跳至主要内容
临床试验/NCT02944136
NCT02944136已完成不适用

Collaborative Care Intervention for Cancer Caregivers

University of Pittsburgh4 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2016年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1
试验地点
4
主要终点
Caregiver Quality of Life Questionnaire

研究概览

简要总结

The proposed randomized controlled trial will test the efficacy of a stepped collaborative care intervention, versus enhanced usual care arm, to reduce depression of cancer caregivers. Biobehavioral factors will include assessment of changes in health behaviors and biomarkers of inflammation. The investigators will also include measures metabolic abnormalities and clinical markers of CVD. The investigators expect few cardiac events during the study period. The investigators will also measure other health outcomes but CVD risk factors will be the focus of the study.

详细描述

The investigators expect to follow the caregivers for 12 months during the caregiving period.

Based on our prior experience and that of others, patients with clinical levels of symptoms report the greatest benefit from interventions aimed at reducing depressive symptoms. The investigators will screen caregivers for clinical levels of depression using the CES-D scale. If the caregiver screens positive for clinical levels of depressive symptoms (CES-D>16) and the patients and caregiver consent to participation, the dyad will be randomized to the intervention or enhanced usual care arm based on block randomization and stratification by gender (male/female) to assure approximate equal gender distribution in each arm of the study. The screening will take place in UPMC Montefiore and Presbyian.

The participants of this study will be blinded to which arm of the intervention they received, either the stepped collaborative care or enhanced usual care. Prior to randomization they will be asked to provide information on the intervention that they prefer and at the end of the intervention they will be asked what intervention they think they received. The findings will be analyzed to determine if intervention preference or perception of intervention received affected the outcomes.

The care coordinators for the proposed intervention will have Master's degrees in psychology or counseling and training in cognitive-behavioral therapy and have experience working with people diagnosed with cancer and their families. The care coordinators will receive training at the University of Pittsburgh in cultural competence. The therapists will serve as a liaison between the patient and other health care professionals within the spousal and intimate partner caregivers' medical team. A psychiatrist will not be included as part of the study team as many of the spousal and intimate partner caregivers do not reside locally. The care coordinator will work with the spousal and intimate partner caregivers' PCP, psychiatrist, and other health care providers in the spousal and intimate partner caregivers' home community to manage the symptoms and medication if indicated. The care coordinators will be supervised by the PI who is a clinical psychologist who has been working with cancer patients and their caregivers for 20 years.

Patient and caregiver outcomes will be assessed using a battery of standardized questionnaires. The investigators have chosen instruments that are as brief as possible to limit burden to patient and spousal and intimate partner caregivers. All instruments have been demonstrated to be valid and reliable. The order of the instruments in the battery of questionnaires will begin with general, not emotionally laden instruments and also end with instruments which may not increase distress in a participant. The proposed time points (baseline, 4, 8, and 12 months) reflect intervals that permit the ability to capture changes in symptoms and inflammatory biomarkers while not burdening the patient or spousal/intimate partner caregivers. The proposed questionnaires were used in prior studies by this team and with advanced cancer patients and their family caregivers. The investigators have shown better adherence to completing the outcomes measures with self-reported pencil and paper questionnaires versus telephone interviews (K07CA118576; R01CA176809). However, the investigators will also offer telephone interviews for spousal and intimate partner caregivers or patients who have low levels of literacy, sensory impairments, or prefer a telephone interview. For all interviews, the research associate will be blinded to the participant's assigned treatment arm to prevent bias. The investigators have found no differences by method of administration (paper and pencil versus telephone interview). Inter-operator variability will be addressed by ensuring that the research staff performing measurement of blood pressure, and waist circumference will be trained together, tested by the PI for inter-operator consistency, and be assessed at intervals every 4 months for continued consistency in measurement of blood pressure and abdominal girth. Consistency in laboratory personnel techniques (inter operator variability) will be monitored by Dr. Butterfield.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Expected survival < 2 years
  • Age >21 years
  • Living with spouse or intimate partner
  • Age >21 years
  • CES-D score >=16
  • Living with a spouse or intimate partner with cancer

排除标准

  • Lack of fluency in written and spoken English
  • Cannot identify spouse or intimate partner
  • Evidence of thought disorder, suicidal ideation, hallucinations or delusions
  • Lack of fluency in written and spoken English
  • Taking corticosteroids or engaged in shift work
  • Evidence of thought disorder, suicidal ideation, hallucinations or delusions

结局指标

主要结局

Caregiver Quality of Life Questionnaire

时间窗: change from baseline at 4 months, 8 months and 12 months

Caregiver Quality of Life Index

Caregiver's Perceived Stress Questionnaire

时间窗: change from baseline at 4 months, 8 months and 12 months

Perceived Stress

Caregiver's Depression Questionnaire

时间窗: change from baseline at 4 months, 8 months and 12 months

CES-D

次要结局

  • Caregiver's IL-6, TNFα, fibrinogen, CRP(change from baseline at 4 months, 8 months and 12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jennifer Steel

Associate Professor of Surgery

University of Pittsburgh

研究点 (4)

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