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

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ClinicalTrials.gov Identifier: NCT04169542
Recruitment Status : Recruiting
First Posted : November 20, 2019
Last Update Posted : December 9, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.

Condition or disease Intervention/treatment
Breast Ductal Carcinoma In Situ COVID-19 Infection Hereditary Breast Carcinoma Invasive Breast Carcinoma Other: Questionnaire Administration

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.

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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : May 21, 2019
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Group/Cohort Intervention/treatment
Observational (questionnaire)
Patients complete up to 4 electronic questionnaires over 15 minutes before surgery and at 6, 12, and 24 months after surgery.
Other: Questionnaire Administration
Complete questionnaires




Primary Outcome Measures :
  1. Prevalence of financial toxicity [ Time Frame: 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.


Secondary Outcome Measures :
  1. Correlation between economic disruption from coronavirus disease 2019 (COVID-19) and financial toxicity [ Time Frame: Up to 1 year after completion of study ]
    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.

  2. Relationship between financial toxicity and patient reported quality of life [ Time Frame: Up to 1 year after completion of study ]
    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.

  3. Relationship between financial toxicity and patient reported satisfaction with breast reconstruction [ Time Frame: Up to 1 year after completion of study ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04169542


Contacts
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Contact: Anaeze Offodile 713-794-1247 acoffodile@mdanderson.org

Locations
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United States, Texas
MD Anderson in The Woodlands Recruiting
Conroe, Texas, United States, 77384
Contact: Elizabeth FitzSullivan       efitzsullivan@mdanderson.org   
Principal Investigator: Elizabeth FitzSullivan         
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Anaeze Offodile    713-794-1247      
Principal Investigator: Anaeze Offodile         
MD Anderson League City Recruiting
League City, Texas, United States, 77573
Contact: Richard A. Ehlers       rehlers@mdanderson.org   
Principal Investigator: Richard A. Ehlers         
MD Anderson in Sugar Land Recruiting
Sugar Land, Texas, United States, 77478
Contact: Makesha V. Miggins       mvmiggins@mdanderson.org   
Principal Investigator: Makesha V. Miggins         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Anaeze Offodile M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT04169542    
Other Study ID Numbers: PA18-1077
NCI-2019-07463 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
PA18-1077 ( Other Identifier: M D Anderson Cancer Center )
First Posted: November 20, 2019    Key Record Dates
Last Update Posted: December 9, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Breast Neoplasms
Carcinoma in Situ
Carcinoma, Ductal
Carcinoma, Intraductal, Noninfiltrating
Carcinoma, Ductal, Breast
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary
Breast Carcinoma In Situ