Pilot Study for a Prospective Surveillance Program for Rehabilitation Following Surgery for Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 主要终点
- Number of Participants With Arm Morbidity at 12 Months Post-surgery - Upper Body Muscle Strength
研究概览
简要总结
Breast cancer treatment often results in long-term arm morbidity. A prospective surveillance model with arm assessment pre-surgery followed by ongoing surveillance and targeted physiotherapy treatment after breast cancer surgery may improve early detection and management of arm morbidity. This study aims to determine the effect of prospective surveillance to target physiotherapy on the prevalence of arm morbidity in the surveillance group compared to control group at 12-months after breast cancer surgery.
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
- •age 30-75 years; receiving surgery for breast cancer, including those who will have immediate breast reconstruction.
排除标准
- •prior breast cancer surgery; a pre-existing shoulder pathology on the side of breast surgery that limits shoulder range of motion <75% of non-affected side; or a diagnosis of primary lymphedema
研究组 & 干预措施
Prospective Surveillance Group
Women assigned to surveillance group were assessed for arm morbidity at pre-surgery and at 3, 6, and 9 months post-surgery. If arm morbidity was detected at any time-point post-surgery, then a physiotherapy intervention was prescribed.
干预措施: Prospective Surveillance Group (Behavioral)
Education Group
Participants in the education group received the usual post-operative follow-up.
干预措施: Education Group (Behavioral)
结局指标
主要结局
Number of Participants With Arm Morbidity at 12 Months Post-surgery - Upper Body Muscle Strength
时间窗: 12 months
Arm morbidity due to decreased upper body muscle strength was defined as ≥25% decrease in muscle strength from pre-surgery. This was measured using a hand-held dynamometer and evaluated in kilograms.
Number of Participants With Arm Morbidity at 12 Months Post-surgery - Arm Volume
时间窗: 12 months
Arm morbidity due to increase in arm volume was defined as a ≥200 mL increase from pre-surgery. Arm volume was measured using a perometer.
Number of Participants With Arm Morbidity at 12 Months Post-surgery - Shoulder Mobility
时间窗: 12 months
Arm morbidity due to decreased shoulder mobility was defined as ≥10% decrease in mobility from pre-surgery. This was measured using a goniometer and evaluated the degrees of shoulder mobility in flexion, abduction and external rotation.
Number of Participants With Arm Morbidity at 12 Months Post-surgery - Upper Body Function
时间窗: 12 months
Arm morbidity due to decreased upper body function was defined as ≥10 points decrease in function from pre-surgery. This was measured using the Upper Extremity Functional Index that scores 0 to 80, with higher scores indicating greater level of function.
次要结局
未报告次要终点
研究者
Kristin Campbell
Associate Professor
University of British Columbia