Fu Mei Rosemary, Axelrod Deborah, Guth Amber, Scagliola Joan, Rampertaap Kavita, El-Shammaa Nardin, Fletcher Jason, Zhang Yan, Qiu Jeanna M, Schnabel Freya, Hiotis Karen, Wang Yao, D'Eramo Melkus Gail
College of Nursing, New York University, New York, NY, United States.
JMIR Res Protoc. 2016 Jan 21;5(1):e7. doi: 10.2196/resprot.5104.
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, ie, abnormal accumulation of lymph fluid in the ipsilateral upper limb or body. Grounded in research-driven behavioral strategies, The-Optimal-Lymph-Flow is a unique Web- and mobile-based system focusing on self-care strategies to empower, rather than inhibit, how breast cancer survivors manage daily pain and symptoms. It features a set of safe, feasible, and easily-integrated-into-daily-routine exercises to promote lymph flow and drainage, as well as guidance to maintain an optimal body mass index (BMI).
To conduct a randomized clinical trial (RCT) to evaluate the efficacy of the Web- and mobile-based The-Optimal-Lymph-Flow system for managing chronic pain and symptoms related to lymphedema. The primary outcome includes pain reduction, and the secondary outcomes focus on symptom relief, limb volume difference by infra-red perometer, BMI, and quality of life (QOL) related to pain. We hypothesize that participants in the intervention group will have improved pain and symptom experiences, limb volume difference, body mass index, and QOL.
A parallel RCT with a control-experimental, pre- and post-test, repeated-measures design is used in this study. A total of 120 patients will be randomized according to the occurrence of pain. Participants will be recruited face-to-face at the point of care during clinical visits. Participants in the intervention group will receive the Web- and mobile-based The-Optimal-Lymph-Flow intervention and will have access to and learn about the program during the first in-person research visit. Participants in the control group will receive the Web- and mobile-based Arm Precaution program and will have access to and learn about the program during the first in-person research visit. Participants will be encouraged to enhance their learning by accessing the program and following the daily exercises during the study period. Participants will have monthly online self-report of pain and symptoms at 4 and 8 weeks post-intervention. During the two in-person research visits prior to and 12 weeks post-intervention, participants will be measured for limb volume difference, BMI, and complete self-report of pain, symptoms, self-care behaviors, and QOL.
This trial is currently open for recruitment. The anticipated completion date for the study is July 2017. The primary endpoint for the study is absence or reduction of pain reported by the participants at week 12 post-intervention.
The-Optimal-Lymph-Flow is a unique Web- and mobile-based self-care and patient-reported outcome system designed to effectively help women treated for breast cancer manage daily pain and symptoms related to lymphedema. Patients learn self-care strategies from a Web- and mobile-based program and track their symptoms. The RCT will directly benefit all women treated for breast cancer who suffer from or at risk for pain and symptoms related to lymph fluid accumulation.
Clinicaltrials.gov NCT02462226; https://clinicaltrials.gov/ct2/show/NCT02462226 (Archived by WebCite at http://www.webcitation.org/6du4IupG5).
尽管目前癌症治疗取得了进展，但许多乳腺癌幸存者仍面临长期术后挑战，因为她们每天都承受疼痛以及与淋巴水肿相关的其他令人痛苦的症状，即同侧上肢或身体中淋巴液的异常积聚。基于研究驱动的行为策略，“最佳淋巴流动”是一个独特的基于网络和移动设备的系统，专注于自我护理策略，以增强而非抑制乳腺癌幸存者应对日常疼痛和症状的能力。它具有一套安全、可行且易于融入日常生活的锻炼方法，以促进淋巴流动和引流，以及关于维持最佳体重指数（BMI）的指导。
进行一项随机临床试验（RCT），以评估基于网络和移动设备的“最佳淋巴流动”系统对管理与淋巴水肿相关的慢性疼痛和症状的疗效。主要结局包括疼痛减轻，次要结局侧重于症状缓解、通过红外线肢体周径仪测量的肢体体积差异、BMI以及与疼痛相关的生活质量（QOL）。我们假设干预组的参与者在疼痛和症状体验、肢体体积差异、体重指数和生活质量方面将有所改善。
本研究采用平行随机对照试验，采用对照 - 实验、前后测、重复测量设计。总共120名患者将根据疼痛情况进行随机分组。参与者将在临床就诊时在护理点进行面对面招募。干预组的参与者将接受基于网络和移动设备的“最佳淋巴流动”干预，并将在首次面对面研究访问期间访问并了解该计划。对照组的参与者将接受基于网络和移动设备的手臂预防计划，并将在首次面对面研究访问期间访问并了解该计划。鼓励参与者在研究期间通过访问该计划并遵循日常锻炼来加强学习。参与者将在干预后4周和8周每月进行一次疼痛和症状的在线自我报告。在干预前和干预后12周的两次面对面研究访问期间，将测量参与者的肢体体积差异、BMI，并完成疼痛、症状、自我护理行为和生活质量的自我报告。
该试验目前正在招募参与者。研究的预期完成日期为2017年7月。该研究的主要终点是干预后第12周参与者报告的疼痛减轻或消失。
“最佳淋巴流动”是一个独特的基于网络和移动设备的自我护理和患者报告结局系统，旨在有效帮助接受乳腺癌治疗的女性管理与淋巴水肿相关的日常疼痛和症状。患者从基于网络和移动设备的计划中学习自我护理策略并跟踪他们的症状。该随机对照试验将直接惠及所有接受乳腺癌治疗且患有或有与淋巴液积聚相关疼痛和症状风险的女性。
Clinicaltrials.gov NCT02462226；https://clinicaltrials.gov/ct2/show/NCT02462226（由WebCite存档于http://www.webcitation.org/6du4IupG5）。
