Computerized Cognitive Training in Breast Cancer Survivors

NCT05570604 | Completed Results DMC

• 1 other identifier: IUSCC-0625
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

For millions of cancer survivors, cognitive impairment is a prevalent, severe, and persistent problem that is associated with other symptoms (depressive symptoms, anxiety and fatigue), poorer work ability, and poorer quality of life. Available evidence, including work by the investigators own group, suggests that cognitive training may be a viable treatment option. However, to date, these studies are limited as none have been conducted in the home and therefore fail to address the transferability of these empirically based cognitive training programs to general practice. The purpose of this translational research is to conduct a home based single-blind, randomized controlled trial to test the feasibility, satisfaction, and preliminary efficacy of cognitive training compared to attention control in breast cancer survivors (BCS) as well as to explore potential biomarkers of intervention effects. This research innovatively builds on investigator's previous research by: 1) translating findings from the laboratory to the home setting and importantly seeks to identify facilitators and barriers of intervention use; 2) addresses limitations of previous trials (uses an attention control rather than a no-contact or wait-list control), (3) examines cognitive training effects on real-life outcomes such as associated symptoms, perceived work ability and quality of life; and (4) will be the first study in cancer survivors to explore levels of BDNF as a potentially sensitive outcome measure of intervention effects over time compared to attention control. Findings from this study will provide necessary information about the feasibility, satisfaction and preliminary efficacy of the home-based cognitive training on memory performance and processing speed as well as its effects on associated outcomes in BCS. Positive results will lead to a larger, full-scale study to determine efficacy and build evidence-based treatment for clinicians to use in treating BCS with cognitive impairment.

Conditions

Breast Cancer; Cognitive Change; Cognitive Impairment; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Client Satisfaction Questionnaire

  Likert-based 8-item questionnaire rating overall satisfaction, quality of training, etc. 4-point scale (range from 8-32) with higher scores indicating greater acceptability and satisfaction.

  Within 1 week post-intervention

Secondary Outcomes (6)

• Change in Patient Reported Outcomes Measurement Information System (PROMIS) Cognitive Abilities Between Baseline and 1 Week Post-intervention

  Baseline and within 1 week post-intervention

• Change in Patient Reported Outcomes Measurement Information System (PROMIS) Cognitive Concerns Between Baseline and 1 Week Post-intervention

  Baseline and within 1 week post-intervention

• Change in Work Ability Index (WAI) Between Baseline and 1 Week Post-intervention

  Baseline and within 1 week post-intervention

• Change in Medical Outcomes Study-Short-Form Health Survey (MOS SF-36) General Perceptions of Health Between Baseline and 1 Week Post-intervention

  Baseline and within 1 week post-intervention

• Change in Medical Outcomes Study-Short-Form Health Survey (MOS SF-36) Perceived Change in Health Between Baseline and 1 Week Post-intervention

  Baseline and within 1 week post-intervention

Other Outcomes (8)

• Change in Rey Auditory Verbal Learning Test (Rey AVLT) Total Between Baseline and 1 Week Post-intervention

  Baseline and within 1 week post-intervention

• Change in Rey Auditory Verbal Learning Test (Rey AVLT) Delayed Between Baseline and 1 Week Post-intervention

  Baseline and within 1 week post-intervention

• Change in Rivermead Behavioral Paragraph Recall Test Between Baseline and 1 Week Post-intervention

  Baseline and within 1 week post-intervention

Study Arms (2)

Cognitive Training

EXPERIMENTAL

As tested in the investigator's pilot, the Brain HQ program is designed to enhance specific areas of cognitive functioning that will be tested in this study. The goals of the Brain HQ program are to improve visual processing speed, learning and memory and attention. The exercises include time-order judgment, discrimination, spatial-match, forward-span, instruction-following, and narrative-memory tasks. This program systematically reduces the stimulus duration during a series of increasingly difficult information-processing tasks presented via computer. The exercises automatically adjust to user performance to maintain an 85% correct rate. The program will include 4 hours per week over a 10-week period for a total of up to 40 hours. The study team has support from the original developer and Posit Science. For the purposes of this trial, any participants who do not complete the total of up to 40 hours will not be counted as deviations.

Behavioral: Sweep Seeker; Behavioral: Bird Safari; Behavioral: Jewel Diver; Behavioral: Master Gardener; Behavioral: Road Tour

Attention Control

PLACEBO COMPARATOR

Control participants will be asked to complete activities on the computer. The program offers a choice of activities that will consist of crossword puzzles and word jumbles. The program offers a pre-determined set of computerized crossword puzzles. The site has over 100,000 puzzles and can be accessed easily via the web and are free to users. The computerized crossword puzzles do not provide for progressive challenges of increasing speed, visual field size, number of distractors or degree of difficulty of targeted stimulus differentiation. Training: Participants will be instructed to perform this active attention control intervention 4 hours per week over 10 weeks for a total of up to 40 hours, the same as BrainHQ.

