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

Trial Summary

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 data supports the effectiveness of the treatment Metacognitive Strategy Training (MCST) for breast cancer survivors?

Research shows that Metacognitive Strategy Training (MCST) may help improve cognitive performance and brain connectivity in women who have experienced cognitive issues after chemotherapy for breast cancer. This suggests that MCST could be a promising approach for managing cognitive difficulties in breast cancer survivors. ^{1 2 3 4 5}

Is cognitive rehabilitation safe for breast cancer survivors?

The studies on cognitive rehabilitation, including metacognitive strategy training, for breast cancer survivors suggest it is generally safe. Participants reported high satisfaction and improvements in cognitive function, with no significant safety concerns mentioned. ^{1 2 3 5 6}

How is Metacognitive Strategy Training (MCST) different from other treatments for cognitive issues in breast cancer survivors?

Metacognitive Strategy Training (MCST) is unique because it focuses on improving cognitive performance by enhancing self-awareness and self-regulation of thinking processes, rather than just targeting specific cognitive skills. This approach aims to improve overall cognitive function and neural connectivity, particularly in the frontoparietal network, which is different from other treatments that may focus on specific cognitive exercises or speed of processing. ^{1 3 4 5 7}

What is the purpose of this trial?

The goal of this proposed project is to evaluate the feasibility and preliminary effect of metacognitive strategy training to improve activity performance, cognition, and quality of life in breast cancer survivors with cancer-related cognitive impairment (CRCI). The other goal of this proposed project is to examine the effects of CO-OP on resting (rsFC)- and task-state functional connectivity as compared to an inactive control group.

Research Team

Anna E Boone, PhD, OTR/L

Principal Investigator

University of Missouri Occupational Therapy

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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 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]

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]

References

1. 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]

2. England pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral management of chemotherapy-related cognitive change. [2022]

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

Speed of processing training in middle-aged and older breast cancer survivors (SOAR): results of a randomized controlled pilot. [2019]

4. 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]

5. Germany pubmed.ncbi.nlm.nih.gov

Randomized double-masked controlled trial of cognitive training in breast cancer survivors: a preliminary study. [2023]

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

Cognitive training for improving executive function in chemotherapy-treated breast cancer survivors. [2022]

7. 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]