Clinical Trials Directory

Trials / Terminated

TerminatedNCT04835597

Precision Performance Status Assessment in Breast Cancer Patients Receiving Neoadjuvant Chemotherapy

Status
Terminated
Phase
—
Study type
Observational
Enrollment
27 (actual)
Sponsor
M.D. Anderson Cancer Center · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALBehavioral AssessmentComplete movement assessment
OTHERElectronic Health Record ReviewSAE data is collected

Timeline

Start date
2022-08-15
Primary completion
2024-08-21
Completion
2024-08-21
First posted
2021-04-08
Last updated
2024-08-26

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04835597. Inclusion in this directory is not an endorsement.