Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Female
Accepts Healthy 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 Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Observational (questionnaire) Patients complete up to 4 electronic questionnaires over 15 minutes before surgery and at 6, 12, and 24 months after surgery.
  • Other: Questionnaire Administration
    Complete questionnaires

Recruiting Locations

MD Anderson in The Woodlands
Conroe, Texas 77384
Contact:
Elizabeth FitzSullivan
efitzsullivan@mdanderson.org

M D Anderson Cancer Center
Houston, Texas 77030
Contact:
Carrie Chu, MD
ckchu@mdanderson.org

MD Anderson League City
League City, Texas 77573
Contact:
Richard A. Ehlers
rehlers@mdanderson.org

MD Anderson in Sugar Land
Sugar Land, Texas 77478
Contact:
Makesha V. Miggins
mvmiggins@mdanderson.org

More Details

NCT ID
NCT04169542
Status
Recruiting
Sponsor
M.D. Anderson Cancer Center

Study Contact

Carrie Chu, MD
713-794-1247
ckchu@mdanderson.org

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.