Precision Performance Status Assessment in Breast Cancer Patients Receiving Neoadjuvant Chemotherapy

Study Overview
=================
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 if movement and fitness trackers can be used to predict side effects in cancer patients receiving chemotherapy.

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 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.

Official Title
-----------------
Precision Performance Status Assessment in Breast Cancer Patients Receiving Neoadjuvant Chemotherapy

Conditions
-----------------
Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IIB Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIIB Breast Cancer AJCC v8, Prognostic Stage I Breast Cancer AJCC v8, Prognostic Stage IA Breast Cancer AJCC v8, Prognostic Stage IB Breast Cancer AJCC v8, Prognostic Stage II Breast Cancer AJCC v8, Prognostic Stage IIA Breast Cancer AJCC v8, Prognostic Stage IIB Breast Cancer AJCC v8, Prognostic Stage III Breast Cancer AJCC v8, Prognostic Stage IIIA Breast Cancer AJCC v8, Prognostic Stage IIIB Breast Cancer AJCC v8, Prognostic Stage IIIC Breast Cancer AJCC v8, Triple-Negative Breast Carcinoma

Intervention / Treatment
-----------------
* Behavioral: Behavioral Assessment
* Other: Electronic Health Record Review


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational (movement assessment, medical data collection)<br>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. | Behavioral: Behavioral Assessment<br>* Complete movement assessment<br>Other: Electronic Health Record Review<br>* SAE data is collected<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of non-hematologic serious adverse events occurring during neoadjuvant chemotherapy (i.e. correlate Microsoft motion tracking data and baseline metabolic equivalents [METs] group with incidence of serious adverse events) |  | Up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of severe adverse event (SAE)s |  | During the final 3 months of neoadjuvant chemotherapy | 
| The number of SAEs based on laboratory results |  | Over the final 3 months of neoadjuvant chemotherapy | 
| The number of SAEs based on symptoms |  | Over the final 3 months of neoadjuvant chemotherapy | 
| The number of unexpected healthcare encounters |  | In the final 3 months of neoadjuvant chemotherapy | 
| Correlation between patient reported outcomes (PRO) data and movement tracker data | Will calculate the Pearson correlation between PRO data and movement tracker data. Will also fit a linear mixed model with PRO data as the dependent variable and movement tracker data as covariates. Intra-subject correlation will be adjusted in linear mixed model analysis. | 6 months |