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

NCT ID: NCT04741308

Last Updated: 2022-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2023-03-30

Brief Summary

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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

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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.

Conditions

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Colorectal Cancer Cognitive Behavior Therapy Immune Function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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CBT group

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

Group Type EXPERIMENTAL

cognitive behavior therapy

Intervention Type BEHAVIORAL

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai 10th People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yuan Shen, MD, PhD

Chief of Psychiatry

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Shanghai 10th People's Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Yanxia Guo, M.D.

Role: primary

021-65982875

References

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Wang M, Xu Y, Shi J, Zhuang C, Zhuang Y, Li J, Cashin PH. The effect of cognitive behavioral therapy on chemotherapy-induced side effects and immune function in colorectal cancer patients undergoing chemotherapy: study protocol for a randomized controlled trial. J Gastrointest Oncol. 2023 Aug 31;14(4):1869-1877. doi: 10.21037/jgo-23-625. Epub 2023 Aug 30.

Reference Type DERIVED
PMID: 37720456 (View on PubMed)

Other Identifiers

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dsyy006

Identifier Type: -

Identifier Source: org_study_id

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