Enhancing Well-Being During Breast Cancer Recurrence. SWOG Study S9832.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 322
- 试验地点
- 216
- 主要终点
- Assess effectiveness of a telephone intervention delivered by breast cancer survivors on well-being of patients experiencing a first recurrence of breast cancer
研究概览
简要总结
RATIONALE: Telephone counseling by breast cancer survivors may enhance the well-being and quality of life of women who have recurrent breast cancer.
PURPOSE: Randomized clinical trial to study the effectiveness of telephone counseling by breast cancer survivors on the well-being of women who have recurrent breast cancer.
详细描述
OBJECTIVES:
- Determine whether telephone counseling delivered by breast cancer survivors enhances the well-being of women with recurrent breast cancer.
- Determine the impact of sociodemographic, clinical, and psychosocial predictors of well-being in these patients.
- Determine the changes in well-being over time since disease recurrence in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (under 50 vs 50 and over), time since initial diagnosis (less than 2 years vs 2 years or more), and recurrence site (soft tissue without bone vs soft tissue with bone vs visceral). Patients are randomized to one of two study arms.
- Arm I (control arm): Patients receive the standard level of support by continuing to use existing resources. Patients receive written materials from the counseling group at 6 months.
- Arm II (intervention arm): Patients receive weekly telephone counseling sessions by breast cancer survivors over 4 weeks for a total of 4-8 sessions. Patients receive written materials from the counseling group after the first session.
In both arms, quality of life is assessed at baseline and at 3 and 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Assess effectiveness of a telephone intervention delivered by breast cancer survivors on well-being of patients experiencing a first recurrence of breast cancer
时间窗: 6 months
次要结局
- Examine impact of sociodemographic, clinical, and psychosocial predictors of well-being in patients experiencing a first recurrence of breast cancer.(6 months)
- Examine changes in well-being over time since recurrence(6 months)