NCT01013233

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 12, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 13, 2009

Completed
18 days until next milestone

Study Start

First participant enrolled

December 1, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

November 13, 2009

Status Verified

November 1, 2009

Enrollment Period

1.8 years

First QC Date

November 12, 2009

Last Update Submit

November 12, 2009

Conditions

Keywords

cognitive dysfunction chemotherapy

Outcome Measures

Primary Outcomes (1)

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

    one weeks following the end of the cognitive training

Secondary Outcomes (1)

  • quality of life and subjective perception of cognitive problems

    7 weeks

Study Arms (2)

training

EXPERIMENTAL

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

Behavioral: cognitive training

control

PLACEBO COMPARATOR

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

Other: control group

Interventions

cognitive training over 6 weeks, consist of 6 meetings (a 45minutes), three sessions focus on concentration tasks and three sessions on memory problems.

Also known as: training group
training

no intervention

Also known as: controll group
control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with cancer 6 weeks after chemotherapy

You may not qualify if:

  • patients with neurological or psychiatric disorders
  • patients without compliance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charite Universitätsmedizin Berlin

Berlin, State of Berlin, 12200, Germany

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Cognitive TrainingSensitivity Training GroupsControl Groups

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Neurological RehabilitationRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesPsychotherapy, GroupSocioenvironmental TherapyPsychotherapyBehavioral Disciplines and ActivitiesEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Michael Niedeggen, PhD

    Freie Universität Berlin

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 12, 2009

First Posted

November 13, 2009

Study Start

December 1, 2009

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

November 13, 2009

Record last verified: 2009-11

Locations