Effects of Computer-Assisted Cognitive Rehabilitation Programs With Breast Cancer Survivors

NCT ID: NCT04027400

Last Updated: 2019-08-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-26
• Study Completion Date: 2020-02-26

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.

Detailed Description

Potential study participants will be recruited using a recruitment script and recruitment brochure at breast cancer survivor support groups. Participants recruited to the study will be contacted to set up a pre-test data collection session. Prior to any testing, informed consent will be obtained with a form approved by the TWU IRB. After informed consent is obtained participants will complete tests of Digit Span Task, FACT-Cognitive Function (Version 3), Quality of Life Patient/Cancer Survivor Version and Engagement in Meaningful Activities Survey, and issued a tablet if they prefer. 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. 6. At the end of the study, the four pretests will be repeated, a satisfaction survey administered, and any issued tablets collected. Pre and post testing, obtaining of written consent, and issuing and returning a tablet will occur at the support group location. If this location is not available, they will occur at TWU in a quiet room. If TWU is not convenient to the participant, a quiet location that is suitable to maintain confidentiality for the participant will be chosen in collaboration with the participant.

Conditions

Cognitive Impairment; Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Primarily visual computer exercises

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

Group Type: ACTIVE_COMPARATOR

computer-assisted rehabilitation

Intervention Type: BEHAVIORAL

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.

Visual+Audio

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

Group Type: EXPERIMENTAL

computer-assisted rehabilitation

Intervention Type: BEHAVIORAL

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.

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

visual and audio computer exercises

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Texas Woman's University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Theresa M Smith, PhD

Role: PRINCIPAL_INVESTIGATOR

Associate Professor

Locations

Texas Woman's University

Houston, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Tracy Lindsay

Role: CONTACT

TLindsay@twu.edu

940 898-3377

Donna Tilley

Role: CONTACT

940-898-3401

Facility Contacts

Theresa M Smith, PhD

Role: primary

tsmith12@twu.edu

504-583-0295

Other Identifiers

19959

Identifier Type: -

Identifier Source: org_study_id