Cancer Patient Perspectives During COVI… | Clinical Trial

Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Neoplasms Neoplasms by Site Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Skin Diseases Skin and Connective Tissue Diseases Virus Diseases

Age range

18 year–60 year

Sex eligibility

Female

Study type

Observational

Primary location

Colorado Research Center

Aurora, Colorado, 80217, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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
Number of participants with treatment concerns during COVID-19 pandemic

Time frame: 12 months

Patients with treatment concerns during the COVID-19 pandemic
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

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study title

Patient Perspectives in Breast Cancer Care During COVID-19

Important dates

Study start: 2020
Primary completion: 2021
Study completion: 2024
First posted: Sep 30, 2021
Registry last updated: Jul 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Not Yet Recruiting