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NCT Number: NCT05864274

Improve Cancer-related Cognitive Impairment

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.

Recruiting

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Key information

Age range

18 year–90 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location status: Recruiting

Location contact

Teresa KL Boitano, MD

CONTACT

[email protected]

205-934-0462

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive training application

Device

Patients will participate with a cognitive training application and undergo neurocognitive testing during and after chemotherapy.

Other names: study

Primary outcomes

  1. Neurocognitive function

    Time frame: From initiation of chemotherapy through 2 years

    Evaluated by the NIH Toolbox of Assessment of Neurologic Behavioral Function

  2. Neurocognitive function

    Time frame: From initiation of chemotherapy through 2 years

    Evaluated by the FACT-Cog survey

Study contacts

Contact information is provided by the study sponsor or research team.

Rebecca Arend, MD

CONTACT

[email protected]

Teresa K Boitano, MD

CONTACT

[email protected]

2059344986

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

Using a Novel Mobile Cognitive Training Application to Improve Cancer-related Cognitive Impairment in Gynecologic Oncology Patients

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
May 18, 2023
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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