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Posterior Fossa Mutism on Quality of Life

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ClinicalTrials.gov Identifier: NCT02048176
Recruitment Status : Completed
First Posted : January 29, 2014
Last Update Posted : February 5, 2016
Sponsor:
Information provided by (Responsible Party):
Rishi Lulla, Ann & Robert H Lurie Children's Hospital of Chicago

Brief Summary:
Posterior fossa mutism (PFM) occurs in up to 30% of patients after resection of a posterior fossa tumor, most commonly a medulloblastoma. PFM is characterized by delayed onset of mutism 1-6 days after surgery that can spontaneously improve on average from 7-8 weeks later. Few patients recover normal speech. Most of their speech continues to be marked by dysarthria, dysfluency and slowed rate. Researchers have not identified the pathophysiologic mechanism for PFM nor have they found a cure. Despite the improvements in speech, patients with PFM have shown multiple areas of neurocognitive deficits 12 months after diagnosis. Few studies have looked at long term outcomes of patients affected by PFM. We propose to survey patients who developed PFM after resection of a medulloblastoma to determine long term effects of PFM on patient's quality of life.

Condition or disease
Posterior Fossa Mutism

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Study Type : Observational
Actual Enrollment : 24 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Long-Term Impact of Posterior Fossa Mutism on Quality of Life
Study Start Date : July 2011
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Group/Cohort
Posterior Fossa Mutism
Patients with Posterior Fossa Mutism
Non Posterior Fossa Mutism
Patients that did not develop Mutism



Primary Outcome Measures :
  1. Quality of Life [ Time Frame: Thirty minutes, no follow-up. ]

Secondary Outcome Measures :
  1. quality of life in terms of anger, anxiety, depression, fatigue, social functioning, pain and stigma [ Time Frame: 30 minutes, no follow-up ]


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Ages Eligible for Study:   8 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients must be between 8 years and 25 years of age at the time of enrollment and have completed treatment for their initial diagnosis of medulloblastoma.

We will identify a group of patients who developed PFM as well as a group of appropriately matched controls with regard to age, sex and treatment protocol who did not develop PFM.

Criteria

Inclusion Criteria:

Patients must be between 8 years and 25 years of age at the time of enrollment and have completed treatment for their initial diagnosis of medulloblastoma.

Exclusion Criteria:

  1. Patient is less than 8 years old or greater than 25 years old at the time of the administration of the survey.
  2. Patients are too ill to complete the survey as identified by their treating physician.
  3. Patients who are unable to speak or understand English.
  4. Patients who are currently being treated for their original diagnosis of medulloblastoma.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02048176


Locations
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United States, Illinois
Ann & Robert H Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Ann & Robert H Lurie Children's Hospital of Chicago

Publications:

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Responsible Party: Rishi Lulla, Principal Investigator, Ann & Robert H Lurie Children's Hospital of Chicago
ClinicalTrials.gov Identifier: NCT02048176     History of Changes
Other Study ID Numbers: 2011-14721
First Posted: January 29, 2014    Key Record Dates
Last Update Posted: February 5, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Rishi Lulla, Ann & Robert H Lurie Children's Hospital of Chicago:
Mutism
Additional relevant MeSH terms:
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Mutism
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurodevelopmental Disorders
Mental Disorders