Patient Reported Outcomes for Vascular Malformations EmbolizatioN (PROVEN)

Study Overview
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Brief Summary
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The purpose of this study is to develop a standardized assessment for patients treated for venous malformations (VM). Venous malformations result from the abnormal development of veins which may result in pain, swelling, bleeding, functional impairment, disfigurement, and psychological distress. The impact of VM on patient quality of life varies based on the location and size of the malformation. A patient reported outcome (PRO) is a patient's own account of patient's health condition. PRO measures are valued to clinicians, as many treatment effects are known only to the patient. No studies to date have analyzed the validity of existing PRO measures for VM patients. Current assessment does not include all symptoms or take in to account the relevance of VM location. Past studies show a discrepancy between treatment outcomes reported by patients and physicians. Therefore, there is a need to develop VM-specific PROs to better understand the effectiveness and benefits of treatment for VM.

Official Title
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Patient Reported Outcomes for Vascular Malformations EmbolizatioN (PROVEN)

Conditions
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Vascular Malformations, VM - Vascular Malformation

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and Female pediatric patients, aged between 0-17 with diagnosis of vascular malformations. Male and Female adult patients aged 18-100 with diagnosis of vascular malformations. Vascular malformation symptoms significant enough to seek treatment. Exclusion Criteria: Patients with extensive VM not suitable for sclerotherapy. Prior therapy for treatment of a VM within 3 months. Condition or impairment that may render the patient unable to take part in the study (e.g. cognitive, sight, hearing, etc.).

Ages Eligible for Study
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Minimum Age: 0 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in patient reported VM pain | Patients are asked to rate pain associated with VM during the past seven days on a 0-10 scale. | 1 month, 3 months and 6 months post-procedure; and all subsequent visits up to 1 year | 
| Change in patient reported VM impact on daily life | Patients are asked to rate the impact that their VM has on daily life with the options Not at all, A little bit, Somewhat, Quite a bit or Very Much. | 1 month, 3 months and 6 months post-procedure; and all subsequent visits up to 1 year | 
| Change in patient reported efficacy of treatment | Patients are asked to rate the efficacy of their treatment with the options Not at all, A little bit, Somewhat, Quite a bit or Very Much. | 1 month, 3 months and 6 months post-procedure; and all subsequent visits up to 1 year | 
| Change in patient reported relevancy of the PROVEN Questionnaire | Patients are asked to rate the personal relevancy and clarity of the survey questions with the options Not at all, A little bit, Somewhat, Quite a bit or Very Much. | 1 month, 3 months and 6 months post-procedure; and all subsequent visits up to 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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VM, vascular malformation