SmartCare: Innovations in Caregiving Interventions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Change in depression from baseline at 4 months on the shortened CES-D
研究概览
简要总结
This is a study to evaluate the effectiveness of using an established intervention for depressive symptom management in conjunction with a needs-based caregiver intervention for improving the psychological and physical health of family caregivers of persons recently diagnosed with a Primary Malignant Brain Tumor.
详细描述
We have designed a needs-based intervention to improve neuro-oncology caregivers' health. Our novel approach treats depressive symptoms prior to implementing a needs-based intervention in a sample of PMBT family caregivers who score above threshold on depressive symptoms. Study outcomes are psychological responses (unmet needs, depressive symptoms, anxiety, and burden) and physical responses (levels of stimulated and circulating IL-6 and IL-1β, C-reactive protein, peripheral blood mono-nuclear cells, physical symptoms, and new diagnoses or exacerbations of co-morbid conditions). The proposed study addresses research priorities set by both NCI and NINR to improve the quality of life of patients and their families and NINR's emphasis on integrating bio-behavioral science and adopting, adapting and generating new technologies.
Primary aims:
- Compare the efficacy of a) an intervention for depressive symptoms (Beating the Blues) delivered prior to a needs-based caregiver intervention (SmartCare©) versus b) SmartCare© alone versus c) enhanced care as usual (CAU+) in improving caregivers' psychological and physical responses.
H1: At 4- and 6-months, caregivers who receive Beating the Blues prior to SmartCare© will display improved psychological and physical responses compared to caregivers who receive CAU+.
H2: At 4- and 6-months, caregivers who receive SmartCare© alone will display improved psychological and physical responses compared to caregivers who receive CAU+.
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
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Care recipient:
- •Over 21 years of age.
- •Newly (within 1 month) diagnosed with a PMBT (tumor verified via pathology report to be a glioblastoma multiforme, anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic oligoastrocytoma, medulloblastoma, or anaplastic ependymoma).
- •Primary nonprofessional, non-paid caregiver, as identified by the care recipient.
- •Over 21 years of age with telephone access.
- •Reads-speaks English
- •Obtains a score of >6 on the shortened CES-D.
- •Caregivers may or may not be receiving pharmacotherapy for depressive symptoms
排除标准
- •Currently considers self to be a primary caregiver for anyone else other than children
- •Currently receiving any type of formal counselling for depressive symptoms
研究组 & 干预措施
CAU+ (Enhanced Care as Usual)
CAU+ (Enhanced Care as Usual) is defined as the care received from the care recipient's oncologist supplemented by unlimited access to three components of the study website: caregiver guides, links to web-based resources, and a basic friends and family page for the 10 month duration of the study.
干预措施: CAU+ (Enhanced Care as Usual) (Behavioral)
CAU+ and SmartCare
CAU+ (Enhanced Care as Usual) for eight weeks, followed by eight weeks of SmartCare. SmartCare is a web-based, nurse guided intervention for caregivers based on the Representational Approach of symptom management.
干预措施: CAU+ (Enhanced Care as Usual) (Behavioral)
CAU+ and SmartCare
CAU+ (Enhanced Care as Usual) for eight weeks, followed by eight weeks of SmartCare. SmartCare is a web-based, nurse guided intervention for caregivers based on the Representational Approach of symptom management.
干预措施: SmartCare (Behavioral)
CAU+ and Beating the Blues and SmartCare
CAU+ (Enhanced Care as Usual) and Beating the Blues concurrently for eight weeks, followed by SmartCare for eight weeks. Beating the Blues is an established, web-based, self-directed, cognitive behavioral therapy for managing depressive symptoms.
干预措施: CAU+ (Enhanced Care as Usual) (Behavioral)
CAU+ and Beating the Blues and SmartCare
CAU+ (Enhanced Care as Usual) and Beating the Blues concurrently for eight weeks, followed by SmartCare for eight weeks. Beating the Blues is an established, web-based, self-directed, cognitive behavioral therapy for managing depressive symptoms.
干预措施: Beating the Blues (Behavioral)
CAU+ and Beating the Blues and SmartCare
CAU+ (Enhanced Care as Usual) and Beating the Blues concurrently for eight weeks, followed by SmartCare for eight weeks. Beating the Blues is an established, web-based, self-directed, cognitive behavioral therapy for managing depressive symptoms.
干预措施: SmartCare (Behavioral)
结局指标
主要结局
Change in depression from baseline at 4 months on the shortened CES-D
时间窗: Baseline and 4 months
Depressive symptoms will be measured using the 10-item shortened version of the Center for Epidemiologic Studies - Depression (CES-D).
次要结局
- Change in unmet needs from baseline at 4 months on the CNS(Baseline and 4 months)
- Change in mastery from baseline at 4 months on the Caregiver Mastery Scale(Baseline and 4 months)
- Change in optimism from baseline at 4 months on the Life Orientation Test(Baseline and 4 months)
- Change spirituality from baseline at 4 months on the FACIT.(Baseline and 4 months.)
- Change in oversight demand from baseline at 4 months on the caregiver vigilance scale.(Baseline and 4 months)
- Change in social support from baseline at 4 months on the ISEL.(Baseline and 4 months.)
- Changes in positive aspects of providing care from baseline at 4 months on the PAC.(Baseline and 4 months)
- Change in occupational functioning from baseline at 4 months on the WLQ.(Baseline and 4 months.)
- Change in unmet needs from baseline at 6 months on the CNS(Baseline and 6 months)
- Change in mastery from baseline at 6 months on the Caregiver Mastery Scale(Baseline and 6 months)
- Change in optimism from baseline at 6 months on the Life Orientation Test(Baseline and 6 months)
- Change spirituality from baseline at 6 months on the FACIT.(Baseline and 6 months.)
- Change in oversight demand from baseline at 6 months on the caregiver vigilance scale.(Baseline and 6 months)
- Change in social support from baseline at 6 months on the ISEL.(Baseline and 6 months.)
- Change in occupational functioning from baseline at 6 months on the WLQ.(Baseline and 6 months.)
- Changes in positive aspects of providing care from baseline at 6 months on the PAC.(Baseline and 6 months)
研究者
Paula Sherwood
Professor, Vice Chair of Research, Dept. of Acute and Tertiary Care, School of Nursing; Professor, Dept. of Neurological Surgery, School of Medicine
University of Pittsburgh