Cancer Patient Perspectives During COVID-19

Breast Cancer Clinical Trial

Official title:

Patient Perspectives in Breast Cancer Care During COVID-19

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05062538
• Other study ID #: 20-1434.cc
• Status: Active, not recruiting
• Start date: August 24, 2020
• Est. completion date: June 2024

Study information

• Verified date: July 2023
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 89
• Est. completion date: June 2024
• Est. primary completion date: February 20, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• COVID-19

Locations

Country	Name	City	State
United States	Colorado Research Center	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Number of participants with treatment concerns during COVID-19 pandemic	Patients with treatment concerns during the COVID-19 pandemic	12 months
Primary	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