Recruiting

Observational Study

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT04169542

Conditions

Breast Ductal Carcinoma In Situ

COVID-19 Infection

Hereditary Breast Carcinoma

Invasive Breast Carcinoma

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Questionnaire Administration

Study Details

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.

Conditions

Breast Ductal Carcinoma In Situ

COVID-19 Infection

Hereditary Breast Carcinoma

Invasive Breast Carcinoma

Study ID

NCT04169542

Start date

May 21, 2019

Status verified date

Apr, 2026

Completion date

Mar 31, 2028

Anticipated

Primary completion date

Mar 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

600 participants

Anticipated

Interventions and Outcome Measures

Arms

Observational (questionnaire)

Patients complete up to 4 electronic questionnaires over 15 minutes before surgery and at 6, 12, and 24 months after surgery.

Interventions

Questionnaire Administration

Complete questionnaires

Primary outcome measure

  • Prevalence of financial toxicity [ Time Frame: Up to 1 year after completion of study ]

Central Contacts and Locations

Central contacts

Carrie Chu, MD

713-794-1247ckchu@mdanderson.org

Locations

MD Anderson in The Woodlands

Recruiting

Conroe, Texas, United States, 77384

Contacts

Elizabeth FitzSullivan

efitzsullivan@mdanderson.org

Principal Investigator:

Elizabeth FitzSullivan

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Carrie Chu, MD

ckchu@mdanderson.org

Principal Investigator:

Carrie Chu, MD

MD Anderson League City

Recruiting

League City, Texas, United States, 77573

Contacts

Richard A. Ehlers

rehlers@mdanderson.org

Principal Investigator:

Richard A. Ehlers

MD Anderson in Sugar Land

Recruiting

Sugar Land, Texas, United States, 77478

Contacts

Makesha V. Miggins

mvmiggins@mdanderson.org

Principal Investigator:

Makesha V. Miggins

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

May 4, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-05-04.