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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05716542
Other study ID # 202302077
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date May 11, 2023
Est. completion date August 31, 2024

Study information

Verified date June 2024
Source Washington University School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 41
Est. completion date August 31, 2024
Est. primary completion date August 31, 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Eligibility Criteria: - Diagnosis of breast cancer (stage I-III). - Female. - At least 18 years old. - Scheduled to receive curative-intent chemotherapy. - English speaking. - Deemed fit to participate in a PA intervention by their oncologist. - Not currently participating in another physical activity research study. - Low active, defined by self-report as no more than 2 times per week of regular physical activity in the last six months - Able to understand and willing to sign an IRB-approved written informed consent document.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Physical Activity Intervention
Fitbit wearable device, home exercise sessions, and telehealth appointments with physical therapist.

Locations

Country Name City State
United States Washington University School of Medicine Saint Louis Missouri

Sponsors (2)

Lead Sponsor Collaborator
Washington University School of Medicine The Foundation for Barnes-Jewish Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
Primary 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)
Secondary 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. Pre-chemotherapy and post-chemotherapy (estimated to be 12 weeks)
Secondary 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)
Secondary 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)
Secondary 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)
Secondary 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)
Secondary 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)
Secondary 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)
Secondary 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)
Secondary 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)
Secondary 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)
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