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

COVID-19 Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04169542
• Other study ID #: PA18-1077
• Secondary ID: NCI-2019-07463PA
• Status: Recruiting
• Start date: May 21, 2019
• Est. completion date: March 31, 2024

Study information

• Verified date: November 2023
• Source: M.D. Anderson Cancer Center
• Contact: Carrie Chu, MD
• Phone: 713-794-1247
• Email: ckchu[@]mdanderson.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: March 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Ductal Carcinoma In Situ
• Breast Neoplasms
• Carcinoma
• Carcinoma in Situ
• Carcinoma, Ductal
• Carcinoma, Ductal, Breast
• Carcinoma, Intraductal, Noninfiltrating
• COVID-19
• COVID-19 Infection
• Hereditary Breast Carcinoma
• Invasive Breast Carcinoma

Intervention

Other:
• Questionnaire Administration
Complete questionnaires

Locations

Country	Name	City	State
United States	MD Anderson in The Woodlands	Conroe	Texas
United States	M D Anderson Cancer Center	Houston	Texas
United States	MD Anderson League City	League City	Texas
United States	MD Anderson in Sugar Land	Sugar Land	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Up to 1 year after completion of study
Secondary	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.	Up to 1 year after completion of study
Secondary	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.	Up to 1 year after completion of study
Secondary	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.	Up to 1 year after completion of study

External Links

•   http://www.mdanderson.org