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Clinical Trials in Italy / NCT06844461
Recruiting Observational

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

NCT06844461 · tracked via the Priya Life Science Italy tracker
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Phase
Observational
Started
2024-01-20
Last updated
2025-02-25

Condition(s) studied

Quality of Life OutcomesAcoustic Schwannoma

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • VSQOL-It — 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 — 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

Trial sites (1)

FacilityCityRegionStatus
Irccs Aou Bologna Bologna Italy Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06844461 on ClinicalTrials.gov ↗ ← All trials in Italy