An interventional study of Physical Activity Intervention in Breast Cancer and Cancer of the Breast, sponsored by Washington University School of Medicine. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-28.
Sponsored by Washington University School of Medicine · Not applicable, Interventional, and Supportive care
The investigators propose to deliver a pilot randomized controlled trial to 40 women newly diagnosed with breast cancer and scheduled to undergo chemotherapy. The current objectives are: 1) to evaluate the preliminary efficacy of the prehabilitation physical activity (PA) intervention delivered by a physical therapist and 2) assess the intervention's feasibility, acceptability, and appropriateness. The long-term goal is to scale this intervention for implementation into the standard of cancer care to prevent, mitigate, and treat cancer-related cognitive decline (CRCD).
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 41 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Washington University School of Medicine is the lead sponsor of 1,765 studies on the registry; 271 are open to participants now.
Of its 324 completed or terminated interventional studies of FDA-regulated products, 212 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Eligibility Criteria:
* Participants will complete a primarily home-based PA intervention, with the goal of safely increasing their steps/day by incorporating moderate-to-vigorous physical activity (MVPA) * Participants will receive Fitbits with heart rate capabilities to support maintenance of the prescribed intensity during home exercise sessions and participants' self-monitoring of daily steps. * Participants will strategize aerobic MVPA behaviors with the intervention PT to identify preferable and enjoyable PA modalities (e.g., walking, cycling), while also identifying alternative options to allow for flexibility if life- or cancer-specific barriers arise * During the first Zoom coaching session, the intervention PT will train participants on using the Fitbit and completing home exercise logs. The PT will continue to meet with participants to support exercise maintenance, review home exercise sessions, strategize new exercises, and troubleshoot emerging chemotherapy-related health declines.
Other: Physical Activity Intervention
-Participants in the control group will proceed with their treatment regimen as prescribed by their oncologist(s). To prevent drop out and high attrition rates as well as promote healthy behavior, control group participants will receive a Fitbit at the initial set-up meeting to wear during chemotherapy, as well as an individualized home exercise program and up to two Zoom coaching sessions with a PT after chemotherapy completion.
Fitbit wearable device, home exercise sessions, and telehealth appointments with physical therapist.
Changes in self-reported cognition function as measured by FACT-Cog
The FACT-Cog examines a range of self-reported cognitive domains, including perceived cognitive impairment (PCI, range 0-71), perceived cognitive abilities (PCA, range 0-28), impact of cognitive impairment on quality of life (CogQOL, range 0-16), cognitive impairment perceived by others (CogOth, range 0-16), and a total cognitive functioning score (the sum of the other 4 subscales). Higher scores indicate fewer cognitive difficulties.
Time frame: Pre-chemotherapy and post-chemotherapy (estimated to be 12 weeks)
Feasibility of the intervention as measured by Feasibility of Intervention Measure (FIM)
The FIM measures the degree to which a participant feels an intervention is feasible to them. It ranges from 4-20, and higher scores indicate more feasibility. We will use a cutoff of 16 to indicate "feasible"
Time frame: After completion of intervention (estimated to be 12 weeks)
Changes in objective measures of cognition function as measured by BrainBaseline Spatial Working Memory
BrainBaseline is a tool that delivers a battery of objective cognitive tests. The investigators will measure the participant's ability to hold information about an object's location in short term memory. Overall accuracy is the primary measure of performance. Accuracy ranges from 0-100%. Higher accuracy scores represent better accuracy.
Time frame: Pre-chemotherapy and post-chemotherapy (estimated to be 12 weeks)
Changes in objective measures of cognition function as measured by BrainBaseline N-back
BrainBaseline is a tool that delivers a battery of objective cognitive tests. The investigators will assess the participant's ability to retain sequentially presented information in short-term memory. Overall accuracy is considered the primary measure of performance. Accuracy ranges from 0-100%. Higher accuracy scores represent better accuracy.
Time frame: Pre-chemotherapy and post-chemotherapy (estimated to be 12 weeks)
Changes in objective measures of cognition function as measured by BrainBaseline Flanker
BrainBaseline is a tool that delivers a battery of objective cognitive tests. The investigators will assess the participant's ability to focus attention and block irrelevant information. Task performance is assessed by observing reaction time cost. Reaction time ranges from 0-5000 milliseconds. Higher reaction times represent slower reaction time.
Time frame: Pre-chemotherapy and post-chemotherapy (estimated to be 12 weeks)
Changes in objective measures of cognition function as measured by BrainBaseline Trails A&B
BrainBaseline is a tool that delivers a battery of objective cognitive tests. The investigators will assess the participant's ability to connect-the-dots, drawing a line between targets in a specified ascending order. Task performance is assessed by observing time to completion. A higher time to completion represents a slower ability to connect-the-dots.
Time frame: Pre-chemotherapy and post-chemotherapy (estimated to be 12 weeks)
Changes in objective measures of cognition function as measured by BrainBaseline Stroop
BrainBaseline is a tool that delivers a battery of objective cognitive tests. The investigators will measure the participant's ability to focus attention on a particular stimulus dimension while ignoring another. Task performance is assessed by observing the reaction time cost. Reaction time ranges from 0-5000 milliseconds. Higher reaction time scores represent slower reaction time.
Time frame: Pre-chemotherapy and post-chemotherapy (estimated to be 12 weeks)
Changes in objective measures of cognition function as measured by BrainBaseline Task switching
BrainBaseline is a tool that delivers a battery of objective cognitive tests. The investigators will measure the participant's ability to switch between two separate tasks. The primary outcome measure is switch cost. Reaction time ranges from 0-5000 milliseconds. Higher reaction time scores represent slower reaction time.
Time frame: Pre-chemotherapy and post-chemotherapy (estimated to be 12 weeks)
Changes in objective measures of cognition function as measured by BrainBaseline Digit Symbol Substitution
BrainBaseline is a tool that delivers a battery of objective cognitive tests. The investigators will measure the participant's ability to quickly and precisely shift attention from location to another, as well as measuring motor skill. The primary outcome measure is the number of correct substitutions made within the 90-second limit.
Time frame: Pre-chemotherapy and post-chemotherapy (estimated to be 12 weeks)
Acceptability of the intervention as measured by the Acceptability of Intervention Measure (AIM)
The AIM measures the degree to which a participant feels an intervention is acceptable to them. It ranges from 4-20, and higher scores indicate more acceptability. The investigators will use a cutoff of 16 to indicate "acceptable"
Time frame: After completion of intervention (estimated to be 12 weeks)
Appropriateness of the intervention as measured by the Intervention Appropriateness Measure (IAM)
The IAM measures the degree to which a participant feels an intervention is appropriate for them. It ranges from 4-20, and higher scores indicate more appropriateness. The investigators will use a cutoff of 16 to indicate "appropriate"
Time frame: After completion of intervention (estimated to be 12 weeks)
Adherence of the intervention as measured by percentage of home exercise sessions and PT telehealth appointments completed
Time frame: After completion of intervention (estimated to be 12 weeks)
Plan to share: No
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Washington University School of Medicine