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Cognitive Behavior Therapy (CBT) and Psychological Status and Immune Function

Primary Purpose

Colorectal Cancer, Cognitive Behavior Therapy, Immune Function

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
cognitive behavior therapy
Sponsored by
Shanghai 10th People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colorectal Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Shanghai 10th People's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

CBT group

non-CBT group

Arm Description

Patients randomly assigned to CBT group will receive 8 times of CBT treatment during chemotherapy.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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).

Secondary Outcome Measures

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).
Change from baseline sleep quality at follow-up.
It will be assessed by Pittsburgh sleep quality index (PSQI).
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.
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.
Change from baseline chemotherapy response at follow-up.
It will be evaluated by M.D. Anderson Symptom Inventory-Gastrointestinal Cancer Module (MDASI-GI).

Full Information

First Posted
January 27, 2021
Last Updated
February 25, 2022
Sponsor
Shanghai 10th People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04741308
Brief Title
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

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
March 30, 2023 (Anticipated)
Study Completion Date
March 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai 10th People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Cognitive Behavior Therapy, Immune Function

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CBT group
Arm Type
Experimental
Arm Description
Patients randomly assigned to CBT group will receive 8 times of CBT treatment during chemotherapy.
Arm Title
non-CBT group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
cognitive behavior therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline stress perception at follow-up.
Description
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).
Title
Change from baseline depressionat at follow-up.
Description
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).
Title
Change from baseline anxiety at follow-up.
Description
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).
Title
Change from baseline cognitive function at follow-up.
Description
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).
Title
Change from baseline immune function at follow-up.
Description
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).
Secondary Outcome Measure Information:
Title
Change from baseline quality of life of patient at follow-up.
Description
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).
Title
Change from baseline sleep quality at follow-up.
Description
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).
Title
Change from baseline self efficacy at follow-up.
Description
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).
Title
Social support
Description
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.
Title
Change from baseline chemotherapy response at follow-up.
Description
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).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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: 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.
Facility Information:
Facility Name
Shanghai 10th People's Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200072
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanxia Guo, M.D.
Phone
021-65982875
Email
guoyx_2000@tongji.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
No

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Cognitive Behavior Therapy (CBT) and Psychological Status and Immune Function

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