"Moving On" - A Randomized Controlled Trial for Acceptability and Feasibility of an Early Physical Therapy Education Intervention for Breast Cancer Surgical Candidates
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- Change in active shoulder range of motion
研究概览
简要总结
The purpose of this study is to test the acceptability, feasibility and explore the possible effects of an early physical therapy education intervention for breast cancer survivors.
详细描述
This study uses a randomized controlled and longitudinal study design. We will compare two groups - an intervention group and a control group - to test the effects of an early physical therapy education intervention for breast cancer survivors who are candidates for breast cancer surgery. Because of the nature of the intervention (patient early education with 1:1 discussion of educational materials) we will be unable to introduce blinding of the participant as well as the staff.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed with unilateral breast cancer
- •Candidate for breast cancer surgery as first line of cancer treatment
- •Undergo breast cancer surgery at Brigham and Woman's Hospital, Boston, Massachusetts
- •English speaking
- •Greater than or equal to 21 years old
排除标准
- •Previous history of breast cancer and/or recurrent/metastatic disease
- •Receiving neoadjuvant chemotherapy treatment
- •Bilateral breast cancer
- •History of shoulder impairments or severe upper quarter scarring
- •Pregnancy
- •Central nervous system damage
- •History of other previous cancers (except non-melanoma skin)
- •Systemic medical conditions (e.g.: fibromyalgia, rheumatoid arthritis, etc.)
- •Amputation of either upper extremity
研究组 & 干预措施
Moving On After Breast Cancer - Intervention Arm
Participants are randomized to the intervention arm after their breast cancer diagnosis (but before cancer surgery) and baseline measurements (T0) are taken. They are followed up again at 2 weeks after their breast cancer surgery (T1), and again at 3 months after surgery (T2). Participants are given the patient education materials (booklet, therapeutic exercise DVD, small ball, range of motion wand). The research assistant orients the participant to the education materials and summarizes each section of the booklet. The research assistant also teaches the participant how to do the therapeutic exercises in the booklet. All participants in the intervention also receive usual care.
干预措施: Moving On After Breast Cancer (Behavioral)
Usual Care
Participants are randomized to the usual care arm after their breast cancer diagnosis (but before cancer surgery) and baseline measurements (T0) are taken. They are followed up again at 2 weeks after their breast cancer surgery (T1), and again at 3 months after surgery (T2). Usual care consists of pre-operative testing, pre-operative nursing education on care of the surgical incision and pain management followed by breast cancer surgery.
结局指标
主要结局
Change in active shoulder range of motion
时间窗: 3 months
Active shoulder range of motion is measured with a standard goniometer in degrees. Change from baseline to 3 months for shoulder flexion, extension, abduction, and internal and external ranges are measured.
次要结局
未报告次要终点
研究者
Ann Marie Flores
Assistant Professor
Northeastern University