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临床试验/NCT07014657
NCT07014657已完成不适用

Effect of Digital Combined Decongestive Therapy in Patients With Breast Cancer-related Lymphedema: a Follow-up Study

Bezmialem Vakif University1 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2018年1月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
29
试验地点
1
主要终点
Change in Limb Volume

研究概览

简要总结

This study investigated the short- and long-term effects of digital combined decongestive therapy in breast cancer-related lymphedema. Limb volume and quality of life (Lymph-ICF) were assessed at baseline, post-treatment, and 12-week follow-up.

详细描述

This study evaluated the feasibility and effectiveness of a digital combined decongestive therapy (CDT) program in patients with breast cancer-related lymphedema. After an initial face-to-face training session on self-bandaging, self-manual lymphatic drainage, breathing exercises, and skin care, patients followed a 4-week digital CDT program with remote guidance. Compression garments were used during the maintenance phase. Limb volume was measured using circumference method. Quality of life was assessed with the Lymph-ICF questionnaire. Assessments were repeated post-treatment and at 12-week follow-up.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

性别
Female
接受健康志愿者
否

入选标准

  • •Diagnosed with breast cancer-related lymphedema (BCRL) within the last 6 to 60 months.
  • •Voluntarily agreed to participate in the study.

排除标准

  • •Presence of active infection.
  • •History of bilateral breast surgery.
  • •Severe breast cancer-related lymphedema.

研究组 & 干预措施

Digital Combined Decongestive Therapy Group

Experimental

Participants received digital combined decongestive therapy including self-bandaging, self-manual lymphatic drainage, decongestive and breathing exercises, supervised remotely through telecommunication technologies for 4 weeks, followed by maintenance therapy with compression stockings.

干预措施: Digital Combined Decongestive Therapy (Behavioral)

结局指标

主要结局

Change in Limb Volume

时间窗: At baseline, at week 4 (end of treatment), and at week 12 (follow-up)

Limb volume was assessed by measuring the circumference of the affected arm at 4-cm intervals from the ulnar styloid to the axillary region using a standard tape measure. These measurements were used to calculate the total limb volume to evaluate changes after the intervention and at follow-up.

次要结局

  • Change in Quality of Life(At baseline, at week 4 (end of treatment), and at week 12 (follow-up))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Selva Otsay

Principal Investigator

Bezmialem Vakif University

研究点 (1)

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