Mobile App for Shoulder Rehabilitation Following Breast Reconstruction: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Shoulder Range of Motion (ROM)
研究概览
简要总结
Breast cancer is the most common cancer for Canadian women. Of the women who will have a mastectomy each year in Canada, one in five will elect to have breast reconstruction. However, the significant benefits for body-image, self-esteem, sexuality, and quality of life are tempered by post-treatment shoulder dysfunction for many. As a means to decrease shoulder morbidities in breast cancer survivors (BCS), this study will introduce a mobile application (app)-based shoulder rehabilitation program as an option to improve functional outcomes of the shoulder, for those who have had breast reconstruction.
详细描述
The percentage of Canadian women surviving at least 5 years beyond initial diagnosis is currently approaching 90% and many of these women are choosing to have breast reconstruction following mastectomy. Potential sequelae from both mastectomy and all types of breast reconstruction surgeries can result in various functional limitations. The most common adverse effect from breast cancer surgery is shoulder morbidity, having both short and long-term consequences for survivors, and evidence suggests women who undergo breast reconstruction are at even higher risk of developing shoulder problems. Shoulder/arm pain, reductions in strength, and limitations in range of motion (ROM) are some of the common physical issues plaguing BCS, often for years after the initial treatment. Fibrosis of the direct area of the target tissue is a common finding post radiation therapy, specifically of the anterior chest/ pectoralis and axilla regions in BCS and most noticeable starting six months post-surgically.
The researchers' interest in the feasibility of a shoulder rehabilitation mobile app for post-surgical BCS is to improve access to rehabilitation (including education, exercises, and remote support with a physical therapist, PT) for these women, allowing for better functional outcomes which could translate into decreased reliance on medical care, improved quality of life (QoL), and ability to participate in life roles.
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •minimum 18 years of age
- •scheduled for immediate or delayed breast reconstruction (implant type only)
- •6 weeks or less from time of surgery
- •must have mobile phone capable of app download
- •need desk top or laptop computer for Zoom meetings
- •medically stable
- •able to be informed and consent in English
排除标准
- •ongoing or current health-related issues that would interfere with the ability to complete the program (i.e. metastatic cancer, severe cardiovascular disease)
- •lack of access to a mobile phone and laptop or desk top computer for Zoom meetings
- •inability to comprehend the English language
结局指标
主要结局
Shoulder Range of Motion (ROM)
时间窗: At start of the study, at 4 weeks into the study and again at the end of the study (8 weeks into the study).
ROM measurements of both shoulders (flexion, extension, abduction, internal and external rotation) will be taken post-operatively, via the downloaded app on each participant's phone, and by visual examination of the research assistant (registered, licensed PT) during the virtual assessment via Zoom. These ROM measures, taken at the beginning of the intervention (week one), mid-intervention (week four), and end of intervention (week eight) will be used as a guide for exercise progression throughout the intervention. The measurements will also be used in our data analysis to understand changes in shoulder ROM from the beginning of the intervention to the end of intervention.
次要结局
- Quick Disability of Arm, Shoulder and Hand (Quick DASH)(At start of the study, at 4 weeks into the study and again at the end of the study (8 weeks into the study).)
- Visual Analogue Scale (VAS)(At start of the study, at 4 weeks into the study and again at the end of the study (8 weeks into the study).)
- Fatigue Assessment Scale (FAS)(At start of the study, at 4 weeks into the study and again at the end of the study (8 weeks into the study).)
- Short Form 36 (SF-36)(At start of the study, at 4 weeks into the study and again at the end of the study (8 weeks into the study).)
研究者
Soo Kim
Associate Professor
University of Saskatchewan