Long-Term Multidisciplinary Physiotherapy for Breast Cancer Survivors: Evaluation of the 12-Month Effectiveness on Pain, Upper Limb Function, and Cancer-Related Fatigue in a Multi-Center, Parallel-Group Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- Pain Intensity (Visual Analog Scale - VAS)
研究概览
简要总结
This multi-center randomized controlled trial (RCT) evaluates the long-term (12-month) effectiveness of a standardized multidisciplinary physiotherapy program versus standard care on persistent pain, upper limb (UL) dysfunction, and cancer-related fatigue (CRF) in breast cancer survivors. The study also examines improvements in quality of life and psychological well-being. The standardized intervention combines specific exercise therapy, manual therapy, education, and mind-body interventions and is designed to produce sustained benefits beyond the acute rehabilitation phase.
详细描述
Breast cancer survivors frequently experience persistent pain, upper limb dysfunction, and CRF well into the survivorship phase, even after completion of acute treatment. Despite various studies evaluating individual interventions, long-term outcomes remain inconclusive due to heterogeneity and short follow-up durations (Devoogdt & De Groef, 2024; McNeely et al., 2010). This study proposes a standardized, multidisciplinary physiotherapy program that integrates:
Specific Exercise Therapy: Structured stretching and strengthening sessions targeting UL mobility and overall fitness (30-60 minutes per session, three times weekly for 8 weeks under supervision, followed by individual home-based maintenance).
Manual Therapy: Targeted soft-tissue mobilization and myofascial release (20-30 minutes per session, twice weekly for 4 weeks).
Education: In-person and online sessions on pain neuroscience and self-management delivered in three sessions.
Mind-Body Interventions: Yoga or tai chi sessions (40 minutes per session, once weekly for 6 weeks).
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)
盲法说明
Due to the nature of the interventions, participants, care providers, and investigators will be aware of the treatment allocation; however, outcome assessors will remain blinded to reduce assessment bias.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Women aged between 18 and 65 years. History of breast cancer surgery (with or without axillary lymph node dissection).
- •Completed acute cancer treatment (surgery, chemotherapy, and/or radiation) at least 6 months prior to enrollment.
- •Currently in the survivorship phase, with no active evidence of disease.
- •Experiencing persistent sequelae related to treatment, such as:
- •Moderate to severe pain (e.g., VAS score ≥ 30 on a 0-100 scale), and/or Upper limb dysfunction, and/or Cancer-related fatigue (as measured by FACIT-Fatigue). Able to understand and provide written informed consent.
排除标准
- •Diagnosis of recurrent or metastatic breast cancer. Currently receiving active cancer treatment (chemotherapy, radiation for active disease, or immunotherapy).
- •Participation in another interventional trial targeting pain or rehabilitation within the past 3 months.
- •Presence of severe comorbidities (e.g., uncontrolled cardiovascular disease, severe orthopedic or neurological conditions) that would preclude safe participation in physiotherapy.
- •Any physical or psychological condition that, in the opinion of the investigator, would interfere with participation or adherence to the study protocol (e.g., severe cognitive impairment).
- •Pregnancy or breastfeeding.
研究组 & 干预措施
Multidisciplinary Physiotherapy Program
Participants in this arm will undergo a standardized multidisciplinary physiotherapy program consisting of:
Specific Exercise Therapy: 30-60-minute sessions conducted thrice weekly for 8 weeks (supervised) with subsequent home-based maintenance.
Manual Therapy: 20-30-minute soft-tissue mobilization sessions twice weekly for 4 weeks.
Education: Three sessions (in-person and online) focusing on pain neuroscience and self-management strategies.
Mind-Body Interventions: 40-minute yoga or tai chi sessions once weekly for 6 weeks.
干预措施: Multidisciplinary Physiotherapy Program (MD Physio) (Behavioral)
Control - Standard Care
Participants in the control arm will receive "standard care" as currently practiced. This includes routine follow-up and basic physiotherapy advice typically provided to breast cancer survivors without the structured, multidisciplinary program.
干预措施: Standard Physiotherapy Care (Behavioral)
结局指标
主要结局
Pain Intensity (Visual Analog Scale - VAS)
时间窗: Baseline, 3 months, 6 months, and 12 months post-intervention.
The VAS is a 0-100 scale used to measure patient-reported pain intensity, where 0 indicates no pain and 100 indicates the worst imaginable pain.
Upper Limb Function (DASH Questionnaire)
时间窗: Baseline, 3 months, 6 months, and 12 months post-intervention.
The Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire assesses upper limb function and symptoms with higher scores indicating greater disability.
Cancer-Related Fatigue (FACIT-Fatigue)
时间窗: Baseline, 3 months, 6 months, and 12 months post-intervention.
The FACIT-Fatigue scale is a validated tool used to assess the level of fatigue experienced by patients, with lower scores representing greater fatigue.
次要结局
- Quality of Life (SF-36 Health Survey)(Baseline, 3 months, 6 months, and 12 months post-intervention.)
- Psychological Well-Being (Hospital Anxiety and Depression Scale - HADS)(Baseline, 3 months, 6 months, and 12 months post-intervention.)