Status:
TERMINATED
Precision Performance Status Assessment in Breast Cancer Patients Receiving Neoadjuvant Chemotherapy
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Anatomic Stage I Breast Cancer AJCC v8
Anatomic Stage IA Breast Cancer AJCC v8
Eligibility:
All Genders
18+ years
Brief Summary
This study assesses the performance status in stage I-III triple negative breast cancer patients who are receiving neoadjuvant chemotherapy. Information collected in this study may help doctors learn ...
Detailed Description
PRIMARY OBJECTIVE: I. To determine if in-office movement trackers or baseline metabolic equivalents (METs) groups identify those patients who are at highest risk for severe adverse event (SAE)s on ne...
Eligibility Criteria
Inclusion
- Patients with pathologically confirmed breast cancer with any receptor status, who will receive neoadjuvant chemotherapy. Patients with denovo oligo-metastatic disease, where the intent of therapy is curative with incorporation of local therapy (surgery/radiation to the breast and/or metastatic sites) are also eligible.
- Age \>= 18 years
- Ability to understand and the willingness to sign a written informed consent
- Willingness to wear sensors to track physical activity, global positioning system (GPS) location, and provide symptom ratings each night during the screening period of their clinical trial and 180 days after starting treatments
- Able to read English, Spanish, or Mandarin to complete patient reported outcomes
- Able to ambulate without an assistive device
Exclusion
- Missing lower limbs
- Known movement disorder such as Parkinson's disease, choreo-athetoid movement disorders, essential tremor if that movement disorder is of sufficient severity to require drug therapy
Key Trial Info
Start Date :
August 15 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 21 2024
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT04835597
Start Date
August 15 2022
End Date
August 21 2024
Last Update
August 26 2024
Active Locations (1)
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1
M D Anderson Cancer Center
Houston, Texas, United States, 77030