Breast CancerNCT01182506
Rehabilitation of Cognitive Changes in Breast Cancer Survivors
A study testing Cogmed Working Memory Training Program in people with Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to test a memory training program for breast cancer survivors who have problems with memory after receiving chemotherapy. Since breast cancer survivors have been reported to have trouble with their memory, a program to help these problems is important. Read more about this study
- Who is it for?
- Ages 18 to 69 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Cogmed Working Memory Training Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 69 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients
- Female breast cancer survivors who have received adjuvant chemotherapy 1-10 years from the time of recruitment either at MSKCC or elsewhere
- Stage I, II, III breast cancer as noted in pathology reports or by clinician judgement.
- No evidence of disease at time of screening
- Age range 18 years old through <70 years old
- Must be able speak, read and write English well enough to complete written and verbal assessments and neurocognitive tests. The software was developed and validated in English and are not currently available in other languages. Translation of questionnaires into other languages would require reestablishing the reliability and validity of these measures.
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- Must demonstrate cognitive deficiency, which is defined as 1.0 standard deviations below normative data on at least one of the pre-screen phone assessments (WAIS-III Digit Span, Symbol Digit Modalities Test, Controlled Oral Word Association Test, Rey Auditory Verbal Learning Test) or must have 1.0 standard deviations difference from the pre-morbid estimate of cognitive functioning, Wide Range Achievement Test 4: Reading subtest, and one of the pre-screen phone assessment measures.
- Must have basic computer skills such as able to turn on a computer, open the program, login, and use a mouse.
- Participants must have the ability to upload their data via the internet. A study laptop can be loaned out to participants who do not have a computer or the appropriate operating systems.
- Collateral Participant (if such person is available to the participant, not a requirement of the study) Family member or friend (i.e., collateral) identified by a patient who has at least weekly face to face contact with the patient
- Collateral person is at least 18 years of age
- Family member or friend has adequate English fluency for completion of data collection. The surveys were designed and validated in English and are not currently available in other languages. Translation of questionnaires into other languages would require reestablishing the reliability and validity of these measures.
- Able to provide informed consent
Who cannot join
- Patients
- History of neurological disorder with cognitive symptoms (e.g., Alzheimer's disease, Parkinson's disease, multiple sclerosis, seizure disorder) as per self report or as documented in the electronic medical record.
- History of mental retardation, learning disorder bipolar disorder, schizophrenia, substance use disorder(s), or uncontrolled depression as per self report or as documented in the medical record.
- History of Traumatic Brain Injury with > or = to 30 minutes loss of consciousness or cognitive sequelae as per self report or as documented in the medical record.
- History of Stroke as per self report or as documented in the medical record.
- Prior history or secondary diagnosis of other cancers except for basal cell carcinoma or melanoma treated with surgery only
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- History of multiple courses of chemotherapy.
- Evidence of recurrence at time of screening
- A hearing or visual deficit that impairs the ability to use the software.
- Significant cognitive or psychiatric disturbance sufficient, in the investigator's judgment, to preclude providing informed consent.
- Males will be excluded as only a minority of men gets breast cancer. Thus, there would not be enough men to have equivalent groups to statistically control for possible gender effects.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10021
About this study
The purpose of this study is to test a memory training program for breast cancer survivors who have problems with memory after receiving chemotherapy. Since breast cancer survivors have been reported to have trouble with their memory, a program to help these problems is important. Studies have shown that a 5-week software training program improved memory in pediatric cancer survivors and other disorders like stroke, but it has not been tested for breast cancer survivors. This study will see if breast cancer survivors can improve their memory and attention problems by using either one of two software versions of the program. One version is called Cogmed Working Memory Training, and the other is a comparison version of the software that has the same exercises but is less difficult. People who decide to participate in the study will be randomly given one of the two versions.
- Conditions
- Breast Cancer
- Being tested
- Cogmed Working Memory Training Program
- Keywords
- Cogmed Working Memory Training (CWMT), cognitive, 10-105, Breast cancer survivor
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cogmed Working Memory Training ProgramBehavioural
Women will be randomized to one of two 5-week rehabilitation software training programs that train working memory called Cogmed Working Memory Training Program.
The training software will be provided to each participant. For each group, training occurs for 30 minutes a day, 5 days a week for 5 weeks. As part of the set-up, training data is uploaded to the internet at a minimum of every 3 days. This function allows the "coach" (in this case, the PI and RSA) to review the training. A weekly "coach" phone call is made to review the training results, answer questions, troubleshoot, and motivate the participant. Participants can load the software onto multiple computers to provide flexibility for them to do training at home, after work, when they are away from home.
| Study group | Role | What they receive |
|---|---|---|
| Breast cancer survivors | Experimental | Participants from both groups will be asked to complete two follow up neurocognitive assessments face to face at MSKCC. The first will be completed within 1-4 weeks after completing the memory training and the second will take place 3-4 months after completing the memory training. Collateral sources will be contacted at these same points to complete their brief assessments as well to test for maintenance of the treatment effect. Receives: Behavioral: Cogmed Working Memory Training Program |
| Collateral source | Experimental | Participants from both groups will be asked to complete two follow up neurocognitive assessments face to face at MSKCC. The first will be completed within 1-4 weeks after completing the memory training and the second will take place 3-4 months after completing the memory training. Collateral sources will be contacted at these same points to complete their brief assessments as well to test for maintenance of the treatment effect. Receives: Behavioral: Cogmed Working Memory Training Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the efficacy of working memory training
in breast cancer survivors based on improved performance on neuropsychological tests of working memory.
