Cognitive Training App for Chemobrain

Overseen By Rebecca C. Arend

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Dementia, Multiple mental medications, others

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

Compensation: Varies

Number of Visits: 5

Duration: 10 weeks

64 Participants Needed

Trial Summary

What is the purpose of this trial?

Cancer-related cognitive impairment (CRCI), also known as "chemobrain," is the cognitive decline that negatively impacts the majority of cancer patients undergoing chemotherapy, radiation, and/or hormonal treatments. This application focuses on evaluating if using a cognitive mobile training application can decrease the impact of CRCI in gynecologic oncology patients through a multidisciplinary approach with patients undergoing assessments by our neurocognitive team.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on more than one medication for significant mental health issues, you may not be eligible to participate.

What data supports the effectiveness of the treatment Cognitive training application for chemobrain?

Research shows that video-game based cognitive training can help improve cognitive decline in breast cancer survivors, suggesting that similar cognitive training apps might be effective for chemobrain. Additionally, adaptive cognitive training has shown benefits in cognitive abilities for women treated for breast cancer, indicating potential positive effects for chemobrain as well. ^{1 2 3 4 5}

Is the cognitive training app safe for humans?

The research articles do not provide specific safety data on cognitive training apps, but they discuss cognitive impairments related to chemotherapy, suggesting a need for interventions to reduce these effects. Further research is needed to determine the safety of such apps. ^{2 6 7 8 9}

How does the cognitive training app treatment differ from other treatments for chemobrain?

The cognitive training app is unique because it offers a non-drug approach to managing chemobrain by using exercises designed to improve cognitive functions like memory and attention, which are often affected by chemotherapy. Unlike traditional treatments that may focus on medication, this app provides a more interactive and engaging way to potentially enhance brain function without the side effects associated with drugs. ^{4 6 10 11 12}

Eligibility Criteria

This trial is for adults over 21 with a new diagnosis of gynecologic cancer (like uterine, cervical, ovarian) who are starting chemotherapy and own a smartphone or tablet. It's not suitable for those who can't use the cognitive training app.

Inclusion Criteria

own a smartphone or tablet with ability to download cognitive training application

I am over 21 years old.

I have a new diagnosis of a gynecologic cancer and am starting chemotherapy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use a cognitive mobile training application to reduce the impact of cancer-related cognitive impairment during chemotherapy

10 weeks

5 sessions per week

Follow-up

Participants are monitored for neurocognitive function using the FACT-Cog survey

Up to 2 years

Treatment Details

Interventions

• Cognitive training application

Trial Overview The study tests whether a mobile app designed for cognitive training can help reduce 'chemobrain' symptoms—cognitive issues that often affect cancer patients receiving treatments like chemotherapy.

Participant Groups

Group I: MOBILE COGNITIVE TRAINING APP Experimental Treatment 1 Intervention

These patients will undergo neuropsychology evaluation and use the cognitive mobile training application

Group II: OBSERVATION Active Control 1 Intervention

PATIENTS WILL PARTICIPATE IN THE NEUROPSYCHOLOGY EVALUATION BUT WILL NOT USE THE COGNITIVE MOBILE TRAINING APPLICATION.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

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]

Adjuvant chemotherapy for breast cancer can lead to significant cognitive impairments, fatigue, and mood changes, which may persist even after treatment ends, highlighting the need for better assessment methods.

This study emphasizes the importance of using standardized neuropsychological measures to track cognitive changes in women undergoing chemotherapy, comparing their performance with those who have completed treatment, to better understand the long-term effects of chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing cognitive dysfunction in breast cancer: what are the tools? Freeman, JR., Broshek, DK.[2019]

Metacognitive strategy training (MCST) showed a positive effect on cognitive performance and quality of life in women experiencing chemotherapy-induced cognitive impairment (CICI) after breast cancer treatment, based on a study involving 10 participants who completed a 12-session intervention.

