Breaking Through the Brain Fog: An Online Research Study

Study Overview
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Brief Summary
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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 your own home.

Detailed Description
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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. Group assignment will not be disclosed until study is completed. Participants may be reimbursed for their time.

Official Title
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Breaking Through the Brain Fog: An Online Study for Breast Cancer Survivors

Conditions
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Breast Cancer Female

Intervention / Treatment
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* Behavioral: Brain Training A
* Behavioral: Brain Training B
* Behavioral: Brain Training C


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brain Training A<br>This group will access one type of online brain-health oriented training. | Behavioral: Brain Training A<br>* Interventions may include education, exercises, and/or strategies to support brain health<br>|
| Active Comparator: Brain Training B<br>This group will access a distinct type of online brain-health oriented training. | Behavioral: Brain Training B<br>* Interventions may include education, exercises, and/or strategies to support brain health<br>|
| Active Comparator: Brain Training C<br>This group will access a distinct type of online brain-health oriented training. | Behavioral: Brain Training C<br>* Interventions may include education, exercises, and/or strategies to support brain health<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BrainHealth Index Score | We will assess change on a holistic measure of cognitive, social, well-being, and daily life health on the BrainHealth Index (BHI) across multiple timepoints. Higher score = Better outcome | Baseline, 3 month, 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Assessment of Cancer Therapy - Cognitive Function (FACT_Cog) | We will assess change in self-reported cognitive deficits following an online training program. (Higher score = better outcome) | Baseline, 3 month, 6 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive Intervention