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

Texas Woman's University

Status: Unknown

Conditions: Breast Cancer; Cognitive Impairment

Treatments: Behavioral: computer-assisted rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT04027400

19959

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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52 participants in 2 patient groups

Primarily visual computer exercises

Active Comparator group

Description:

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

Treatment:

Behavioral: computer-assisted rehabilitation

Visual+Audio

Experimental group

Description:

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

Treatment:

Behavioral: computer-assisted rehabilitation