Evaluation of a Social-networking Intervention to Reduce Cancer-related Distress
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 347
- 试验地点
- 1
- 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
- 否
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
研究组 & 干预措施
Social-networking intervention
Individuals interested in participating in the study will be randomized to receive access to a 12-week internet-based treatment group. Subjects assigned to the treatment group will have access to a group discussion board, a structured 12-week coping-skills training course, professional facilitation of the group, a real-time chat board, and personal profiles established by other group members. Subjects will be asked to complete online self-report measures of distress, mood disturbance, and quality of life at baseline and again after participation in the 12-week group.
干预措施: online social-networking intervention (Behavioral)
Control group
12 week wait-list control subjects will be able to join a group after they complete the 12-week assessment and will be asked to complete a 24-week assessment in order to measure change over time. Subjects will have access to a group discussion board, a structured 12-week coping-skills training course, professional facilitation of the group, a real-time chat board, and personal profiles established by other group members. Subjects will be asked to complete online self-report measures of distress, mood disturbance, and quality of life at baseline and again after participation in the 12-week group.
干预措施: online social-networking intervention (Behavioral)
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
Jason Owen, Phd.
Associate Professor
Loma Linda University