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Cognitive Training to Improve Cognitive Function Following Chemotherapy (KT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Charite University, Berlin, Germany.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Freie Universität Berlin
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01013233
First received: November 12, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Cognitive Dysfunction
Behavioral: cognitive training
Other: control group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Training of Cognitive Function of Patients After Chemotherapy

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • several cognitive tests (TAP, VLMT, TMT, Stroop, RWT, D2, LGT-3) [ Time Frame: one weeks following the end of the cognitive training ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • quality of life and subjective perception of cognitive problems [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: December 2009
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: training
Patients in this group start the cognitive training over 6 weeks directly after randomization.
Behavioral: cognitive training
cognitive training over 6 weeks, consist of 6 meetings (a 45minutes), three sessions focus on concentration tasks and three sessions on memory problems.
Other Name: training group
Placebo Comparator: control
In this control group begin the training in a cross-over design 7 weeks after randomization.
Other: control group
no intervention
Other Name: controll group

Detailed Description:

Patients following chemotherapy invited for a cognitive training. Before and after cognitive function will evaluate.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with cancer 6 weeks after chemotherapy

Exclusion Criteria:

  • patients with neurological or psychiatric disorders
  • patients without compliance
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01013233

Contacts
Contact: Susanne Effenberger, MSc +49-30-8445-2410 susanne.effenberger@charite.de
Contact: Fernando Dimeo, MD +49-30-8445-4834 fernando.dimeo@charite.de

Locations
Germany
Charite Universitätsmedizin Berlin Not yet recruiting
Berlin, Germany, 12200
Contact: Susanne Effenberger, MSc    +49-30-8445-2410    susanne.effenberger@charite.de   
Principal Investigator: susanne Effenberger, MSc         
Sponsors and Collaborators
Charite University, Berlin, Germany
Freie Universität Berlin
Investigators
Principal Investigator: Michael Niedeggen, PhD Freie Universität Berlin
  More Information

No publications provided

Responsible Party: Fernando Dimeo, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01013233     History of Changes
Other Study ID Numbers: KTST09
Study First Received: November 12, 2009
Last Updated: November 12, 2009
Health Authority: Germany: Ethics Commission

Keywords provided by Charite University, Berlin, Germany:
cognitive dysfunction chemotherapy

Additional relevant MeSH terms:
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on November 25, 2014