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临床试验/NCT01976949
NCT01976949已完成不适用

Evaluation of a Social-networking Intervention to Reduce Cancer-related Distress

Loma Linda University2 个研究点 分布在 1 个国家目标入组 347 人开始时间: 2009年7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
347
试验地点
2
主要终点
Change in -Overall Psychological Functioning (OQ-45)

研究概览

简要总结

It is hypothesized that the treatment group will show greater improvements in quality of life and mood disturbance compared to the control group and that greater levels of engagement with the intervention materials will be associated with greater improvements in mood and quality of life.

详细描述

Individuals with cancer face an array of psychosocial needs, and it has been estimated that up to 35% of cancer survivors experience clinically-significant levels of distress. Psychosocial interventions may be effective for improving quality of life and reducing levels of mood disturbance in these patients. Unfortunately, barriers to accessing psychosocial intervention are common, and many are unable to access those services. Internet- based psychosocial interventions improve accessibility of care and offer additional methodological advantages, including the ability to easily collect self-report data, track exposure to the intervention, and evaluate effects of specific intervention components. The proposed study will evaluate whether a website developed specifically for providing psychological treatment and enhancing communication between cancer survivors can improve distress among cancer survivors who indicate that they have high levels of distress. If successful, the study will also provide valuable information needed to improve the treatment and to adequately conduct a larger trial comparing internet-based and face-to-face treatments.

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
None

入排标准

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

入选标准

  • at least 18 years of age,
  • previous cancer diagnosis other than non-melanoma skin cancer,
  • fluent in English, 5) routine access to the Internet, and 6) presence of greater than mild distress as identified by having distress greater than or equal to 4 on initial screening with the Distress Thermometer

排除标准

  • 未提供

结局指标

主要结局

Change in -Overall Psychological Functioning (OQ-45)

时间窗: 3-month change

The OQ-45 measures the global functioning of a client and is composed of 3 subscales that measure subjective discomfort (intrapsychic functioning), interpersonal relationships, and social role performance. The OQ-45 has adequate internal consistency (a = .93) and reliability (r = .84) (Lambert, et al., 2004).

Change in-Center for Epidemiologic Studies Depress (CES-D) scale

时间窗: 3-month change

The CES-D is a self-report measure that consists of 20 items rated on a 4-point Likert scale to assess depressive symptoms experienced in the previous week. The CES-D has demonstrated excellent reliability and validity (Radloff, 1977). The standard cutoff score of 16 will be used to identify depression.

Anxiety

时间窗: 3-month change

Anxiety subscale of the brief Profile of Mood States (b-POMS; Shacham, 1983), which utilizes 37 descriptive mood adjectives to describe how a participant felt during the past week on a 5-point Likert scale. Specifically look at anxiety (anx subscale of POMS), vigor (subscale of POMS), and fatigue (subscale of POMS).

次要结局

  • Vigor(3-month change)
  • Fatigue(3-month change)

研究者

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

Jason Owen, Phd.

Associate Professor

Loma Linda University

研究点 (2)

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