Assessing Functional Status Needs Via PRO Measures for Pts With Metastatic Breast Cancer

NCT05755347 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2024-04-11

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • UNC Lineberger Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Sasha Knowlton, MD · UNC Lineberger Comprehensive Cancer Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-17
Primary Completion
2024-02-05
Completion
2024-02-05

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05755347 on ClinicalTrials.gov