Randomized Controlled Trial of Sitting Time Interventions in Breast Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Feasibility as measured by recruitment and retention rates
研究概览
简要总结
Excessive sitting time (sedentary time) has been associated with risk of insulin resistance and other factors which may be relevant to breast cancer prognosis. This 8-week study tests different strategies for helping breast cancer survivors to modify their levels of sitting time. Participants will be assigned with equal likelihood to one of three groups (1) overall reduction in sitting time, (2) interruption of sitting time with standing breaks, and (3) usual care.
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
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •diagnosed with Stage 0-III breast cancer. Bilateral or multiple primary breast cancers are permitted.
- •Completed primary treatment defined as definitive surgery, (neo)adjuvant chemotherapy and/or (neo)adjuvant radiation. Participants still receiving adjuvant endocrine or HER2 targeted therapies are eligible.
- •Report sitting for ≥8 accumulated waking hours on a typical day,
- •Willing and able to attend 3 study visits at the UW,
- •Willing to attempt reduction of sitting time,
- •Use the internet on a regular basis,
- •Willing and able to complete study requirements, and
- •Currently considered postmenopausal (no menstrual periods in past 12 months), even if pre-menopausal at diagnosis.
排除标准
- •Evidence of recurrence or metastatic disease,
- •Unable to move from sitting to standing without difficulty and to walk 1 block.
研究组 & 干预措施
Reducing Sitting Time Group
This group will be asked to reduce overall accumulated sitting time by 2 hours per day.
干预措施: Reducing Sitting Time Group (Behavioral)
Re-Patterning Sitting Time Group
This group will be asked to use standing breaks to interrupt long bouts of sitting time.
干预措施: Re-Patterning Sitting Time Group (Behavioral)
Usual Care
This is an attention control group and is not asked to make changes to sitting time.
干预措施: Usual Care (Behavioral)
结局指标
主要结局
Feasibility as measured by recruitment and retention rates
时间窗: 12 months
Feasibility of recruiting participants to the study
次要结局
- Sedentary behavior as measured by ActivPal(7 days)
- Physical activity as measured by ActiGraph(7 days)
- Sedentary time as measured by ActiGraph(7 days)