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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
100
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.
Shanghai 10th People's Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGChange 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: Baseline and follow-up ( immediately after intervention, 3 months and 6 months after intervention).
Change from baseline quality of life of patient at follow-up.
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It will be assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Colorectal Cancer 29 (EORTC QLQ-CR29).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: Baseline.
Change from baseline chemotherapy response at follow-up.
It will be evaluated by M.D. Anderson Symptom Inventory-Gastrointestinal Cancer Module (MDASI-GI).
Time frame: Baseline and follow-up ( immediately after intervention, 3 months and 6 months after intervention).