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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04169542
Other study ID # PA18-1077
Secondary ID NCI-2019-07463PA
Status Recruiting
Phase
First received
Last updated
Start date May 21, 2019
Est. completion date March 31, 2026

Study information

Verified date May 2024
Source M.D. Anderson Cancer Center
Contact Carrie Chu, MD
Phone 713-794-1247
Email ckchu@mdanderson.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 600
Est. completion date March 31, 2026
Est. primary completion date March 31, 2026
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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


Intervention

Other:
Questionnaire Administration
Complete questionnaires

Locations

Country Name City State
United States MD Anderson in The Woodlands Conroe Texas
United States M D Anderson Cancer Center Houston Texas
United States MD Anderson League City League City Texas
United States MD Anderson in Sugar Land Sugar Land Texas

Sponsors (2)

Lead Sponsor Collaborator
M.D. Anderson Cancer Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Secondary 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. Up to 1 year after completion of study
Secondary 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
Secondary 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
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