Breaking Through the Brain Fog: An Online Research Study
- Conditions
- Breast Cancer Female
- Interventions
- Behavioral: Brain Training ABehavioral: Brain Training BBehavioral: Brain Training C
- Registration Number
- NCT05444231
- Lead Sponsor
- The University of Texas at Dallas
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 193
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
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Brain Training A Brain Training A This group will access one type of online brain-health oriented training. Brain Training B Brain Training B This group will access a distinct type of online brain-health oriented training. Brain Training C Brain Training C This group will access a distinct type of online brain-health oriented training.
- Primary Outcome Measures
Name Time Method BrainHealth Index Score 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 Outcome Measures
Name Time Method Delayed matching to sample 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)
Double Decision 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)
Rapid Visual Information Processing 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)
Functional Assessment of Cancer Therapy - Cognitive Function (FACT_Cog) 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)
Trial Locations
- Locations (1)
The Center for BrainHealth at the University of Texas at Dallas
🇺🇸Dallas, Texas, United States