The Effects of 'Gentle Touch' in the Management of Lymphedema in Women Treated for Breast Cancer: A Preliminary Single-blind, Parallel-group Randomized Controlled Trial.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Change of Upper Limb Lymphedema Volume
研究概览
简要总结
This is a single-blind, parallel-group Randomized Controlled Trial (RCT) comparing the efficacy of a specialized manual technique, Gentle Touch (GT), versus a control intervention, both added to the usual rehabilitative care. The study investigates 36 women aged 30 to 75 with Breast Cancer-Related Lymphedema (BCRL). The primary objective is to evaluate the reduction of lymphedema volume in the upper limb. Secondary objectives include assessing the improvement in patients' quality of life and the potential reduction in care burden and costs. The treatment protocol involves 10 bi-weekly sessions over 5 weeks.
详细描述
Breast cancer (BC) treatment often leads to lymphedema, a condition affecting up to 40% of survivors and negatively impacting their quality of life due to swelling, pain, and functional limitations. Manual Lymphatic Drainage (MLD) is a proven treatment method. This study focuses on the Gentle Touch (GT) approach, a specific tactile stimulus applied to the skin intended to promote emotional support, relaxation, and stress alleviation.
The Primary Objective is to evaluate the efficacy of the Gentle Touch-based MLD in reducing the volume of upper limb lymphedema in women who have undergone surgery for BC.
The Secondary Objectives are to evaluate whether the GT approach can improve the quality of life of the treated women, including emotional, psychological, and social aspects and reduce the care burden and costs compared to the control group, potentially by reducing the number of treatments required compared to conventional approaches.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Gender: Women.
- •Age: Between 30 and 75 years old
- •Surgical History: Women who have undergone surgery for breast cancer (BC). This includes being subjected to one of the following interventions: Axillary dissection with removal of all 3 lymph node levels; Axillary dissection with removal of only one lymph node level; Removal of the sentinel lymph node only.
- •Clinical Lymphedema: Clinically evaluated lymphedema symptoms, defined as a circumference difference of greater than 20mm between the two arms
排除标准
- •Concurrent Diseases: Concomitant diseases that may interfere with the study.
研究组 & 干预措施
Gentle Touch (GT) Lymphatic Drainage + Usual Care
Participants in this arm will receive the Gentle Touch (GT) lymphatic drainage technique, which is based on the ANDOS manual technique, in addition to their existing rehabilitation pathway. The GT is a tactile stimulus applied to the skin aimed at promoting relaxation, improving pain, sleep management, and therapeutic participation. The treatment involves 10 sessions administered with a bi-weekly frequency.
干预措施: Gentle Touch (GT) Lymphatic Drainage (ANDOS technique) (Other)
Passive Mobilization and Active-Assisted Exercises + Usual Care
Participants in this arm will receive 10 sessions of passive mobilization and active-assisted exercises for the upper limb. This is provided in addition to the existing rehabilitation program. The sessions will be carried out with the same frequency (bi-weekly) as the experimental group.
干预措施: Passive Mobilization and Active-Assisted Exercises for the Upper Limb (Other)
结局指标
主要结局
Change of Upper Limb Lymphedema Volume
时间窗: Baseline (T0), 5 weeks (T1), and 2-month follow-up (T2)
The volume of lymphedema will be measured volumetrically, comparing the difference in volume of the affected limb relative to the contralateral limb.
次要结局
- Change in Lymphedema-Specific Quality of Life (LYMQOL)(Baseline (T0), 5 weeks (T1), and 2-month follow-up (T2))
- Change in Upper Limb Function and Disability (DASH)(Baseline (T0), 5 weeks (T1), and 2-month follow-up (T2))
- Change in General Health (SF-36)(Baseline (T0), 5 weeks (T1), and 2-month follow-up (T2))
- Change in Well-being (PROMIS-29)(Baseline (T0), 5 weeks (T1), and 2-month follow-up (T2))