Memory Training for Breast Cancer Survivors

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Neurological disorders, Bipolar, Schizophrenia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 5 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a memory training program for breast cancer survivors who have experienced memory problems after chemotherapy. The study assesses whether these individuals can improve memory and attention using one of two software versions: the Cogmed Working Memory Training Program or a less challenging comparison version. Participants will be randomly assigned to one of these versions. Women who have survived Stage I-III breast cancer, completed chemotherapy in the past 1-10 years, and have noticeable memory issues might be a good fit for this trial. As an unphased trial, this study offers participants the opportunity to contribute to research that could enhance cognitive recovery for future breast cancer survivors.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this memory training program is safe for breast cancer survivors?

Studies have shown that the Cogmed Working Memory Training Program is generally safe. This program has been used in various settings without major safety issues. It is software designed to improve memory and attention.

Research on similar programs has demonstrated effectiveness for individuals with cognitive issues following cancer treatment. These programs have been safely used with both children and adults, including those recovering from cancer and stroke.

The Cogmed program has not been linked to harmful side effects. Users typically do not experience negative effects, suggesting it is well-tolerated, even as it is specifically tested for breast cancer survivors in this study. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Cogmed Working Memory Training Program because it offers a non-drug approach to address cognitive difficulties experienced by breast cancer survivors. Unlike traditional treatments that may involve medication to manage symptoms, this program focuses on enhancing cognitive function through targeted exercises designed to improve working memory. This method provides a promising alternative for those looking to avoid medication-related side effects, offering potential improvements in memory and cognition without pharmaceutical intervention.

What evidence suggests that this memory training program could be effective for breast cancer survivors?

Studies have shown that the Cogmed Working Memory Training Program can improve memory in cancer patients, including those recovering from chemotherapy. For example, a 5-week program helped young cancer survivors enhance their memory. Research also shows that similar training has led to better memory and verbal learning in cancer patients. Although it hasn't been tested specifically on breast cancer survivors, these findings suggest it might help with memory issues after chemotherapy. This trial will evaluate the effectiveness of the Cogmed Working Memory Training Program specifically for breast cancer survivors. Early results from other studies indicate that cognitive training can effectively improve memory in breast cancer patients. ^{1 2 6 7 8}

Who Is on the Research Team?

Elizabeth Ryan, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for female breast cancer survivors aged 18-69 who've had chemotherapy 1-10 years ago and are currently disease-free. They must speak English, have basic computer skills, internet access, and show memory problems on specific tests. Excluded are those with significant past brain injury or cognitive issues from other conditions.

Inclusion Criteria

You need to show that your memory and thinking skills are below a certain level compared to others, based on specific tests and assessments.

Must be able speak, read and write English well enough to complete written and verbal assessments and neurocognitive tests

I have a family member or friend who sees me at least once a week.

Exclusion Criteria

I have a neurological disorder like Alzheimer's, Parkinson's, MS, or epilepsy.

I have had a traumatic brain injury with significant loss of consciousness or lasting effects.

My cancer has come back.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 5-week memory training program using one of two software versions to improve memory and attention problems

5 weeks

Follow-up

Participants complete two follow-up neurocognitive assessments to test for maintenance of treatment effect

4 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Cogmed Working Memory Training Program

Trial Overview The study evaluates a memory training program called Cogmed Working Memory Training to see if it improves memory and attention in breast cancer survivors post-chemotherapy. Participants will use either the standard software or a less challenging version randomly assigned.

How Is the Trial Designed?

Group I: Collateral source Experimental Treatment 1 Intervention

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.

Group II: Breast cancer survivors Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

MARTELL FOUNDATION

Collaborator

Trials

1

Recruited

60+

Published Research Related to This Trial

In a study involving 82 breast cancer survivors, both memory training and speed of processing training showed significant improvements in cognitive function, with speed of processing training leading to immediate and lasting enhancements in processing speed and verbal memory.

