Investigating Cognitive Function for Patients Participating in the BIG Trial 1-98 in Select Centers
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 135
- 试验地点
- 24
- 主要终点
- Objective cognitive function as measured by the CogState battery
研究概览
简要总结
RATIONALE: Studying cognitive function, such as thinking, attention, concentration, and memory, in postmenopausal women receiving hormone therapy for breast cancer may help improve quality of life and the ability to plan treatment for cancer.
PURPOSE: This phase III trial is studying cognitive function in postmenopausal women with breast cancer receiving hormone therapy on clinical trial IBCSG-1-98.
详细描述
OBJECTIVES:
Primary
- Compare cognitive function in postmenopausal women with breast cancer who have received 5 years of adjuvant tamoxifen vs letrozole on protocol IBCSG-1-98.
Secondary
- Compare cognitive function in patients who have received a single hormonal therapy for 5 years vs those who have received that same hormonal therapy for 3 years, having previously received an alternate hormonal therapy for 2 years.
- Compare improvement in cognitive function 1 year after cessation of adjuvant hormonal therapy.
- Compare changes in cognitive function in patients who have received prior adjuvant chemotherapy vs those who have not received adjuvant chemotherapy.
- Assess the relationship between objective and subjective measures of cognitive function, including specific cognitive domains.
- Assess the relationship between cognitive function and psychological distress, fatigue, and quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 30 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
研究组 & 干预措施
Tamoxifen for 5 years
Patients treated with tamoxifen for 5 years after randomization.
干预措施: cognitive assessment (Procedure)
Letrozole for 5 years
Patients treated with letrozole for 5 years after randomization.
干预措施: fatigue assessment and management (Procedure)
Tamoxifen for 5 years
Patients treated with tamoxifen for 5 years after randomization.
干预措施: fatigue assessment and management (Procedure)
Tamoxifen for 5 years
Patients treated with tamoxifen for 5 years after randomization.
干预措施: psychologic distress (Procedure)
Tamoxifen for 5 years
Patients treated with tamoxifen for 5 years after randomization.
干预措施: quality-of-life assessment (Procedure)
Letrozole for 5 years
Patients treated with letrozole for 5 years after randomization.
干预措施: cognitive assessment (Procedure)
Letrozole for 5 years
Patients treated with letrozole for 5 years after randomization.
干预措施: psychologic distress (Procedure)
Letrozole for 5 years
Patients treated with letrozole for 5 years after randomization.
干预措施: quality-of-life assessment (Procedure)
Tamoxifen 2 years plus letrozole 3 years
Patients treated with tamoxifen for 2 years and afterwards with letrozole for 3 years.
干预措施: cognitive assessment (Procedure)
Tamoxifen 2 years plus letrozole 3 years
Patients treated with tamoxifen for 2 years and afterwards with letrozole for 3 years.
干预措施: fatigue assessment and management (Procedure)
Tamoxifen 2 years plus letrozole 3 years
Patients treated with tamoxifen for 2 years and afterwards with letrozole for 3 years.
干预措施: psychologic distress (Procedure)
Tamoxifen 2 years plus letrozole 3 years
Patients treated with tamoxifen for 2 years and afterwards with letrozole for 3 years.
干预措施: quality-of-life assessment (Procedure)
Letrozole for 2 years plus tamoxifen for 3 years
Patients treated with letrozole for 2 years and afterwards with tamoxifen for 3 years.
干预措施: cognitive assessment (Procedure)
Letrozole for 2 years plus tamoxifen for 3 years
Patients treated with letrozole for 2 years and afterwards with tamoxifen for 3 years.
干预措施: fatigue assessment and management (Procedure)
Letrozole for 2 years plus tamoxifen for 3 years
Patients treated with letrozole for 2 years and afterwards with tamoxifen for 3 years.
干预措施: psychologic distress (Procedure)
Letrozole for 2 years plus tamoxifen for 3 years
Patients treated with letrozole for 2 years and afterwards with tamoxifen for 3 years.
干预措施: quality-of-life assessment (Procedure)
结局指标
主要结局
Objective cognitive function as measured by the CogState battery
时间窗: 6 years after randomization
次要结局
- Fatigue as measured by the Brief Fatigue Inventory (BFI)(6 years after randomization)
- Quality of life as measured by the IBCSG QL Core Form(6 years after randomization)
- Subjective cognitive function as measured by the Cognitive Failures Questionnaire (CFQ)(6 years after randomization)
- Psychological distress as measured by the General Health Questionnaire (GHQ)(6 years after randomization)