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

NCT05755347 | Completed DMC

• 1 other identifier: LCCC2241
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Metastasis

Keywords

patient reported outcomes; quality of life; functional status

Outcome Measures

Primary Outcomes (1)

• Physical activity levels

  Physical activity levels will be measured using the Godin Leisure-Time Exercise Questionnaire. Godin Leisure-Time Exercise Questionnaire has 3 dichotomous questions, answers will be "yes" or "no". There will be reason questions if the answer is no.

  Baseline

Secondary Outcomes (7)

• Acceptability of survey

  Baseline

• Health-related quality of life - FACT-G

  Baseline

• Health-related quality of life - PROMIS

  Baseline

• Diet quality

  Baseline

• the percentage of subjects referred

  Baseline

Study Arms (1)

Single Arm

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

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

Interventions

General health survey questionnaires OTHER

Patient-reported outcome survey will be offered at baseline.

Single Arm

PROMIS Cancer Function Brief 3D profile questionnaires OTHER

Patient-reported outcome survey will be offered at baseline.

Single Arm

FACT-G questionnaires OTHER

Patient-reported outcome survey will be offered at baseline.

Single Arm

Godin Leisure-Time Exercise Questionnaire OTHER

Patient-reported outcome survey will be offered at baseline.

Single Arm

REAP-S questionnaires OTHER

Patient-reported outcome survey will be offered at baseline.

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subject with metastatic breast cancer receive treatment at the University of North Carolina, Lineberger Comprehensive Cancer Center.

You may qualify if:

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

You may not qualify if:

• Inability to read or speak English.
• 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.
• Current incarceration.
• Subject has already received treatment for metastatic breast cancer prior to screening.

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead

Study Sites (1)

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

Chapel Hill, North Carolina, 27599, United States

Location

Related Links

• Clinical trials at UNC Lineberger

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sasha Knowlton, MD

  UNC Lineberger Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2023
• First Posted: March 6, 2023
• Study Start: March 17, 2023
• Primary Completion: February 5, 2024
• Study Completion: February 5, 2024
• Last Updated: April 11, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)