Breast Ductal Carcinoma In SituNCT04169542
Impact of COVID-19 Pandemic on Out-of-Pocket Costs, Lost Wages, and Unemployment in Patients With Breast Cancer Undergoing Breast Surgery
An observational study of Breast Ductal Carcinoma In Situ and COVID-19 Infection, run by M.D. Anderson Cancer Center at 4 sites in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Ductal Carcinoma In Situ, COVID-19 Infection, Hereditary Breast Carcinoma
- What is being tested?
- Questionnaire Administration
- How many people
- 600 participants
- Where
- 4 sitesUnited States
- Study dates
- 21 May 2019to 31 Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
MD Anderson in The Woodlands
Conroe, Texas, 77384
Elizabeth FitzSullivan, efitzsullivan@mdanderson.org
Elizabeth FitzSullivan
- Recruiting
M D Anderson Cancer Center
Houston, Texas, 77030
Carrie Chu, MD, ckchu@mdanderson.org
Carrie Chu, MD
- Recruiting
MD Anderson League City
League City, Texas, 77573
Richard A. Ehlers, rehlers@mdanderson.org
Richard A. Ehlers
- Recruiting
MD Anderson in Sugar Land
Sugar Land, Texas, 77478
Makesha V. Miggins, mvmiggins@mdanderson.org
Makesha V. Miggins
About this study
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
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Conditions
- Breast Ductal Carcinoma In Situ, COVID-19 Infection, Hereditary Breast Carcinoma, Invasive Breast Carcinoma
- Being tested
- Questionnaire Administration
- Medical subject headings
- Carcinoma, Intraductal, Noninfiltrating, COVID-19, Breast Cancer, Familial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire AdministrationOther
Complete questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Observational (questionnaire) | Patients complete up to 4 electronic questionnaires over 15 minutes before surgery and at 6, 12, and 24 months after surgery. Receives: Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 1 year after completion of study
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Up to 1 year after completion of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2019
- Study start21 May 2019
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Ductal Carcinoma In SituStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Carrie Chu, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04169542
- Sponsor's protocol ID
- PA18-1077
- Other IDs
- NCI-2019-07463, PA18-1077
- Status last verified
- Oct 2026
- First submitted
- 18 Nov 2019
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04169542
- Acronym / sponsor ID
- PA18-1077
- Conditions
- Breast Ductal Carcinoma In Situ, COVID-19 Infection, Hereditary Breast Carcinoma, Invasive Breast Carcinoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 21 May 2019 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 20 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (questionnaire) | – | Other: Questionnaire AdministrationPatients complete up to 4 electronic questionnaires over 15 minutes before surgery and at 6, 12, and 24 months after surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire AdministrationComplete questionnaires | Other | Observational (questionnaire) |
Primary outcome
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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- http://www.mdanderson.orgLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carrie Chu, MD principal investigator
M.D. Anderson Cancer Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Ductal Carcinoma In Situ and COVID-19 Infection, run by M.D. Anderson Cancer Center at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carrie Chu, MD (713-794-1247, ckchu@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of financial toxicity (time frame: Up to 1 year after completion of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.