Precision Performance Status Assessment in Breast Cancer Patients Receiving Neoadjuvant Chemotherapy

Terminated

• Conditions: Anatomic Stage I Breast Cancer AJCC v8; Anatomic Stage IB Breast Cancer AJCC v8; Anatomic Stage IA Breast Cancer AJCC v8; Prognostic Stage I Breast Cancer AJCC v8; Prognostic Stage II Breast Cancer AJCC v8; Prognostic Stage IIA Breast Cancer AJCC v8; Anatomic Stage IIIA Breast Cancer AJCC v8; Prognostic Stage IB Breast Cancer AJCC v8; Anatomic Stage II Breast Cancer AJCC v8; Prognostic Stage IA Breast Cancer AJCC v8
• Interventions: Behavioral: Behavioral Assessment; Other: Electronic Health Record Review

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

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.

Study Timeline

• Study First Submitted: 2021-04-05
• Study First Submitted QC: 2021-04-05
• Study First Posted: 2021-04-08
• Study Start: 2022-08-15
• Status Verified: 2024-08
• Primary Completion: 2024-08-21
• Study Completion: 2024-08-21
• Last Update Submitted: 2024-08-23
• Last Update Posted: 2024-08-26

Recruitment & Eligibility

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

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

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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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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational (movement assessment, medical data collection)	Behavioral Assessment	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.
Observational (movement assessment, medical data collection)	Electronic Health Record Review	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.

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)	Up to 6 months

Secondary Outcome Measures

Name	Time	Method
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	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.
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

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States