Precision Performance Status Assessment in Breast Cancer Patients Receiving Neoadjuvant Chemotherapy

Anatomic Stage III Breast Cancer AJCC v8 Clinical Trial

Official title:

Precision Performance Status Assessment in Breast Cancer Patients Receiving Neoadjuvant Chemotherapy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04835597
• Other study ID #: 2019-1237
• Secondary ID: NCI-2021-0262420
• Status: Active, not recruiting
• Start date: August 15, 2022
• Est. completion date: December 31, 2026

Study information

• Verified date: March 2024
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 27
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• 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
• Breast Neoplasms
• 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

Behavioral:
• Behavioral Assessment
Complete movement assessment

Other:
• Electronic Health Record Review
SAE data is collected

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The number of severe adverse event (SAE)s		During the final 3 months of neoadjuvant chemotherapy
Secondary	The number of SAEs based on laboratory results		Over the final 3 months of neoadjuvant chemotherapy
Secondary	The number of SAEs based on symptoms		Over the final 3 months of neoadjuvant chemotherapy
Secondary	The number of unexpected healthcare encounters		In the final 3 months of neoadjuvant chemotherapy
Secondary	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

External Links

•   MD Anderson Cancer Center