- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04741308
Cognitive Behavior Therapy (CBT) and Psychological Status and Immune Function
The Effect of Cognitive Behavior Therapy (CBT) on Psychological Status and Immune Function of Colorectal Cancer Patients Undergoing Chemotherapy.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200072
- Recruiting
- Shanghai 10th People's Hospital
-
Contact:
- Yanxia Guo, M.D.
- Phone Number: 021-65982875
- Email: guoyx_2000@tongji.edu.cn
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CBT group
Patients randomly assigned to CBT group will receive 8 times of CBT treatment during chemotherapy.
|
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.
|
No Intervention: non-CBT group
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.
Time Frame: 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.
|
Baseline and follow-up ( immediately after intervention, 3 months and 6 months after intervention).
|
Change from baseline depressionat at follow-up.
Time Frame: 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.
|
Baseline and follow-up ( immediately after intervention, 3 months and 6 months after intervention).
|
Change from baseline anxiety at follow-up.
Time Frame: 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.
|
Baseline and follow-up ( immediately after intervention, 3 months and 6 months after intervention).
|
Change from baseline cognitive function at follow-up.
Time Frame: 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.
|
Baseline and follow-up ( immediately after intervention, 3 months and 6 months after intervention).
|
Change from baseline immune function at follow-up.
Time Frame: 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).
|
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.
Time Frame: Baseline and follow-up ( immediately after intervention, 3 months and 6 months after intervention).
|
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.
Time Frame: Baseline and follow-up ( immediately after intervention, 3 months and 6 months after intervention).
|
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.
Time Frame: Baseline and follow-up ( immediately after intervention, 3 months and 6 months after intervention).
|
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
Time Frame: Baseline.
|
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.
Time Frame: Baseline and follow-up ( immediately after intervention, 3 months and 6 months after intervention).
|
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).
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- dsyy006
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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