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

193 Participants Needed

Trial Summary

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 data supports the idea that Brain Training for Breast Cancer Survivors is an effective treatment?

The available research shows that Brain Training for Breast Cancer Survivors, specifically speed of processing training, is effective. It improved processing speed and memory in breast cancer survivors both immediately after the training and two months later. Participants also reported better cognitive functioning, less distress from symptoms like mood disturbance and anxiety, and an improved quality of life. Satisfaction with the treatment was high, suggesting it is a promising option for managing cognitive changes in breast cancer survivors. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Strategic Memory Advanced Reasoning Training (SMART) for breast cancer survivors?

Research shows that cognitive training, like speed of processing and memory training, can improve thinking skills in breast cancer survivors. These types of training have been found to enhance memory and processing speed, reduce distress, and improve quality of life, suggesting that similar treatments like SMART may also be beneficial. ^{1 2 3 4 5}

What safety data exists for the SMART treatment for breast cancer survivors?

The provided research does not directly address the safety data for the SMART treatment or similar cognitive training interventions for breast cancer survivors. The studies focus on cognitive impairments in breast cancer survivors and potential interventions, but do not provide specific safety data for the SMART treatment. ^{1 2 5 6 7}

Is the treatment SMART a promising treatment for breast cancer survivors?

Yes, SMART is a promising treatment for breast cancer survivors because cognitive training can improve skills like memory, attention, and planning, which are often affected after cancer treatment. ^{1 3 8 9 10}

How is the SMART treatment different from other treatments for cognitive issues in breast cancer survivors?

The SMART treatment is unique because it focuses on enhancing strategic memory and advanced reasoning skills, which are specific cognitive functions, rather than general cognitive training or speed of processing. This targeted approach may offer more tailored benefits for breast cancer survivors experiencing cognitive decline. ^{1 3 8 9 10}

What is the purpose of this trial?

This study will investigate the benefits of distinct brain health trainings in breast cancer survivors (age 30-80) with cognitive concerns post-chemotherapy. This study can be completed from the comfort of participant's own home.

Research Team

Sandra B Chapman, PhD

Principal Investigator

Center for BrainHealth

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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 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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

A video-game based cognitive training for breast cancer survivors with cognitive impairment: A prospective randomized pilot trial. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Cognitive function in breast cancer survivors compared to healthy age- and education-matched women. [2021]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Speed of processing training in middle-aged and older breast cancer survivors (SOAR): results of a randomized controlled pilot. [2019]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Advanced cognitive training for breast cancer survivors: a randomized controlled trial. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

What do perceived cognitive problems reflect? [2021]

6. United States pubmed.ncbi.nlm.nih.gov

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

7. Netherlands pubmed.ncbi.nlm.nih.gov

A pilot study of prospective memory functioning in early breast cancer survivors. [2013]

8. United States pubmed.ncbi.nlm.nih.gov

Cognitive training for improving executive function in chemotherapy-treated breast cancer survivors. [2022]

9. Germany pubmed.ncbi.nlm.nih.gov

Randomized double-masked controlled trial of cognitive training in breast cancer survivors: a preliminary study. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Individualized Piano Instruction for Improving Cognition in Breast Cancer Survivors. [2020]