A Non-Randomized Translational Trial of Cognitive Behavioral Cancer Stress Management (CBCSM) and Its Effects on Cancer Distress
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Change in post-traumatic stress (PTS) score
研究概览
简要总结
This clinical trial tests how well cognitive behavioral cancer stress management (CBCSM) group sessions work to decrease psychological distress in cancer patients. CBCSM teaches patients how to recognize and reduce the impacts of cancer associated stress on the biological, psychological, and social life domains.
详细描述
PRIMARY OBJECTIVE:
I. To reduce psychological stress.
SECONDARY OBJECTIVES:
I. To increase post-traumatic growth (PTG). II. To increase patient self-efficacy in utilizing therapy skills. III. To estimate patient acceptability and feasibility of conducting CBCSM within the clinical setting.
IV. To estimate differences of conducting CBCSM virtually during the Public Health Emergency (PHE) versus in person pre-PHE.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Eligible for the cognitive behavioral cancer stress management (CBCSM) clinical service
- •Cancer diagnosis with predicted survival > 1 year
- •Cancer treatment within past 1 year or treatment planning in progress
- •Age >= 18-years
- •Moderate distress screen, indicated by Impact of Event Scale-Revised (IES-R) score >= 14 or clinical judgment
- •Written informed research consent
排除标准
- •Inability to actively participate in and learn from group therapy (e.g., psychotic symptoms, neurological condition, personality pathology) as determined by clinical judgment in clinical consultation (Individual therapy or alternative group therapy will be offered)
研究组 & 干预措施
Group I (CBCSM)
Patients participate in five CBCSM group sessions on study. Patients complete questionnaires throughout the trial and during follow-up at 1, 3, 6, and 12 months.
干预措施: Cognitive Behavior Therapy (Behavioral)
Group I (CBCSM)
Patients participate in five CBCSM group sessions on study. Patients complete questionnaires throughout the trial and during follow-up at 1, 3, 6, and 12 months.
干预措施: Questionnaire Administration (Other)
Group II (no CBCSM)
Patients complete questionnaires throughout the trial and during follow-up at 1, 3, 6, and 12 months.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Change in post-traumatic stress (PTS) score
时间窗: At baseline, 1, 3, 6, and 12 months
Each item on the PTS is rated on a 5-point scale (0=Not at all; 1=A little bit; 2=Moderately; 3=Quite a bit, and 4=Extremely). The total score can range from 0 to 36 with higher scores indicating greater severity of posttraumatic stress disorder.
次要结局
- Patient attendance and feasibility(Baseline to 12 months)
- Change in post-traumatic growth (PTG) score(At baseline, 1, 3, 6, and 12 months)
- Change in self-efficacy score(At baseline, 1, 3, 6, and 12 months)
- Patient acceptability and satisfaction(Baseline to 12 months)
- Anxiety(At baseline, 1, 3, 6, and 12 months)
- Depression(At baseline, 1, 3, 6, and 12 months)
研究者
Shawna L. Ehlers, Ph.D., L.P.
Principal Investigator
Mayo Clinic