Breaking Through the Brain Fog: An Online Research Study

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 30 Years - 80 Years
Gender Female
More Inclusion & Exclusion Criteria

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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05444231
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

The University of Texas at Dallas
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Sandra B Chapman, PhD
Principal Investigator Affiliation Center for BrainHealth
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Breast Cancer Female
Additional Details

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.

Arms & Interventions

Arms

Experimental: Brain Training A

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

Active Comparator: Brain Training B

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

Active Comparator: Brain Training C

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

Interventions

Behavioral: - Brain Training A

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

Behavioral: - Brain Training B

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

Behavioral: - Brain Training C

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Dallas, Texas

Status

Recruiting

Address

The Center for BrainHealth at the University of Texas at Dallas

Dallas, Texas, 75235

Site Contact

Erin Venza

[email protected]

972-883-3208

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