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

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ClinicalTrials.gov Identifier: NCT04027400
Recruitment Status : Unknown
Verified August 2019 by Texas Woman's University.
Recruitment status was:  Recruiting
First Posted : July 22, 2019
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
Texas Woman's University

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.

Condition or disease Intervention/treatment Phase
Cognitive Impairment Breast Cancer Behavioral: computer-assisted rehabilitation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: two groups with different treatment
Masking: Single (Participant)
Masking Description: Participants never told which group they were in.
Primary Purpose: Treatment
Official Title: Effects of Computer-Assisted Cognitive Rehabilitation Programs With Breast Cancer Survivors
Actual Study Start Date : February 26, 2018
Estimated Primary Completion Date : February 25, 2020
Estimated Study Completion Date : February 26, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Primarily visual computer exercises
Participant performs 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.
Other Name: visual and audio computer exercises

Experimental: Visual+Audio
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.
Other Name: visual and audio computer exercises




Primary Outcome Measures :
  1. Digit span [ Time Frame: 10 minutes ]
    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).

  2. FACT-COG [ Time Frame: 10 minutes ]
    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)

  3. CANCER PATIENT/CANCER SURVIVOR VERSION [ Time Frame: 10 minutes ]
    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

  4. EMAS [ Time Frame: 10 minutes ]
    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.


Secondary Outcome Measures :
  1. Satisfaction Survey [ Time Frame: 5 minutes ]
    3 questions delivered post intervention on participant satisfaction with being in the study.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04027400


Contacts
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Contact: Tracy Lindsay 940 898-3377 TLindsay@twu.edu
Contact: Donna Tilley 940-898-3401

Locations
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United States, Texas
Texas Woman's University Recruiting
Houston, Texas, United States, 77030
Contact: Theresa M Smith, PhD    504-583-0295    tsmith12@twu.edu   
Sponsors and Collaborators
Texas Woman's University
Investigators
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Principal Investigator: Theresa M Smith, PhD Associate Professor
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Responsible Party: Texas Woman's University
ClinicalTrials.gov Identifier: NCT04027400    
Other Study ID Numbers: 19959
First Posted: July 22, 2019    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Texas Woman's University:
survivor
cognitive rehabilitation
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases