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Cognitive Training for Cancer Related Cognitive Impairment in Breast Cancer Survivors

Primary Purpose

Breast Cancer, Cognitive Impairments

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Arm 1: Attention Control
Arm 2: Computerized Training (BrainHQ)
Sponsored by
NRG Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Cancer

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: The participant must provide study-specific informed consent prior to any study specific procedures and authorization permitting release of personal health information. The participant must have a first time diagnosis of non-metastatic breast cancer which is Stage I-III. The participant must have a score of less than 12 on the PROMIS Adult v2.0 - Cognitive Function 4a. Participants with greater than or equal to 6 months to 5 years post-treatment (completion of initial surgery +/- adjuvant chemotherapy/radiation therapy) except may still be taking endocrine therapy or HER2-directed adjuvant therapy. The participant must be able to understand, speak, read, and write in English or Spanish. Exclusion Criteria: Scoring less than or equal to 3 on the 6-item cognitive screen. Patient Health Questionnaire-2 item (PHQ-2) score of greater than or equal to 3. Definitive clinical or radiologic evidence of metastatic disease. Prior history of past or current other cancer, except for non-melanoma skin cancer or in situ cervical cancer within the past 5 years. Previous exposure to chemotherapy treatment for another cancer or due to other medical condition (e.g. methotrexate exposure for treatment of rheumatoid arthritis). Previous central nervous system (CNS) radiation, intrathecal therapy or CNS-involved surgery. Participants with history of stroke, traumatic brain injury, brain surgery, Alzheimer's disease or other dementia. Participants with active substance abuse and/or in treatment for substance abuse, or history of bipolar disorder, psychosis, schizophrenia, ADHD, or learning disability.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Arm 1: Attention Control

    Arm 2: Computerized Cognitive Training (BrainHQ)

    Arm Description

    The computerized active attention control intervention is composed of computerized games. The computerized active attention control games are fully developed and are rated E (for everyone) by the Entertainment Software Rating Board. The program will present 8 non-speeded exercises that include spin-offs of such games as breaking hex, lineup four, battleship, gems swap, double klondike, solitaire, reversi, word search, and sudoku.

    BrainHQ provides core elements necessary for inducing neuroplasticity. The five core elements include the principles of speed of processing, accuracy of processing, adaptivity, generalizability, and engagement. Importantly, all of the exercises adapt to user skill and ability. Behavioral tracking built within the program is used to monitor individual performance and ensure that the person is training at their uppermost threshold level. Specifically, we will use eight BrainHQ exercises which are designed to address cognitive concerns most noted in BCS including exercises to improve attention and working memory, processing speed, and executive function.

    Outcomes

    Primary Outcome Measures

    Self-reported perceived cognitive impairment measured-post intervention
    FACT-Cog PCI scale score (Functional Assessment of Cancer Therapy-Cognitive Function-perceived cognitive impairment)

    Secondary Outcome Measures

    Self-reported perceived cognitive impairment measured over time
    FACT-Cog PCI scale score (Functional Assessment of Cancer Therapy-Cognitive Function-perceived cognitive impairment)
    Objectively measured cognitive performance measured over time
    Processing speed score as measured by Telephone-Based Assessment of Neuropsychological Status (TBANS) Symbol Digit Modalities Test

    Full Information

    First Posted
    May 31, 2023
    Last Updated
    May 31, 2023
    Sponsor
    NRG Oncology
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05896189
    Brief Title
    Cognitive Training for Cancer Related Cognitive Impairment in Breast Cancer Survivors
    Official Title
    Cognitive Training for Cancer Related Cognitive Impairment in Breast Cancer Survivors: A Multi-Center Randomized Double-Blinded Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2023 (Anticipated)
    Primary Completion Date
    September 30, 2027 (Anticipated)
    Study Completion Date
    September 30, 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    NRG Oncology
    Collaborators
    National Cancer Institute (NCI)

    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
    This Phase III trial will examine the efficacy of computerized cognitive training (Brain HQ) compared to the attention control on perceived cognitive impairment post intervention as measured by the FACT-Cog PCI scale.
    Detailed Description
    The goal of this trial is to determine the efficacy of advanced cognitive training for cancer survivors suffering from cancer- and cancer-treatment-related cognitive dysfunction. For millions of cancer survivors, cognitive dysfunction is a prevalent, severe, and persistent problem that has long been associated with poor work-related and health-related outcomes. Evidence suggests that a significant subset of breast cancer survivors (BCS) incur cognitive changes that may persist for years after treatment. Unfortunately, the scientific basis for managing these cognitive changes is extremely limited. Available evidence from pilot studies, including our work, suggests that advanced cognitive training, which is based on the principles of neuroplasticity (ability of brain neurons to re-organize and form new neural networks), may be a viable treatment option. However, previous trials to date have been limited by lack of attention-controlled designs, small samples of BCS, or limited outcome measures. Therefore, to overcome limitations of past studies and build on our pilot results, the purpose of this 2-group, double-blind, randomized controlled trial is to conduct a full-scale efficacy trial to compare advanced cognitive training to attention control in BCS.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Cancer, Cognitive Impairments

