Precision Performance Status Assessment in Breast Cancer Patients Receiving Neoadjuvant Chemotherapy

Terminated

• 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

• Registration Number: NCT04835597
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-4-5
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Terminated
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

Inclusion Criteria:<br><br> - Patients with pathologically confirmed breast cancer with any receptor status, who<br> will receive neoadjuvant chemotherapy. Patients with denovo oligo-metastatic<br> disease, where the intent of therapy is curative with incorporation of local therapy<br> (surgery/radiation to the breast and/or metastatic sites) are also eligible.<br><br> - Age >= 18 years<br><br> - Ability to understand and the willingness to sign a written informed consent<br><br> - Willingness to wear sensors to track physical activity, global positioning system<br> (GPS) location, and provide symptom ratings each night during the screening period<br> of their clinical trial and 180 days after starting treatments<br><br> - Able to read English, Spanish, or Mandarin to complete patient reported outcomes<br><br> - Able to ambulate without an assistive device<br><br>Exclusion Criteria:<br><br> - Missing lower limbs<br><br> - Known movement disorder such as Parkinson's disease, choreo-athetoid movement<br> disorders, essential tremor if that movement disorder is of sufficient severity to<br> require drug therapy

Exclusion Criteria

Not provided

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)

Secondary Outcome Measures

Name	Time	Method
The number of severe adverse event (SAE)s;The number of SAEs based on laboratory results;The number of SAEs based on symptoms;The number of unexpected healthcare encounters;Correlation between patient reported outcomes (PRO) data and movement tracker data