Acoustic Schwannoma, Quality of Life Outcomes
Conditions
Brief summary
Italian translation and validation study of two different questionnaire (VSQOL and DRS) about quality of life in patient with acoustic schwannoma.
Interventions
None listed
Sponsors
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PANQOL | From the surgery to the enrollment time (6 months post-treatment) for surgical group. At baseline at enrollment for wait-and-scan group | 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. |
| 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 | 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. |
Countries
Italy
Contacts
Primary ContactCecilia Botti, ENT Specialist
Backup ContactAlessandro Rosti, PhD Student
Outcome results
None listed