Brain Training for Breast Cancer Survivors

Overseen By Erin E Venza, MS

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: The University of Texas at Dallas

Disqualifiers: Males, Neurodegenerative, Psychotic, Stroke, others

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

Compensation: Varies

Number of Visits: 6

Duration: 3 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how different types of online brain training, including Strategic Memory Advanced Reasoning Training (SMART), can assist breast cancer survivors who have noticed changes in their thinking after chemotherapy. Participants will engage in one of three types of brain training to determine if it improves memory and reasoning skills. Conducted entirely online, the trial allows participation from home. It suits women who survived Stage I-III breast cancer, completed chemotherapy 6 months to 5 years ago, and have noticed changes in their thinking since treatment. As an unphased trial, it offers a unique opportunity to contribute to innovative research from the comfort of home.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these brain health trainings are safe for breast cancer survivors?

Research shows that Strategic Memory Advanced Reasoning Training (SMART) is being studied to help breast cancer survivors with thinking and memory problems. So far, studies have not identified any serious safety concerns with this type of brain training. One investigation found no major issues with memory or reasoning training for participants. Another study on online cognitive training for breast cancer survivors also reported no significant safety issues.

While the safety information is limited, the absence of reported harmful effects is encouraging. Additionally, the current trial phase is "Not Applicable," indicating an early testing stage focused more on exploring benefits than safety concerns. Overall, the available data suggests that SMART is well-tolerated by participants, with no serious adverse events reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the brain training techniques being explored for breast cancer survivors because these methods offer a new way to support cognitive health post-treatment. Unlike traditional approaches that may involve medication to manage cognitive difficulties, these brain training programs use online platforms to enhance strategic memory and advanced reasoning skills. This innovative, non-invasive approach could provide survivors with a practical and accessible way to improve brain function, potentially leading to better quality of life and daily functioning without the side effects associated with medication.

What evidence suggests that this trial's brain training treatments could be effective for breast cancer survivors with cognitive concerns?

Research has shown that Strategic Memory Advanced Reasoning Training (SMART) can improve thinking skills in breast cancer survivors. One study found that this brain training enhanced working memory in women with breast cancer, even without specific training for it. Another study discovered that this training could reduce cancer-related cognitive impairment, often described as mental fogginess, in patients. This trial will compare different types of online brain-health-oriented training, including SMART, to assess their effectiveness. These findings suggest that SMART could assist breast cancer survivors with memory and thinking skills after chemotherapy. ^{1 4 6 7 8}

Who Is on the Research Team?

Sandra B Chapman, PhD

Principal Investigator

Center for BrainHealth

Are You a Good Fit for This Trial?

This study is for female breast cancer survivors aged 30-80 who have completed chemotherapy between 6 months and 5 years ago, are fluent in English, and feel their thinking has changed since treatment. Participants need internet access and a device to join the online training but can't join if they've had brain injuries post-chemotherapy, substance abuse issues, certain neurological or psychotic disorders, recent cognitive training, or severe hearing/vision problems.

Inclusion Criteria

I am a female breast cancer survivor aged between 30 and 80.

I am a female breast cancer survivor who received chemotherapy.

I am a female breast cancer survivor and I consider myself fluent in English.

Exclusion Criteria

You have a vision or hearing problem that would make it hard for you to read or listen to training material.

I am male.

My breast cancer has come back or I have been diagnosed with another type.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized into one of three online training programs to support cognitive function for 3 months

3 months

Online assessments at Month 0 and Month 3

Follow-up

Participants are monitored for maintained cognitive gains after ending training

3 months

Online assessment at Month 6

What Are the Treatments Tested in This Trial?

Interventions

• Strategic Memory Advanced Reasoning Training (SMART)

Trial Overview The trial explores three different online brain health trainings (A, B, C) designed to help improve cognitive function in breast cancer survivors experiencing 'brain fog' after chemotherapy. The effectiveness of each method will be compared to see which one offers the most benefit.

How Is the Trial Designed?

Group I: Brain Training A Experimental Treatment 1 Intervention

This group will access one type of online brain-health oriented training.

Group II: Brain Training B Active Control 1 Intervention

This group will access a distinct type of online brain-health oriented training.

Group III: Brain Training C Active Control 1 Intervention

This group will access a distinct type of online brain-health oriented training.

Who Is Running the Clinical Trial?

The University of Texas at Dallas

Lead Sponsor

Trials

71

Recruited

108,000+

Published Research Related to This Trial

Breast cancer survivors (n = 52) reported higher levels of subjective memory loss and performed significantly worse on cognitive tests compared to matched healthy controls (n = 52).

