NCT05755347Completed
Assessing Functional Status Needs Via PRO Measures for Pts With Metastatic Breast Cancer
Assessing Functional Status Needs Via Patient-Reported Outcomes Measures in the Pre-treatment Setting With Metastatic Breast Cancer Patients
Source: ClinicalTrials.gov · Last updated 11 Apr 2024
Brief summary (registry, in English)
The purpose of this single-site non-randomized study is to identify areas of need related to functional status and overall health, including nutrition and mental health in subjects with metastatic breast cancer (MBC). A decline in functional status is observed after breast cancer diagnosis and exacerbated by treatment. Declining functional status impacts the quality of life and can lead to increased comorbidity burden, hospitalization, and increased mortality. Functional status is assessed by specific provider-graded scales. Patient Reported Outcome (PRO) measures may better assess certain aspects of patient health and symptom domains. Thus, potentially supporting the future implementation of effective prehabilitation strategies. This study explores whether a PRO-based survey will identify the physical and emotional health and the social and financial status of patients newly diagnosed with MBC.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 50 (actual)
- First submitted
- 22 Feb 2023
- Start date
- 17 Mar 2023
- Primary completion date
- 5 Feb 2024
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Diseases
- Metastatic breast cancer
- NCT number
- NCT05755347
What you commit to
- Study type: Observational
- Participants enrolled: 50
- From 17 Mar 2023 to the primary completion date, 5 Feb 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subject has already received treatment for metastatic breast cancer prior to screening.
Other illness
- Dementia, altered mental status, or any psychiatric condition as determined by clinical or study team that would prohibit the understanding or rendering of informed consent.
Other
- Exclusion Criteria
- Inability to read or speak English.
- Current incarceration.
Who the study is looking for
- Written informed consent was obtained from participants in the study and HIPAA authorization for release of personal health information.
- Subject is willing and able to comply with study procedures based on the judgment of the investigator or protocol designee.
- Age ≥ 18 years at the time of consent.
- Recent diagnosis of new metastatic breast cancer at time of screening.
Criteria the registry did not label
- In order to participate in this study a subject must meet all of the eligibility criteria outlined below.
Age in the registry: 18 years to - · Sex: All
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Lineberger Comphrehensive Cancer Center at University of North Carolina at Chapel Hill Coordinator of this site? Confirm its status | Chapel Hill | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.