Measured: 2 years
Secondary outcomes (2)
Test whether or not working memory training in breast cancer survivors is associated with greater gains in the software's "Improvement Index".
Measured: 2 years
Investigate whether breast cancer survivors perceive functional improvement following working memory training.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- MARTELL FOUNDATION
- Responsible party
- Sponsor
- Investigators
- Elizabeth Ryan, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01182506
- Sponsor's protocol ID
- 10-105
- Status last verified
- Sep 2026
- First submitted
- 12 Aug 2010
- Last updated
- 9 Sep 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation of Cognitive Changes in Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT01182506
- Acronym / sponsor ID
- 10-105
- Conditions
- Breast Cancer
- Keywords
- Cogmed Working Memory Training (CWMT), cognitive, 10-105, Breast cancer survivor
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- MARTELL FOUNDATION
- Study start
- Aug 2010
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 16 Aug 2010 (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 test a memory training program for breast cancer survivors who have problems with memory after receiving chemotherapy. Since breast cancer survivors have been reported to have trouble with their memory, a program to help these problems is important. Studies have shown that a 5-week software training program improved memory in pediatric cancer survivors and other disorders like stroke, but it has not been tested for breast cancer survivors. This study will see if breast cancer survivors can improve their memory and attention problems by using either one of two software versions of the program. One version is called Cogmed Working Memory Training, and the other is a comparison version of the software that has the same exercises but is less difficult. People who decide to participate in the study will be randomly given one of the two versions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breast cancer survivors | Experimental | Behavioral: Cogmed Working Memory Training ProgramParticipants from both groups will be asked to complete two follow up neurocognitive assessments face to face at MSKCC. The first will be completed within 1-4 weeks after completing the memory training and the second will take place 3-4 months after completing the memory training. Collateral sources will be contacted at these same points to complete their brief assessments as well to test for maintenance of the treatment effect. |
| Collateral source | Experimental | Behavioral: Cogmed Working Memory Training ProgramParticipants from both groups will be asked to complete two follow up neurocognitive assessments face to face at MSKCC. The first will be completed within 1-4 weeks after completing the memory training and the second will take place 3-4 months after completing the memory training. Collateral sources will be contacted at these same points to complete their brief assessments as well to test for maintenance of the treatment effect. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patients
- Female breast cancer survivors who have received adjuvant chemotherapy 1-10 years from the time of recruitment either at MSKCC or elsewhere
- Stage I, II, III breast cancer as noted in pathology reports or by clinician judgement.
- No evidence of disease at time of screening
- Age range 18 years old through <70 years old
Key exclusion criteria (11 listed)
- Patients
- History of neurological disorder with cognitive symptoms (e.g., Alzheimer's disease, Parkinson's disease, multiple sclerosis, seizure disorder) as per self report or as documented in the electronic medical record.
- History of mental retardation, learning disorder bipolar disorder, schizophrenia, substance use disorder(s), or uncontrolled depression as per self report or as documented in the medical record.
- History of Traumatic Brain Injury with > or = to 30 minutes loss of consciousness or cognitive sequelae as per self report or as documented in the medical record.
- History of Stroke as per self report or as documented in the medical record.
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 |
|---|---|---|
| Cogmed Working Memory Training ProgramWomen will be randomized to one of two 5-week rehabilitation software training programs that train working memory called Cogmed Working Memory Training Program. The training software will be provided to each participant. For each group, training occurs for 30 minutes a day, 5 days a week for 5 weeks. As part of the set-up, training data is uploaded to the internet at a minimum of every 3 days. This function allows the "coach" (in this case, the PI and RSA) to review the training. A weekly "coach" phone call is made to review the training results, answer questions, troubleshoot, and motivate the participant. Participants can load the software onto multiple computers to provide flexibility for them to do training at home, after work, when they are away from home. | Behavioural | Breast cancer survivors, Collateral source |
Primary outcome
Determine the efficacy of working memory training
Time frame: 2 years
in breast cancer survivors based on improved performance on neuropsychological tests of working memory.
2 secondary outcomes
Test whether or not working memory training in breast cancer survivors is associated with greater gains in the software's "Improvement Index".
Time frame: 2 years
Investigate whether breast cancer survivors perceive functional improvement following working memory training.
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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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.
Elizabeth Ryan, PhD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cogmed Working Memory Training Program in people with Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
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 13 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 9 Sep 2026. 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 United States. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the efficacy of working memory training (time frame: 2 years). 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 9 Sep 2026.