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The Influence of Radiotherapy on Cognitive Function

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2007 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00457210
First Posted: April 6, 2007
Last Update Posted: April 6, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Mindstreams
Information provided by:
Tel-Aviv Sourasky Medical Center
  Purpose
The cognitive function of 150 patients that undergone any Radiotherapy treatment to the brain will be assessed at 3 time points before and after the treatment.

Condition Intervention
Radiotherapy Brain Neoplasms Quality of Life Procedure: Brain Radiotherapy/Stereotactic Radiosurgery

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Cross-Sectional
Time Perspective: Prospective
Official Title: The Influence of the Radiotherapy or Stereotactic Radiosurgery on the Cognitive Function of the Patients With the Neurotrax Assessment System and a Cognitive Questionnaire.

Further study details as provided by Tel-Aviv Sourasky Medical Center:

Estimated Enrollment: 150
Study Start Date: April 2007
Detailed Description:
The basic cognitive function and QOL of 150 oncologic patients that undergone Radiotherapy or Radiosurgery treatment to the brain due to primary tumor, metastases or increased risk of brain metastases, will be assessed at 3 time points: before the treatment, immediately after the treatment, and on the next follow up visit. The assessment tools that will be used are Neurotrax standard cognitive computerized tests and 2 short questionnaires.Patients that will receive a one-day treatment will be tested on 2 time points only- before the treatment and on FU.The research will reveal the positive and the negative influences of the Radiotherapy, along with the assessment of norms for the cognitive function and quality of life of oncologic patients being treated by RT.Eligibility criteria:oncologic patients of both genders, with primary brain tumors, metastases or with increased risk of brain metastases, that are referred to conformal/palliative or preventive Radiotherapy treatment or to Stereotactic Radiosurgery, who are able to follow instructions in Hebrew.The participants will be 20-80 years old.Main comparisons will be performed between the cognitive tests results on 3 time points mentioned. The study will continue until the needed number of participants will be achieved.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 20-80 years old oncologic patients, of both genders, that are referred to Brain Radiotherapy or Stereotactic Radiosurgery due to primary brain tumor/ brain metastases or increased risk for brain metastases.
  • Are able to follow instructions in Hebrew.

Exclusion Criteria:

  • Non-Hebrew speakers can not participate.
  Contacts and Locations
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): NCT00457210


Contacts
Contact: Ben Corn, MD 972-52-426-6533 bencorn@tasmc.health.gov.il

Locations
Israel
Tel Aviv sourasky Medical Center Recruiting
Tel Aviv, Israel, 64239
Principal Investigator: Ben Corn, PhD         
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Mindstreams
Investigators
Principal Investigator: Ben Corn, PhD Tel-Aviv Sourasky Medical Center
  More Information

ClinicalTrials.gov Identifier: NCT00457210     History of Changes
Other Study ID Numbers: TASMC-07-BC-040-CTIL
First Submitted: April 5, 2007
First Posted: April 6, 2007
Last Update Posted: April 6, 2007
Last Verified: April 2007

Keywords provided by Tel-Aviv Sourasky Medical Center:
Psychology

Additional relevant MeSH terms:
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases