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Recruiting NCT04169542

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

— Observational Breast Ductal Carcinoma In Situ COVID-19 Infection Hereditary Breast Carcinoma Invasive Breast Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Questionnaire Administration.
Who it may be relevant to
Registry conditions: Breast Ductal Carcinoma In Situ, COVID-19 Infection, Hereditary Breast Carcinoma, Invasive Breast Carcinoma. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Other Questionnaire Administration
    Complete questionnaires

Primary outcome measures

  • Prevalence of financial toxicity [Time frame: Up to 1 year after completion of study]
Secondary outcome measures (3)
  • Correlation between economic disruption from coronavirus disease 2019 (COVID-19) and financial toxicity [Time frame: Up to 1 year after completion of study]
  • Relationship between financial toxicity and patient reported quality of life [Time frame: Up to 1 year after completion of study]
  • Relationship between financial toxicity and patient reported satisfaction with breast reconstruction [Time frame: Up to 1 year after completion of study]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 4 centers
  • MD Anderson in The Woodlands — Conroe
  • M D Anderson Cancer Center — Houston
  • MD Anderson League City — League City
  • MD Anderson in Sugar Land — Sugar Land

Identifiers

NCT: NCT04169542 · PA18-1077 · NCI-2019-07463 · PA18-1077

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