Exercise Rehabilitation Via a Mobile Application for Individuals With Breast Cancer Undergoing Chemotherapy (EMPOWER): A Randomized Controlled Feasibility Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Completion rate
研究概览
简要总结
The primary purpose of this study is to determine the feasibility of our proposed intervention approach involving (1) an integrated physiotherapy and exercise intervention for individuals with breast cancer who are undergoing chemotherapy and (2) delivery of programming via an electronic health (eHealth) application. The secondary objective is to determine the efficacy of the program on upper extremity outcomes, general physical fitness, cancer treatment-related symptoms and quality of life.
详细描述
EMPOWER is a multi-methods feasibility randomized controlled trial. The study will recruit a minimum of 30 individuals with breast cancer who are undergoing adjuvant chemotherapy following surgery for breast cancer. The study will be conducted in two phases:
Phase I: Randomized Controlled Feasibility Trial The aim of this phase is to determine the feasibility and preliminary efficacy of a 10-week integrated physiotherapy and exercise intervention compared to an exercise intervention alone.
Phase II: Qualitative Study The aim of this phase is to evaluate the acceptability of the Healthy Eating, Active Living and Mindful Energy (HEAL-ME) Research App design, program delivery, program components and perceived effectiveness of the intervention at the level of the participant.
PHASE I: Randomized Controlled Feasibility Trial A randomized controlled trial design will be used to randomize individuals with breast cancer to one of two groups: 1) Comparison group: general exercise intervention + education; and 2) Experimental group: integrated physiotherapy and general exercise intervention + education. The study will be carried out over a 10-week period. The outcome measures will be assessed at baseline and at 10 weeks.
Randomization: An independent researcher will generate the randomization sequence using a computer-generated randomization module within the Trial's REDCap database. Randomization will occur following baseline testing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Independent assessors will be used for collection of objective outcomes. The independent assessors will be blinded to group allocation.
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
- •adult females with a diagnosis of breast cancer (Stage Ic-III);
- •be able to participate in mild levels of activity at minimum;
- •have completed cancer surgery involving a mastectomy or breast conserving surgery involving either an axillary lymph node dissection or sentinel lymph node biopsy;
- •having completed or undergoing adjuvant chemotherapy +/- biological therapy treatment (eligible from 4 weeks to one year post-surgery at baseline);
- •speak and understand English.
排除标准
- •unable to commit to the 10-week virtual program including testing sessions at the Cancer Rehabilitation clinic in the Corbett Hall at the University of Alberta;
- •do not have regular access to the internet and a smart device or computer in the home.
- •are scheduled to undergo neoadjuvant chemotherapy
研究组 & 干预措施
Standard exercise program
Participants in this group will take part the general exercise program delivered through the Active Living module of the HEAL-ME application. The program comprises (1) supervised group exercise sessions (connection via zoom platform embedded in HEAL-ME), (2) independent exercise workouts within the application, and (3) exercise specific education within the Education Module of the HEAL-ME application.
干预措施: general exercise (Behavioral)
Integrated physiotherapy and exercise
Participants in this group will take part in an integrated physiotherapy and exercise intervention delivered through the Active Living module of the HEAL-ME application. The program comprises (1) supervised group physiotherapeutic exercise sessions (connection via zoom platform embedded in HEAL-ME), (2) independent physiotherapeutic exercise workouts, and (3) breast cancer specific physiotherapy education delivered through weekly modules.
干预措施: general exercise (Behavioral)
结局指标
主要结局
Completion rate
时间窗: 10 weeks
Defined as \>70% participants completing at least 70% of exercise sessions and the post-study assessment
次要结局
- Program Satisfaction(10 weeks)
- Symptoms(10 weeks)
- Recruitment rate(one year)
- Attendance rate(10 weeks)
- Cost-effectiveness(10 weeks)
- Flexibility Shoulder External Rotation(10 weeks)
- Physical Activity(10 weeks)
- Flexibility Shoulder Internal Rotation(10 weeks)
- Balance(10 weeks)
- Health-related Quality of Life(10 weeks)
- Walking endurance(10 weeks)
- Flexibility Shoulder Abduction(10 weeks)
- Flexibility Shoulder Horizontal Abduction(10 weeks)
- Body weight(10 weeks)
- Flexibility Shoulder Flexion(10 weeks)
- Flexibility lower body(10 weeks)
- Arm volume(10 weeks)
- Fatigue(10 weeks)
- Lower body strength(10 weeks)
- Body height(10 weeks)