Clinical trial NCT04169542: Impact of COVID-19 Pandemic on Out-of-Pocket Costs, Lost Wages, and Unemployment in Patients With Breast Cancer Undergoing Breast Surgery
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Ductal Carcinoma In Situ
COVID-19 Infection
Hereditary Breast Carcinoma
Invasive Breast Carcinoma
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-11-20
Enrollment: 600
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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

Brief 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.

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.

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

Primary outcomes:
measure: Prevalence of financial toxicity
timeFrame: Up to 1 year after completion of study
Secondary outcomes:
measure: Correlation between economic disruption from coronavirus disease 2019 (COVID-19) and financial toxicity
timeFrame: Up to 1 year after completion of study
measure: Relationship between financial toxicity and patient reported quality of life
timeFrame: Up to 1 year after completion of study
measure: Relationship between financial toxicity and patient reported satisfaction with breast reconstruction
timeFrame: Up to 1 year after completion of study
Other outcomes:
Locations:
city: Conroe
country: United States
facility: MD Anderson in The Woodlands
state: Texas
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
city: League City
country: United States
facility: MD Anderson League City
state: Texas
city: Sugar Land
country: United States
facility: MD Anderson in Sugar Land
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Carrie Chu, MD
role: PRINCIPAL_INVESTIGATOR
References: