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Improve Cancer-related Cognitive Impairment

Primary Purpose

Gynecologic Cancer, Chemotherapy Effect, Chemo-brain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cognitive training application
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Gynecologic Cancer focused on measuring CHEMOTHERAPY SIDE EFFECTS, GYNECOLOGIC CANCERS, CHEMO-BRAIN, CANCER-RELATED COGNITIVE IMPAIRMENT

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion criteria are: newly diagnosed gynecologic malignancy (uterine, cervical, ovarian, primary peritoneal, vulvar, or vaginal) and undergoing chemotherapy own a smartphone or tablet with ability to download cognitive training application and age >21 years old Exclusion criteria include: medical diagnosis of dementia significant underlying mental diagnoses for which they are on more than 1 medication for (patients with depression or anxiety on single-agent therapy will be able to participate age <21

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    OBSERVATION

    MOBILE COGNITIVE TRAINING APP

    Arm Description

    PATIENTS WILL PARTICIPATE IN THE NEUROPSYCHOLOGY EVALUATION BUT WILL NOT USE THE COGNITIVE MOBILE TRAINING APPLICATION.

    These patients will undergo neuropsychology evaluation and use the cognitive mobile training application

    Outcomes

    Primary Outcome Measures

    Neurocognitive function
    Evaluated by the NIH Toolbox of Assessment of Neurologic Behavioral Function
    Neurocognitive function
    Evaluated by the FACT-Cog survey

    Secondary Outcome Measures

    Full Information

    First Posted
    April 11, 2023
    Last Updated
    September 28, 2023
    Sponsor
    University of Alabama at Birmingham
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05864274
    Brief Title
    Improve Cancer-related Cognitive Impairment
    Official Title
    Using a Novel Mobile Cognitive Training Application to Improve Cancer-related Cognitive Impairment in Gynecologic Oncology Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2023 (Anticipated)
    Primary Completion Date
    August 1, 2025 (Anticipated)
    Study Completion Date
    August 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Alabama at Birmingham

    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
    Cancer-related cognitive impairment (CRCI), also known as "chemobrain," is the cognitive decline that negatively impacts the majority of cancer patients undergoing chemotherapy, radiation, and/or hormonal treatments. This application focuses on evaluating if using a cognitive mobile training application can decrease the impact of CRCI in gynecologic oncology patients through a multidisciplinary approach with patients undergoing assessments by our neurocognitive team.
    Detailed Description
    Cancer-related cognitive impairment (CRCI), also known as "chemobrain," is the cognitive decline that negatively impacts the majority of cancer patients undergoing chemotherapy, radiation, and/or hormonal treatments [1]. Occurring in the majority of patients receiving cancer therapy, CRCI adverse events can, unfortunately, be lifelong and significantly affect patients' quality of life [2-4]. Given the increased lifespan of gynecologic oncology cancer patients due to the use of modern therapeutics, increased focus has been placed on evaluating quality of life during and after treatments. CRCI, alternatively known as "chemo brain" or "chemo fog" is a common side effect of cancer therapy. These symptoms frequently include augmentation of clear thinking with memory difficulties that can are very distressing to patients both during treatment and beyond. Despite effecting the majority of cancer patients, CRCI data and research is underrepresented in the gynecologic oncology population. In breast cancer, up to 77% of patient with breast cancer who received chemotherapy reported cognitive symptoms associated with the therapy [9]. In a meta-analysis looking at patient with breast cancer who were treated with chemotherapy, the most effected domains were processing speed and language, executive function, and memory [10]. In general, a significant knowledge gap in gynecologic oncology related CRCI exists as interventions to help improve this frequent and life altering group of side effects have not been evaluated to date. Therefore, to our knowledge, this proposal is the first of its kind in gynecologic oncology patients undergoing cancer therapy. In the dementia literature, mobile applications have been utilized in cognitive training management to improve outcomes in patients [11-13]. Cognitive impairment (CI) is a precursor to dementia and can be defined as mild and major. Mild CI does not yet interfere with instrumental activities of daily living (IADLs) whereas major CI does [14]. In a recent systematic review looking at interventions to delay age-related cognitive decline, it was found that cognitive training and physical activity showed the most promise [15]. One cognitive training application (CTA) showed improvement in cognitive ability following five, fifteen-minute training applications a week for ten weeks [12]. Furthermore, a Cochrane review showed that in a group of randomized non-pharmacologic interventions in women with breast cancer, the use of cognitive training applications may reduce the risk of CRCI [16]. Unfortunately, no data currently exists on CTA use in gynecologic oncology patients. The goal of this study is to evaluate the use of a CTA in gynecologic oncology patients undergoing primary chemotherapy in order to reduce the impact of CRCI.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gynecologic Cancer, Chemotherapy Effect, Chemo-brain, Cancer-related Cognitive Difficulties
    Keywords
    CHEMOTHERAPY SIDE EFFECTS, GYNECOLOGIC CANCERS, CHEMO-BRAIN, CANCER-RELATED COGNITIVE IMPAIRMENT

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    64 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    OBSERVATION
    Arm Type
    No Intervention
    Arm Description
    PATIENTS WILL PARTICIPATE IN THE NEUROPSYCHOLOGY EVALUATION BUT WILL NOT USE THE COGNITIVE MOBILE TRAINING APPLICATION.
    Arm Title
    MOBILE COGNITIVE TRAINING APP
    Arm Type
    Experimental
    Arm Description
    These patients will undergo neuropsychology evaluation and use the cognitive mobile training application
    Intervention Type
    Behavioral
    Intervention Name(s)
    Cognitive training application
    Intervention Description
    Patients will participate with a cognitive training application and undergo neurocognitive testing during and after chemotherapy.
    Primary Outcome Measure Information:
    Title
    Neurocognitive function
    Description
    Evaluated by the NIH Toolbox of Assessment of Neurologic Behavioral Function
    Time Frame
    From initiation of chemotherapy through 2 years
    Title
    Neurocognitive function
    Description
    Evaluated by the FACT-Cog survey
    Time Frame
    From initiation of chemotherapy through 2 years

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    Individuals with gynecologic cancers
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion criteria are: newly diagnosed gynecologic malignancy (uterine, cervical, ovarian, primary peritoneal, vulvar, or vaginal) and undergoing chemotherapy own a smartphone or tablet with ability to download cognitive training application and age >21 years old Exclusion criteria include: medical diagnosis of dementia significant underlying mental diagnoses for which they are on more than 1 medication for (patients with depression or anxiety on single-agent therapy will be able to participate age <21
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Teresa K Boitano, MD
    Phone
    2059344986
    Email
    tlboitano@uabmc.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Rebecca Arend, MD
    Email
    rarend@uabmc.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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