NCT04169542

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
23mo left

Started May 2019

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress79%
May 2019Mar 2028

Study Start

First participant enrolled

May 21, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 20, 2019

Completed
8.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2028

Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

8.9 years

First QC Date

November 18, 2019

Last Update Submit

April 28, 2026

Conditions

Breast Ductal Carcinoma In SituCOVID-19 InfectionHereditary Breast CarcinomaInvasive Breast Carcinoma

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Correlation between economic disruption from coronavirus disease 2019 (COVID-19) and financial toxicity

    Up to 1 year after completion of study

  • Relationship between financial toxicity and patient reported quality of life

    Up to 1 year after completion of study

  • Relationship between financial toxicity and patient reported satisfaction with breast reconstruction

    Up to 1 year after completion of study

Study Arms (1)

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

Interventions

Questionnaire AdministrationOTHER

Complete questionnaires

Observational (questionnaire)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

MD Anderson in The Woodlands

Conroe, Texas, 77384, United States

RECRUITING

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

MD Anderson League City

League City, Texas, 77573, United States

RECRUITING

MD Anderson in Sugar Land

Sugar Land, Texas, 77478, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Carcinoma, Intraductal, NoninfiltratingCOVID-19Breast Cancer, Familial

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsBreast Carcinoma In SituCarcinoma in SituNeoplasms, Ductal, Lobular, and MedullaryPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Carrie Chu, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Carrie Chu, MD

CONTACT

713-794-1247ckchu@mdanderson.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2019

First Posted

November 20, 2019

Study Start

May 21, 2019

Primary Completion (Estimated)

March 31, 2028

Study Completion (Estimated)

March 31, 2028

Last Updated

May 4, 2026

Record last verified: 2026-04

Locations

US(4)