Clinical trial NCT04027400: Effects of Computer-Assisted Cognitive Rehabilitation Programs With Breast Cancer Survivors
Official title: Effects of Computer-Assisted Cognitive Rehabilitation Programs With Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cognitive Impairment
Breast Cancer
Keywords: survivor
cognitive rehabilitation
Lead sponsor: Texas Woman's University
Sponsor class: OTHER
First posted: 2019-07-22
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two groups with different treatment
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Digit span
timeFrame: 10 minutes
measure: FACT-COG
timeFrame: 10 minutes
measure: CANCER PATIENT/CANCER SURVIVOR VERSION
timeFrame: 10 minutes
measure: EMAS
timeFrame: 10 minutes
Secondary outcomes:
measure: Satisfaction Survey
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Houston
country: United States
facility: Texas Woman's University
state: Texas
Study officials:
affiliation: Associate Professor
name: Theresa M Smith, PhD
role: PRINCIPAL_INVESTIGATOR
References: