Clinical trial NCT05755347: Assessing Functional Status Needs Via PRO Measures for Pts With Metastatic Breast Cancer
Official title: Assessing Functional Status Needs Via Patient-Reported Outcomes Measures in the Pre-treatment Setting With Metastatic Breast Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Metastasis
Keywords: patient reported outcomes
quality of life
functional status
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2023-03-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subject with metastatic breast cancer receive treatment at the University of North Carolina, Lineberger Comprehensive Cancer Center.

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Physical activity levels
timeFrame: Baseline
Secondary outcomes:
measure: Acceptability of survey
timeFrame: Baseline
measure: Health-related quality of life - FACT-G
timeFrame: Baseline
measure: Health-related quality of life - PROMIS
timeFrame: Baseline
measure: Diet quality
timeFrame: Baseline
measure: the percentage of subjects referred
timeFrame: Baseline
measure: Barriers to access exercise
timeFrame: Baseline
measure: health-related opinions
timeFrame: Baseline
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: Lineberger Comphrehensive Cancer Center at University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: UNC Lineberger Comprehensive Cancer Center
name: Sasha Knowlton, MD
role: PRINCIPAL_INVESTIGATOR
References: