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

UNC Lineberger Comprehensive Cancer Center

Status: Completed

Conditions: Breast Cancer; Metastasis

Treatments: Other: Godin Leisure-Time Exercise Questionnaire; Other: PROMIS Cancer Function Brief 3D profile questionnaires; Other: FACT-G questionnaires; Other: REAP-S questionnaires; Other: General health survey questionnaires

Study type: Observational

Funder types: Other

Identifiers

NCT05755347

LCCC2241

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

In order to participate in this study a subject must meet all of the eligibility criteria outlined below.

Inclusion Criteria:

1. Written informed consent was obtained from participants in the study and HIPAA authorization for release of personal health information.
2. Subject is willing and able to comply with study procedures based on the judgment of the investigator or protocol designee.
3. Age ≥ 18 years at the time of consent.
4. Recent diagnosis of new metastatic breast cancer at time of screening.

Exclusion Criteria:

1. Exclusion Criteria
2. Inability to read or speak English.
3. 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.
4. Current incarceration.
5. Subject has already received treatment for metastatic breast cancer prior to screening.

Trial design

50 participants in 1 patient group

Single Arm

Description:

Subjects with metastatic breast carcinoma have been receiving treatment at the study center and responding to survey questionnaires.

Treatment:

Other: Godin Leisure-Time Exercise Questionnaire

Other: General health survey questionnaires

Other: FACT-G questionnaires

Other: REAP-S questionnaires

Other: PROMIS Cancer Function Brief 3D profile questionnaires