Reduce Sedentary Behavior During Cancer Treatment - the RedSedCan Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 172
- 试验地点
- 2
- 主要终点
- Sedentary behavior time
研究概览
简要总结
Summary
Reducing sedentary behavior during treatment is important to reduce the risk of future health problems in individuals undergoing cancer treatment. Therefore, the goal of this project is with a multicenter randomised controlled design investigate whether a digital support intervention during ongoing neo- or adjuvant cancer treatment for breast, prostate or colon cancer is effective in reducing sedentary lifestyle and improving well-being in the short and long term.
详细描述
Description of the project
This project is about investigating the effect of a digital support intervention to reduce sedentary behavior in people with breast, prostate, or colorectal cancer during neo- or adjuvant cancer treatment. The digital support intervention has been developed with patients and researchers and consists of existing high-quality technology that provides support for setting and following goals. The people who use the digital support intervention also receive support from a physiotherapist to set goals for reduced sedentary time and get to choose which activities will replace the time spent sedentary.
The goal of the project
The goal of the project is to investigate the effects of a digital support intervention on reduced sedentary and well-being during ongoing cancer treatment, both in the short and long term. In addition, the project will study the health-economic effects, and climate benefits of using the digital support intervention. By focusing on reducing a sedentary lifestyle and replacing it with daily activities and/or physical activity, the health of individuals is expected to be positively affected in the short term through, for example, increased well-being and reduced side effects from cancer treatment, and the long term through a reduced risk of developing complications and new illness related to the cancer treatment, such as cardiovascular disease.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals diagnosed with breast, prostate, or colorectal cancer planned for or resently started neo- or adjuvant treatment (e.g. chemotherapy, radiotherapy, endocrine treatment) at the hospitals in Uppsala and Västerås, Sweden.
排除标准
- •Individuals diagnosed with dementia.
- •Individuals diagnosed with severe psychiatric disease.
- •Individuals with severe loss of vision, or communicative ability.
- •Individuals who cannot walk independently indoors with or without a walking aid.
- •Individuals completed treatment for other cancer diseases less than 12 months ago or not recovered from previous cancer treatment.
研究组 & 干预措施
Intervention
Participants receive a digital support intervention
干预措施: Digital self-management program (Behavioral)
Control
Control condition. Individuals receive the care as usual provided by the healthcare only.
结局指标
主要结局
Sedentary behavior time
时间窗: At baseline, 3-months, 6 months, 12 months and 24 months. Axivity is worn for 7 consecutive days at each measurement point.
The Axivity accelerometer is used for measuring the primary outcome of sedentary time, i.e. mean time spent in sedentary behavior/day.
次要结局
- Health-related quality of life(At baseline, 3-months, 6 months, 12 months and 24 months.)
- Sedentary behavior bouts(At baseline, 3-months, 6 months, 12 months and 24 months. Axivity is worn for 7 consecutive days at each measurement point.)
- Physical activity(At baseline, 3-months, 6 months, 12 months and 24 months. Axivity is worn for 7 consecutive days at each measurement point.)
- Cancer related fatigue(At baseline, 3-months, 6 months, 12 months and 24 months.)
- Fear of movement(At baseline, 3-months, 6 months, 12 months and 24 months.)
- Changes in health(At 3-months, 6 months, 12 months and 24 months.)
- Work ability(At baseline, 3-months, 6 months, 12 months and 24 months.)
- Self-efficacy for reducing sedentary behavior(At baseline, 3-months, 6 months, 12 months and 24 months.)
- Perceived support from peers(At baseline, 3-months, 6 months, 12 months and 24 months.)