Recruiting

Cognitive Rehabilitation

Sponsor:

Texas Woman's University

Code:

NCT04027400

Conditions

Cognitive Impairment

Breast Cancer

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

computer-assisted rehabilitation

Study Details

Brief summary:

Potential study participants will be recruited at breast cancer survivor support groups. Informed consent will be obtained with a form approved by the TWU IRB and participants will complete 4 tests. Then participants will be randomly assigned to one of two computer-assisted cognitive programs. Participants will be sent by email, exercises specific to their assigned computer-assisted cognitive program from Happyneuron Pro (http://ie.scientificbraintrainingpro.eu/). Cognitive training on the computer entails 30 minutes a day, five times a week for one month. At the end of the study, the four pretests will be repeated, a satisfaction survey administered.

Conditions

Cognitive Impairment

Breast Cancer

Study ID

NCT04027400

Start date

Feb 26, 2018

Status verified date

Aug, 2019

Completion date

Feb 26, 2020

Anticipated

Primary completion date

Feb 25, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • study participant self-identifies as breast cancer survivor
  • had treatment that may have included surgery, chemotherapy, radiation, pharmacological or any combination of these treatments
  • participant states has cognitive problems due to cancer treatment

Exclusion Criteria:

  • persons who cannot read or understand spoken English
  • have disorders that may affect their cognition including major mental disorder, central nervous system disorders, Alzheimer's disease, dementia, developmental delay, traumatic brain injury, or cerebrovascular accident.

Study Design

Enrollment

52 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Primarily visual computer exercises

Participant performs visual computer exercises 30 minutes a day, five days a week for one month.

experimental: Visual+Audio

Participant performs audio computer exercises and some visual computer exercises 30 minutes a day, five days a week for one month

Interventions

computer-assisted rehabilitation

Participant is presented with 10 exercises a day, 3 minutes each. When participant achieves 100% accuracy of the exercise, he/she gets a higher level of exercise. Levels of range from 1-9. Exercises are changed every week by researcher.

Primary outcome measure

  • Digit span [ Time Frame: 10 minutes ]
  • FACT-COG [ Time Frame: 10 minutes ]
  • CANCER PATIENT/CANCER SURVIVOR VERSION [ Time Frame: 10 minutes ]
  • EMAS [ Time Frame: 10 minutes ]

Central Contacts and Locations

Central contacts

Tracy Lindsay

940 898-3377TLindsay@twu.edu

Donna Tilley

940-898-3401

Locations

Texas Woman's University

Recruiting

Houston, Texas, United States, 77030

Contacts

Theresa M Smith, PhD

504-583-0295tsmith12@twu.edu

More Information

Sponsor

Texas Woman's University

Last update posted

Aug 13, 2019

Last verified

Aug, 2019

Keywords

  • survivor
  • cognitive rehabilitation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Texas Woman's University on 2019-08-13.