Self-management Interventions for Pain in Advanced Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Acceptability
研究概览
简要总结
The purpose of this research study is to evaluate whether self-management discussion groups are helpful for women with advanced breast cancer who are experiencing pain. The study is looking at the usefulness of two different types of discussion groups, one of which also includes gentle exercise.
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)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •diagnosis of Stage IV breast cancer or recurrent metatastic breast cancer
- •receiving care at Duke Cancer Institute,
- •life expectancy ≥9 months as estimated by the treating oncologist,
- •speak and read English,
- •be at least age 18
- •be able to travel to the Duke Cancer Institute
排除标准
- •cognitive impairment as assessed by the 6-item Mini-mental Status Exam,
- •Karnofsky Performance Rating of <60 as rated by the oncology provider, an ECOG rating of 0-2
- •treatment for serious psychiatric illness (e.g., schizophrenia, severe depression) in the past 6 months,
- •currently engaged in yoga practice ≥ 1 day per week
研究组 & 干预措施
discussion group
Eight weekly group sessions in which participants will engage in discussions regarding issues related to coping with advanced cancer and pain
干预措施: discussion group (Behavioral)
discussion group + exercise
Eight weekly group sessions in which participants will engage in discussions regarding issues related to coping with advanced cancer and pain and learn gentle exercise and breathing techniques
干预措施: discussion group (Behavioral)
discussion group + exercise
Eight weekly group sessions in which participants will engage in discussions regarding issues related to coping with advanced cancer and pain and learn gentle exercise and breathing techniques
干预措施: gentle exercise (Behavioral)
结局指标
主要结局
Acceptability
时间窗: 36 months
Acceptability will be assessed via participant ratings on a standardized measure of treatment effectiveness/satisfaction, supplemented by exit interview
Feasibility
时间窗: 36 months
Feasibility will be indicated by our ability to meet accrual goals, and by at least 70% of patients attending ≥4 of 8 sessions and providing post-test assessments
次要结局
- Change in pain(study entry, following completion of the intervention (approximately 3 months), 6 months, and 9 months)
- Change in Psychological distress(study entry, following completion of the intervention (approximately 3 months), 6 months, and 9 months)
- Change in fatigue(study entry, following completion of the intervention (approximately 3 months), 6 months, and 9 months)
- Change in functional capacity(study entry, following completion of the intervention (approximately 3 months), 6 months, and 9 months)
- Change in sleep disturbance(study entry, following completion of the intervention (approximately 3 months), 6 months, and 9 months)