- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01013233
Cognitive Training to Improve Cognitive Function Following Chemotherapy (KT)
November 12, 2009 updated by: Charite University, Berlin, Germany
Training of Cognitive Function of Patients After Chemotherapy
The purpose of this study is to improve cognitive dysfunction following chemotherapy, the investigators investigated to see whether a cognitive training for memory and concentration skills can improve cognitive performance in patients following cancer treatment.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Patients following chemotherapy invited for a cognitive training.
Before and after cognitive function will evaluate.
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Susanne Effenberger, MSc
- Phone Number: +49-30-8445-2410
- Email: susanne.effenberger@charite.de
Study Contact Backup
- Name: Fernando Dimeo, MD
- Phone Number: +49-30-8445-4834
- Email: fernando.dimeo@charite.de
Study Locations
-
-
-
Berlin, Germany, 12200
- Charite Universitatsmedizin Berlin
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Contact:
- Susanne Effenberger, MSc
- Phone Number: +49-30-8445-2410
- Email: susanne.effenberger@charite.de
-
Principal Investigator:
- susanne Effenberger, MSc
-
-
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.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- patients with cancer 6 weeks after chemotherapy
Exclusion Criteria:
- patients with neurological or psychiatric disorders
- patients without compliance
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: training
Patients in this group start the cognitive training over 6 weeks directly after randomization.
|
cognitive training over 6 weeks, consist of 6 meetings (a 45minutes), three sessions focus on concentration tasks and three sessions on memory problems.
Other Names:
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Placebo Comparator: control
In this control group begin the training in a cross-over design 7 weeks after randomization.
|
no intervention
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
several cognitive tests (TAP, VLMT, TMT, Stroop, RWT, D2, LGT-3)
Time Frame: one weeks following the end of the cognitive training
|
one weeks following the end of the cognitive training
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
quality of life and subjective perception of cognitive problems
Time Frame: 7 weeks
|
7 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Michael Niedeggen, PhD, Freie Universität Berlin
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 Major Dates
Study Start
December 1, 2009
Primary Completion (Anticipated)
October 1, 2011
Study Completion (Anticipated)
October 1, 2011
Study Registration Dates
First Submitted
November 12, 2009
First Submitted That Met QC Criteria
November 12, 2009
First Posted (Estimate)
November 13, 2009
Study Record Updates
Last Update Posted (Estimate)
November 13, 2009
Last Update Submitted That Met QC Criteria
November 12, 2009
Last Verified
November 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KTST09
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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