NCT04741308

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P25-P50 for not_applicable colorectal-cancer

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 5, 2021

Completed
24 days until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2023

Completed
Last Updated

March 14, 2022

Status Verified

February 1, 2022

Enrollment Period

2.1 years

First QC Date

January 27, 2021

Last Update Submit

February 25, 2022

Conditions

Colorectal CancerCognitive Behavior TherapyImmune Function

Outcome Measures

Primary Outcomes (5)

  • 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).

  • 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).

  • 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).

  • 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).

  • 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).

    Baseline and follow-up ( immediately after intervention, 3 months and 6 months after intervention).

Secondary Outcomes (5)

  • Change from baseline quality of life of patient at follow-up.

    Baseline and follow-up ( immediately after intervention, 3 months and 6 months after intervention).

  • Change from baseline sleep quality at follow-up.

    Baseline and follow-up ( immediately after intervention, 3 months and 6 months after intervention).

  • Change from baseline self efficacy at follow-up.

    Baseline and follow-up ( immediately after intervention, 3 months and 6 months after intervention).

  • Social support

    Baseline.

  • Change from baseline chemotherapy response at follow-up.

    Baseline and follow-up ( immediately after intervention, 3 months and 6 months after intervention).

Study Arms (2)

CBT group

EXPERIMENTAL

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

Behavioral: cognitive behavior therapy

non-CBT group

NO INTERVENTION

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.

Interventions

cognitive behavior therapyBEHAVIORAL

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.

CBT group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≤age≤75; 2.Being scheduled to undergo colorectal cancer surgery; 3.Being able to complete all the assessment.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai 10th People's Hospital

Shanghai, Shanghai Municipality, 200072, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 37720456DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Psychiatry

Study Record Dates

First Submitted

January 27, 2021

First Posted

February 5, 2021

Study Start

March 1, 2021

Primary Completion

March 30, 2023

Study Completion

March 30, 2023

Last Updated

March 14, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)