NCT05864274

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
15mo left

Started Sep 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress58%
Sep 2024Aug 2027

First Submitted

Initial submission to the registry

April 11, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 18, 2023

Completed
1.3 years until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

November 24, 2025

Status Verified

November 1, 2025

Enrollment Period

2.9 years

First QC Date

April 11, 2023

Last Update Submit

November 18, 2025

Conditions

Gynecologic CancerChemotherapy EffectChemo-brainCancer-related Cognitive Difficulties

Keywords

CHEMOTHERAPY SIDE EFFECTSGYNECOLOGIC CANCERSCHEMO-BRAINCANCER-RELATED COGNITIVE IMPAIRMENT

Outcome Measures

Primary Outcomes (2)

  • Neurocognitive function

    Evaluated by the NIH Toolbox of Assessment of Neurologic Behavioral Function

    From initiation of chemotherapy through 2 years

  • Neurocognitive function

    Evaluated by the FACT-Cog survey

    From initiation of chemotherapy through 2 years

Study Arms (2)

OBSERVATION

NO INTERVENTION

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

MOBILE COGNITIVE TRAINING APP

EXPERIMENTAL

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

Device: Cognitive training application

Interventions

Cognitive training applicationDEVICE

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

Also known as: study
MOBILE COGNITIVE TRAINING APP

Eligibility Criteria

Age18 Years - 90 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsIndividuals with gynecologic cancers
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

RECRUITING

Central Study Contacts

Teresa K Boitano, MD

CONTACT

2059344986tlboitano@uabmc.edu

Rebecca Arend, MD

CONTACT

rarend@uabmc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 11, 2023

First Posted

May 18, 2023

Study Start

September 1, 2024

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

November 24, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)