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Completed

NCT Number: NCT05716542

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

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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Key information

Conditions

Breast Cancer Behavior Breast Diseases Breast Neoplasms Cancer of the Breast Motor Activity Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Physical Activity Intervention

Other

Fitbit wearable device, home exercise sessions, and telehealth appointments with physical therapist.

Primary outcomes

  1. Changes in self-reported cognition function as measured by FACT-Cog

    Time frame: Pre-chemotherapy and post-chemotherapy (estimated to be 12 weeks)

    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.

  2. Feasibility of the intervention as measured by Feasibility of Intervention Measure (FIM)

    Time frame: After completion of intervention (estimated to be 12 weeks)

    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"

Secondary outcomes

  1. Changes in objective measures of cognition function as measured by BrainBaseline Spatial Working Memory

    Time frame: Pre-chemotherapy and post-chemotherapy (estimated to be 12 weeks)

    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.

  2. Changes in objective measures of cognition function as measured by BrainBaseline N-back

    Time frame: Pre-chemotherapy and post-chemotherapy (estimated to be 12 weeks)

    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.

  3. Changes in objective measures of cognition function as measured by BrainBaseline Flanker

    Time frame: Pre-chemotherapy and post-chemotherapy (estimated to be 12 weeks)

    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.

  4. Changes in objective measures of cognition function as measured by BrainBaseline Trails A&B

    Time frame: Pre-chemotherapy and post-chemotherapy (estimated to be 12 weeks)

    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.

  5. Changes in objective measures of cognition function as measured by BrainBaseline Stroop

    Time frame: Pre-chemotherapy and post-chemotherapy (estimated to be 12 weeks)

    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.

  6. Changes in objective measures of cognition function as measured by BrainBaseline Task switching

    Time frame: Pre-chemotherapy and post-chemotherapy (estimated to be 12 weeks)

    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.

  7. Changes in objective measures of cognition function as measured by BrainBaseline Digit Symbol Substitution

    Time frame: Pre-chemotherapy and post-chemotherapy (estimated to be 12 weeks)

    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.

  8. Acceptability of the intervention as measured by the Acceptability of Intervention Measure (AIM)

    Time frame: After completion of intervention (estimated to be 12 weeks)

    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"

  9. Appropriateness of the intervention as measured by the Intervention Appropriateness Measure (IAM)

    Time frame: After completion of intervention (estimated to be 12 weeks)

    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"

  10. 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)

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • The Foundation for Barnes-Jewish Hospital

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 8, 2023
Registry last updated
Aug 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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