Online General Exercise Management (GEM) Program for patients with Breast Cancer-Related Lymphedema: A Protocol for a Pilot Randomized Controlled Trial

Background: Breast cancer-related lymphedema (BCRL) requires a lifetime commitment to self-care. Aims: This is a study protocol for a pilot parallel-group randomized controlled trial which will assess the effectiveness of an online version of the General Exercise Management (GEM) program for patients with BCRL. Methods: Sixty patients will be recruited through online advertisements and randomly allocated to either an intervention or control group. The intervention group will be provided with an educational program on standard self-care for BCRL as well as the GEM program, while the control group will receive only the self-care education program. Both groups will participate in a six-month online program, perform daily self-checks and participate in monthly small-group sessions. All participants, session facilitators and a statistical analyst will be blinded to group allocation. Anticipated Results: The primary expected outcome is a reduction of BCRL symptoms, and the secondary outcomes are health-related quality of life and self-care adherence improvements. Conclusions: The findings will inform further investigation in a Phase III trial. Declaration of Interest: All authors declare that they have no competing financial interests.