Effect of STructured Exercise Program in improving functional morbidity and quality of life in Breast Cancer patients undergoing curative-intent surgery: A Randomized Controlled Trial (STEP-BC)
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- To assess whether the structured exercise program (SEP) improves the
研究概览
简要总结
The study has been proposed with an aim to study the impact of structured exercise programme in comparison to usual care on postoperative functional outcomes in patients with breast cancer undergoing curative intent surgery. This has been supported with the background of improved post operative functional outcome in terms of improved DASH score, Quality of life in terms of FACT B+4 score and improved metabolic syndrome score (MetS z score) and improved fatigue score (FACT-F score). All women undergoing breast cancer surgery in our institute will be included in the study. Women already having some shoulder dysfunction or with metastatic breast carcinoma will be excluded from the study.One structured exercise programme will be developed which will be
validated among the current study population and it can be delivered by the treating surgeon himself/herself to all the breast cancer survivors for their long term functional recovery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- Female
入选标准
- •Eastern Clinical Oncology Group- Performance score (ECOG-PS): 0-2
- •Biopsy proven- non metastatic breast carcinoma
- •Undergoing surgery with curative intent.
排除标准
- •1.Second primary/ recurrent cancer.
- •Patients with severe comorbidities, distant metastasis 3.Patients already having shoulder disability due to preexisting shoulder joint pathology
- •Patient’s current physical or mental condition not allowing to undergo a vigorous exercise programme
- •Patients not willing to participaTe.
结局指标
主要结局
To assess whether the structured exercise program (SEP) improves the
时间窗: 3 and 6 months
functional morbidity in the form of DASH (Disability of Arm, Hand, and Shoulder) score at 3
时间窗: 3 and 6 months
and 6 months among breast cancer patients undergoing curative-intent surgery.
时间窗: 3 and 6 months
次要结局
- 1. To compare short- and long-term morbidity (wound related, pain, fatigue, lymphedema,(etc. between two groups)