The-Optimal-Lymph-Flow ™: An e-Health Approach to Enhancing Management of Chronic Pain and Symptoms Related to Lymphedema Among Women Treated for Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- The Lymphedema and Breast Cancer Symptom Experience Index (BCLE-SEI
研究概览
简要总结
The purpose of this research study is to conduct a randomized clinical trial to evaluate the efficacy of the web-based The-Optimal-Lymph-Flow ™ system for managing chronic pain and symptoms related to lymphedema focusing on primary outcomes of pain reduction, secondary outcomes of symptom relief, limb volume difference by infra-red perometer, body mass index, quality of life related to pain.
Recruitment includes 120 patients who will be randomized according to pain/aching/soreness, and tenderness. Participants in the intervention group will be provided the web-based The-Optimal-Lymph-Flow ™ intervention and encourage to access and learn about the program during the 1-4 weeks of the study. Participants in the control group will receive the web-based arm precaution program. All the participants will have monthly online assessment of pain and symptoms at 4 and 8 weeks post-intervention as well as two in-person research visits, that is, prior to intervention and 12 weeks post-intervention.
详细描述
Despite current advances in cancer treatment, many breast cancer survivors still face long-term post-operative challenges as a result of suffering from daily pain and other distressing symptoms related to lymphedema, i.e. abnormal accumulation of lymph fluid in the ipsilateral upper limb or body.
The purpose of this research study is to conduct a randomized clinical trial to evaluate the efficacy of the web-based The-Optimal-Lymph-Flow ™ system for managing chronic pain and symptoms related to lymphedema focusing on primary outcomes of pain reduction, secondary outcomes of symptom relief, limb volume difference by infra-red perometer, body mass index, quality of life related to pain.
Recruitment includes 120 patients who will be randomized according to pain/aching/soreness, and tenderness. Participants in the intervention group will be provided the web-based The-Optimal-Lymph-Flow ™ intervention and encourage to access and learn about the program during the 1-4 weeks of the study. Participants in the control group will receive the web-based arm precaution program. All the participants will have monthly online assessment of pain and symptoms at 4 and 8 weeks post-intervention as well as two in-person research visits, that is, prior to intervention and 12 weeks post-intervention. The study length for patients is 12 weeks.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 89 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients who have been surgically treated for breast cancer more than 3 months; healing usually occurs within 3 months of surgical treatment for cancer
- •Patients who report persistent or intermittent pain, including aching, tenderness, soreness;
- •Patients may or may not report any of symptoms related to lymphedema (i.e. swelling, heaviness, tightness, firmness, numbness, tingling, stiffness, limb fatigue, limb weakness, and impaired limb mobility of shoulder, arm, elbow, wrist, and fingers);
- •Patients may or may not have a history of lymphedema or have been treated for lymphedema.
- •Patients have Internet access to the web-based program at home or willing to access the web-based program using the computer provided by the researchers at the Cancer Center.
- •Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Patients who do not report any pain, including aching, tenderness, and soreness;
- •Patients who have known metastatic disease or other bulk disease in the thoracic or cervical regions;
- •Patients who have lymphedema due to cancer recurrence.
- •Patients with documented advanced cardiac or renal disease.
结局指标
主要结局
The Lymphedema and Breast Cancer Symptom Experience Index (BCLE-SEI
时间窗: 12 weeks
The Lymphedema and Breast Cancer Symptom Experience Index (BCLE-SEI) is a valid and reliable self-report tool to assess pain, including aching, soreness, tenderness, as well as symptoms related to lymphedema (i.e. , arm swelling, breast swelling, chest wall swelling, heaviness, firmness, tightness, stiffness, burning, stabbing numbness, tenderness, stiffness, redness, blistering, and tingling (pins and needles. Each symptom can be treated as categorical variable by choosing a "Yes" or "No" to indicate the presence or absence of a given symptom. Each item can also be rated on a Likert-type scale from 0 (no presence of a given symptom) to 4 (greatest severity of a given symptom). Higher scores indicate more severe symptom presence. A response frame of last three months will be used for all participants to ensure the chronicity of symptom presence.
次要结局
- Risk Reduction Behavior Checklist(12 Weeks)
- Limb Volume Difference by Infra-red Perometer.(12 weeks)
- The Pain Impact Questionnaire™ (PIQ-6™)(12 Weeks)
- Body Weight and Body Mass Index [BMI](12 Weeks)