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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

NCT ID: NCT04169542Sponsor: M.D. Anderson Cancer CenterLast updated: 2026-05-04

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.

Arms & interventions

  • OtherQuestionnaire Administration

    Complete questionnaires

Outcome measures

Primary

  • Prevalence 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

Secondary

  • Correlation between economic disruption from coronavirus disease 2019 (COVID-19) and financial toxicity

    Time frame: Up to 1 year after completion of study

  • Relationship between financial toxicity and patient reported quality of life

    Time frame: Up to 1 year after completion of study

  • Relationship between financial toxicity and patient reported satisfaction with breast reconstruction

    Time frame: Up to 1 year after completion of study

Eligibility criteria

Sex: FemaleAge: 18 Years and olderHealthy volunteers: No
Inclusion Criteria: * Have an indication for surgical treatment of invasive breast cancer or ductal breast carcinoma in situ (DCIS) or prophylaxis in the setting of genetic mutations or strong family history * English-speaking * Able to complete consent * Able to fill out computer survey material Exclusion Criteria: * Non-English-speaking * Those with recurrent or metastatic disease or concurrent primary cancers * Patients undergoing breast conservation therapy will also be excluded from the study

Study locations (4)

MD Anderson in The Woodlands

Conroe, Texas, 77384

Recruiting
Elizabeth FitzSullivan · Contact
Elizabeth FitzSullivan · Principal Investigator

M D Anderson Cancer Center

Houston, Texas, 77030

Recruiting
Carrie Chu, MD · Contact
Carrie Chu, MD · Principal Investigator

MD Anderson League City

League City, Texas, 77573

Recruiting
Richard A. Ehlers · Contact
Richard A. Ehlers · Principal Investigator

MD Anderson in Sugar Land

Sugar Land, Texas, 77478

Recruiting
Makesha V. Miggins · Contact
Makesha V. Miggins · Principal Investigator