NCT04027400

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 26, 2018

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

July 17, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 22, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2020

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 26, 2020

Completed
Last Updated

August 13, 2019

Status Verified

August 1, 2019

Enrollment Period

2 years

First QC Date

July 17, 2019

Last Update Submit

August 9, 2019

Conditions

Cognitive ImpairmentBreast Cancer

Keywords

survivorcognitive rehabilitation

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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 Outcomes (1)

  • Satisfaction Survey

    5 minutes

Study Arms (2)

Primarily visual computer exercises

ACTIVE COMPARATOR

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

Behavioral: computer-assisted rehabilitation

Visual+Audio

EXPERIMENTAL

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

Interventions

computer-assisted rehabilitationBEHAVIORAL

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
Primarily visual computer exercisesVisual+Audio

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas Woman's University

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Cognitive DysfunctionBreast Neoplasms

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Theresa M Smith, PhD

    Associate Professor

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tracy Lindsay

CONTACT

940 898-3377TLindsay@twu.edu

Donna Tilley

CONTACT

940-898-3401

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants never told which group they were in.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: two groups with different treatment
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2019

First Posted

July 22, 2019

Study Start

February 26, 2018

Primary Completion

February 25, 2020

Study Completion

February 26, 2020

Last Updated

August 13, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)