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Breast CancerNCT05716542

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

A study testing Physical Activity Intervention in people with Breast Cancer and Cancer of the Breast, run by Washington University School of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer, Cancer of the Breast
What is being tested?
Physical Activity Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
1 siteUnited States
Study dates
11 May 2023to 4 Oct 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Washington University School of Medicine

    St Louis, Missouri, 63110

Other trials in United States

About this study

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).

Being tested
Physical Activity Intervention
Keywords
prehabilitation, physical activity, cancer-related cognitive decline, telehealth, physical therapy, survivorship, breast cancer
Medical subject headings
Breast Neoplasms, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Physical Activity InterventionOther

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

Study groups in NCT05716542
Study groupRoleWhat they receive
Physical Activity InterventionExperimental* 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.
Receives: Other: Physical Activity Intervention
Usual care, wait-list control conditionNo 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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"

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

Secondary outcomes (10)

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. 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.

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

  6. 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.

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

  7. 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.

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

  8. 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"

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

  9. 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"

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

  10. Adherence of the intervention as measured by percentage of home exercise sessions and PT telehealth appointments completed

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2023
  2. Study start11 May 2023
  3. Primary completion4 Oct 2024
  4. Study completion4 Oct 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05716542
Sponsor's protocol ID
202302077
Status last verified
Aug 2025
First submitted
17 Jan 2023
Last updated
28 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Salerno EA, Harriss C, Andrade DC, Peterson LL, Duncan RP, Kepper MM, Luo J, Creel P, Colditz GA. Exercise during Chemotherapy to Prevent Breast Cancer-Related Cognitive Decline: Protocol for a Pilot Randomized Controlled Trial. Front Cognit. 2023;2:1289415. doi: 10.3389/fcogn.2023.1289415. Epub 2023 Nov 26.

    PubMed 42948582

Questions about this trial

What is this clinical trial studying?

A study testing Physical Activity Intervention in people with Breast Cancer and Cancer of the Breast, run by Washington University School of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in self-reported cognition function as measured by FACT-Cog (time frame: Pre-chemotherapy and post-chemotherapy (estimated to be 12 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05716542, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025.

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