RECRUITING

Patient Reported Outcomes for Vascular Malformations EmbolizatioN (PROVEN)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Patient Reported Outcomes for Vascular Malformations EmbolizatioN (PROVEN)

Quick Facts

Study Start:2019-07-22
Study Completion:2026-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04104464

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:0 Years to 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male and Female pediatric patients, aged between 0-17 with diagnosis of vascular malformations.
  2. * Male and Female adult patients aged 18-100 with diagnosis of vascular malformations.
  3. * Vascular malformation symptoms significant enough to seek treatment.
  1. * Patients with extensive VM not suitable for sclerotherapy.
  2. * Prior therapy for treatment of a VM within 3 months.
  3. * Condition or impairment that may render the patient unable to take part in the study (e.g. cognitive, sight, hearing, etc.).

Contacts and Locations

Study Contact

Clifford R Weiss, MD
CONTACT
410-614-0601
cweiss@jhmi.edu
Hannatu A Bwayili, BS
CONTACT
hbwayil1@jh.edu

Principal Investigator

Clifford R Weiss, MD
PRINCIPAL_INVESTIGATOR
Johns Hopkins University

Study Locations (Sites)

Johns Hopkins Hospital
Baltimore, Maryland, 21287
United States

Collaborators and Investigators

Sponsor: Johns Hopkins University

  • Clifford R Weiss, MD, PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-07-22
Study Completion Date2026-07

Study Record Updates

Study Start Date2019-07-22
Study Completion Date2026-07

Terms related to this study

Keywords Provided by Researchers

  • vascular malformation
  • VM

Additional Relevant MeSH Terms

  • Vascular Malformations
  • VM - Vascular Malformation