NCT04169542

Impact of COVID-19 Pandemic on Out-of-Pocket Costs, Lost Wages, and Unemployment in Patients With Breast Cancer Undergoing Breast Surgery

Potential Impact of the COVID -19 Pandemic on Financial Toxicity in Breast Cancer Surgical Patients: The Impact on Out of Pocket Costs, Lost Wages and Economic Strain

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 600 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study investigates the impact of COVID-19 pandemic on out-of-pocket costs, lost wages, and unemployment in patients with breast cancer undergoing breast surgery. Post-mastectomy reconstructive patients are at high risk for financial toxicity (adverse effects of escalating health care cost on well-being). The goal of this study is to collect information about financial costs patients may have as a result of surgical treatment for cancer with or without breast reconstruction and to learn if COVID-19 affects patient costs of breast reconstruction. This may help researchers demonstrate the financial consequences of undergoing breast surgery.

Detailed description

PRIMARY OBJECTIVES: I. Obtain Comprehensive Score for financial Toxicity (COST) questionnaire data from the patients who are undergoing any form of mastectomy (with or without breast reconstruction). II. To determine which patients are at higher risk of financial toxicity while pursuing breast reconstruction. III. Assess if financial toxicity or distress is associated with worse BREAST-questionnaire (Q) performance as well as quality of life. IV. Identify relationships between coronavirus disease 2019 (COVID-19) related productivity losses and financial toxicity. OUTLINE: Patients complete up to 4 electronic questionnaires over 15 minutes before surgery and at 6, 12, and 24 months after surgery. After completion of study, patients will be followed up for 1 year.

Conditions

• Breast Ductal Carcinoma In Situ
• COVID-19 Infection
• Hereditary Breast Carcinoma
• Invasive Breast Carcinoma

Interventions

Type	Name	Description
OTHER	Questionnaire Administration	Complete questionnaires

Timeline

• Start date: 2019-05-21
• Primary completion: 2026-03-31
• Completion: 2026-03-31
• First posted: 2019-11-20
• Last updated: 2025-10-27

Locations

4 sites across 1 country: United States