The Effect of Cognitive Behavior Therapy (CBT) on Psychological Status and Immune Function of Colorectal Cancer Patients Undergoing Chemotherapy.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change from baseline immune function at follow-up.
研究概览
简要总结
To explore the effect of CBT on psychological status of colorectal cancer patients undergoing chemotherapy. To explore the effect of CBT on immune function of colorectal cancer patients undergoing chemotherapy.
详细描述
Cancer patients undergoing chemotherapy are often subjected to considerable psychological stress. CBT is considered as one of the effective methods to relieve stress. CBT is effective in alleviating depression and anxiety, but the effect of CBT on cognitive and immune function in patients with colorectal cancer undergoing chemotherapy remains uninvestigated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.18≤age≤75; 2.Being scheduled to undergo colorectal cancer surgery; 3.Being able to complete all the assessment.
排除标准
- •Having a history of tumor, mental disorders(including dementia), brain trauma or other cerebral diseases;
- •Having severe depression and anxiety currently;
- •Having alcohol dependence or other substance dependence;
- •Having serious physical illness;
- •Participating in other clinical studies.
结局指标
主要结局
Change from baseline immune function at follow-up.
时间窗: Baseline and follow-up ( immediately after intervention, 3 months and 6 months after intervention).
Immune function assessment includes cytokine levels (IL-1α, IL-1β, IL-6, IL-8, TNF-α, TNF-β, CRP) and immune cell levels (CD4+T cell, CD8+T cell, natural killer, monocytes, B cell).
Change from baseline depressionat at follow-up.
时间窗: Baseline and follow-up ( immediately after intervention, 3 months and 6 months after intervention).
Depression will be assessed by Patient Health Questionnaire (PHQ-9). The sum score of PHQ-9 ranges from 0 to 27. Higher scores mean a worse outcome.
Change from baseline cognitive function at follow-up.
时间窗: Baseline and follow-up ( immediately after intervention, 3 months and 6 months after intervention).
Cognitive function will be assessed by Mini-mental State Examination (MMSE), Hopkins Verbal Learning Test-Revised, Digit Span Test, Digit-symbol Test and Trail Making Test.
Change from baseline anxiety at follow-up.
时间窗: Baseline and follow-up ( immediately after intervention, 3 months and 6 months after intervention).
Anxiety will be assessed by Generalized Anxiety Disorder (GAD-7). The sum score of GAD-7 ranges from 0 to 21. Higher scores mean a worse outcome.
Change from baseline stress perception at follow-up.
时间窗: Baseline and follow-up ( immediately after intervention, 3 months and 6 months after intervention).
Stress perception will be assessed by Perceived Stress Scale (PSS-10). The sum score of PSS-10 ranges from 0 to 40. Higher scores mean a worse outcome.
次要结局
- Change from baseline quality of life of patient at follow-up.(Baseline and follow-up ( immediately after intervention, 3 months and 6 months after intervention).)
- Change from baseline sleep quality at follow-up.(Baseline and follow-up ( immediately after intervention, 3 months and 6 months after intervention).)
- Social support(Baseline.)
- Change from baseline chemotherapy response at follow-up.(Baseline and follow-up ( immediately after intervention, 3 months and 6 months after intervention).)
- Change from baseline self efficacy at follow-up.(Baseline and follow-up ( immediately after intervention, 3 months and 6 months after intervention).)
研究者
Yuan Shen, MD, PhD
Chief of Psychiatry
Shanghai 10th People's Hospital