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Breaking Through the Brain Fog: An Online Research Study

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05444231
Enrollment
193
Registered
2022-07-05
Start date
2023-08-23
Completion date
2025-03-09
Last updated
2025-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer Female

Keywords

Cognitive Intervention

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALBrain Training A

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

BEHAVIORALBrain Training B

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

BEHAVIORALBrain Training C

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

Sponsors

The University of Texas at Dallas
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
30 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
BrainHealth Index ScoreBaseline, 3 month, 6 monthThe 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

MeasureTime frameDescription
Functional Assessment of Cancer Therapy - Cognitive Function (FACT_Cog)Baseline, 3 month, 6 monthThe investigators will assess change in self-reported cognitive deficits following an online training program. (Min value = 0, Max value = 148) (Higher score = better outcome)
Double DecisionBaseline, 3 month, 6 monthThe investigators will assess change scores on a visual processing speed task (Min value = 0, Max value = 100) (Higher score = Better performance)
Rapid Visual Information ProcessingBaseline, 3 month, 6 monthThe investigators will assess change scores on measure of selective attention (Min value = 0, Max value = 100) (Higher score = Better performance)
Delayed matching to sampleBaseline, 3 month, 6 monthThe investigators will assess change scores on measure of visual memory (Min value = 0, Max value = 100) (Higher score = Better performance)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026