Feasibility of Symptom Management for Patients With Metastatic Breast Cancer to Increase Exercise
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Feasibility of referral to Get Real and Heel
研究概览
简要总结
This study will examine unmet exercise needs among patients with metastatic breast cancer (MBC) at UNC and assess whether participation in Get Real and Heel (GRH) can increase physical activity. The proposed research aims to improve multiple domains of well-being, quality of life, physical function, social support and reduce social isolation through a community based exercise intervention. By leveraging underutilized University of North Carolina Chapel Hill (UNC) resources, this work seeks to reduce barriers to accessibility, awareness, and appropriateness of exercise programming for this underserved population. Findings will help close the gap between patients' exercise needs, interest, and participation, with potential benefits for symptoms, functioning, and quality of life.
详细描述
Patients with MBC are living longer due to improved treatments, yet up to 92% experience functional decline and reduced quality of life. Exercise is a recommended, safe, and effective intervention for improving function, strength, fitness, and quality of life, but most patients do not meet guidelines. At UNC, a recent needs-assessment survey study of MBC patients (n=50) found that 52% were sedentary, although 72% believed increased exercise would improve treatment tolerance. GRH, established in 2006, offers 16 weeks of free, expert-led exercise including aerobic, strength, balance, and flexibility training tailored to participant needs. Despite its availability, only 4% of surveyed patients had been referred.
This study will evaluate the feasibility of implementing GRH for all MBC patients at UNC and assess its impact on quality of life, physical functioning, fatigue, and social isolation. Feasibility will be defined as attending ≥24 of 32 sessions. Patient-reported outcomes including Functional Assessment of Cancer Therapy- Breast (FACT-B), Patient-Reported Outcomes Measurement Information System (PROMIS) -Physical Function, the modified Medical Outcomes Social Support Survey, and PROMIS Social Isolation-will be collected electronically at baseline and at 16 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
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
- •In order to participate in this study a subject must meet all of the eligibility criteria outlined below.
- •Inclusion Criteria:
- •Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
- •Subjects are willing and able to comply with study procedures based on the judgement of the investigator or protocol designee.
- •Age > 18 years at the time of consent.
- •Diagnosis of metastatic breast cancer within two years of consent date
- •Receives medical clearance from clinical team for moderate intensity exercise programming
- •Indicates intent to receive ongoing cancer care at the enrolling institution
- •English Speaking - program and measures are in English and not practicably translatable for a study this size.
排除标准
- •Currently on hospice.
- •Bed-bound status or other contraindication to exercise
- •Participation in GRH since their diagnosis with MBC
结局指标
主要结局
Feasibility of referral to Get Real and Heel
时间窗: Up to 16 weeks
The proportion of consented patients who are successfully referred to the Get Real and Heel program and complete at least 24 sessions (32 total available; 2 sessions per week) in person.
次要结局
- Differences in quality of life - Functional Assessment of Cancer Therapy- Breast (The FACT-B)(16 weeks)
- Differences in quality of life - Patient Reported Outcomes Measurement Information System (PROMIS) -Physical Function(16 weeks)
- Differences in quality of life - Patient Reported Outcomes Measurement Information System (PROMIS) -Social Isolation(16 weeks)
- Differences in social support(16 weeks)