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临床试验/NCT02148575
NCT02148575已完成不适用

Integrating Palliative Care Into Self-Management of Breast Cancer

Yale University2 个研究点 分布在 1 个国家目标入组 109 人开始时间: 2014年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
109
试验地点
2
主要终点
Knowledge of Care Options Test

研究概览

简要总结

The purpose of this study is to test a psycho-educational intervention, Managing Cancer Care: A Personal Guide (MCC), that is intended to improve patients' knowledge of palliative care and to facilitate its timely integration into self-management of their breast cancer. The MCC will be tested with patients with Stage I-IV breast cancer at baseline, one, and three months following enrollment. The intervention group will receive the MCC, and the attention-control group will receive a symptom management toolkit. Participants' family caregivers will also be enrolled to provide information on patients' self-management. Investigators hypothesize that users of MCC, as compared to attention-control participants, will demonstrate improved knowledge, feelings, and behaviors related to self-management of their cancer care. This innovative research can help to establish palliative care as a mainstay of self-management interventions that target serious illnesses.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • •Over the age of 21
  • •Stage I-IV breast cancer
  • •Live in the State of Connecticut
  • •Speak English
  • •Receiving any kind of treatment for breast cancer
  • •Prognosis of at least 6 months

排除标准

  • 未提供

研究组 & 干预措施

Self-Management Group

Experimental

Managing Cancer Care: A Personal Guide (MCC) is a set of magazine-format, printed modules that includes information about key self-management topics, worksheets, "conversation starters", and targeted links to local and internet resources, among other features.

干预措施: Self-Management Group (Behavioral)

Symptom Management Group

Active Comparator

Participants in the Symptom Management Group will be given a symptom management toolkit that provides information on the most commonly experienced symptoms and side effects of cancer treatment, including fatigue, nausea, and sleep problems, among others. Each chapter includes information on when and why the symptom may occur, how the symptom can be managed, and when to call a provider.

干预措施: Symptom Management Group (Behavioral)

结局指标

主要结局

Knowledge of Care Options Test

时间窗: baseline

Knowledge of Care Options Test

时间窗: 1 month

Knowledge of Care Options Test

时间窗: 3 months

次要结局

  • Medical Communication Competence Scale(baseline)
  • Hospital Anxiety and Depression Scale(baseline)
  • Uncertainty in Illness Scale(baseline)
  • Goals of Care Conversations Form(baseline)
  • Control Preferences Scale(baseline)
  • Measurement of Transitions Scale(baseline)
  • Chronic Disease Self-Efficacy Scale(baseline)
  • Health Care Utilization Form(3 months)
  • Goals of Care Conversations Form(1 month)
  • Control Preferences Scale(3 months)
  • Medical Communication Competence Scale(3 months)
  • Measurement of Transitions Scale(3 months)
  • Chronic Disease Self-Efficacy Scale(3 months)
  • Hospital Anxiety and Depression Scale(3 months)
  • Uncertainty in Illness Scale(3 months)
  • Medical Communication Competence Scale(1 month)
  • Measurement of Transitions Scale(1 month)
  • Control Preferences Scale(1 month)
  • Chronic Disease Self-Efficacy Scale(1 month)
  • Hospital Anxiety and Depression Scale(1 month)
  • Uncertainty in Illness Scale(1 month)
  • Goals of Care Conversations Form(3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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