Computerized Cognitive Training in Breast Cancer Survivors

Completed · Not applicable

Conditions studied: Breast Cancer, Cognitive Change, Cognitive Impairment, Quality of Life

In brief

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.

Key facts

Study ID

NCT05570604

Run by

Ohio State University

People needed

46

Starts

2017-05-17

Expected to finish

2020-03-20

Last updated by the study team

2025-04-24

Who can join

Age: 21 and older. Sex: female. Healthy volunteers: not accepted.

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.

Where it is running

• Indiana University School of Nursing — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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