Treating Depression Among Low-Income Patients With Cancer (ADAPt-C)
Effectiveness Study of a Stepped Care Depression Algorithm for Patients With Cancer
研究概览
详细说明
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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California
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Los Angeles、California、美国、90033
- Los Angeles County+University of Southern California Medical Center
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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:
- 90 days post cancer diagnosis receiving acute cancer treatment or active follow-up
Exclusion Criteria:
- patients with advanced cancer or another medical condition that limited life expectancy to less than 6 months
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:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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无干预:Enhanced Usual Care
EUC patients receive medical center standard oncology care and supportive services routinely provided to all patients with cancer.
In addition, EUC patients are given a patient focused and a family focused educational pamphlet on depression and cancer and a listing of financial and community resources (in Spanish for Spanish-speaking patients).
With patient consent, as described in the informed written consent, the treating oncologist is informed via medical chart note if EUC patients screen positive for major depression.
Treating oncology attending physicians, fellows and residents are invited to attend a didactic session led by the study psychiatrist on treating depression in cancer patients.
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实验性的:ADAPt-C intervention
Intervention patients receive: first-line choice of antidepressant medication management,psychotherapy or both; depression education, and maintenance/relapse prevention counseling based on a stepped care depression treatment algorithm, treatment follow-up and feedback to the oncologist, and systems navigation; a psychiatric consultant who prescribes antidepressant medication for individual patients; and a didactic for oncologists on depression management.
Cultural adaptations include: patient choice of first line treatment and degree of family participation in their depression care; PST tailored for literacy and patients with cancer; bilingual, bicultural CDCS; Spanish educational materials.
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Experimental Arm patients receive: first-line choice of antidepressant medication management,psychotherapy or both; depression education, and maintenance/relapse prevention counseling based on a stepped care depression treatment algorithm, treatment follow-up and feedback to the oncologist, and systems navigation; a psychiatric consultant who prescribes antidepressant medication for individual patients; and a didactic for oncologists on depression management.
Cultural adaptations include: patient choice of first line treatment and degree of family participation in their depression care; PST tailored for literacy and patients with cancer; bilingual, bicultural CDCS; Spanish educational materials.
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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 |
|---|---|---|
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Reduced Depression Symptoms
大体时间:12 months
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Number of participants with 50% PHQ-9 score reduction since baseline
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12 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Physical Composite Summary Score (PCS) Derived From the 12-item Short Form (SF-12) Health Survey
大体时间:12 months
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The SF-12 measures 8 health domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health.
PCS is a summary score measuring physical health derived by summing responses across scale items and then transforming to a 0-100 scale (higher scores indicate better health).
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12 months
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合作者和调查者
调查人员
- 首席研究员:Kathleen R Ell, DSW、University of Southern California, School of Social Work
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
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
National Cancer Institute, "Project ADAPT-C" selected for Research-Tested Interventions NCI Program 2014, http://rtips.cancer.gov/rtips/programDetails.do?programId=3551008. https://researchtoreality.cancer.gov/featured-r2r-partners/kathleen-ell-dsw
1. ADAPt-C randomized clinical trial selected by the Predicting OptimaL cAncer RehabIlitation and Supportive care (POLARIS Consortia) led by the Netherlands
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