Geriatric Oncology Assessment to Link With Support for Older Women Taking Adjuvant Aromatase Inhibitor Therapy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 452
- 主要终点
- Change in pain severity and interference as measured by the Brief Pain Inventory - Short Form
研究概览
简要总结
Older women (≥65 years) with HR+ non-metastatic breast cancer experience high symptom burden and reduced quality of life during aromatase inhibitor (AI) therapy. This hierarchical 2×2 factorial randomized controlled trial will test two interventions: (1) a clinic-level geriatric oncology assessment and support program (GOAL-AI) and (2) a patient-level CBT-based coping skills training (CST-AI). The study aims to improve pain, symptom burden, and health-related quality of life compared to enhanced usual care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female, age ≥65 years
- •HR+ non-metastatic breast cancer
- •Within 12 months of starting AI therapy
- •English-speaking
- •Able to provide consent
排除标准
- •Age <65 years
- •Metastatic cancer
- •Cognitive impairment preventing consent
- •Receiving care at multiple participating sites
研究组 & 干预措施
GOAL-AI + CST-AI
Combination of clinic-level geriatric assessment and CBT-based coping skills training.
干预措施: GOAL-AI (Behavioral)
GOAL-AI + CST-AI
Combination of clinic-level geriatric assessment and CBT-based coping skills training.
干预措施: CST-AI (Behavioral)
GOAL-AI alone
Clinic-level geriatric assessment and support only.
干预措施: GOAL-AI (Behavioral)
CST-AI alone
CBT-based coping skills training only.
干预措施: CST-AI (Behavioral)
Enhanced Usual Care
Standard care with educational materials.
结局指标
主要结局
Change in pain severity and interference as measured by the Brief Pain Inventory - Short Form
时间窗: Baseline, 6 months, 12 months
The Brief Pain Inventory-Short Form (BPI-SF) will be used to assess pain severity and interference from pain across important life domains (e.g., general activity, work, relations with others). To calculate a pain severity score, the BPI-SF averages worst, least, average and current pain severity ratings on a 0 to 10 scale, with higher scores indicating more severe pain. To calculate a pain interference score, 7 items asking about interference from pain across different life domains will be averaged, with higher scores indicating higher pain interference.
次要结局
- Change in emotional distress, as measured by the PROMIS® Anxiety and Depression 4-item Short Forms(Baseline, 6 months, 12 months)
- Change in fatigue, as measured by the PROMIS® Fatigue 6-item Short Form(Baseline, 6 months, 12 months)
- Change in physical function, as measured by the Five Times Sit to Stand Test (5xSST)(Baseline, 6 months, 12 months)