Clinical trial · Observational
Quality of Life and Decisional Regret in Patients Affected by Acoustic Neuroma
NCT06844461CI-TRIAL-00086423QOL-DR-NEUROMArecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Italian translation and validation study of two different questionnaire (VSQOL and DRS) about quality of life in patient with acoustic schwannoma.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acoustic Schwannoma | Vestibular Schwannoma | ALIAS | 0.90 |
| Quality of Life Outcomes | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Wait-and-scan cohort
- description
- Clinico-radiological follow-up with annual brain MRI to detect increase of volume and size of the tumor
- label
- Surgery cohort
- description
- Surgical cohort with tumor excision through any possible approach to lateral skull base
Primary outcomes (2)
- measure
- VSQOL-It
- timeFrame
- From the surgery to the enrollment time (6 months post-treatment) for surgical group. At baseline at enrollment for wait-and-scan group
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.