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

Primary Purpose

Cognitive Impairment, Breast Cancer

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
computer-assisted rehabilitation
Sponsored by
Texas Woman's University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cognitive Impairment focused on measuring survivor, cognitive rehabilitation

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Texas Woman's UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Primarily visual computer exercises

Visual+Audio

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).
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)
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
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.

Secondary Outcome Measures

Satisfaction Survey
3 questions delivered post intervention on participant satisfaction with being in the study.

Full Information

First Posted
July 17, 2019
Last Updated
August 9, 2019
Sponsor
Texas Woman's University
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1. Study Identification

Unique Protocol Identification Number
NCT04027400
Brief Title
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

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 26, 2018 (Actual)
Primary Completion Date
February 25, 2020 (Anticipated)
Study Completion Date
February 26, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Texas Woman's University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Impairment, Breast Cancer
Keywords
survivor, cognitive rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
two groups with different treatment
Masking
Participant
Masking Description
Participants never told which group they were in.
Allocation
Randomized
Enrollment
52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Primarily visual computer exercises
Arm Type
Active Comparator
Arm Description
Participant performs visual computer exercises 30 minutes a day, five days a week for one month.
Arm Title
Visual+Audio
Arm Type
Experimental
Arm Description
Participant performs audio computer exercises and some visual computer exercises 30 minutes a day, five days a week for one month
Intervention Type
Behavioral
Intervention Name(s)
computer-assisted rehabilitation
Other Intervention Name(s)
visual and audio computer exercises
Intervention Description
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.
Primary Outcome Measure Information:
Title
Digit span
Description
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
Title
FACT-COG
Description
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
Title
CANCER PATIENT/CANCER SURVIVOR VERSION
Description
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
Title
EMAS
Description
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
Secondary Outcome Measure Information:
Title
Satisfaction Survey
Description
3 questions delivered post intervention on participant satisfaction with being in the study.
Time Frame
5 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tracy Lindsay
Phone
940 898-3377
Email
TLindsay@twu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Donna Tilley
Phone
940-898-3401
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Theresa M Smith, PhD
Organizational Affiliation
Associate Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Texas Woman's University
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Theresa M Smith, PhD
Phone
504-583-0295
Email
tsmith12@twu.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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

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