Status:
COMPLETED
Breast Cancer Pre-habilitation and Prospective Surveillance to Prevent, Detect, and Optimize Physical and Function
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
Northwestern Medicine
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The goal of this research study is to determine the feasibility and potential effects of physical therapy and enhanced patient education delivered before breast cancer treatment. Physical therapy befo...
Eligibility Criteria
Inclusion
- Patients with newly diagnosed Breast Cancer (BC) (stages 0-4) deemed eligible by the oncology physician team to undergo intent-to-cure treatment
- Patients must have an Eastern Cooperative Oncology Group (ECOG) Performance Scale score of 0 (Fully active, able to carry on all pre-disease performance without restriction), 1 (Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house- work, office work); or 2 (Ambulatory and capable of all self-care but unable to carry out any work activities; up and about more than 50% of waking hours)
- Patients must be Female \[Note: Males are not included as BC in males is less than 1% of all cases\]
- Patients must be English speaking
- Patients must be age ≥ 18 years
- Patients must have regular access to a mobile phone that can receive text messages and phone calls
- Patients must have the ability to understand and the willingness to sign a written informed consent document prior to registration on study
Exclusion
- Patient with any prior malignancy (except non-melanoma skin)
- Patients with an ECOG Performance Scale score of 3 (Capable of only limited self-care; confined to bed or chair more than 50% of waking hours), 4 (Completely disabled; cannot carry on any self-care; totally confined to bed or chair) or 5 (dead)
- History of pre-existing upper extremity functional impairment, lymphedema, central nervous system damage, other systemic medical condition (e.g. fibromyalgia, rheumatoid arthritis, diabetes)
- Actively receiving physical therapy at the time of recruitment and baseline measurement
- Patients with brain metastasis with adverse events attributable to the metastasis ≥ grade 3
- Patients who are pregnant or lactating
- Patients with any issue that would limit their ability to comply with study requirements
Key Trial Info
Start Date :
November 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 13 2025
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT06081127
Start Date
November 20 2023
End Date
May 13 2025
Last Update
December 30 2025
Active Locations (1)
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1
Northwestern University
Chicago, Illinois, United States, 60611