Cognitive Rehabilitation for Breast Cancer Survivors

Overseen By Juliana H. Earwood, OTD, OTR/L

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Missouri-Columbia

Must be taking: Antidepressants

Disqualifiers: Neurological conditions, Severe depression, others

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

Compensation: Varies

Number of Visits: 10

Duration: 10 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach called Metacognitive Strategy Training (MCST) to assist breast cancer survivors experiencing memory and thinking problems after treatment. Researchers aim to determine if this training can enhance daily activities, thinking skills, and overall quality of life. Participants will either receive the MCST or join a control group that receives regular phone check-ins. This trial suits breast cancer survivors who have noticed significant cognitive issues and completed their cancer treatment 6 months to 3 years ago. As an unphased trial, it offers participants the chance to contribute to innovative research that could improve cognitive recovery for future breast cancer survivors.

Will I have to stop taking my current medications?

The trial requires that you have been on stable doses of medications that affect cognitive function, like anti-depressants, for at least 90 days before joining. So, you won't need to stop taking them, but you shouldn't change the dosage either.

What prior data suggests that metacognitive strategy training is safe for breast cancer survivors?

Research has shown that metacognitive strategy training (MCST) is generally manageable for participants. Studies indicate that this method can enhance daily activity performance and improve quality of life. Previous research has not identified major safety issues. Participants in these studies did not experience significant negative effects from the training. Therefore, MCST appears to be a safe option for those seeking to boost cognitive function after breast cancer treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Metacognitive Strategy Training (MCST) for breast cancer survivors because it offers a fresh approach to cognitive rehabilitation. Unlike traditional cognitive therapies that often focus on exercises to improve memory or attention, MCST emphasizes teaching strategies to help patients better manage their daily tasks and challenges. This method is delivered through personalized, in-person sessions with a trained occupational therapist, providing tailored support that could lead to more significant improvements in daily life performance. By targeting metacognitive skills, MCST aims to empower patients with tools to enhance their cognitive function in practical, meaningful ways.

What evidence suggests that metacognitive strategy training could be effective for breast cancer survivors with cognitive impairment?

Research has shown that Metacognitive Strategy Training (MCST), which participants in this trial may receive, can improve thinking skills and quality of life for breast cancer survivors experiencing memory and concentration difficulties. Studies have found that MCST enhances both mental abilities and brain communication, suggesting it might aid in cognitive function and neural messaging. Some early findings indicate that MCST also assists with daily tasks and overall well-being. While more research is needed, these initial results offer promise for those facing cognitive challenges after breast cancer treatment. ^{1 2 3 6 7}

Who Is on the Research Team?

Anna E Boone, PhD, OTR/L

Principal Investigator

University of Missouri Occupational Therapy

Are You a Good Fit for This Trial?

This trial is for breast cancer survivors who feel their thinking skills have worsened after treatment. They should be English speakers, able to consent, expect to live more than 6 months, finished cancer treatment between 6 months and 3 years ago, and not changed any brain-impacting meds recently.

Inclusion Criteria

I feel my thinking has been moderately to extremely affected and my CFQ score is over 30.

Able to provide valid informed consent

Have a life expectancy of greater than 6 months at time of enrollment

Exclusion Criteria

Pregnancy

Dementia symptoms as indicated by a score of <23 on the Montreal Cognitive Assessment (MoCA)

History of severe traumatic brain injury, prolonged loss of consciousness (e.g., coma)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive metacognitive strategy training (MCST) through 10 weekly, 45-minute sessions delivered in-person by a trained occupational therapist

10 weeks

10 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Inactive Control Group
• Metacognitive Strategy Training (MCST)

Trial Overview The study tests if Metacognitive Strategy Training (MCST) can help improve daily activities, thinking abilities, and life quality in those with cognitive issues post-cancer. It's compared against a group doing no such training to see the difference.

How Is the Trial Designed?

Group I: Metacognitive strategy training (MCST) Experimental Treatment 1 Intervention

Each MCST session will be follow the procedures of Cognitive Orientation to daily Occupational Performance (CO-OP) intervention. There will be 10, 45-minute, weekly sessions. All sessions will be delivered in-person with a trained occupational therapist.

Group II: Inactive Control Group Active Control 1 Intervention

Participants will receive a weekly phone call from study staff to maintain contact and monitor changes in activity.

Who Is Running the Clinical Trial?

University of Missouri-Columbia

Lead Sponsor

Trials

387

Recruited

629,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Published Research Related to This Trial

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]

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]

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 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]

A pilot study involving 29 breast cancer survivors, averaging 8 years post-chemotherapy, showed that a cognitive-behavioral treatment called Memory and Attention Adaptation Training (MAAT) led to significant improvements in self-reported cognitive function and quality of life.

Participants reported high satisfaction with MAAT, indicating it is a feasible and practical approach to help manage cognitive dysfunction related to chemotherapy, suggesting further evaluation is warranted.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral management of chemotherapy-related cognitive change. Ferguson, RJ., Ahles, TA., Saykin, AJ., et al.[2022]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5016221/

The feasibility of using metacognitive-strategy training to ... This study found that MCST was associated with a positive effect on cognitive performance and neural connectivity in women with CICI following treatment for ...

2. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/45/NCT05505045/Prot_SAP_ICF_000.pdf

Feasibility of using remotely-delivered metacognitive ... Our preliminary data suggest that CO-OP may have a positive impact on activity performance, subjective and objective cognition, and quality of life in breast ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06545045

Cognitive Rehabilitation Following Breast Cancer Treatment The goal of this proposed project is to evaluate the feasibility and preliminary effect of metacognitive strategy training to improve activity performance, ...

4. 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 ...

5. ctv.veeva.com ctv.veeva.com/study/metacognitive-strategy-training-in-cancer-related-cognitive-impairment

Metacognitive Strategy Training in Cancer-related Cognitive ... The investigators' preliminary data suggest that CO-OP may have a positive impact on activity performance, subjective and objective cognition, ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S1551714425000527

Cognitive remediation in breast cancer survivors: A study ... This project aims to assess the effectiveness of a cognitive remediation protocol called Oncogite in reducing cancer treatment-related cognitive impairment.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3677054/

Advanced cognitive training for breast cancer survivors Primary outcomes were performance on objective neuropsychological tests of memory and speed of processing. Secondary outcomes were perceived cognitive function, ...