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Arm 1: Attention Control
    Arm Type
    Active Comparator
    Arm Description
    The computerized active attention control intervention is composed of computerized games. The computerized active attention control games are fully developed and are rated E (for everyone) by the Entertainment Software Rating Board. The program will present 8 non-speeded exercises that include spin-offs of such games as breaking hex, lineup four, battleship, gems swap, double klondike, solitaire, reversi, word search, and sudoku.
    Arm Title
    Arm 2: Computerized Cognitive Training (BrainHQ)
    Arm Type
    Experimental
    Arm Description
    BrainHQ provides core elements necessary for inducing neuroplasticity. The five core elements include the principles of speed of processing, accuracy of processing, adaptivity, generalizability, and engagement. Importantly, all of the exercises adapt to user skill and ability. Behavioral tracking built within the program is used to monitor individual performance and ensure that the person is training at their uppermost threshold level. Specifically, we will use eight BrainHQ exercises which are designed to address cognitive concerns most noted in BCS including exercises to improve attention and working memory, processing speed, and executive function.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Arm 1: Attention Control
    Intervention Description
    The program will includes 8 non-speeded exercises that include spin-offs of such games as breaking hex, lineup four, battleship, gems swap, double klondike, solitaire, reversi, word search, and sudoku. These games are well matched for time on task, novelty, and progression across levels. These are strategy-based games without adaptive, speeded, or accuracy-based algorithms underlying their personalization.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Arm 2: Computerized Training (BrainHQ)
    Intervention Description
    Cognitive training exercises include Double Decision (targets visual speed of processing and useful field of view), Target Tracker (targets visuospatial working memory capacity), Visual Sweeps (targets speed of processing), Syllable Stacks (targets auditory memory), Eye for Detail (targets eye movement speed and visuo-spatial working memory), Mind Bender (targets mental flexibility), Divided Attention (a shape-color-pattern inhibitory control exercise that focuses on rapidly determining whether flashing colors, shapes, or patterns meet a pre-specified rule), Right Turn (targets spatial reasoning).
    Primary Outcome Measure Information:
    Title
    Self-reported perceived cognitive impairment measured-post intervention
    Description
    FACT-Cog PCI scale score (Functional Assessment of Cancer Therapy-Cognitive Function-perceived cognitive impairment)
    Time Frame
    12 weeks from randomization
    Secondary Outcome Measure Information:
    Title
    Self-reported perceived cognitive impairment measured over time
    Description
    FACT-Cog PCI scale score (Functional Assessment of Cancer Therapy-Cognitive Function-perceived cognitive impairment)
    Time Frame
    36 weeks from randomization
    Title
    Objectively measured cognitive performance measured over time
    Description
    Processing speed score as measured by Telephone-Based Assessment of Neuropsychological Status (TBANS) Symbol Digit Modalities Test
    Time Frame
    36 weeks from randomization

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: The participant must provide study-specific informed consent prior to any study specific procedures and authorization permitting release of personal health information. The participant must have a first time diagnosis of non-metastatic breast cancer which is Stage I-III. The participant must have a score of less than 12 on the PROMIS Adult v2.0 - Cognitive Function 4a. Participants with greater than or equal to 6 months to 5 years post-treatment (completion of initial surgery +/- adjuvant chemotherapy/radiation therapy) except may still be taking endocrine therapy or HER2-directed adjuvant therapy. The participant must be able to understand, speak, read, and write in English or Spanish. Exclusion Criteria: Scoring less than or equal to 3 on the 6-item cognitive screen. Patient Health Questionnaire-2 item (PHQ-2) score of greater than or equal to 3. Definitive clinical or radiologic evidence of metastatic disease. Prior history of past or current other cancer, except for non-melanoma skin cancer or in situ cervical cancer within the past 5 years. Previous exposure to chemotherapy treatment for another cancer or due to other medical condition (e.g. methotrexate exposure for treatment of rheumatoid arthritis). Previous central nervous system (CNS) radiation, intrathecal therapy or CNS-involved surgery. Participants with history of stroke, traumatic brain injury, brain surgery, Alzheimer's disease or other dementia. Participants with active substance abuse and/or in treatment for substance abuse, or history of bipolar disorder, psychosis, schizophrenia, ADHD, or learning disability.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Director Regulatory Affairs
    Phone
    412-339-5300
    Email
    langerj@nrgoncology.org
    First Name & Middle Initial & Last Name or Official Title & Degree
    Norman Wolmark, MD

    12. IPD Sharing Statement

    Learn more about this trial

    Cognitive Training for Cancer Related Cognitive Impairment in Breast Cancer Survivors

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