Quality of Life and Decisional Regret in Patients Affected by Acoustic Neuroma (QOL-DR-NEUROMA)

Italian translation and validation study of two different questionnaire (VSQOL and DRS) about quality of life in patient with acoustic schwannoma.

Study Overview

• Status: Recruiting
• Conditions: Acoustic Schwannoma; Quality of Life Outcomes

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Cecilia Botti, ENT Specialist; Phone Number: +39 0512143266; Email: cecilia.botti@aosp.bo.it
• Study Contact Backup: Name: Alessandro Rosti, PhD Student; Phone Number: +39 3462245614; Email: alessandro.rosti3@studio.unibo.it

Study Locations

• Italy
  • Bologna, Italy, 40138
    • Recruiting
    • Irccs Aou Bologna
    • Contact: Cecilia Botti; Phone Number: +39 0512143266; Email: cecilia.botti@aosp.bo.it
    • Principal Investigator: Cecilia Botti, ENT specialist

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2024
• Primary Completion (Estimated): April 20, 2025
• Study Completion (Estimated): April 30, 2025

Study Registration Dates

• First Submitted: January 28, 2025
• First Submitted That Met QC Criteria: February 24, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 24, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Otorhinolaryngologic Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nervous System Neoplasms; Nerve Sheath Neoplasms; Peripheral Nervous System Neoplasms; Neuroendocrine Tumors; Ear Diseases; Otorhinolaryngologic Neoplasms; Cranial Nerve Diseases; Cranial Nerve Neoplasms; Vestibulocochlear Nerve Diseases; Retrocochlear Diseases; Neuroma; Neurilemmoma; Neuroma, Acoustic
• Other Study ID Numbers: QOL-DR-NEUROMA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No