Cancer SurvivorsNCT04230863
Neuroplasticity-Based Cognitive Remediation for Chemotherapy-Related Cognitive Impairment
A study testing Neuroplasticity-based Computerized Cognitive Remediation in people with Cancer Survivors and Chemotherapy-related Cognitive Impairment, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
The investigators propose to apply neuroplasticity-based computerized cognitive remediation (nCCR) to treat chemotherapy-related cognitive impairment (CRCI). Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Cancer Survivors, Chemotherapy-related Cognitive Impairment
- What is being tested?
- Neuroplasticity-based Computerized Cognitive Remediation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Feb 2020to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
About this study
The investigators propose to apply neuroplasticity-based computerized cognitive remediation (nCCR) to treat chemotherapy-related cognitive impairment (CRCI).
Read the 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.
- Being tested
- Neuroplasticity-based Computerized Cognitive Remediation
- Keywords
- Chemotherapy, Cognitive Impairment, neuroplasticity-based computerized cognitive remediation, nCCR
- Medical subject headings
- Chemotherapy-Related Cognitive Impairment, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuroplasticity-based Computerized Cognitive RemediationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Neuroplasticity-based Computerized Cognitive Remediation | Experimental | Participants will receive a 45-hour of Neuroplasticity-based Computerized Cognitive Remediation. Receives: Behavioral: Neuroplasticity-based Computerized Cognitive Remediation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate completion rates of nCCR
Assess the percentage of enrolled participants who completed of the 40-hour nCCR treatment
Measured: 2 years
Evaluate visit frequency throughout nCCR treatment
Assess the frequency of visits during nCCR treatment
Measured: through study completion, an average of 5 weeks.
Evaluate visit duration throughout nCCR treatment
Assess the duration of visits during nCCR treatment
Measured: through study completion, an average of 5 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start17 Feb 2020
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer SurvivorsStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A single-arm, open label design; All analyses are pre-post, with participants serving as their own controls.
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Utah
- Responsible party
- Principal investigator, Paul Newhouse, Vanderbilt University Medical Center
- Investigators
- Paul A Newhouse, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04230863
- Sponsor's protocol ID
- 191394
- Status last verified
- Oct 2021
- First submitted
- 10 Jan 2020
- Last updated
- 5 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroplasticity-Based Cognitive Remediation for Chemotherapy-Related Cognitive Impairment
- ClinicalTrials.gov ID
- NCT04230863
- Acronym / sponsor ID
- 191394
- Keywords
- Chemotherapy, Cognitive Impairment, neuroplasticity-based computerized cognitive remediation, nCCR
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- University of Utah
- Study start
- 17 Feb 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 18 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A single-arm, open label design; All analyses are pre-post, with participants serving as their own controls.
| Arm | Type | Receives |
|---|---|---|
| Neuroplasticity-based Computerized Cognitive Remediation | Experimental | Behavioral: Neuroplasticity-based Computerized Cognitive RemediationParticipants will receive a 45-hour of Neuroplasticity-based Computerized Cognitive Remediation. |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuroplasticity-based Computerized Cognitive RemediationThe 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. | Behavioural | Neuroplasticity-based Computerized Cognitive Remediation |
Primary outcome
Evaluate completion rates of nCCR
Time frame: 2 years
Assess the percentage of enrolled participants who completed of the 40-hour nCCR treatment
Evaluate visit frequency throughout nCCR treatment
Time frame: through study completion, an average of 5 weeks.
Assess the frequency of visits during nCCR treatment
Evaluate visit duration throughout nCCR treatment
Time frame: through study completion, an average of 5 weeks.
Assess the duration of visits during nCCR treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2021.
- Individual participant dataSharing planned: No
Related trials for Cancer Survivors
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
Recruiting
Study of a Support Program for Quality of Life in Chinese Cancer Patients and Survivors
Cancer, Survivorship
RecruitingPhase 3
Evaluating Whether an Educational Website Called Current Together After Cancer (CTAC) Improves Follow-up Care for Colorectal Cancer Survivors
Colorectal Cancer Stage II, Colorectal Cancer Stage III
Recruiting
Facial Expression Awareness Training to Understand and Recognize Emotions
Survivors of Pediatric Brain Tumors, Pediatric Cancer
Recruiting
High-Intensity Interval Exercise in Young Adult Survivors of Pediatric Brain Tumors: A Pilot Feasibility Study
Pediatric Brain Tumor
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul A Newhouse, MD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuroplasticity-based Computerized Cognitive Remediation in people with Cancer Survivors and Chemotherapy-related Cognitive Impairment, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate completion rates of nCCR (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2021.