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Neuroplasticity-Based Cognitive Remediation for Chemotherapy-Related Cognitive Impairment

Primary Purpose

Cancer Survivors, Chemotherapy-related Cognitive Impairment

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

About this trial

This is an interventional treatment trial for Cancer Survivors 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
  1. Inclusion Criteria:

    All participants will:

    1. Be between 35 and 80 years of age,
    2. Have been diagnosed with noninvasive or invasive (Stage 1, 2, or 3A) breast cancer, colon cancer, lymphoma, endometrial cancer or ovarian cancer
    3. Have undergone treatment with systemic chemotherapy within the last 1-8 years,
    4. Endorse persistent CRCI subjective complaints (as defined below),
    5. Have no active cardiac, neurologic, or psychiatric illness,
    6. Fluent in and able to read English.
  2. Exclusion Criteria:

Participants will be excluded for:

  1. Any active neurologic psychiatric disease, clinically significant cognitive impairment or dementia, history of significant head trauma followed by persistent neurologic deficits, or known structural brain abnormalities,
  2. Current major depression or another major psychiatric disorder as described in DSM-5 (use of CNS active medications (e.g. antidepressants) will be permitted, provided dosing has been stable for at least 3 months),
  3. Any history of alcohol or substance abuse or dependence within the past 2 years (DSM-5 criteria),
  4. Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the protocol.
  5. Use of any investigational drugs within 30 days or 5 half-lives, whichever is longer, prior to screening, and
  6. Use of cholinergic agents will be discouraged but will be reviewed on a case-by-case basis by the PI.
  7. Red-green color blindness. Other types of color blindness will be reviewed on a case-by-case basis by the PI.

Sites / Locations

  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Neuroplasticity-based Computerized Cognitive Remediation

Arm Description

Participants will receive a 45-hour of Neuroplasticity-based Computerized Cognitive Remediation.

Outcomes

Primary Outcome Measures

Evaluate completion rates of nCCR
Assess the percentage of enrolled participants who completed of the 40-hour nCCR treatment
Evaluate visit frequency throughout nCCR treatment
Assess the frequency of visits during nCCR treatment
Evaluate visit duration throughout nCCR treatment
Assess the duration of visits during nCCR treatment

Secondary Outcome Measures

Full Information

First Posted
January 10, 2020
Last Updated
October 4, 2021
Sponsor
Vanderbilt University Medical Center
Collaborators
University of Utah
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1. Study Identification

Unique Protocol Identification Number
NCT04230863
Brief Title
Neuroplasticity-Based Cognitive Remediation for Chemotherapy-Related Cognitive Impairment
Official Title
Neuroplasticity-Based Cognitive Remediation for Chemotherapy-Related Cognitive Impairment
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
February 17, 2020 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)

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
Advances in cancer treatment are producing a growing number of cancer survivors; therefore, issues surrounding quality of life during and following cancer treatment have become increasingly important. Chemotherapy-related cognitive impairment (CRCI) is one such quality of life issue that is commonly reported following chemotherapy treatment in adults. Although studies reporting cognitive impairments associated with chemotherapy have been reported since the 1980s, the phenomenon commonly referred to as 'chemo brain' or 'chemo fog' is poorly understood, and for some patients becomes the most distressful survivorship issue faced. Studies suggest that while up to up to 75% exhibit cognitive decline during treatment, many patients will return to their pre-chemo level of functioning 1 year after completing treatment. However, for 30-35% of cancer patients, their cognitive issues persist. Studies suggest that this persistent chemotherapy-related cognitive impairment (pCRCI) can remain for months to years after completing treatment, which may have implications for the trajectory of how both normal cognitive aging occurs, but also the risk of cognitive disorders such as Alzheimer's disease, for the growing number of long-term cancer survivors. These concerns are particularly relevant for older individuals as risk for not only cancer, but cognitive impairment (such as dementia) increases with age. As of January 2016, 62% of cancer survivors (9.61 million) are currently 65 years or older, and this number is expected to increase dramatically over the coming decades. Therefore, as the number of older cancer survivors who have will have to cope with pCRCI is likely to increase, it is crucial that The investigators understand the cognitive impairments, the impact on survivors' functioning, and develop treatments for pCRCI. The investigators propose to target cognitive deficit in CRCI using a novel cognitive enhancement strategy. Our choice of cognitive focus is informed by clinical, behavioral and neurobiological data suggesting a reliable association between cognitive control deficits (CCD), damage to the cognitive control network (CCN), and decline in cognitive functioning. The CCN is a neural network that supports important cognitive control functions such as alerting and orienting attention, response selection, cognitive flexibility, strategy generation, and inhibition of prepotent responses. The investigators propose to apply neuroplasticity-based computerized cognitive remediation (nCCR) to the treatment of CRCI as it has demonstrated training and transfer effects of enhanced CCN function in a similar, abnormally aging population. The theory guiding neuroplasticity-based cognitive interventions is that network abnormalities associated with negative disease-specific clinical outcomes can be altered through the induction of neuroplasticity (even in the aging brain) resulting in enhanced functioning of the target network, and symptomatic improvements.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer Survivors, 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
Single Group Assignment
Model Description
A single-arm, open label design; All analyses are pre-post, with participants serving as their own controls.
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neuroplasticity-based Computerized Cognitive Remediation
Arm Type
Experimental
Arm Description
Participants will receive a 45-hour of Neuroplasticity-based Computerized Cognitive Remediation.
Intervention Type
Behavioral
Intervention Name(s)
Neuroplasticity-based Computerized Cognitive Remediation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Evaluate completion rates of nCCR
Description
Assess the percentage of enrolled participants who completed of the 40-hour nCCR treatment
Time Frame
2 years
Title
Evaluate visit frequency throughout nCCR treatment
Description
Assess the frequency of visits during nCCR treatment
Time Frame
through study completion, an average of 5 weeks.
Title
Evaluate visit duration throughout nCCR treatment
Description
Assess the duration of visits during nCCR treatment
Time Frame
through study completion, an average of 5 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: Be between 35 and 80 years of age, Have been diagnosed with noninvasive or invasive (Stage 1, 2, or 3A) breast cancer, colon cancer, lymphoma, endometrial cancer or ovarian cancer Have undergone treatment with systemic chemotherapy within the last 1-8 years, Endorse persistent CRCI subjective complaints (as defined below), Have no active cardiac, neurologic, or psychiatric illness, Fluent in and able to read English. Exclusion Criteria: Participants will be excluded for: Any active neurologic psychiatric disease, clinically significant cognitive impairment or dementia, history of significant head trauma followed by persistent neurologic deficits, or known structural brain abnormalities, Current major depression or another major psychiatric disorder as described in DSM-5 (use of CNS active medications (e.g. antidepressants) will be permitted, provided dosing has been stable for at least 3 months), Any 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, and Use of cholinergic agents will be discouraged but will be reviewed on a case-by-case basis by the PI. Red-green color blindness. Other types of color blindness will be reviewed on a case-by-case basis by the PI.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul A Newhouse, MD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Neuroplasticity-Based Cognitive Remediation for Chemotherapy-Related Cognitive Impairment

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