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

M.D. Anderson Cancer Center

Status: Enrolling

Conditions: Invasive Breast Carcinoma; Breast Ductal Carcinoma In Situ; Hereditary Breast Carcinoma; COVID-19 Infection

Treatments: Other: Questionnaire Administration

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT04169542

PA18-1077 (Other Identifier)

NCI-2019-07463 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 600 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

600 participants in 1 patient group

Observational (questionnaire)

Description:

Patients complete up to 4 electronic questionnaires over 15 minutes before surgery and at 6, 12, and 24 months after surgery.

Treatment:

Other: Questionnaire Administration