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
- 109
- 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
- •DISEASE CHARACTERISTICS:
- •Received prior definitive surgical treatment for stage I-IIIa breast cancer with or without adjuvant chemotherapy, hormonal therapy, and/or radiotherapy
- •No more than 56 days since diagnosis of first recurrence
- •Any distant metastatic site, chest wall recurrence, scar recurrence, or nodal recurrence
- •No ipsilateral breast tumor recurrence after lumpectomy or isolated contralateral new primary breast tumors
- •Receiving or planning to receive first therapy for recurrence
- •No prior therapy for this recurrence except surgical treatment for in-breast relapse after lumpectomy or local palliative radiotherapy
- •Hormone receptor status:
- •Not specified
- •PATIENT CHARACTERISTICS:
- •Not specified
- •Menopausal status:
- •Not specified
- •Performance status:
- •Not specified
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Not specified
- •Not specified
- •Not specified
- •No psychiatric diagnosis that would preclude study
- •Must be able to read and understand English
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •See Disease Characteristics
- •Chemotherapy:
- •See Disease Characteristics
- •Endocrine therapy:
- •See Disease Characteristics
- •Radiotherapy:
- •See Disease Characteristics
- •See Disease Characteristics
排除标准
- 未提供
研究组 & 干预措施
Control
Standard level of support after recurrence diagnosis
Intervention
Phone intervention for patients experiencing first recurrence with quality of life questionnaires, psychosocial assessment and care.
干预措施: psychosocial assessment and care (Procedure)
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)