Behavioral: Computerized Crossword Puzzles

Interventions

Sweep Seeker BEHAVIORAL

The person is asked to clear the rows of blocks presented on the screen, either by moving them into horizontal or vertical blocks that have identical color. The goal is to refine and increase the response of primary visual cortex neurons and to enable the person to increase speed and accuracy of visual processing (executive function) and visual memory.

Cognitive Training

Bird Safari BEHAVIORAL

The user is first presented with a target bird. Subsequently, a group of birds is presented in the peripheral vision and then disappears when the trial begins. The user selects the section of the screen where the target bird appeared. The presentation speed adapts with user performance (i.e. better performance = faster presentation). The goal is to improve speed and accuracy of object identification in peripheral vision and improve visual precision important for improving memory.

Cognitive Training

Jewel Diver BEHAVIORAL

The person is first presented objects (jewels) on the screen. The objects are then covered with occluders (bubbles) and then identical distracters are presented. The objects move around in screen and when the movement stops, the user chooses the occluders that cover the jewels. The number of jewels adapts to performance (more jewels = better performance). The goal is to improve divided visual attention, sustained visual attention, visual working memory, and visual precision.

Cognitive Training

Master Gardener BEHAVIORAL

The person is presented a series of target stimuli and distracters which are presented at one time and then disappear. The locations of the stimuli are marked by icons, and the user chooses the icons where the target stimuli were once located. The goal is to increase speed and accuracy as well as the ability to extract information accurately.

Cognitive Training

Road Tour BEHAVIORAL

The person is presented with a target vehicle briefly in both the center of the screen and in one of eight locations in the periphery. Two vehicles are then presented briefly in the center of the screen, one of which is the target vehicle. The user must identify the location of the target vehicle in the periphery as well as identify which was the target vehicle that appeared in the center. The goal of this activity is to improve divided attention and ability to extract information and discard irrelevant information from peripheral vision.

Cognitive Training

Computerized Crossword Puzzles BEHAVIORAL

The program offers a pre-determined set of computerized crossword puzzles. The site has over 100,000 puzzles and can be accessed easily via the web and are free to users. The computerized crossword puzzles do not provide for progressive challenges of increasing speed, visual field size, number of distractors or degree of difficulty of targeted stimulus differentiation.

Attention Control

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female gender
• ≥ 21 years old at the time of informed consent
• Ability to provide written informed consent and HIPAA authorization
• First diagnosis of non-metastatic breast cancer.
• Self-reported cognitive impairment
• Subjects seeking treatment though not currently being treated or with prior treatment history for cognitive impairment.
• ≥ 1 year post-treatment including surgery, radiation, and/or chemotherapy
• Ability to understand, speak, read, and write English

You may not qualify if:

• Comorbidities that would sufficiently impair performance or inhibit cognitive training such as: history of stroke, encephalitis, traumatic brain injury, brain surgery, dementia, or Alzheimers disease.
• Cranial radiation or intrathecal therapy.
• Current active major depression or substance abuse or history of bipolar disorder psychosis, schizophrenia, or learning disability.
• History of current or other cancer except for basal cell skin cancer.

Sponsors & Collaborators

• Ohio State University: lead
• Indiana University: collaborator

Study Sites (1)

Indiana University School of Nursing

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Diane Von Ah
• Organization: Ohio State University

vonah.1@osu.edu

614-688-0722

Study Officials

• Diane Von Ah, PhD

  Ohio State University College of Nursing.

  PRINCIPAL INVESTIGATOR

• Tina Opoku, BS

  Ohio State University College of Nursing

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: A blinded and trained tester will perform data collection and neuropsychological testing at two time points
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Distinguished Professor of Cancer Research, College of Nursing Director of Cancer Research Center for Healthy Aging, Self-Management and Complex Care

Model Details: The purpose of this translational research is to conduct a home based single-blind, randomized controlled trial to test the feasibility, satisfaction, and preliminary efficacy of cognitive training compared to attention control in breast cancer survivors (BCS) as well as to explore potential biomarkers of intervention effects.

Study Record Dates

• First Submitted: December 15, 2021
• First Posted: October 6, 2022
• Study Start: May 17, 2017
• Primary Completion: March 20, 2020
• Study Completion: March 20, 2020
• Last Updated: April 24, 2025
• Results First Posted: April 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)