Core Outcome Measures in Effectiveness Trials

A core outcome set for clinical trials of breast cancer related lymphedema (BCRL)

General Information

Lymphedema is one of the most important complications after breast cancer surgery, not only can cause limb morphological changes, restricted upper limb function, but also have a negative impact on patients' psychological status and daily life, seriously affecting postoperative quality of life in breast cancer patients. At present, clinical treatment methods are diverse, mainly including conservative treatments and surgical treatments. However, due to the inconsistent clinical evaluation criteria for lymphedema, lack of practicality, the remission rates of different therapies vary greatly, and the best treatment plan cannot be selected. Therefore, a series of accurate and effective assessment method(s) is needed, and it is necessary to establish a core outcome set (COS) for clinical trials of lymphedema after breast cancer surgery.

Organisation:Center for Clinical transformation and evaluation of acupuncture of Tianjin university of traditional Chinese medicine
Principal investigator: Hao Zhang

Further Study Information

Current Stage:
January 2019 - December 2019
Funding source(s):
To be confirmed

Health Area

Disease Category

Disease Name
Breast cancer related lymphedema (BCRL)

Target Population

Age Range
18 - 80


Nature / type of Intervention


Consensus conference
Delphi process
Systematic review

First, search all date bases for all interventions for breast cancer-associated lymphedema and develop a plan and publish it, then take all the results, systematically evaluate them, and then meet with clinical experts and patient representatives to set up a core outcome set.

Stakeholders Involved

Clinical experts
Conference participants
Consumers (patients)
Journal editors
Patient/ support group representatives

Study Type

COS for clinical trials or clinical research
COS for practice

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