Quality of Life and Decisional Regret in Patients Affected by Acoustic Neuroma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna
About this trial
Italian translation and validation study of two different questionnaire (VSQOL and DRS) about quality of life in patient with acoustic schwannoma.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient with sporadic acoustic neuroma in follow-up with wait and scan protocol or treated with microsurgical resection with any approach
Disqualifiers
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
Trial 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.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
40 Participants
are grouped into 2 trial groupsGroup A: Wait-and-scan cohort
Group B: Surgery cohort
Trial outcomes
Primary outcomes
1
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
Time frame
From the surgery to the enrollment time (6 months post-treatment) for surgical group. At baseline at enrollment for wait-and-scan group2
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
Time frame
From the surgery to the enrollment time (6 months post-treatment) for surgical group. At baseline at enrollment for wait-and-scan groupSecondary outcomes
1
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.
Time frame
From the surgery to the enrollment time (6 months post-treatment) for surgical group. At baseline at enrollment for wait-and-scan group2
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.
Time frame
From the surgery to the enrollment time (6 months post-treatment) for surgical group. At baseline at enrollment for wait-and-scan groupSponsors and contacts
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Source ClinicalTrials.gov