Assessing Functional Status Needs Via Patient-Reported Outcomes Measures in the Pre-treatment Setting With Metastatic Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Physical activity levels
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Exclusion Criteria
- •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.
结局指标
主要结局
Physical activity levels
时间窗: Baseline
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.
次要结局
- Diet quality(Baseline)
- Health-related quality of life - FACT-G(Baseline)
- health-related opinions(Baseline)
- the percentage of subjects referred(Baseline)
- Barriers to access exercise(Baseline)
- Acceptability of survey(Baseline)
- Health-related quality of life - PROMIS(Baseline)