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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2019-07463 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| PA18-1077 | Other Identifier | M D Anderson Cancer Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational (questionnaire) | Patients complete up to 4 electronic questionnaires over 15 minutes before surgery and at 6, 12, and 24 months after surgery. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaire Administration | Other | Complete questionnaires |
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| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of financial toxicity | 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. | Up to 1 year after completion of study |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between economic disruption from coronavirus disease 2019 (COVID-19) and financial toxicity | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carrie Chu, MD | Contact | 713-794-1247 | ckchu@mdanderson.org |
| Name | Affiliation | Role |
|---|---|---|
| Carrie Chu, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MD Anderson in The Woodlands | Recruiting | Conroe | Texas | 77384 | United States |
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| Label | URL |
|---|---|
| http://www.mdanderson.org | View source |
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| Up to 1 year after completion of study |
| Relationship between financial toxicity and patient reported quality of life | Will be assessed using the Short Form-12 survey. 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. | Up to 1 year after completion of study |
| Relationship between financial toxicity and patient reported satisfaction with breast reconstruction | Will be assessed using the Breast-Q survey. 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. | Up to 1 year after completion of study |
| M D Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
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| MD Anderson League City | Recruiting | League City | Texas | 77573 | United States |
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| MD Anderson in Sugar Land | Recruiting | Sugar Land | Texas | 77478 | United States |
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| ID | Term |
|---|---|
| D002285 | Carcinoma, Intraductal, Noninfiltrating |
| D000086382 | COVID-19 |
| C562840 | Breast Cancer, Familial |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D000071960 | Breast Carcinoma In Situ |
| D002278 | Carcinoma in Situ |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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