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PURPOSE: To evaluate the application effects of The-Optimal-Lymph-Flow IT System in Chinese patients at high risk of developing breast cancer-related lymphedema. METHODS: A total of 104 breast cancer patients were randomly assigned to either the control group or the intervention group. The intervention group was provided with the The-Optimal-Lymph-Flow program, while the control group received the usual care. Trial outcomes including symptom experience, quality of life, and limb volume were evaluated at baseline, and at end of the 1- and 3-month trials. RESULTS: After controlling for covariates, the incidence of eight symptoms was significantly higher in the control group than in the intervention group. There were significant differences in the changes in the severity of symptoms and arm volume between the two groups from baseline to 3 months after the intervention. CONCLUSIONS: The application of TOLF in patients at high risk of developing lymphedema following breast cancer treatment significantly improved the lymphedema-related symptoms experienced in the early stage after surgery. Trial registration ChiCTR1800016713.
RESUMEN
A substantial proportion of more than 50% of breast cancer survivors, who remain undiagnosed with lymphedema, encounter a daily struggle with the presence of multiple and concomitant lymphedema associated symptoms (i.e., lymphedema symptoms). The-Optimal-Lymph-Flow (TOLF) program was developed based on physiological-cognitive-behavioral principles to educate breast cancer survivors on effective self-care strategies. Physiologically, TOLF program was designed to stimulate lymphatic system to enhance lymph flow, thereby alleviating lymphedema symptoms and mitigating the risk and severity of lymphedema. The dataset presented in this article was obtained from a randomized clinical trial (RCT) that assessed the preventive effects of the TOLF program in improving lymphedema symptom experience and optimizing lymph fluid status among breast cancer survivors who were at higher risk for lymphedema. Between January 2019 and June 2020, a RCT was conducted to recruit 92 eligible participants who were assigned randomly to either the TOLF group (intervention) or the arm mobility group (control). Demographic and clinical data were collected at baseline and updated over the study period. Outcome data were collected at baseline and three months after intervention. Study outcomes included lymphedema symptom experience (i.e., number, severity, distress of lymphedema symptoms, and impact on daily activities) and lymph fluid status. The Breast Cancer and Lymphedema Symptom Experience Index (BCLE-SEI) was utilized to assess lymphedema symptoms and circumferential arm measurement was utilized to estimate limb volume differences (a surrogate for lymph fluid status). The dataset based on the RCT allowed confirmation of positive effects of the TOLF intervention during early postoperative period. The dataset can be further utilized as a benchmark reference in clinical settings or experimental research to determine the effects of optimal lymphatic exercise dosage on lymphedema risk reduction and symptom alleviation as well as provide a basis for future research related to this topic.
RESUMEN
Background: Many breast cancer survivors face long-term postoperative challenges as a result of developing lymphedema symptoms and chronic lymphedema. The-Optimal-Lymph-Flow (TOLF) program is an intervention based on physiological-cognitive-behavioral principles that teaches patients self-management strategies to activate lymphatic system and promote lymph flow to decrease lymphatic pain, reduce the risk and severity of lymphedema. Objective: The purpose of this pilot clinical trial was to evaluate the use of TOLF program as an early intervention on improving lymphedema symptom experience (i.e., symptom number, symptom severity, symptom distress, and the impact of symptoms on patients' activities of daily living) and optimizing lymph fluid levels (measured by the arm volume differences) among breast cancer survivors. Methods: This study is a parallel, randomized clinical trial. A total of 92 breast cancer patients were randomly assigned to either the TOLF intervention group or the control group focusing on promoting arm mobility. Data were collected at baseline and end of the trial at the 3-month post intervention. The Breast Cancer and Lymphedema Symptom Experience Index was used to measure lymphedema symptom experience. Anthropometric measurements were used for circumferential arm measurements. Generalized linear mixed-effects models were used to evaluate the trial outcomes. Results: Significant improvements of lymphedema symptom experience were found in patients in the TOLF intervention group in comparison with patients in control group: the number of lymphedema symptoms (P<0.001) and the severity of lymphedema symptoms (P<0.001) as well as the impact of symptoms on patients' daily living function (P<0.001). Patients in both groups showed improvements in all study outcomes over the 3 months, whereas those in the TOLF group gained greater benefits in reducing the number and severity of lymphedema symptoms. Moreover, the TOLF group had significantly fewer patients with ≥5% arm volume differences ([5/45] vs [13/43], P=0.035) at the study endpoint. Conclusions: Findings of the study demonstrated positive outcomes of relieving lymphedema symptom experience, optimizing arm circumference and halting the progression of lymphedema status in breast cancer survivors receiving TOLF intervention during early postoperative time. Given its feasibility, acceptability, and effectiveness, this program may be incorporated in routine breast cancer care. Clinical Trial Registration: http://www.chictr.org.cn/index.aspx, identifier ChiCTR1800016713.