Cognitive Training for Breast Cancer Survivors

Recruiting at 681 trial locations

Overseen By Shahzad Siddique

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NRG Oncology

Disqualifiers: Metastatic disease, Other cancer, CNS radiation, Stroke, Substance abuse, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

386 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether computer games can aid breast cancer survivors with memory and thinking issues. Two types of games are involved: Computerized Cognitive Training-Global Stimulation Games, which focus on fun and engagement, and Computerized Cognitive Training-Neuroplasticity Games, designed to enhance brain flexibility and improve skills like attention and memory. Women who have had non-metastatic breast cancer and completed their initial treatments 6 months to 5 years ago may be suitable candidates, especially if they experience ongoing attention or memory problems. As an unphased trial, this study provides a unique opportunity to explore innovative methods for improving cognitive health after cancer treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you can continue taking endocrine therapy and/or trastuzumab.

What prior data suggests that these computerized cognitive training methods are safe for breast cancer survivors?

Research has shown that computerized brain training is generally safe and well-tolerated by breast cancer survivors. Studies have found that these brain games can improve thinking skills without causing major side effects. The games used in the Global Stimulation and Neuroplasticity training are designed to be fun and adjust to each person's skill level, making them suitable for everyone.

Similar studies have used these computerized training methods, and participants have responded positively. No significant negative effects have been reported, suggesting their safety for users. Overall, evidence supports the safety and comfort of these brain training games for breast cancer survivors. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these cognitive training games for breast cancer survivors because they offer a fresh approach to addressing cognitive challenges often experienced after treatment. Unlike traditional therapies, which might involve medication or non-specific brain exercises, these games are designed to specifically stimulate brain plasticity. The neuroplasticity games adapt to each user's skill level, ensuring they are always challenged and engaged, which can directly enhance attention, memory, and processing speed. Meanwhile, the global stimulation games provide a fun, game-based environment that serves as active attention control, potentially improving cognitive function while keeping the process enjoyable and less stressful.

What evidence suggests that this trial's treatments could be effective for cognitive impairment in breast cancer survivors?

Research has shown that computer-based brain training can improve thinking skills in breast cancer survivors. This trial will compare two types of training: Global Stimulation Games and Neuroplasticity Games. Studies have found that these games noticeably enhance attention, memory, and processing speed. Participants in those studies reported improved thinking abilities and real-life benefits after using these training methods. The games are designed to be enjoyable and adapt to each person's skill level for optimal effectiveness. Overall, these methods have been well received and show promise in reducing the cognitive challenges faced by breast cancer survivors. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for breast cancer survivors who've finished their initial treatment between 6 months and 5 years ago, but may still be on endocrine or HER2-directed therapy. They should have a first-time diagnosis of non-metastatic breast cancer (Stage I-III) and feel like they're experiencing cognitive issues post-treatment.

Inclusion Criteria

I finished my initial cancer treatment between 6 months and 5 years ago, but may still be on hormone or HER2 therapy.

I can understand, speak, read, and write in English or Spanish.

I have given my consent for this study and allowed my health information to be shared.

Exclusion Criteria

Participants with history of stroke, traumatic brain injury, brain surgery, Alzheimer's disease or other dementia

I have had brain surgery or treatment for my brain.

I have had chemotherapy for a condition other than my current cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo computerized cognitive training using either global stimulation games or neuroplasticity games

12 weeks

Follow-up

Participants are monitored for cognitive performance and perceived cognitive impairment

24 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Computerized Cognitive Training-Global Stimulation Games
• Computerized Cognitive Training-Neuroplasticity Games

Trial Overview The study compares two types of computerized cognitive training games to see if they help with the perceived mental fog that some breast cancer survivors experience after treatment. Participants will use Brain HQ's neuroplasticity or global stimulation games.

How Is the Trial Designed?

Group I: Arm 2: Computerized Cognitive Training-Neuroplasticity Games Experimental Treatment 1 Intervention

The neuroplasticity games provide core elements necessary for inducing neuroplasticity. The five core elements include the principles of speed of processing, accuracy of processing, adaptivity, generalizability, and engagement. Importantly, all of the exercises adapt to user skill and ability. Behavioral tracking built within the program is used to monitor individual performance and ensure that the person is training at their uppermost threshold level. Specifically, we will use eight of these exercises which are designed to address cognitive concerns most noted in BCS including exercises to improve attention and working memory, processing speed, and executive function.

Group II: Arm 1: Computerized Cognitive Training-Global Stimulation Games Active Control 1 Intervention

The global stimulation games active attention control intervention is composed of computerized games. These games are fully developed and are rated E (for everyone) by the Entertainment Software Rating Board. The program will present 8 non-speeded exercises that include spin-offs of such games as breaking hex, lineup four, battleship, gems swap, double klondike, solitaire, reversi, word search, and sudoku.

Computerized Cognitive Training-Global Stimulation Games is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Computerized Cognitive Training for:

• Cancer-related cognitive impairment
• Mild cognitive impairment
• Alzheimer's disease prevention

Approved in European Union as Computerized Cognitive Training for:

• Cognitive impairment in older adults
• Dementia prevention
• Neurocognitive disorders

Approved in Canada as Computerized Cognitive Training for:

• Cognitive rehabilitation
• Brain injury rehabilitation
• Neurodegenerative diseases

Who Is Running the Clinical Trial?

NRG Oncology

Lead Sponsor

Trials

242

Recruited

105,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Computerized cognitive training (CCT) has a modest effect on improving cognitive performance in healthy older adults, with an overall effect size of 0.22 based on a systematic review of 52 studies involving 4,885 participants.

