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NCT Number: NCT05444231

Breaking Through the Brain Fog: An Online Research Study

This study will investigate the benefits of distinct brain health trainings in breast cancer survivors (age 30-80) with cognitive concerns post-chemotherapy. This study can be completed from the comfort of participant's own home.

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Key information

Conditions

Breast Cancer Female

Age range

30 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The Center for BrainHealth at the University of Texas at Dallas

Dallas, Texas, 75235, United States

About this study

Participants will complete online assessments at 3 timepoints over 6 months (Month 0, 3, 6). During the first 3 months of the study, participants will be randomized into one of three online training programs to support cognitive function; training will end after the first 3 months. The third online assessment (Month 6) will measure maintained gains since ending training. Participants will not be aware of the interventions assigned to other participants. Participants may be reimbursed for their time.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Female breast cancer survivors who...

  • are between ages of 30-80
  • were diagnosed with Stage I-III
  • received chemotherapy
  • completed chemotherapy at least 6 months ago but not more than 5 years
  • endorse changes in thinking since end of chemotherapy treatment
  • have working internet and a device
  • consider themselves fluent in English

Exclusion criteria

  • Males
  • A re-occurrence of breast cancer or a diagnosis of another
  • An uncorrected hearing or vision issue that would hinder ability to read and/or listen to training material
  • Participation in a cognitive training program in the last 12 months.
  • A reported substance abuse problem
  • Diagnosis of a neurodegenerative disease or psychotic disorder
  • History of stroke, concussion, or brain injury since completing chemotherapy
  • Inability to function independently due to Autism Spectrum Disorder diagnosis

Treatment and study plan

Brain Training A

Behavioral

Interventions may include education, exercises, and/or strategies to support brain health

Brain Training B

Behavioral

Interventions may include education, exercises, and/or strategies to support brain health

Brain Training C

Behavioral

Interventions may include education, exercises, and/or strategies to support brain health

Primary outcomes

  1. BrainHealth Index Score

    Time frame: Baseline, 3 month, 6 month

    The investigators will assess change on a holistic measure of cognitive, social, well-being, and daily life health on the BrainHealth Index across multiple timepoints. (Min value = 16, Max value = 1032) (Higher score = Better outcome)

Secondary outcomes

  1. Functional Assessment of Cancer Therapy - Cognitive Function (FACT_Cog)

    Time frame: Baseline, 3 month, 6 month

    The investigators will assess change in self-reported cognitive deficits following an online training program. (Min value = 0, Max value = 148) (Higher score = better outcome)

  2. Double Decision

    Time frame: Baseline, 3 month, 6 month

    The investigators will assess change scores on a visual processing speed task (Min value = 0, Max value = 100) (Higher score = Better performance)

  3. Rapid Visual Information Processing

    Time frame: Baseline, 3 month, 6 month

    The investigators will assess change scores on measure of selective attention (Min value = 0, Max value = 100) (Higher score = Better performance)

  4. Delayed matching to sample

    Time frame: Baseline, 3 month, 6 month

    The investigators will assess change scores on measure of visual memory (Min value = 0, Max value = 100) (Higher score = Better performance)

Sponsors and collaborators

Lead sponsor

The University of Texas at Dallas

Other

Registry information

Official study title

Breaking Through the Brain Fog: An Online RCT for Breast Cancer Survivors

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 5, 2022
Registry last updated
Jun 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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