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

NCT ID: NCT05755347

Last Updated: 2024-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-17

Study Completion Date

2024-02-05

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer Metastasis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Single Arm

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

General health survey questionnaires

Intervention Type OTHER

Patient-reported outcome survey will be offered at baseline.

PROMIS Cancer Function Brief 3D profile questionnaires

Intervention Type OTHER

Patient-reported outcome survey will be offered at baseline.

FACT-G questionnaires

Intervention Type OTHER

Patient-reported outcome survey will be offered at baseline.

Godin Leisure-Time Exercise Questionnaire

Intervention Type OTHER

Patient-reported outcome survey will be offered at baseline.

REAP-S questionnaires

Intervention Type OTHER

Patient-reported outcome survey will be offered at baseline.

Interventions

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General health survey questionnaires

Patient-reported outcome survey will be offered at baseline.

Intervention Type OTHER

PROMIS Cancer Function Brief 3D profile questionnaires

Patient-reported outcome survey will be offered at baseline.

Intervention Type OTHER

FACT-G questionnaires

Patient-reported outcome survey will be offered at baseline.

Intervention Type OTHER

Godin Leisure-Time Exercise Questionnaire

Patient-reported outcome survey will be offered at baseline.

Intervention Type OTHER

REAP-S questionnaires

Patient-reported outcome survey will be offered at baseline.

Intervention Type OTHER

Eligibility Criteria

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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

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UNC Lineberger Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sasha Knowlton, MD

Role: PRINCIPAL_INVESTIGATOR

UNC Lineberger Comprehensive Cancer Center

Locations

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Lineberger Comphrehensive Cancer Center at University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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LCCC2241

Identifier Type: -

Identifier Source: org_study_id

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