NCT05062538

Brief Summary

A web-based survey will be emailed to all adult women diagnosed with invasive breast cancer or ductal carcinoma in situ who have been seen as surgical consultations within the last year (06/01/19-06/01/20).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
89

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

August 24, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 29, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 30, 2021

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2024

Completed
Last Updated

July 26, 2024

Status Verified

July 1, 2024

Enrollment Period

6 months

First QC Date

September 29, 2021

Last Update Submit

July 25, 2024

Conditions

Breast Cancer

Keywords

COVID-19

Outcome Measures

Primary Outcomes (3)

  • Number of participants with changes implemented to breast cancer treatment

    Number of participants with changes implemented to breast cancer treatment during the COVID-19 pandemic

    12 months

  • Number of participants with treatment concerns during COVID-19 pandemic

    Patients with treatment concerns during the COVID-19 pandemic

    12 months

  • Number of participants with effects of COVID-19 on psychological, social, and physical well-being of breast cancer patients

    Number of participants with effects of COVID-19 on psychological, social, and physical well-being of breast cancer patients

    12 months

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Adult females with diagnosis of invasive breast cancer or ductal carcinoma in situ, seen as surgical consultation between 06/01/19-06/01/20

You may qualify if:

  • Adult females with diagnosis of invasive breast cancer or ductal carcinoma in situ, seen as surgical consultation between 06/01/19-06/01/20

You may not qualify if:

  • Males
  • Patients with non-cancer diagnoses
  • Patients with no history of breast cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Colorado Research Center

Aurora, Colorado, 80217, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsCOVID-19

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Sarah Tevis

    University of Colorado Health

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 29, 2021

First Posted

September 30, 2021

Study Start

August 24, 2020

Primary Completion

February 20, 2021

Study Completion

July 15, 2024

Last Updated

July 26, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)