Clinical trial NCT05716542: Prehabilitation to Revolutionize Oncology: Telehealth Exercise for Cognitive Triumphs (The PROTECT Trial)
Official title: Prehabilitation to Revolutionize Oncology: Telehealth Exercise for Cognitive Triumphs (The PROTECT Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Cancer of the Breast
Keywords: prehabilitation
physical activity
cancer-related cognitive decline
telehealth
physical therapy
survivorship
breast cancer
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: The Foundation for Barnes-Jewish Hospital
First posted: 2023-02-08
Enrollment: 41
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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).


Eligibility criteria: 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.

Primary outcomes:
measure: Changes in self-reported cognition function as measured by FACT-Cog
timeFrame: Pre-chemotherapy and post-chemotherapy (estimated to be 12 weeks)
measure: Feasibility of the intervention as measured by Feasibility of Intervention Measure (FIM)
timeFrame: After completion of intervention (estimated to be 12 weeks)
Secondary outcomes:
measure: Changes in objective measures of cognition function as measured by BrainBaseline Spatial Working Memory
timeFrame: Pre-chemotherapy and post-chemotherapy (estimated to be 12 weeks)
measure: Changes in objective measures of cognition function as measured by BrainBaseline N-back
timeFrame: Pre-chemotherapy and post-chemotherapy (estimated to be 12 weeks)
measure: Changes in objective measures of cognition function as measured by BrainBaseline Flanker
timeFrame: Pre-chemotherapy and post-chemotherapy (estimated to be 12 weeks)
measure: Changes in objective measures of cognition function as measured by BrainBaseline Trails A&B
timeFrame: Pre-chemotherapy and post-chemotherapy (estimated to be 12 weeks)
measure: Changes in objective measures of cognition function as measured by BrainBaseline Stroop
timeFrame: Pre-chemotherapy and post-chemotherapy (estimated to be 12 weeks)
measure: Changes in objective measures of cognition function as measured by BrainBaseline Task switching
timeFrame: Pre-chemotherapy and post-chemotherapy (estimated to be 12 weeks)
measure: Changes in objective measures of cognition function as measured by BrainBaseline Digit Symbol Substitution
timeFrame: Pre-chemotherapy and post-chemotherapy (estimated to be 12 weeks)
measure: Acceptability of the intervention as measured by the Acceptability of Intervention Measure (AIM)
timeFrame: After completion of intervention (estimated to be 12 weeks)
measure: Appropriateness of the intervention as measured by the Intervention Appropriateness Measure (IAM)
timeFrame: After completion of intervention (estimated to be 12 weeks)
measure: Adherence of the intervention as measured by percentage of home exercise sessions and PT telehealth appointments completed
timeFrame: After completion of intervention (estimated to be 12 weeks)
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Elizabeth A Salerno, Ph.D., MPH
role: PRINCIPAL_INVESTIGATOR
References: