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Cognitive Training to Improve Cognitive Function Following Chemotherapy (KT)

Primary Purpose

Cognitive Dysfunction

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
cognitive training
control group
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cognitive Dysfunction focused on measuring cognitive dysfunction chemotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients with cancer 6 weeks after chemotherapy

Exclusion Criteria:

  • patients with neurological or psychiatric disorders
  • patients without compliance

Sites / Locations

  • Charite Universitätsmedizin Berlin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

training

control

Arm Description

Patients in this group start the cognitive training over 6 weeks directly after randomization.

In this control group begin the training in a cross-over design 7 weeks after randomization.

Outcomes

Primary Outcome Measures

several cognitive tests (TAP, VLMT, TMT, Stroop, RWT, D2, LGT-3)

Secondary Outcome Measures

quality of life and subjective perception of cognitive problems

Full Information

First Posted
November 12, 2009
Last Updated
November 12, 2009
Sponsor
Charite University, Berlin, Germany
Collaborators
Freie Universität Berlin
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1. Study Identification

Unique Protocol Identification Number
NCT01013233
Brief Title
Cognitive Training to Improve Cognitive Function Following Chemotherapy
Acronym
KT
Official Title
Training of Cognitive Function of Patients After Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Unknown status
Study Start Date
December 2009 (undefined)
Primary Completion Date
October 2011 (Anticipated)
Study Completion Date
October 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Charite University, Berlin, Germany
Collaborators
Freie Universität Berlin

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
Patients following chemotherapy invited for a cognitive training. Before and after cognitive function will evaluate.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Dysfunction
Keywords
cognitive dysfunction chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
training
Arm Type
Experimental
Arm Description
Patients in this group start the cognitive training over 6 weeks directly after randomization.
Arm Title
control
Arm Type
Placebo Comparator
Arm Description
In this control group begin the training in a cross-over design 7 weeks after randomization.
Intervention Type
Behavioral
Intervention Name(s)
cognitive training
Other Intervention Name(s)
training group
Intervention Description
cognitive training over 6 weeks, consist of 6 meetings (a 45minutes), three sessions focus on concentration tasks and three sessions on memory problems.
Intervention Type
Other
Intervention Name(s)
control group
Other Intervention Name(s)
controll group
Intervention Description
no intervention
Primary Outcome Measure Information:
Title
several cognitive tests (TAP, VLMT, TMT, Stroop, RWT, D2, LGT-3)
Time Frame
one weeks following the end of the cognitive training
Secondary Outcome Measure Information:
Title
quality of life and subjective perception of cognitive problems
Time Frame
7 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients with cancer 6 weeks after chemotherapy Exclusion Criteria: patients with neurological or psychiatric disorders patients without compliance
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Susanne Effenberger, MSc
Phone
+49-30-8445-2410
Email
susanne.effenberger@charite.de
First Name & Middle Initial & Last Name or Official Title & Degree
Fernando Dimeo, MD
Phone
+49-30-8445-4834
Email
fernando.dimeo@charite.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Niedeggen, PhD
Organizational Affiliation
Freie Universität Berlin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charite Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
12200
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susanne Effenberger, MSc
Phone
+49-30-8445-2410
Email
susanne.effenberger@charite.de
First Name & Middle Initial & Last Name & Degree
susanne Effenberger, MSc

12. IPD Sharing Statement

Learn more about this trial

Cognitive Training to Improve Cognitive Function Following Chemotherapy

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