Cognitive Behavior Therapy (CBT) and Psychological Status and Immune Function

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
The Effect of Cognitive Behavior Therapy (CBT) on Psychological Status and Immune Function of Colorectal Cancer Patients Undergoing Chemotherapy.

Conditions
-----------------
Colorectal Cancer, Cognitive Behavior Therapy, Immune Function

Intervention / Treatment
-----------------
* Behavioral: cognitive behavior therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1.18≤age≤75; 2.Being scheduled to undergo colorectal cancer surgery; 3.Being able to complete all the assessment. Exclusion Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBT group<br>Patients randomly assigned to CBT group will receive 8 times of CBT treatment during chemotherapy. | Behavioral: cognitive behavior therapy<br>* The CBT intervention is a 8-times group-based intervention that meets 2-3 weeks.Each session will be performed during chemotherapy and will last for 60 min, including 45 min cognitive behavior therapy and 15 min relaxation training.Our CBT intervention is designed to be conducted in groups of 3 to 6 patients led by two group facilitators. Group leaders will: guide participants relaxation training, develop a supportive group environment, encourage emotional expression, assist participants develop a sense of self-confidence, identify maladaptive coping and encourage adaptive coping responses.<br>|
| No Intervention: non-CBT group<br>Patients randomly assigned to non-CBT group will receive four sessions of health education in a month after surgery. Each session will last 1 hour, including lectures and Q&A . The content of each session is different, including: diagnosis and treatment of colorectal cancer, adverse reactions and management of chemotherapy, nutritional support during chemotherapy and physical exercise during chemotherapy. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline stress perception at follow-up. | 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. | Baseline and follow-up ( immediately after intervention, 3 months and 6 months after intervention). | 
| Change from baseline depressionat at follow-up. | 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. | Baseline and follow-up ( immediately after intervention, 3 months and 6 months after intervention). | 
| Change from baseline anxiety at follow-up. | 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. | Baseline and follow-up ( immediately after intervention, 3 months and 6 months after intervention). | 
| Change from baseline cognitive function at follow-up. | 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. | Baseline and follow-up ( immediately after intervention, 3 months and 6 months after intervention). | 
| Change from baseline immune function at follow-up. | 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). | Baseline and follow-up ( immediately after intervention, 3 months and 6 months after intervention). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline quality of life of patient at follow-up. | It will be assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Colorectal Cancer 29 (EORTC QLQ-CR29). | Baseline and follow-up ( immediately after intervention, 3 months and 6 months after intervention). | 
| Change from baseline sleep quality at follow-up. | It will be assessed by Pittsburgh sleep quality index (PSQI). | Baseline and follow-up ( immediately after intervention, 3 months and 6 months after intervention). | 
| Change from baseline self efficacy at follow-up. | It will be assessed by General Self Efficacy (GSES). The sum score of General Self Efficacy ranges from 10 to 40. Higher scores mean a better outcome. | Baseline and follow-up ( immediately after intervention, 3 months and 6 months after intervention). | 
| Social support | It will be assessed by Social Support Rating Scale (SSRS). The sum score of Social Support Rating Scale ranges from 12 to 66. Higher scores mean a better outcome. | Baseline. | 
| Change from baseline chemotherapy response at follow-up. | It will be evaluated by M.D. Anderson Symptom Inventory-Gastrointestinal Cancer Module (MDASI-GI). | Baseline and follow-up ( immediately after intervention, 3 months and 6 months after intervention). |