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| Name | Class |
|---|---|
| The Foundation for Barnes-Jewish Hospital | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physical Activity Intervention | Experimental |
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| Usual care, wait-list control condition | No 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical Activity Intervention | Other | Fitbit wearable device, home exercise sessions, and telehealth appointments with physical therapist. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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" | After completion of intervention (estimated to be 12 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Eligibility Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lindsay Peterson, M.D., MSCR | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
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| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| 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. | 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. | 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. | 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. | 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. | 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. | 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" | 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" | 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 | After completion of intervention (estimated to be 12 weeks) |
| D017437 |
| Skin and Connective Tissue Diseases |
| D001519 | Behavior |