Prehabilitation to Revolutionize Oncology: Telehealth Exercise for Cognitive Triumphs (The PROTECT Trial)

Breast Cancer Clinical Trial

Official title:

Prehabilitation to Revolutionize Oncology: Telehealth Exercise for Cognitive Triumphs (The PROTECT Trial)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05716542
• Other study ID #: 202302077
• Status: Recruiting
• Phase: N/A
• Start date: May 11, 2023
• Est. completion date: November 30, 2024

Study information

• Verified date: May 2023
• Source: Washington University School of Medicine
• Contact: Elizabeth A Salerno, Ph.D., MPH
• Phone: 314-362-4654
• Email: e.salerno[@]wustl.edu
• Is FDA regulated: No
• 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: Recruiting
• Enrollment: 40
• Est. completion date: November 30, 2024
• Est. primary completion date: November 30, 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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Cancer of the Breast

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)

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine