Clinical trial NCT04835597: Precision Performance Status Assessment in Breast Cancer Patients Receiving Neoadjuvant Chemotherapy
Official title: Precision Performance Status Assessment in Breast Cancer Patients Receiving Neoadjuvant Chemotherapy
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: 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
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
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2021-04-08
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with triple negative breast cancer who will receive neoadjuvant chemotherapy

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: Up to 6 months
Secondary outcomes:
measure: The number of severe adverse event (SAE)s
timeFrame: During the final 3 months of neoadjuvant chemotherapy
measure: The number of SAEs based on laboratory results
timeFrame: Over the final 3 months of neoadjuvant chemotherapy
measure: The number of SAEs based on symptoms
timeFrame: Over the final 3 months of neoadjuvant chemotherapy
measure: The number of unexpected healthcare encounters
timeFrame: In the final 3 months of neoadjuvant chemotherapy
measure: Correlation between patient reported outcomes (PRO) data and movement tracker data
timeFrame: 6 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Meghan Karuturi, MD
role: PRINCIPAL_INVESTIGATOR
References: