NCT05755347

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 50 (actual)
• Sponsor: UNC Lineberger Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

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.

Conditions

• Breast Cancer
• Metastasis

Interventions

Type	Name	Description
OTHER	General health survey questionnaires	Patient-reported outcome survey will be offered at baseline.
OTHER	PROMIS Cancer Function Brief 3D profile questionnaires	Patient-reported outcome survey will be offered at baseline.
OTHER	FACT-G questionnaires	Patient-reported outcome survey will be offered at baseline.
OTHER	Godin Leisure-Time Exercise Questionnaire	Patient-reported outcome survey will be offered at baseline.
OTHER	REAP-S questionnaires	Patient-reported outcome survey will be offered at baseline.

Timeline

• Start date: 2023-03-17
• Primary completion: 2024-02-05
• Completion: 2024-02-05
• First posted: 2023-03-06
• Last updated: 2024-04-11

Locations

1 site across 1 country: United States