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Outcome Measures

Primary Outcomes (2)

• 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

  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

  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

  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

  From the surgery to the enrollment time (6 months post-treatment) for surgical group. At baseline at enrollment for wait-and-scan group

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Patient with sporadic acoustic neuroma in follow-up with wait and scan protocol or treated with microsurgical resection with any approach

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

Irccs Aou Bologna

Bologna, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Neuroma, Acoustic

Condition Hierarchy (Ancestors)

Neurilemmoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neuroma; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Cranial Nerve Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Peripheral Nervous System Neoplasms; Vestibulocochlear Nerve Diseases; Retrocochlear Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Otorhinolaryngologic Neoplasms; Cranial Nerve Diseases; Nervous System Diseases

Central Study Contacts

Cecilia Botti, ENT Specialist

CONTACT

+39 0512143266; cecilia.botti@aosp.bo.it

Alessandro Rosti, PhD Student

CONTACT

+39 3462245614; alessandro.rosti3@studio.unibo.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2025
• First Posted: February 25, 2025
• Study Start: January 20, 2024
• Primary Completion: April 20, 2025
• Study Completion: April 30, 2025
• Last Updated: February 25, 2025

Record last verified: 2024-12

Locations

IT (1)