Precision Performance Status Assessment in Breast Cancer Patients Receiving Neoadjuvant Chemotherapy
NCT ID: NCT04835597
Last Updated: 2024-08-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
27 participants
OBSERVATIONAL
2022-08-15
2024-08-21
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Observational (movement assessment, medical data collection)
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 Assessment
Complete movement assessment
Electronic Health Record Review
SAE data is collected
Interventions
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Behavioral Assessment
Complete movement assessment
Electronic Health Record Review
SAE data is collected
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Meghan Karuturi, MD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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MD Anderson Cancer Center
Other Identifiers
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NCI-2021-02624
Identifier Type: REGISTRY
Identifier Source: secondary_id
2019-1237
Identifier Type: OTHER
Identifier Source: secondary_id
2019-1237
Identifier Type: -
Identifier Source: org_study_id
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