An interventional study of computer-assisted rehabilitation in Cognitive Impairment and Breast Cancer, sponsored by Texas Woman's University. Status unknown at 1 site in United States. Open to participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-13.
Sponsored by Texas Woman's University · Not applicable, Interventional, and Treatment
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.
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 52 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Texas Woman's University is the lead sponsor of 82 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
Participant performs visual computer exercises 30 minutes a day, five days a week for one month.
Behavioral: computer-assisted rehabilitation
Participant performs audio computer exercises and some visual computer exercises 30 minutes a day, five days a week for one month
Behavioral: 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.
Also known as: visual and audio computer exercises
Digit span
Working memory was measured by the digit span, shown to discriminate between BCS and controls.19 It takes approximately 10 minutes to administer and has high reliability (.891) for forward span and low for backwards span (.598).
Time frame: 10 minutes
FACT-COG
The FACT-COG contains 4 subscales of perceived cognitive impairment, comments from others, perceived cognitive abilities, and impact of cognition on quality of life which are summed to provide a score. Fact-Cog demonstrates acceptable test-retest reliability (.707) and validity (.762)
Time frame: 10 minutes
CANCER PATIENT/CANCER SURVIVOR VERSION
Quality of life as it relates to cancer survival, was measured with the 41 item Quality of Life Instrument (CANCER PATIENT/CANCER SURVIVOR VERSION).21 The overall QOL-CS tool test re-test reliability is .89
Time frame: 10 minutes
EMAS
Frequency of engagement in meaningful activities was assessed with the Engagement in Meaningful Activities Survey (EMAS) to calculate how often a subject participates in 12 activities.
Time frame: 10 minutes
Satisfaction Survey
3 questions delivered post intervention on participant satisfaction with being in the study.
Time frame: 5 minutes
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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