Evaluation of a Novel Strategy to Implement Exercise Evidence Into Clinical Practice in Breast Cancer Care: The NEXT-BRCA Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Change in baseline physical activity level
研究概览
简要总结
BACKGROUND:
One in eight women will develop breast cancer in their lifetime. With improved screening and treatment techniques, more women are surviving breast cancer. However, women live with physical and emotional side effects secondary to treatment for years after cancer treatments have ended. Exercise can help to manage these side effects, however, less than 30% of this population takes part in regular exercise. The objective of this trial is to determine the feasibility and effectiveness of a novel exercise and education program for women with breast cancer during chemotherapy.
METHODS:
Participants in this study include women with a diagnosis of stage 1 - 3 breast cancer undergoing chemotherapy. Women will be divided into three groups. The first group will include 8 sessions of exercise and self-management education during their chemotherapy treatment. The second group will receive self-management education only, and the third group will receive usual care. Outcomes will be compared between groups at baseline, post-intervention, and at 6- and 12- month follow up. Outcomes to be assessed include exercise level, functional mobility, muscle strength, quality of life, health status, and use of health care services.
EXPECTED OUTCOMES:
Women with breast cancer are among the least active segment of the Canadian population. It is well known that inactivity can lead to physical and psychological side effects, cancer recurrence, and an increase in comorbid conditions. This proposed project addresses a long-standing need to help women with breast cancer become and stay more active by implementing a novel exercise and education program.
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
- Double (Investigator, Outcomes Assessor)
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
- •community-dwelling
- •English-speaking women
- •over 18 years of age
- •currently undergoing adjuvant or neoadjuvant chemotherapy for Stage 1-3 breast cancer
- •cleared by their oncologist to participate in moderate intensity aerobic exercise
排除标准
- •self-report any chronic condition, cognitive impairment, or injury that would prevent them from participating independently in moderate intensity exercise
研究组 & 干预措施
Institution-Based Exercise and Self-Management (EXSM)
Eight session of supervised exercise within the cancer institution plus 8 self-management modules focusing on goal setting and action planning for safe and effective exercise strategies (this is based on our team's successful pilot intervention). Four booster sessions will be provided to this group.
干预措施: Exercise (Behavioral)
Institution-Based Exercise and Self-Management (EXSM)
Eight session of supervised exercise within the cancer institution plus 8 self-management modules focusing on goal setting and action planning for safe and effective exercise strategies (this is based on our team's successful pilot intervention). Four booster sessions will be provided to this group.
干预措施: Self-Management (Behavioral)
Institution-Based Exercise and Self-Management (EXSM)
Eight session of supervised exercise within the cancer institution plus 8 self-management modules focusing on goal setting and action planning for safe and effective exercise strategies (this is based on our team's successful pilot intervention). Four booster sessions will be provided to this group.
干预措施: Booster Sessions (Behavioral)
Institution-Based Self-management only (SM)
Eight SM sessions for safe and effective exercise strategies will be provided to this group (described above). Four booster sessions will be provided to this group.
干预措施: Self-Management (Behavioral)
Institution-Based Self-management only (SM)
Eight SM sessions for safe and effective exercise strategies will be provided to this group (described above). Four booster sessions will be provided to this group.
干预措施: Booster Sessions (Behavioral)
Usual care
Participants in this group will receive care as normally provided by their treating oncologist. This can be heterogeneous between different physicians and centres, but usually includes oncologists encouraging their patients to 'stay active'
结局指标
主要结局
Change in baseline physical activity level
时间窗: 16-weeks, 6-months, 12-months
To be assessed using the Godin Leisure Time Exercise Questionnaire (total score 0-no maximum; higher scores indicating higher levels of physical activity) and activity tracker (Fitbit) data (demonstrating steps/day and total time of moderate levels of physical activity; higher scores indicate higher levels of activity).
次要结局
- Change in level of exercise knowledge(16-weeks, 6-months, 12-months)
- Change in baseline quality of life(16-weeks, 6-months, 12-months)
- Change in baseline perception of health status(16-weeks, 6-months, 12-months)
- Change in baseline aerobic capacity(16-weeks, 6-months, 12-months)
- Change in baseline levels of lower extremity strength(16-weeks, 6-months, 12-months)
- Change in patient engagement in health services(16-weeks, 6-months, 12-months)
- Change in baseline levels of resting BP(16-weeks, 6-months, 12-months)
- Change in baseline resting heart rate(16-weeks, 6-months, 12-months)