Recruiting

Cognitive Training

Sponsor:

University of Alabama at Birmingham

Code:

NCT05864274

Conditions

Gynecologic Cancer

Chemotherapy Effect

Chemo-brain

Cancer-related Cognitive Difficulties

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Cognitive training application

Study Details

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.

Conditions

Gynecologic Cancer

Chemotherapy Effect

Chemo-brain

Cancer-related Cognitive Difficulties

Study ID

NCT05864274

Start date

Sep 1, 2024

Status verified date

Nov, 2025

Completion date

Aug 1, 2027

Anticipated

Primary completion date

Aug 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

64 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

no intervention: OBSERVATION

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

experimental: MOBILE COGNITIVE TRAINING APP

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

Interventions

Cognitive training application

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

Primary outcome measure

  • Neurocognitive function [ Time Frame: From initiation of chemotherapy through 2 years ]
  • Neurocognitive function [ Time Frame: From initiation of chemotherapy through 2 years ]

Central Contacts and Locations

Central contacts

Teresa K Boitano, MD

2059344986tlboitano@uabmc.edu

Rebecca Arend, MD

rarend@uabmc.edu

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Teresa KL Boitano, MD

205-934-0462tlboitano@uabmc.edu

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Nov 24, 2025

Last verified

Nov, 2025

Keywords

  • CHEMOTHERAPY SIDE EFFECTS
  • GYNECOLOGIC CANCERS
  • CHEMO-BRAIN
  • CANCER-RELATED COGNITIVE IMPAIRMENT

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2025-11-24.