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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a cognitive training app can help reduce "chemobrain," a type of mental decline many cancer patients experience during treatment. Participants will either use the app or undergo evaluations to determine the app's effectiveness. The study focuses on women with newly diagnosed gynecologic cancers, such as uterine or ovarian, who are receiving chemotherapy. Participants must own a smartphone or tablet to use the app. This trial may suit individuals experiencing memory or focus difficulties due to cancer treatment. As an unphased trial, it offers participants a chance to contribute to innovative research that could improve cognitive health during 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, if you are on more than one medication for significant mental health issues, you may not be eligible to participate.

What prior data suggests that this cognitive training application is safe for gynecologic oncology patients?

Studies have shown that cognitive training apps can improve thinking and memory skills. Research suggests these apps are generally safe and easy to use. However, specific safety information for the app used in this trial is not available. This trial is in a "Not Applicable" phase, indicating the app is considered low-risk, similar to other health and wellness apps. For any concerns, participants should consult the trial team. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the cognitive training app for chemobrain because it offers a non-drug approach to managing cognitive issues that arise after chemotherapy. Unlike traditional treatments that might involve medication or therapy sessions, this app provides a convenient, digital platform for cognitive exercises that patients can use at their own pace and in their own homes. This flexibility and accessibility are big advantages, potentially reaching more people who may not have easy access to in-person care. Additionally, the app can adapt to individual user needs, offering personalized training to target specific cognitive deficits caused by chemobrain.

What evidence suggests that this cognitive training application is effective for chemobrain?

Research shows that brain exercises can improve thinking skills in cancer patients experiencing "chemobrain," the mental fog that can occur during chemotherapy. A review of studies has found that these exercises enhance mental abilities and improve quality of life. One study discovered that online brain training effectively boosted overall thinking skills, including problem-solving and memory. Additionally, training that encourages people to think about their own thinking positively affected mental performance in women receiving chemotherapy. In this trial, some participants will use a mobile cognitive training app designed to address these issues, while others will be observed without using the app. Overall, evidence suggests that brain exercises hold promise for helping those with cancer-related thinking difficulties. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06686823

NCT06686823 | Effects of a Cognitive Training Program on ... Effects of a Cognitive Training Program on Chemotherapy-induced Cognitive Impairment (Chemobrain) in Breast Cancer Patients Undergoing Active Treatment.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12340179/

Effect of Cognitive Training on Cancer‐Related ... This systematic review with meta‐analysis evaluated the efficacy of cognitive training in improving cancer‐related cognitive impairment in ...

3. withpower.com withpower.com/trial/phase-cognitive-dysfunction-7-2023-4ec4d

Cognitive Training App for Chemobrain · Info for Participants Metacognitive strategy training (MCST) showed a positive effect on cognitive performance and quality of life in women experiencing chemotherapy-induced ...

4. brainhq.com brainhq.com/partners/brainhq-for-clinicians/nci/?RELEASE_DATE=12-02-24

Cognitive Training and Chemobrain The evidence indicates that cognitive training is likely to be effective in improving cognitive performance in cancer survivors.

5. nature.com nature.com/articles/s41523-024-00694-8

Computerized cognitive training improves ... In this prospective pilot study, web-based cognitive training was efficacious in improving overall cognitive performance and executive function.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11443049/

Computerized cognitive training improves ... In this prospective pilot study, web-based cognitive training was efficacious in improving overall cognitive performance and executive function.

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

A Cognitive Training Programme on Cancer-Related ... Cognitive, emotional, and functional variables will be assessed before and after the intervention: cognitive function (MoCA test), everyday cognition (PECC), ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0753332225007759

Review Cognitive dysfunction in chemobrain: Molecular ... Chemotherapy-induced cognitive impairment (CICI), commonly referred to as chemobrain, is a prevalent side effect of cancer treatment that severely affects ...