Clinical trial NCT04741308: Cognitive Behavior Therapy (CBT) and Psychological Status and Immune Function
Official title: The Effect of Cognitive Behavior Therapy (CBT) on Psychological Status and Immune Function of Colorectal Cancer Patients Undergoing Chemotherapy.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Cancer
Cognitive Behavior Therapy
Immune Function
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2021-02-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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:

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.

Primary outcomes:
measure: Change from baseline stress perception at follow-up.
timeFrame: Baseline and follow-up ( immediately after intervention, 3 months and 6 months after intervention).
measure: Change from baseline depressionat at follow-up.
timeFrame: Baseline and follow-up ( immediately after intervention, 3 months and 6 months after intervention).
measure: Change from baseline anxiety at follow-up.
timeFrame: Baseline and follow-up ( immediately after intervention, 3 months and 6 months after intervention).
measure: Change from baseline cognitive function at follow-up.
timeFrame: Baseline and follow-up ( immediately after intervention, 3 months and 6 months after intervention).
measure: Change from baseline immune function at follow-up.
timeFrame: Baseline and follow-up ( immediately after intervention, 3 months and 6 months after intervention).
Secondary outcomes:
measure: Change from baseline quality of life of patient at follow-up.
timeFrame: Baseline and follow-up ( immediately after intervention, 3 months and 6 months after intervention).
measure: Change from baseline sleep quality at follow-up.
timeFrame: Baseline and follow-up ( immediately after intervention, 3 months and 6 months after intervention).
measure: Change from baseline self efficacy at follow-up.
timeFrame: Baseline and follow-up ( immediately after intervention, 3 months and 6 months after intervention).
measure: Social support
timeFrame: Baseline.
measure: Change from baseline chemotherapy response at follow-up.
timeFrame: Baseline and follow-up ( immediately after intervention, 3 months and 6 months after intervention).
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai 10th People's Hospital
state: Shanghai
Study officials:
References: