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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Patients who are evaluated for breast reconstruction at MD Anderson Cancer Center (Texas Medical Center, Katy, League City, Memorial City, Sugar Land, The Woodlands) and, pending Institutional Review Board approval, domestic institutions in the MD Anderson Cancer Network

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Questionnaire Administration

    Other intervention

    Complete questionnaires

Treatment groups

600 Participants
are divided into 1 treatment group
Group A: Observational (questionnaire)1 intervention

Trial outcomes

Primary outcomes

1

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 outcomes

1

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
2

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
3

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

M.D. Anderson Cancer Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator