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Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

Verified date February 2022
Source Shanghai 10th People's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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.

Study Design


Intervention

Behavioral:
cognitive behavior therapy
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.

Locations

Country Name City State
China Shanghai 10th People's Hospital Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Shanghai 10th People's Hospital

Country where clinical trial is conducted

China, 

Outcome

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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