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An Online Research Study: BrainHealth in Breast Cancer Survivors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05444231
Recruitment Status : Recruiting
First Posted : July 5, 2022
Last Update Posted : July 5, 2022
Sponsor:
Information provided by (Responsible Party):
The University of Texas at Dallas

Brief Summary:
This study is being done to evaluate the impact of online cognitive interventions on improving brain health and performance in breast cancer survivors (ages 28-80) who report changes in thinking since treatment.

Condition or disease Intervention/treatment Phase
Breast Cancer Female Behavioral: Strategic Memory Advanced Reasoning Training (SMART) Not Applicable

Detailed Description:
Participants will be randomized into one of two groups - (1) active and (2) delayed active. Both groups will complete the online assessments and questionnaires (appx 100 minutes) at baseline, 3 months, and 9 months. After baseline assessment, active group will complete online trainings and education (15 min/week) in their dashboard and 45-minute group coaching calls (1/month). The delayed-active group will access the same content after their 3 month (Time 2) assessment. So each group will have the opportunity to complete the training and experience at least 5 group coaching sessions.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: BrainHealth in Breast Cancer Survivors
Actual Study Start Date : June 1, 2022
Estimated Primary Completion Date : June 1, 2024
Estimated Study Completion Date : June 1, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Active
The Active Group will receive access to all online training content after baseline testing.
Behavioral: Strategic Memory Advanced Reasoning Training (SMART)
  • Research-based strategies to more effectively process information & manage stress.
  • Scientific information about the importance of sleep & actionable tips on how to get better sleep.
  • Quick, interactive activities that reinforce information learned in online modules. These also build awareness of how our daily habits (sleep, nutrition, exercise, social interactions, etc.) may be impacting our performance for better or worse.

Placebo Comparator: Delayed Active
The Delayed Active Group will receive access to all online training content after their second BrainHealth Index (3 months).
Behavioral: Strategic Memory Advanced Reasoning Training (SMART)
  • Research-based strategies to more effectively process information & manage stress.
  • Scientific information about the importance of sleep & actionable tips on how to get better sleep.
  • Quick, interactive activities that reinforce information learned in online modules. These also build awareness of how our daily habits (sleep, nutrition, exercise, social interactions, etc.) may be impacting our performance for better or worse.




Primary Outcome Measures :
  1. BrainHealth Index Score [ Time Frame: Baseline, 3 month, 9 month ]
    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


Secondary Outcome Measures :
  1. Functional Assessment of Cancer Therapy - Cognitive Function (FACT_Cog) [ Time Frame: Baseline, 3 month, 9 month ]
    We will assess change in self-reported cognitive deficits following an online training program. (Higher score = better outcome)



Information from the National Library of Medicine

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Ages Eligible for Study:   28 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female
  • English-speaking
  • Ages 28-80
  • Diagnosed Stages l to lll
  • If underwent chemotherapy, it was within past 6 months-5 years
  • Internet and device with audio/video capability

Exclusion Criteria:

  • Males
  • Individuals who may have an uncorrected hearing or vision issue that would hinder their ability to read and/or listen to training material
  • Individuals that have one any of the following at onset of study, as determined by a self- report screening form:
  • Diagnosed neurodegenerative disease
  • History of stroke, concussion, or brain injury that currently hinders you from functioning at your prior level
  • Diagnosed with Autism Spectrum Disorder and not functioning independently

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05444231


Contacts
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Contact: Erin E Venza, MS 972-883-3208 erin.venza@utdallas.edu

Locations
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United States, Texas
The Center for BrainHealth at the University of Texas at Dallas Recruiting
Dallas, Texas, United States, 75235
Contact: Erin Venza    972-883-3208    erin.venza@utdallas.edu   
Sponsors and Collaborators
The University of Texas at Dallas
Investigators
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Principal Investigator: Sandra B Chapman, PhD Center for BrainHealth
Publications:

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Responsible Party: The University of Texas at Dallas
ClinicalTrials.gov Identifier: NCT05444231    
Other Study ID Numbers: 19-133
First Posted: July 5, 2022    Key Record Dates
Last Update Posted: July 5, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The University of Texas at Dallas:
Cognitive Intervention
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases