Precision Performance Status Assessment in Breast Cancer Patients Receiving Neoadjuvant Chemotherapy

NCT04835597 | Terminated

• 2 other identifiers: 2019-1237NCI-2021-02624
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• The number of severe adverse event (SAE)s

  During the final 3 months of neoadjuvant chemotherapy

• The number of SAEs based on laboratory results

  Over the final 3 months of neoadjuvant chemotherapy

• The number of SAEs based on symptoms

  Over the final 3 months of neoadjuvant chemotherapy

• The number of unexpected healthcare encounters

  In the final 3 months of neoadjuvant chemotherapy

• Correlation between patient reported outcomes (PRO) data and movement tracker data

  6 months

Study Arms (1)

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: Behavioral Assessment; Other: Electronic Health Record Review

Interventions

Behavioral Assessment BEHAVIORAL

Complete movement assessment

Observational (movement assessment, medical data collection)

Electronic Health Record Review OTHER

SAE data is collected

Observational (movement assessment, medical data collection)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with triple negative breast cancer who will receive neoadjuvant chemotherapy

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

Neuropsychological Tests

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Psychological Tests; Behavioral Disciplines and Activities

Study Officials

• Meghan Karuturi, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2021
• First Posted: April 8, 2021
• Study Start: August 15, 2022
• Primary Completion: August 21, 2024
• Study Completion: August 21, 2024
• Last Updated: August 26, 2024

Record last verified: 2024-08

Locations

US (1)