nCCR for Chemotherapy Related Cognitive Impairment Randomized Study

Vanderbilt University Medical Center

Status: Enrolling

Conditions: Chemotherapy-Related Cognitive Impairment; Chemo-brain

Treatments: Behavioral: Neuroplasticity-based Computerized Cognitive Remediation; Behavioral: Education Control Condition

Study type: Interventional

Funder types: Other

Identifiers

NCT05283629

211521

Details and patient eligibility

About

The investigators propose to apply neuroplasticity-based computerized cognitive remediation (nCCR) to treat chemotherapy-related cognitive impairment (CRCI).

Full description

Successes in breast cancer treatment are resulting in a growing number of cancer survivors. This has broadened the scope of care from treating the disease alone to improving the quality of life of cancer survivors. Chemotherapy-related cognitive impairment (CRCI), often referred to by patients as 'chemobrain,' is a common and highly distressful side effect of chemotherapy often reported by breast cancer survivors. Managing the symptoms of CRCI should be integrated with routine cancer care as these symptoms diminish quality of life, impair work performance, and make it more difficult for patients to follow treatment regimens. CRCI can persist for months to years following cancer treatment. However, there are currently no established treatments for CRCI.

The most commonly reported CRCI symptoms in breast cancer survivors include problems with executive functions. Executive function is a cognitive domain involved in planning, problem-solving, organization, and time management. In order to improve executive dysfunction and quality of life in breast cancer survivors, we propose to use a new brain training program called neuroplasticity-based computerized cognitive remediation (nCCR). The term 'neuroplasticity' refers to the brain's ability to modify, change, and adapt throughout life and in response to experience. Neuroplacticity can be induced through the use of focused brain training that nCCR offers. Past work demonstrates that this neuroscience-guided brain training benefits other patient populations with similar cognitive problems and has shown preliminary success in cancer survivors in a small pilot study. If successful, this treatment could have significant benefits for large numbers of breast cancer survivors.

Enrollment: 20 estimated patients

Sex: All

Ages: 35 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

All participants will:

• between 35 and 80 years of age
• have been diagnosed with noninvasive or invasive breast cancer
• have undergone treatment with systemic chemotherapy within the last 1- 8 years
• endorse persistent CRCI subjective complaints
• have no active unstable medical condition
• fluent in and able to read English.

Exclusion criteria

Participants will be excluded for

• any active neurologic or untreated/non-remitted psychiatric disease, (e.g. active major depression or another major psychiatric disorder as described in DSM-5)
• clinically significant cognitive impairment identified on cognitive screening, diagnosis of mild cognitive impairment or dementia
• history of significant head trauma followed by persistent neurologic deficits
• history of alcohol or substance abuse or dependence within the past 2 years (DSM-5 criteria)
• any significant systemic illness or unstable medical condition which could lead to difficulty complying with the protocol
• Use of any investigational drugs within 30 days or 5 half-lives, whichever is longer, prior to screening
• red-green color blindness
• Use of certain CNS active medications (e.g. antidepressants) will be permitted, provided dosing has been stable for at least 3 months.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Neuroplasticity-based Computerized Cognitive Remediation

Experimental group

Description:

Behavioral: Neuroplasticity-based Computerized Cognitive Remediation The nCCR has two major components: Bottom up and Top down training. * Bottom up" training: The training includes selected tasks from "Brain HQ", a program designed for older adults, that enhances basic processing of sensory stimuli with the goal to improve fidelity of auditory and visual encoding. * Top down training": We designed programs to target cognitive control functions associated with poor treatment response, i.e., initiation and use of verbal strategy and susceptibility to interference. These "Top Down" Programs include a visual attention program, either Catch the Ball or Neurogrow, and a semantic strategy program, Semantic Organization.

Treatment:

Behavioral: Neuroplasticity-based Computerized Cognitive Remediation

Education Comparison Control

Active Comparator group

Description:

The education control condition is a learning-based approach that utilizes DVDs on history, art, science, etc. This active condition is comparable to nCCR in length of exposure, audio-visual presentation, computer use and contact with research staff.

Treatment:

Behavioral: Education Control Condition