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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 8
- 主要终点
- Prevalence of financial toxicity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Observational (questionnaire)
Patients complete up to 4 electronic questionnaires over 15 minutes before surgery and at 6, 12, and 24 months after surgery.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Prevalence of financial toxicity
时间窗: Up to 1 year after completion of study
Will be measured by the Comprehensive Score for financial Toxicity questionnaire. Summary statistics including mean, standard deviation, median, and range for continuous variables, and frequency count and percentage for categorical variables will be provided. Various subgroup analyses may occur. In these cases, continuous variables will be compared using the two-sample t-test and categorical variables will be compared using chi-squared test or Fisher's exact test. Multivariate regression analysis will be performed to account for confounding and to increase the robustness of any causal inference.
次要结局
- Correlation between economic disruption from coronavirus disease 2019 (COVID-19) and financial toxicity(Up to 1 year after completion of study)
- Relationship between financial toxicity and patient reported quality of life(Up to 1 year after completion of study)
- Relationship between financial toxicity and patient reported satisfaction with breast reconstruction(Up to 1 year after completion of study)