Cognitive DysfunctionKTNCT01013233
Cognitive Training to Improve Cognitive Function Following Chemotherapy
A study testing cognitive training in people with Cognitive Dysfunction, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cognitive Dysfunction
- What is being tested?
- cognitive training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2009to Oct 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with cancer 6 weeks after chemotherapy
Who cannot join
- patients with neurological or psychiatric disorders
- patients without compliance
Trial locations and contacts
1 site in 1 country.
Germany1 site
Charite Universitätsmedizin Berlin
Berlin, State of Berlin, 12200
Susanne Effenberger, MSc, +49-30-8445-2410, susanne.effenberger@charite.de
susanne Effenberger, MSc
About this study
Official title: 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.
Read the detailed description
Patients following chemotherapy invited for a cognitive training. Before and after cognitive function will evaluate.
- Conditions
- Cognitive Dysfunction
- Being tested
- cognitive training, control group
- Keywords
- cognitive dysfunction chemotherapy
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive trainingBehavioural
Also called training group
cognitive training over 6 weeks, consist of 6 meetings (a 45minutes), three sessions focus on concentration tasks and three sessions on memory problems.
control groupOther
Also called controll group
no intervention
| Study group | Role | What they receive |
|---|---|---|
| training | Experimental | Patients in this group start the cognitive training over 6 weeks directly after randomization. Receives: Behavioral: cognitive training |
| control | Placebo comparator | In this control group begin the training in a cross-over design 7 weeks after randomization. Receives: Other: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
several cognitive tests (TAP, VLMT, TMT, Stroop, RWT, D2, LGT-3)
Measured: one weeks following the end of the cognitive training
Secondary outcomes (1)
quality of life and subjective perception of cognitive problems
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2009 (estimated)
- Study startDec 2009
- Primary completionOct 2011 (estimated)
- Study completionOct 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DysfunctionStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Freie Universität Berlin
- Investigators
- Michael Niedeggen, PhD, Principal investigator, Freie Universität Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01013233
- Sponsor's protocol ID
- KTST09
- Acronym
- KT
- Status last verified
- Nov 2009
- First submitted
- 12 Nov 2009
- Last updated
- 13 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Training of Cognitive Function of Patients After Chemotherapy
- ClinicalTrials.gov ID
- NCT01013233
- Acronym / sponsor ID
- KT / KTST09
- Conditions
- Cognitive Dysfunction
- Keywords
- cognitive dysfunction chemotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Freie Universität Berlin
- Study start
- Dec 2009
- Primary completion
- Oct 2011 (estimated)
- Study completion
- Oct 2011 (estimated)
- First posted
- 13 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| training | Experimental | Behavioral: cognitive trainingPatients in this group start the cognitive training over 6 weeks directly after randomization. |
| control | Placebo comparator | Other: control groupIn this control group begin the training in a cross-over design 7 weeks after randomization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with cancer 6 weeks after chemotherapy
Key exclusion criteria (2 listed)
- patients with neurological or psychiatric disorders
- patients without compliance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cognitive trainingAlso: training groupcognitive training over 6 weeks, consist of 6 meetings (a 45minutes), three sessions focus on concentration tasks and three sessions on memory problems. | Behavioural | training |
| control groupAlso: controll groupno intervention | Other | control |
Primary outcome
several cognitive tests (TAP, VLMT, TMT, Stroop, RWT, D2, LGT-3)
Time frame: one weeks following the end of the cognitive training
1 secondary outcome
quality of life and subjective perception of cognitive problems
Time frame: 7 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Niedeggen, PhD principal investigator
Freie Universität Berlin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cognitive training in people with Cognitive Dysfunction, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Susanne Effenberger, MSc (+49-30-8445-2410, susanne.effenberger@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
several cognitive tests (TAP, VLMT, TMT, Stroop, RWT, D2, LGT-3) (time frame: one weeks following the end of the cognitive training). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2009.