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临床试验/NCT02070250
NCT02070250已完成不适用

Examination of a Stress Management Intervention for Cancer Patients as Delivered by Community Mental Health Professionals

Ohio State University Comprehensive Cancer Center30 个研究点 分布在 1 个国家目标入组 158 人开始时间: 2013年11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
158
试验地点
30
主要终点
Change from baseline to post-intensive intervention assessment in cancer-specific stress on the 20-item Impact of Events Scale (IES)

研究概览

简要总结

Psychological interventions for cancer patients have been tested and found to reduce stress and improve quality of life. These interventions have been tested at academic medical centers but have not been available for use by community mental health professionals. One such intervention is the Biobehavioral Intervention (BBI), developed by Professor Barbara L. Andersen and colleagues at Ohio State (OSU). Current funding has enabled the investigators to train mental health professionals from across the country to deliver the BBI at their institution. Recently diagnosed cancer patients who are participating in the BBI group at these institutions may participate in a research study completing self report measures asking about psychological and behavioral outcomes (for example, mood, stress, diet and physical activity). The investigators hypothesize that individuals participating in the intervention will report improvements in outcomes, such as reduced stress and improved mood, reduced symptoms of the disease and treatment, etc., after completing the intervention and continue to report these improvements up to 6 months after the group ends. OSU will coordinate this data collection project but information about participating sites is listed in http://clinicaltrials.gov.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
21 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Recent initial diagnosis of cancer without metastatic disease
  • Able to speak/read English

排除标准

  • Those with concurrent diagnoses of
  • Organic brain syndrome
  • Mental retardation
  • non-English speaking
  • Significant sensory deficit
  • Severe mental illness (e.g., schizophrenia, psychotic disorder)

结局指标

主要结局

Change from baseline to post-intensive intervention assessment in cancer-specific stress on the 20-item Impact of Events Scale (IES)

时间窗: Baseline, up to 18 weeks

The intensive intervention length can vary by location from 4 to 18 weeks.

Change from baseline to post-intensive intervention assessment in mood on the 65-item Profile of Mood States (POMS)

时间窗: Baseline, up to 18 weeks

The intensive intervention length can vary by location from 4 to 18 weeks.

次要结局

  • Change from baseline to post-intensive intervention assessment in social support using the 20 item Perceived Social Support from Your Family Scale (PSS-Fa)(Baseline, up to 18 weeks)
  • Change from baseline to post-intensive intervention assessment in diet on the 23-item Food Habits Questionnaire (FHQ)(Baseline, up to 18 weeks)
  • Change from baseline to post-intensive intervention assessment in physical activity on the 3-item Physical Activity Rating Scale (PAR)(Baseline, up to 18 weeks)
  • Change from baseline to post-intensive intervention assessment in sexual health on the 4-item Your Sexual Life questionnaire(Baseline, up to 18 weeks)

研究者

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

Barbara Andersen

Principal Investigator

Ohio State University Comprehensive Cancer Center

研究点 (30)

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