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.
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.
Study Type
OBSERVATIONAL
Enrollment
600
Complete questionnaires
MD Anderson in The Woodlands
Conroe, Texas, United States
RECRUITINGM D Anderson Cancer Center
Houston, Texas, United States
RECRUITINGMD Anderson League City
League City, Texas, United States
RECRUITINGMD Anderson in Sugar Land
Sugar Land, Texas, United States
RECRUITINGPrevalence of financial toxicity
Will be measured by the Comprehensive Score for financial Toxicity questionnaire. Summary statistics including mean, standard deviation, median, and range for continuous variables, and frequency count and percentage for categorical variables will be provided. Various subgroup analyses may occur. In these cases, continuous variables will be compared using the two-sample t-test and categorical variables will be compared using chi-squared test or Fisher's exact test. Multivariate regression analysis will be performed to account for confounding and to increase the robustness of any causal inference.
Time frame: Up to 1 year after completion of study
Correlation between economic disruption from coronavirus disease 2019 (COVID-19) and financial toxicity
Summary statistics including mean, standard deviation, median, and range for continuous variables, and frequency count and percentage for categorical variables will be provided. Various subgroup analyses may occur. In these cases, continuous variables will be compared using the two sample t-test and categorical variables will be compared using chi-squared test or Fisher's exact test. Multivariate regression analysis will be performed to account for confounding and to increase the robustness of any causal inference.
Time frame: Up to 1 year after completion of study
Relationship between financial toxicity and patient reported quality of life
Will be assessed using the Short Form-12 survey. Summary statistics including mean, standard deviation, median, and range for continuous variables, and frequency count and percentage for categorical variables will be provided. Various subgroup analyses may occur. In these cases, continuous variables will be compared using the two-sample t-test and categorical variables will be compared using chi-squared test or Fisher's exact test. Multivariate regression analysis will be performed to account for confounding and to increase the robustness of any causal inference.
Time frame: Up to 1 year after completion of study
Relationship between financial toxicity and patient reported satisfaction with breast reconstruction
Will be assessed using the Breast-Q survey. Summary statistics including mean, standard deviation, median, and range for continuous variables, and frequency count and percentage for categorical variables will be provided. Various subgroup analyses may occur. In these cases, continuous variables will be compared using the two-sample t-test and categorical variables will be compared using chi-squared test or Fisher's exact test. Multivariate regression analysis will be performed to account for confounding and to increase the robustness of any causal inference.
Time frame: Up to 1 year after completion of study
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