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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04027400
• Other study ID #: 19959
• Status: Recruiting
• Phase: N/A
• Start date: February 26, 2018
• Est. completion date: February 26, 2020

Study information

• Verified date: August 2019
• Source: Texas Woman's University
• Contact: Tracy Lindsay
• Phone: 940 898-3377
• Email: TLindsay[@]twu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: February 26, 2020
• Est. primary completion date: February 25, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Cognitive Dysfunction
• Cognitive Impairment

Intervention

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.

Locations

Country	Name	City	State
United States	Texas Woman's University	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Texas Woman's University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	10 minutes
Primary	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)	10 minutes
Primary	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	10 minutes
Primary	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.	10 minutes
Secondary	Satisfaction Survey	3 questions delivered post intervention on participant satisfaction with being in the study.	5 minutes