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nCCR for Chemotherapy Related Cognitive Impairment Randomized Study

Primary Purpose

Chemo-brain, Chemotherapy-Related Cognitive Impairment

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Neuroplasticity-based Computerized Cognitive Remediation
Education Control Condition
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chemo-brain focused on measuring Chemotherapy, Cognitive Impairment, neuroplasticity-based computerized cognitive remediation, nCCR

Eligibility Criteria

35 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Center for Cognitive Medicine at Vanderbilt UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Neuroplasticity-based Computerized Cognitive Remediation

Education Comparison Control

Arm 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.

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.

Outcomes

Primary Outcome Measures

Assess whether nCCR training produces change in subjective cognitive complaints breast cancer survivors with CRCI.
Paired samples t-tests will be used to assess FACT-Cog PCI Scores. We hypothesize that nCCR treatment will improve FACT-Cog scores in breast cancer patients with persistent CRCI over 6 weeks of treatment compared to the education control group. The primary measure used to assess subjective cognitive performance was the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) scale and evaluates memory, concentration, mental acuity, verbal fluency, functional interference, and multitasking ability. At baseline and post-treatment visits, participants rated on a 5-point Likert scale how they assessed various aspects of their cognitive functioning over the last 7 days. Higher scores indicate better ratings of cognitive functioning. Higher scores indicate better ratings of cognitive functioning.

Secondary Outcome Measures

Assess whether 6-weeks of nCCR training produces change in cognitive performance on neuropsychological measures in breast cancer survivors with CRCI.
Paired samples t-tests will be used to assess Trail Making Test performance. We hypothesize that nCCR treatment will improve Trail Making Test performance in breast cancer patients with persistent CRCI over 6 weeks of treatment compared to the education control group. The Trail Making Test (TMT) is widely used in both research and clinical settings as a test of some aspects of executive function. Subtracting TMT A completion time from that of TMT B (TMT B-A) is thought to allow the relative contributions of visual search and psychomotor speed to be parsed from the more complex executive functions (such as cognitive flexibility) required to alternate between numbers and letters. Lower scores indicated better cognitive functioning.

Full Information

First Posted
February 3, 2022
Last Updated
June 28, 2023
Sponsor
Vanderbilt University Medical Center
Collaborators
University of Utah
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1. Study Identification

Unique Protocol Identification Number
NCT05283629
Brief Title
nCCR for Chemotherapy Related Cognitive Impairment Randomized Study
Official Title
Neuroplasticity-Based Cognitive Remediation for Chemotherapy Related Cognitive Impairment Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
March 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center
Collaborators
University of Utah

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemo-brain, Chemotherapy-Related Cognitive Impairment
Keywords
Chemotherapy, Cognitive Impairment, neuroplasticity-based computerized cognitive remediation, nCCR

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Neuroplasticity-based Computerized Cognitive Remediation
Arm Type
Experimental
Arm 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.
Arm Title
Education Comparison Control
Arm Type
Active Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Neuroplasticity-based Computerized Cognitive Remediation
Intervention 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.
Intervention Type
Behavioral
Intervention Name(s)
Education Control Condition
Intervention 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.
Primary Outcome Measure Information:
Title
Assess whether nCCR training produces change in subjective cognitive complaints breast cancer survivors with CRCI.
Description
Paired samples t-tests will be used to assess FACT-Cog PCI Scores. We hypothesize that nCCR treatment will improve FACT-Cog scores in breast cancer patients with persistent CRCI over 6 weeks of treatment compared to the education control group. The primary measure used to assess subjective cognitive performance was the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) scale and evaluates memory, concentration, mental acuity, verbal fluency, functional interference, and multitasking ability. At baseline and post-treatment visits, participants rated on a 5-point Likert scale how they assessed various aspects of their cognitive functioning over the last 7 days. Higher scores indicate better ratings of cognitive functioning. Higher scores indicate better ratings of cognitive functioning.
Time Frame
6-weeks
Secondary Outcome Measure Information:
Title
Assess whether 6-weeks of nCCR training produces change in cognitive performance on neuropsychological measures in breast cancer survivors with CRCI.
Description
Paired samples t-tests will be used to assess Trail Making Test performance. We hypothesize that nCCR treatment will improve Trail Making Test performance in breast cancer patients with persistent CRCI over 6 weeks of treatment compared to the education control group. The Trail Making Test (TMT) is widely used in both research and clinical settings as a test of some aspects of executive function. Subtracting TMT A completion time from that of TMT B (TMT B-A) is thought to allow the relative contributions of visual search and psychomotor speed to be parsed from the more complex executive functions (such as cognitive flexibility) required to alternate between numbers and letters. Lower scores indicated better cognitive functioning.
Time Frame
6-weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicole T Nguyen, MA
Phone
(615) 327-7030
Email
nicole.tp.nguyen@vumc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer N Vega, PhD
Phone
(615) 327-7030
Email
jennifer.n.vega.1@vumc.org
Facility Information:
Facility Name
Center for Cognitive Medicine at Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicole T Nguyen, MA
Email
nicole.tp.nguyen@vumc.org
First Name & Middle Initial & Last Name & Degree
Jennifer N Vega, PhD
Email
jennifer.n.vega.1@vumc.org
First Name & Middle Initial & Last Name & Degree
Jennifer N Vega, PhD
First Name & Middle Initial & Last Name & Degree
Paul A Newhouse, MD
First Name & Middle Initial & Last Name & Degree
Sarah S Morimoto, PsyD

12. IPD Sharing Statement

Plan to Share IPD
No

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nCCR for Chemotherapy Related Cognitive Impairment Randomized Study

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