Approximately 17% of breast cancer survivors showed clinically significant cognitive impairment in total learning and delayed recall, indicating that cognitive issues are a common concern in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive function in breast cancer survivors compared to healthy age- and education-matched women. Von Ah, D., Harvison, KW., Monahan, PO., et al.[2021]

An eight-week individualized piano instruction program for six breast cancer survivors showed significant improvements in overall cognition, particularly in fluid cognition, suggesting a potential therapeutic benefit.

Participants also reported enhanced quality of life and reductions in depression and anxiety, indicating that IPI could be a valuable addition to survivorship care plans for addressing cognitive impairments related to chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individualized Piano Instruction for Improving Cognition in Breast Cancer Survivors. Rodriguez-Wolfe, M., Anglade, D., Gattamorta, KA., et al.[2020]

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]

A randomized controlled trial involving 41 breast cancer survivors showed that a 12-week online executive function (EF) training program significantly improved cognitive flexibility, verbal fluency, and processing speed.

Participants reported enhanced self-ratings of EF skills, indicating that the training may positively impact real-world cognitive abilities, even years after cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive training for improving executive function in chemotherapy-treated breast cancer survivors. Kesler, S., Hadi Hosseini, SM., Heckler, C., 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]

Women with early-stage breast cancer often report cognitive issues during and after hormonal therapy, highlighting the need for healthcare providers to take these complaints seriously.

The study suggests that patients' perceptions of cognitive problems are linked to actual cognitive impairments, particularly in learning and memory, indicating that further assessment and intervention may be necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What do perceived cognitive problems reflect? Bender, CM., Pacella, ML., Sereika, SM., et al.[2021]

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]

Early breast cancer survivors showed significant deficits in prospective memory compared to healthy controls, with a higher rate of impairment (odds ratio = 5.5).

Fatigue was identified as a major factor contributing to these memory deficits, suggesting a potential link between fatigue symptoms and memory disturbances in breast cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study of prospective memory functioning in early breast cancer survivors. Paquet, L., Collins, B., Song, X., et al.[2013]

A pilot study involving 60 breast cancer survivors showed that home-based speed of processing (SOP) training significantly improved cognitive functions, particularly in speed of processing and executive function, over a 6-month period.

The study had a high retention rate of 96% and included a diverse group of participants, with over half being African American women, highlighting its relevance and potential impact on this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Speed of processing training in middle-aged and older breast cancer survivors (SOAR): results of a randomized controlled pilot. Meneses, K., Benz, R., Bail, JR., et al.[2019]

Adjuvant chemotherapy for breast cancer may lead to cognitive deficits that can significantly affect patients' quality of life, with ongoing studies aiming to better quantify these effects and identify susceptible subgroups.

There is a growing interest in understanding the cognitive impact of estrogen deprivation from aromatase inhibitors and exploring supportive measures to mitigate cognitive effects associated with chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of adjuvant therapy for breast cancer on cognitive function: current evidence and directions for research. Rugo, HS., Ahles, T.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3677054/

Advanced cognitive training for breast cancer survivors The purpose of this study was to evaluate the preliminary efficacy and satisfaction/acceptability of training in memory or speed of processing versus wait-list ...

2. bmjopen.bmj.com bmjopen.bmj.com/content/15/7/e104378

Enhancing cognitive function in breast cancer survivors ... The programme is progressive in nature and designed to help participants achieve aerobic exercise levels consistent with guidelines for cancer survivors.

3. mdpi.com mdpi.com/2077-0383/14/14/5047

A Cognitive Training Programme on Cancer-Related ... Expected results: Findings may guide future interventions and tailored protocols to alleviate CRCI in breast cancer patients undergoing active treatment. Ethics ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/pon.6232

Benefits of adaptive cognitive training on cognitive abilities ... Our study is the first to show transfer benefits of the intervention on WMC to untrained tasks in women with a primary breast cancer diagnosis.

5. researchgate.net researchgate.net/publication/394538033_Effect_of_exercise_interventions_on_cognitive_function_in_breast_cancer_patients_and_survivors_a_systematic_review_with_meta-analysis

(PDF) Effect of exercise interventions on cognitive function ... This systematic review and meta-analysis evaluated the impact of exercise programs on cognitive function in breast cancer survivors. Methods ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12258359/

Enhancing cognitive function in breast cancer survivors ... Emerging evidence suggests aerobic exercise may enhance cognition after breast cancer diagnosis and treatment; yet, CACD remains an understudied ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05896189?utm_source=trialradar

NCT05896189 | Cognitive Training for Cancer Related ... This Phase III trial will examine the efficacy of computerized cognitive training methods on perceived cognitive impairment in breast cancer survivors. Detailed ...

8. tandfonline.com tandfonline.com/doi/full/10.2147/NRR.S312214

Full article: Can Breast Cancer Survivors Benefit from ... Employing the same statistical approach, these beneficial outcomes were not observed for the memory training or the reasoning training groups.