Cancer Patient Perspectives During COVID-19

July 25, 2024 updated by: University of Colorado, Denver

Patient Perspectives in Breast Cancer Care During COVID-19

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).

Study Overview

Status

Completed

Conditions

Detailed Description

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). This will ensure that patients at various stages of treatment are included, from initial diagnosis into survivorship. This will allow the investigators to assess changes to initial consultations, surgeries, chemotherapy, and radiation, as well as patient perspectives as it relates to these changes.

The web-based surveys will be given via Redcap. The study team will use a validated questionnaire developed at the University of Miami (Penedo, 2020), which includes a combination of multiple-choice questions, Likert scale ratings, and yes/no questions. A list of potential questions is listed below.

A group of patients will be contacted for semi-structured interviews via telephone as well if (1) patients indicate willingness to participate on a separate RedCap survey or (2) if the patient does not respond to this survey. Phone interviews will be recorded and transcribed verbatim. Multiple members of the research team will separately code the information and evaluate for themes.

Study Type

Observational

Enrollment (Actual)

89

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80217
        • Colorado Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with changes implemented to breast cancer treatment
Time Frame: 12 months
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
Time Frame: 12 months
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
Time Frame: 12 months
Number of participants with effects of COVID-19 on psychological, social, and physical well-being of breast cancer patients
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Investigators

  • Principal Investigator: Sarah Tevis, University of Colorado Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 24, 2020

Primary Completion (Actual)

February 20, 2021

Study Completion (Actual)

July 15, 2024

Study Registration Dates

First Submitted

September 29, 2021

First Submitted That Met QC Criteria

September 29, 2021

First Posted (Actual)

September 30, 2021

Study Record Updates

Last Update Posted (Actual)

July 26, 2024

Last Update Submitted That Met QC Criteria

July 25, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-1434.cc

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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