A Randomized Study to Prevent Lymphedema in Women Treated for Breast Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 568
- 试验地点
- 150
- 主要终点
- Number of Participants Who Were Lymphedema-free 18 Months After Randomization
研究概览
简要总结
This randomized phase III trial studies how well education with or without physical therapy intervention works in preventing lymphedema in women with stage I, II, or III breast cancer who are undergoing axillary lymph node dissection (surgery to remove lymph nodes found in the armpit region). Lymphedema is a condition in which extra lymph fluid builds up in tissues and causes swelling in an arm or leg if lymph vessels are blocked, damaged, or removed by surgery. A personalized physical therapy intervention and education materials may be better than education materials alone in preventing lymphedema in women with breast cancer who are undergoing axillary lymph node dissection.
详细描述
OBJECTIVES:
I. To test, in a group randomized controlled trial, the efficacy of this program versus education only in reducing the incidence of lymphedema.
II. To compare the severity of lymphedema, in terms of changes in arm circumference at the site of greatest difference as a continuous variable between the two interventions.
III. To assess the agreement between patients' self-report of swelling (mild, moderate, and severe) and the extent of circumferential measurement difference between the treated side and the contralateral arm at the site of greatest difference.
IV. To compare the health-related quality of life (Factional Assessment of Cancer Therapy-Breast [FACT-B]+4 score) between the two interventions.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Eligibility Criteria:
- •Newly diagnosed with stage I-III cancer of the female breast
- •No prior history of carcinoma in situ, lobular carcinoma in situ (LCIS), ductal carcinoma in situ (DCIS), or invasive breast cancer
- •* Patients with a history of other invasive malignancies are eligible as long as they have completed treatment and are 5 years post-diagnosis; patients with basal cell and squamous cell cancer of the skin are eligible
- •Neoadjuvant therapy
- •Patients scheduled to receive any type of radiation therapy to the breast or axilla are eligible; however, they must be registered to this study with pre-surgery measures taken prior to receiving neoadjuvant therapy
- •Patients scheduled to receive neoadjuvant chemotherapy are also eligible; however, they must be registered to this study with pre-surgery measurements taken prior to receiving neoadjuvant therapy
- •Patients receiving no neoadjuvant therapy are eligible
- •May be enrolled on other treatment trials; however, patients enrolled on surgery trials where only one treatment arm is full axillary node dissection are not eligible; NOTE: Patients enrolled on American College of Surgeons Oncology Group (ACOSOG)-Z1071 are eligible to participate in this study; patients concurrently enrolled on this study and ACOSOG-Z1071, may not also be enrolled on the ACOSOG-Z1071 lymphedema sub-study
- •No documented cardiac conduction disturbances, unstable angina, dementia, or any other chronic disease which, in the opinion of the treating physician, significantly increases mortality over the next 2 years
- •No diagnosed lymphedema
- •In order to be properly fitted for the elastic sleeve, eligible patients must have arm measurements for axilla, elbow, and wrist that fall within the ranges for one of the six sleeve sizes
- •Not currently homebound or dependent upon a walker or wheelchair for mobility
- •Able to participate in a mild exercise program
- •Willing to return to the study site for the duration of the study (18 months)
- •Sentinel (SND) or full axillary node dissection (AND) (no minimum number of nodes required)
- •Patients with double mastectomy, axillary node dissection and/or radiation on both arms are ineligible; patients who undergo these treatments (i.e., surgery and/or radiation) on the contralateral arm after registration to Step 2 are still eligible to remain in the study; however, it should be documented appropriately on form C-1628 at the conclusion of study participation
排除标准
- 未提供
研究组 & 干预措施
Arm II (lymphedema education, physical therapy)
Description Patients receive lymphedema education and complete physical assessments and questionnaires as in Arm I. Patients also complete a personalized physical therapy intervention, receive a refrigerator magnet, and a 15-minute video that reinforces information and exercises.
干预措施: quality of life assessment (Other)
Arm II (lymphedema education, physical therapy)
Description Patients receive lymphedema education and complete physical assessments and questionnaires as in Arm I. Patients also complete a personalized physical therapy intervention, receive a refrigerator magnet, and a 15-minute video that reinforces information and exercises.
干预措施: educational intervention (Other)
Arm I (lymphedema education)
Six weeks after surgery, patients receive a brief initial post-operative care session describing lymphedema risk and prevention through oral instruction and written materials. Patients complete physical assessments and questionnaires at 6 weeks and at 6, 12, and 18 months. Patients are also contacted by telephone at 9 and 15 months.
干预措施: quality of life assessment (Other)
Arm I (lymphedema education)
Six weeks after surgery, patients receive a brief initial post-operative care session describing lymphedema risk and prevention through oral instruction and written materials. Patients complete physical assessments and questionnaires at 6 weeks and at 6, 12, and 18 months. Patients are also contacted by telephone at 9 and 15 months.
干预措施: educational intervention (Other)
Arm II (lymphedema education, physical therapy)
Description Patients receive lymphedema education and complete physical assessments and questionnaires as in Arm I. Patients also complete a personalized physical therapy intervention, receive a refrigerator magnet, and a 15-minute video that reinforces information and exercises.
干预措施: Physical therapy (Procedure)
结局指标
主要结局
Number of Participants Who Were Lymphedema-free 18 Months After Randomization
时间窗: 18 months
To test, in a group randomized controlled trial, the efficacy of this program versus education only in reducing the incidence of lymphedema. Reported here is the proportion of patients who are lymphedema-free 18 months after randomization between the two arms
次要结局
- Health-related Quality of Life as Assessed by FACT-B +4 Score(18 months)
- Agreement Between Patients' Self-report of Swelling and the Extent of Circumferential Measurement Difference Between the Treated Side and the Contralateral Arm(18 months)
- Change From Baseline at 18 Months in Arm Circumference at the Site of Greatest Difference(18 months)
- Adherence to Lymphedema Prevention Exercises, Lymphedema Knowledge, Range of Motion, and Arm Strength(from baseline up to 18 months)