Colorectal Cancer Clinical Trial
Official title:
The Effect of Cognitive Behavior Therapy (CBT) on Psychological Status and Immune Function of Colorectal Cancer Patients Undergoing Chemotherapy.
NCT number | NCT04741308 |
Other study ID # | dsyy006 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | March 1, 2021 |
Est. completion date | March 30, 2023 |
Verified date | February 2022 |
Source | Shanghai 10th People's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | March 30, 2023 |
Est. primary completion date | March 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: 1.18=age=75; 2.Being scheduled to undergo colorectal cancer surgery; 3.Being able to complete all the assessment. Exclusion Criteria: 1. Having a history of tumor, mental disorders(including dementia), brain trauma or other cerebral diseases; 2. Having severe depression and anxiety currently; 3. Having alcohol dependence or other substance dependence; 4. Having serious physical illness; 5. Participating in other clinical studies. |
Country | Name | City | State |
---|---|---|---|
China | Shanghai 10th People's Hospital | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Shanghai 10th People's Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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). | |
Primary | 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). | |
Primary | 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). | |
Primary | 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). | |
Primary | Change from baseline immune function at follow-up. | Immune function assessment includes cytokine levels (IL-1a, IL-1ß, IL-6, IL-8, TNF-a, TNF-ß, 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 | 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). | |
Secondary | 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). | |
Secondary | 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). | |
Secondary | 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. | |
Secondary | 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). |
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