Breaking Through the Brain Fog: An Online Research Study

The University of Texas System (UT)

Status: Active, not recruiting

Conditions: Breast Cancer Female

Treatments: Behavioral: Brain Training A; Behavioral: Brain Training B; Behavioral: Brain Training C

Study type: Interventional

Funder types: Other

Identifiers

NCT05444231

24-434

Details and patient eligibility

About

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.

Full 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.

Enrollment: 193 patients

Sex: Female

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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193 participants in 3 patient groups

Brain Training A

Experimental group

Description:

This group will access one type of online brain-health oriented training.

Treatment:

Behavioral: Brain Training A

Brain Training B

Active Comparator group

Description:

This group will access a distinct type of online brain-health oriented training.

Treatment:

Behavioral: Brain Training B

Brain Training C

Active Comparator group

Description:

This group will access a distinct type of online brain-health oriented training.

Treatment:

Behavioral: Brain Training C