老年女性芳香化酶抑制剂治疗的老年肿瘤学评估与应对技能训练 (GOAL-AI)
老年肿瘤评估与辅助芳香化酶抑制剂治疗的老年女性支持服务链接
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.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Smrithi Divakaran, MBBS, MSPH
- 电话号码：919-681-7695
- 邮箱：smrithi.divakaran@duke.edu
研究联系人备份
- 姓名：Michael W Willis, BA
- 电话号码：919-681-8437
- 邮箱：michael.w.willis@duke.edu
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Female, age ≥65 years
- HR+ non-metastatic breast cancer
- Within 12 months of starting AI therapy
- English-speaking
- Able to provide consent
Exclusion Criteria:
- Age <65 years
- Metastatic cancer
- Cognitive impairment preventing consent
- Receiving care at multiple participating sites
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：阶乘赋值
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：GOAL-AI + CST-AI
Combination of clinic-level geriatric assessment and CBT-based coping skills training. |
Clinic-level geriatric assessment and support program. CBT-based coping skills training via telehealth. |
|
实验性的：GOAL-AI alone
Clinic-level geriatric assessment and support only. |
Clinic-level geriatric assessment and support program. |
|
实验性的：CST-AI alone
CBT-based coping skills training only. |
CBT-based coping skills training via telehealth. |
|
无干预：Enhanced Usual Care
Standard care with educational materials. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in pain severity and interference as measured by the Brief Pain Inventory - Short Form
大体时间：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. |
Baseline, 6 months, 12 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in emotional distress, as measured by the PROMIS® Anxiety and Depression 4-item Short Forms
大体时间：Baseline, 6 months, 12 months
|
For the PROMIS® Anxiety and Depression 4-item Short Forms (4a, v1.0) items are summed to create a raw score from 4 to 20 that is converted to a T-score. Responses are on a 5-point scale from "never" (1) to "always" (5). Higher scores indicate higher emotional distress. |
Baseline, 6 months, 12 months
|
|
Change in fatigue, as measured by the PROMIS® Fatigue 6-item Short Form
大体时间：Baseline, 6 months, 12 months
|
For the PROMIS® Fatigue 6-item Short Form (6a, v1.0) items are summed to create a raw score that is converted to a T-score. Participants are asked to think about the last week when responding to each item (e.g., "In the past 7 days, how run-down did you feel, on average?"), providing ratings on a scale from "not at all" (1) to "very much" (5). Sum scores may range from 6 to 30, with higher scores indicating higher fatigue. |
Baseline, 6 months, 12 months
|
|
Change in physical function, as measured by the Five Times Sit to Stand Test (5xSST)
大体时间：Baseline, 6 months, 12 months
|
The Five Times Sit to Stand Test (5xSST) assesses functional lower extremity strength, balance, risk of fall, functional decline, and frailty. The amount of time it takes a patient to sit and stand five times in succession with arms folded across their chest is averaged across three trials. |
Baseline, 6 months, 12 months
|
合作者和调查者
调查人员
- 首席研究员：Rebecca Shelby, PhD、Duke University
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
The following data will be preserved and shared: patient-reported data from study assessments, healthcare utilization data collected from the health record, AI adherence data collected via self-report and from the health record, physical function and geriatric assessment data collected by study staff in clinic and from the health record, and socio-demographic and medical data collected via patient report and health record.
IPD 共享时间框架
Data will be shared either at the time of publication or at the end of the performance period, whichever comes first. All data deposited with the Duke Research Data Repository will be retained for a minimum of 25 years according to their stated Retention Policy.
IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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