The training also improved neural connectivity in the frontoparietal network in 6 out of 10 subjects, indicating a potential mechanism through which MCST enhances cognitive function in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Feasibility of Using Metacognitive Strategy Training to Improve Cognitive Performance and Neural Connectivity in Women with Chemotherapy-Induced Cognitive Impairment. Wolf, TJ., Doherty, M., Kallogjeri, D., et al.[2018]

Women with breast cancer who underwent 12 sessions of online adaptive cognitive training showed significant improvements in working memory capacity and cognitive efficiency, as measured by objective tasks like the Change Detection Task and Flanker task.

The training not only enhanced cognitive abilities but also positively impacted self-reported cognitive and emotional health, with benefits observed up to one year after the training, suggesting long-term advantages for cognitive health in cancer survivorship.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefits of adaptive cognitive training on cognitive abilities in women treated for primary breast cancer: Findings from a 1-year randomised control trial intervention. Chapman, B., Louis, CC., Moser, J., et al.[2023]

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]

A systematic review of 31 studies found that various interventions, such as cognitive behavioral therapy and brain training, show promise in improving cognitive function in cancer patients experiencing cognitive impairment after chemotherapy.

The study highlighted inconsistencies in outcome measurements across different interventions, suggesting a need for standardized assessment tools in future research to better evaluate the effectiveness of these cognitive enhancement strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions promoting cognitive function in patients experiencing cancer related cognitive impairment: A systematic review. Oldacres, L., Hegarty, J., O'Regan, P., et al.[2023]

Chemotherapy-induced cognitive dysfunction, commonly referred to as 'chemobrain,' affects up to 78% of cancer patients, significantly impacting their quality of life and cognitive abilities such as memory and attention.

The underlying mechanisms of chemobrain are not fully understood, but increased proinflammatory cytokines and oxidative stress are believed to play key roles, alongside potential effects on neurotransmission and neurogenesis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Four decades of chemotherapy-induced cognitive dysfunction: comprehensive review of clinical, animal and in vitro studies, and insights of key initiating events. Dias-Carvalho, A., Ferreira, M., Ferreira, R., et al.[2022]

Research on rodents has shown that chemotherapy can lead to long-lasting cognitive impairments, particularly affecting brain regions like the hippocampus and prefrontal cortex, which are crucial for memory and decision-making.

Protective factors such as cognitive reserve, physical exercise, and environmental enrichment may help mitigate these cognitive effects, and pharmacological treatments like donepezil could also be beneficial in reducing cognitive disturbances in cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chemotherapy and cognitive impairment: An animal model approach. Winocur, G.[2018]

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

Assessing cognitive dysfunction in breast cancer: what are the tools? [2019]

3. Switzerland pubmed.ncbi.nlm.nih.gov

The Feasibility of Using Metacognitive Strategy Training to Improve Cognitive Performance and Neural Connectivity in Women with Chemotherapy-Induced Cognitive Impairment. [2018]

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

How to assess and manage cognitive impairment induced by treatments of non-central nervous system cancer. [2020]

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

Benefits of adaptive cognitive training on cognitive abilities in women treated for primary breast cancer: Findings from a 1-year randomised control trial intervention. [2023]

6. Italy pubmed.ncbi.nlm.nih.gov

Neural correlates of chemotherapy-related cognitive impairment. [2022]

7. 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]

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

Cerebral hyporesponsiveness and cognitive impairment 10 years after chemotherapy for breast cancer. [2022]

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

Cognitive dysfunction and symptom burden in women treated for breast cancer: a prospective behavioral and fMRI analysis. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Interventions promoting cognitive function in patients experiencing cancer related cognitive impairment: A systematic review. [2023]

11. Germany pubmed.ncbi.nlm.nih.gov

Four decades of chemotherapy-induced cognitive dysfunction: comprehensive review of clinical, animal and in vitro studies, and insights of key initiating events. [2022]

12. Canada pubmed.ncbi.nlm.nih.gov

Chemotherapy and cognitive impairment: An animal model approach. [2018]