Precision Performance Status Assessment in Breast Cancer Patients Receiving Neoadjuvant Chemotherapy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- M.D. Anderson Cancer Center
- Enrollment
- 27
- Locations
- 1
- Primary Endpoint
- 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)
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 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
Outcomes
Primary Outcomes
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)
Time Frame: Up to 6 months
Secondary Outcomes
- The number of SAEs based on symptoms(Over the final 3 months of neoadjuvant chemotherapy)
- Correlation between patient reported outcomes (PRO) data and movement tracker data(6 months)
- The number of SAEs based on laboratory results(Over the final 3 months of neoadjuvant chemotherapy)
- The number of unexpected healthcare encounters(In the final 3 months of neoadjuvant chemotherapy)
- The number of severe adverse event (SAE)s(During the final 3 months of neoadjuvant chemotherapy)