Breast Cancer Clinical Trial

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

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.

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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.

View Eligibility Criteria

Eligibility Criteria

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 is for people with:

Breast Cancer

Estimated Enrollment:

600

Study ID:

NCT04169542

Recruitment Status:

Recruiting

Sponsor:

M.D. Anderson Cancer Center

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There are 4 Locations for this study

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MD Anderson in The Woodlands
Conroe Texas, 77384, United States More Info
Elizabeth FitzSullivan
Contact
[email protected]
Elizabeth FitzSullivan
Principal Investigator
M D Anderson Cancer Center
Houston Texas, 77030, United States More Info
Anaeze Offodile
Contact
713-794-1247
Anaeze Offodile
Principal Investigator
MD Anderson League City
League City Texas, 77573, United States More Info
Richard A. Ehlers
Contact
[email protected]
Richard A. Ehlers
Principal Investigator
MD Anderson in Sugar Land
Sugar Land Texas, 77478, United States More Info
Makesha V. Miggins
Contact
[email protected]
Makesha V. Miggins
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

600

Study ID:

NCT04169542

Recruitment Status:

Recruiting

Sponsor:


M.D. Anderson Cancer Center

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