Participants reported high satisfaction and acceptability for both interventions, indicating that these cognitive training programs could be beneficial and well-received by breast cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advanced cognitive training for breast cancer survivors: a randomized controlled trial. Von Ah, D., Carpenter, JS., Saykin, A., et al.[2022]

Cognitive training was found to be acceptable and satisfactory for breast cancer survivors, with 36 participants reporting improvements in perceived cognitive function and health outcomes after the intervention.

While the study showed small effect sizes for cognitive abilities, there were notable improvements in work ability and health perception, suggesting potential real-world benefits that warrant further investigation in larger trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized double-masked controlled trial of cognitive training in breast cancer survivors: a preliminary study. Von Ah, D., McDonald, BC., Crouch, AD., et al.[2023]

A pilot study involving 29 breast cancer survivors, averaging 8 years post-chemotherapy, showed that a cognitive-behavioral treatment called Memory and Attention Adaptation Training (MAAT) led to significant improvements in self-reported cognitive function and quality of life.

Participants reported high satisfaction with MAAT, indicating it is a feasible and practical approach to help manage cognitive dysfunction related to chemotherapy, suggesting further evaluation is warranted.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral management of chemotherapy-related cognitive change. Ferguson, RJ., Ahles, TA., Saykin, AJ., et al.[2022]

A web-based cognitive training video game, used alongside standard rehabilitation care, significantly improved self-reported cognitive failures in breast cancer patients, with a notable improvement in the intervention group compared to the control group.

Overall cognitive functioning, as measured by various neuropsychological tests, showed significant enhancements over time, particularly in areas like reaction time and visual memory, indicating that cognitive training can be beneficial for cognitive decline in breast cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A video-game based cognitive training for breast cancer survivors with cognitive impairment: A prospective randomized pilot trial. Bellens, A., Roelant, E., Sabbe, B., et al.[2023]

The study found that web-based working memory training (Cogmed QM) is feasible during inpatient cancer rehabilitation, with 89.6% of eligible patients starting the training and 89.6% adhering to it during their hospital stay.

While participants showed significant improvements in working memory tasks, adherence to the home-based training after discharge was lower (65.5%), indicating that barriers such as time constraints and lack of motivation need to be addressed in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Feasibility of Web-Based Working Memory Training in Patients With Cancer Attending Inpatient Rehabilitation. Engan, H., Skanke, F., Dahl, V., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT01182506?cond=breast+cancer&aggFilters=status%3A

Rehabilitation of Cognitive Changes in Breast Cancer ... The purpose of this study is to test a memory training program for breast cancer survivors who have problems with memory after receiving ...

2. clinicaltrial.be clinicaltrial.be/en/details/13137?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Rehabilitation of Cognitive Changes in Breast Cancer Surv... Studies have shown that a 5-week software training program improved memory in pediatric cancer survivors and other disorders like stroke, but ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10331070/

The Feasibility of Web-Based Working Memory Training in ... The training has demonstrated positive results in cancer patients in objective cognitive functioning, especially in the domains memory and verbal learning and ...

4. withpower.com withpower.com/trial/phase-breast-neoplasms-7-2010-39a29

Memory Training for Breast Cancer Survivors · Info for Participants The purpose of this study is to test a memory training program for breast cancer survivors who have problems with memory after receiving chemotherapy.

5. nature.com nature.com/articles/s41523-024-00694-8

Computerized cognitive training improves ... Our results show that cognitive training in breast cancer patients is both feasible and may be effective already 7 months after primary ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11443049/

Computerized cognitive training improves ... Our results show that web-based cognitive training may be efficient to ameliorate cancer-related cognitive impairment during the immediate post- ...

7. clinicaltrials.gov clinicaltrials.gov/show/NCT02662335

NCT02662335 | Computerized Cognitive Retraining in ... This randomized clinical trial studies computerized cognitive retraining in improving cognitive function in breast cancer survivors.

8. digital.lib.washington.edu digital.lib.washington.edu/researchworks/bitstreams/a13374d3-6d56-4141-9078-d893b70c2821/download

i Feasibility and Acceptability of a Computerized Working ... A Computerized Working Memory Training Program for Breast Cancer Survivors: Study Design and. Protocol. 1. Introduction. Advances in breast cancer diagnosis ...