Cognitive Training for Breast Cancer Survivors

Recruiting at 639 trial locations

Overseen By Shahzad Siddique

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: NRG Oncology

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

No Placebo Group

Trial Summary

What is the purpose of this trial?

This Phase III trial will examine the efficacy of computerized cognitive training methods on perceived cognitive impairment in breast cancer survivors.

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 data supports the effectiveness of the treatment Cognitive Training for Breast Cancer Survivors?

Research shows that cognitive training, including video-game based and computerized programs, can help improve cognitive function in breast cancer survivors experiencing cognitive changes. Similar treatments have also been effective in improving cognitive function in other conditions, such as multiple sclerosis and older adults at risk for dementia. ^{1 2 3 4 5}

Is computerized cognitive training safe for humans?

Computerized cognitive training is generally considered safe for humans, as it has been used in various studies with older adults, stroke patients, and individuals with multiple sclerosis without reported safety concerns. ^{2 3 5 6 7}

How is the treatment 'Computerized Cognitive Training' unique for breast cancer survivors?

Computerized Cognitive Training (CCT) is a unique non-drug treatment that uses brain games to improve cognitive function by targeting different cognitive areas, unlike traditional treatments that may not focus on cognitive rehabilitation. It is particularly novel for breast cancer survivors experiencing cognitive changes, as it offers a structured, engaging way to potentially enhance brain function without medication. ^{4 5 6 8 9}

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Computerized Cognitive Training-Global Stimulation Games (Behavioural Intervention)
• Computerized Cognitive Training-Neuroplasticity Games (Behavioural Intervention)

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.

Participant Groups

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 Canada for the following indications:

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+

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]

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]

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]

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]

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]

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]

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]

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]

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

Cognitive function in multiple sclerosis improves with telerehabilitation: Results from a randomized controlled trial. [2022]

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

Tailored and Adaptive Computerized Cognitive Training in Older Adults at Risk for Dementia: A Randomized Controlled Trial. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Computerized cognitive training in post-treatment hematological cancer survivors: a feasibility study. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Effect of cognitive training on patients with breast cancer reporting cognitive changes: a systematic review and meta-analysis. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Functional improvement in chronic stroke patients when following a supervised home-based computerized cognitive training. [2023]

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

Computerized cognitive training in cognitively healthy older adults: a systematic review and meta-analysis of effect modifiers. [2022]

8. Netherlands 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. [2023]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Effects of computerized cognitive training on cognitive function, activity, and participation in individuals with stroke: A randomized controlled trial. [2022]