Clinical trial NCT02048176: Posterior Fossa Mutism on Quality of Life
Official title: Long-Term Impact of Posterior Fossa Mutism on Quality of Life
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Posterior Fossa Mutism
Keywords: Mutism
Lead sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
Sponsor class: OTHER
First posted: 2014-01-29
Enrollment: 24
Sex: ALL
Minimum age (years): 8
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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.

Primary outcomes:
measure: Quality of Life
timeFrame: Thirty minutes, no follow-up.
Secondary outcomes:
measure: quality of life in terms of anger, anxiety, depression, fatigue, social functioning, pain and stigma
timeFrame: 30 minutes, no follow-up
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Ann & Robert H Lurie Children's Hospital of Chicago
state: Illinois
Study officials:
References:
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citation: Ozgur BM, Berberian J, Aryan HE, Meltzer HS, Levy ML. The pathophysiologic mechanism of cerebellar mutism. Surg Neurol. 2006 Jul;66(1):18-25. doi: 10.1016/j.surneu.2005.12.003.
citation: Robertson PL, Muraszko KM, Holmes EJ, Sposto R, Packer RJ, Gajjar A, Dias MS, Allen JC; Children's Oncology Group. Incidence and severity of postoperative cerebellar mutism syndrome in children with medulloblastoma: a prospective study by the Children's Oncology Group. J Neurosurg. 2006 Dec;105(6 Suppl):444-51. doi: 10.3171/ped.2006.105.6.444.