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A randomized clinical trial comparing the impact of a web-based multimedia intervention versus an educational pamphlet on patient outcomes in breast cancer survivors with chronic secondary lymphedema
Ridner SH, Dietrich MS, Davis AJ, Sinclair V
Journal of Women's Health 2020 May;29(5):734-744
clinical trial
4/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

OBJECTIVE: The purpose of this study was to evaluate the effects of a web-based multimedia intervention (WBMI) for breast cancer-related lymphedema (BCRL) patients on symptom burden, function, psychological well-being, costs, and arm volume. METHODS: Women with BCRL were randomized to intervention (n = 80) or control (n = 80) groups. The WBMI offered 12 modules, each of which took about 30 minutes to complete. The Pamphlet took about 2 hours to read. Data on symptom burden, psychological well-being, function, and costs were collected preintervention; and 1, 3, 6, and 12 months postintervention. A subgroup of 45 regional patients had arm extracellular fluid measured by bioimpedance at baseline and at 3, 6, and 12 months postintervention. Intervention perceived value was also captured. RESULTS: A statistically significant difference (p = 0.011) was observed for rates of intervention completion, WBMI (58%), and Pamphlet (77%). With the exception of the number of biobehavioral symptoms (mood), no statistically significant differences between groups in symptom reduction were apparent between baseline and 1 or 12 months (effect sizes 0.05 to 0.28, p > 0.05) based on the Lymphedema Symptom Intensity and Distress Scale-Arm (LSIDS-A). No statistically significant differences between the groups were observed for changes in other variables. The WBMI was perceived as providing better self-care information than the Pamphlet (p = 0.001). CONCLUSIONS: WBMI participants experienced improved biobehavioral symptoms and higher perceived quality of information. The lack of significant differences on other variables may be due to the high percentage of participants who did not complete the WBMI.

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