The effectiveness of CCT varies by cognitive domain, showing small to moderate improvements in areas like nonverbal memory and processing speed, while home-based training and sessions exceeding three times a week were found to be ineffective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computerized cognitive training in cognitively healthy older adults: a systematic review and meta-analysis of effect modifiers. Lampit, A., Hallock, H., Valenzuela, M.[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]

Cognitive training has been shown to significantly improve subjective cognitive function and certain objective cognitive skills, such as working memory and episodic memory, in breast cancer patients experiencing cognitive changes, based on a systematic review of 9 randomized controlled trials involving 666 patients.

Despite these improvements, cognitive training did not lead to significant changes in attention, short-term memory, executive function, or psychological outcomes like anxiety and depression, indicating that while cognitive training can be beneficial, it may not address all cognitive and emotional challenges faced by these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of cognitive training on patients with breast cancer reporting cognitive changes: a systematic review and meta-analysis. Yan, X., Wei, S., Liu, Q.[2023]

An 8-week home-based computerized cognitive training (CCT) program was assessed for feasibility among 19 patients recently treated for hematological malignancies, but adherence was low, with only one participant fully engaging with the program.

Participants found the CCT program easy to follow and expressed a need for improvements, such as personalized feedback and peer support, to enhance adherence, indicating that while CCT may be beneficial, additional support strategies are necessary for effective implementation in the post-treatment phase.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computerized cognitive training in post-treatment hematological cancer survivors: a feasibility study. Mayo, SJ., Rourke, SB., Atenafu, EG., et al.[2021]

Home-based Computerized Cognitive Training (CCT) tailored to individual needs significantly improved cognitive functions such as memory and learning in older adults with mild cognitive impairment (MCI) and mood-related neuropsychiatric symptoms (MrNPS) over an 8-12 week period.

Participants in the CCT group not only showed enhanced cognitive performance but also reported improved mood and reduced caregiver burden compared to those in the active control group, indicating broader benefits beyond just cognitive outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tailored and Adaptive Computerized Cognitive Training in Older Adults at Risk for Dementia: A Randomized Controlled Trial. Bahar-Fuchs, A., Webb, S., Bartsch, L., et al.[2022]

Thirty patients with chronic cognitive deficits post-stroke participated in a study comparing two types of Computerized Cognitive Training (CCT) over 6 weeks, showing that both types led to improvements in cognitive functioning.

Group A, which received customized CCT, reported fewer subjective complaints, while Group B, which received non-customized CCT, showed better performance-based improvements, indicating that both tailored and standard CCT can be beneficial for cognitive recovery in chronic stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional improvement in chronic stroke patients when following a supervised home-based computerized cognitive training. Gil-Pagés, M., Solana, J., Sánchez-Carrión, R., et al.[2023]

In a study of 107 patients with mild cognitive impairment (MCI), Computerized Cognitive Games Training (CCT) did not show a significant advantage over web-based crossword puzzles in improving within-network functional connectivity of the default mode network (DMN) after 18 months.

However, secondary analyses indicated that crossword puzzles may enhance between-network connectivity and lead to less cognitive decline in patients with late MCI, suggesting they could be more beneficial for this group compared to CCT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Computerized Cognitive Training on Default Mode Network Connectivity in Subjects at Risk for Alzheimer's Disease: A 78-week Randomized Controlled Trial. Petrella, JR., Michael, AM., Qian, M., et al.[2023]

In a study of 39 stroke survivors, computerized cognitive training (CCT) using Lumosity software led to significant improvements in global cognitive function and specific cognitive skills like verbal working memory and processing speed after 12 weeks of training.

While CCT showed immediate cognitive benefits that were maintained for 4 weeks, it did not significantly affect daily activities or participation, and no major differences were found when compared to conventional cognitive training methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of computerized cognitive training on cognitive function, activity, and participation in individuals with stroke: A randomized controlled trial. Ho, HY., Chen, MD., Tsai, CC., et al.[2022]

A study involving 135 participants with multiple sclerosis showed that an adaptive online cognitive training program significantly improved cognitive functioning compared to ordinary computer games, with a notable mean change in cognitive scores (0.25 vs. 0.09, p = 0.03).

The adaptive cognitive remediation program was more effective despite participants in the control group spending more time on their training, highlighting the efficacy of targeted cognitive interventions in improving cognitive impairment in MS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive function in multiple sclerosis improves with telerehabilitation: Results from a randomized controlled trial. Charvet, LE., Yang, J., Shaw, MT., et al.[2022]

Citations

1. 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10278462/

Acceptability of computerized cognitive training and global ... Computerized cognitive training and cognitive stimulating‐based games have been used to improve CRCI. These methods have been shown to be well received and ...

3. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT05570604

Computerized Cognitive Training in Breast Cancer Survivors The goals of the Brain HQ program are to improve visual processing speed, learning and memory and attention. The exercises include time-order judgment, ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10049401/

Effectiveness of a Computerized Home-Based Cognitive ... Previous studies have also shown that computerized cognitive training in breast cancer survivors can lead to subjective improvements and transfer to behavior ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0960977620301235

A video-game based cognitive training for breast cancer ... The results for neuropsychological performance are mixed but most of these trials demonstrated a reduced cognitive impairment after these interventions [9,[23], ...

6. nrgoncology.org nrgoncology.org/CC011

NRG-CC011: Cognitive Training for Breast Cancer Survivors A study to examine computerized training to improve concentration, learning new things, and remembering in breast cancer survivors.

7. salemhealth.org salemhealth.org/you-matter/post/clinical-trial-looks-at-brain-training-to-improve-cognitive-function-in-breast-cancer-survivors

Clinical trial looks at 'brain training' to improve cognitive ... Clinical trial looks at 'brain training' to improve cognitive function in breast cancer survivors. Right now, seven Salem Health Cancer Center patients are ...