Breast Cancer Clinical Trial
Performance Status Assessment in Stage I-III Triple Negative Breast Cancer Patients Receiving Neoadjuvant Chemotherapy
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 if movement and fitness trackers can be used to predict side effects in cancer patients receiving chemotherapy.
Full 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 neoadjuvant chemotherapy.
SECONDARY OBJECTIVES:
I. To determine the association between the occurrence of SAEs, unexpected healthcare encounters, depending on the change in activity level classification between the baseline METs group and mid-treatment METs group (at month 3).
II. Explore association between patient reported outcome (PRO) data and movement tracker data.
OUTLINE:
Patients complete movement assessment 5-15 days prior to the initiation of neoadjuvant chemotherapy and at day 1 of neoadjuvant chemotherapy. Patients' SAE data is collected. Patients are observed during their neoadjuvant chemotherapy for up to 6 months.
Eligibility Criteria
Inclusion Criteria:
Patients with proven triple negative breast cancer (TNBC), defined from standard pathologic assays as negative for estrogen receptor (ER) and progesterone receptor (PR) (< 10% tumor staining) and negative for HER2 (immunohistochemistry [IHC] score < 3, gene copy number not amplified). Clinical stage I to III. Who will receive neoadjuvant chemotherapy
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 Criteria:
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
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There is 1 Location for this study
Houston Texas, 77030, United States More Info
Principal Investigator
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