Effects of CBT-Based Intervention Among Patients With Liver Cancer

Effects of Cognitive Behavioral Therapy-Based Intervention on Depression, Anxiety, Quality of Life, Immune Indicators, and Survival Among Patients With Liver Cancer

This study investigates the effects of a CBT- based intervention on depression, anxiety, immune function, quality of life, and overall survival. It also explores if the effects of the intervention on immune function and quality of life are mediated through the improvements in depression and anxiety among patients with liver cancer.

Study Overview

• Status: Not yet recruiting
• Conditions: Depression; Anxiety; CBT; Liver Cancer
• Intervention / Treatment: Behavioral: Cognitive behavioural therapy-based intervention; Behavioral: Educational group

Detailed Description

In the present research project, the investigators have developed a Cognitive Behavioral Therapy (CBT)-based intervention protocol to investigate the impact of this intervention on depression, anxiety, quality of life, immune function, and overall survival in patients diagnosed with liver cancer. Additionally, this research protocol aims to examine the hypothesized mechanisms underlying the effects of the CBT-based intervention on quality of life and immune function. Specifically, we will investigate: 1) whether the effect of the CBT-based intervention on quality of life is mediated by improvements in anxiety and depression, and 2) whether the effect of the CBT-based intervention on immune function is mediated by improvements in anxiety and depression among patients with liver cancer.

A total of 160 participants will be recruited and randomly assigned to either the CBT-based intervention group or an educational group receiving non-psychological interventions. Assessments will be conducted at baseline (pre-treatment) and at 3, 6, and 12 months after the intervention period. Survival data will be collected throughout the follow-up period until the patients' end-of-life.

By examining the effects of the CBT-based intervention on multiple outcomes and exploring the potential mediating mechanisms, this research project aims to contribute to a comprehensive understanding of the intervention's effectiveness and its impact on the well-being of liver cancer patients.

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hua Yin; Phone Number: +8613823013393; Email: huayin0408@163.com

Study Locations

• China
  • Guangdong
    • Zhuhai, Guangdong, China, 519000
      • Zhuhai People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Adults (aged ≥18);
2. Diagnosed with liver cancer based on pathological findings or imaging findings in the medical record;
3. The severity level of depression and anxiety: Depression > 7 using HAD-D, or Anxiety > 7 using HAD-A (Hospital Anxiety and Depression Scale, HADS; HAD-D, Hospital Depression Scale; HAD-A, Hospital Anxiety Scale).

Exclusion Criteria:

1. Patients who are taking part in another psychological intervention clinical trial or consented to receive another psychotherapy, suffered from aphasia and other communication difficulties will be excluded from the study
2. Patients with active immunological diseases, such as autoimmune diseases, and inflammatory diseases.
3. Patients accepting hormone therapy or taking long-term antibiotic drugs.
4. Patients who lack the basic ability of understanding and expression and are incompetent in giving consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cognitive behavioural therapy-based(CBT-based) intervention group; A specifically designed CBT-based intervention consisting of 8 weekly sessions will be conducted in a group format.	Behavioral: Cognitive behavioural therapy-based intervention; A specifically designed CBT-based intervention consisting of 8 weekly sessions with group format. Each group will be comprised of 4-10 participants, and each session will last 1.5 hours. The content of the weekly sessions will be based on Beck's cognitive theory and the cognitive therapy in groups guidelines. The framework of every session will follow a pre-determined structure.
Active Comparator: Control group; Participants will receive eight health education sessions simultaneously with the CBT-based intervention group.	Behavioral: Educational group; The educational sessions are consisting of 8 weekly sessions with a group format. These sessions will focus on cancer-related information and care knowledge which will be delivered in daily routine care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression symptoms at baseline	Participants' depression score with the depression subscale of the Hospital depression and Depression Scale (HADS). The HADS depression subscale score ranges from 0 to 21, with higher scores indicating more severe depression symptoms.	T0(Baseline)
Change in depression symptoms at 3 months	Change in participants' depression score with the HADS depression subscale from baseline to 3 months. The HADS depression subscale score ranges from 0 to 21, with higher scores indicating more severe depression symptoms.	T1(3 months)
Change in depression symptoms at 6 months	Change in participants' depression score with the HADS depression subscale from baseline to 6 months. The HADS depression subscale score ranges from 0 to 21, with higher scores indicating more severe depression symptoms.	T2(6 months)
Change in depression symptoms at 12 months	Change in participants' depression score with the HADS depression subscale from baseline to 12 months. The HADS depression subscale score ranges from 0 to 21, with higher scores indicating more severe depression symptoms.	T3(12 months)
Anxiety symptoms at baseline	Participants' anxiety score with the Anxiety subscale of the Hospital Anxiety and Depression Scale (HADS). The HADS anxiety subscale score ranges from 0 to 21, with higher scores indicating more severe anxiety symptoms.	T0(Baseline)
Change in anxiety symptoms at 3 months	Change in participants' anxiety score with the HADS anxiety subscale from baseline to 3 months. The HADS anxiety subscale score ranges from 0 to 21, with higher scores indicating more severe anxiety symptoms.	T1(3 months)
Change in anxiety symptoms at 6 months	Change in participants' anxiety score with the HADS anxiety subscale from baseline to 6 months. The HADS anxiety subscale score ranges from 0 to 21, with higher scores indicating more severe anxiety symptoms.	T2(6 months)
Change in anxiety symptoms at 12 months	Change in participants' anxiety score with the HADS anxiety subscale from baseline to 12 months. The HADS anxiety subscale score ranges from 0 to 21, with higher scores indicating more severe anxiety symptoms.	T3(12 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life score (The EORTC QLQ-C30) at baseline	The European Organization for Research and Treatment of Cancer(EORTC) Quality of Life Questionnaire results. Scores range from 0 to 100. A higher score represents a higher ("better") level of functioning, or a higher ("worse") level of symptoms.	T0(Baseline)
Change in Quality of life score (The EORTC QLQ-C30) at 3 months	The European Organization for Research and Treatment of Cancer(EORTC) Quality of Life Questionnaire results. Scores range from 0 to 100. A higher score represents a higher ("better") level of functioning, or a higher ("worse") level of symptoms.	T1(3 months)
Change in Quality of life score (The EORTC QLQ-C30) at 6 months	The European Organization for Research and Treatment of Cancer(EORTC) Quality of Life Questionnaire results. Scores range from 0 to 100. A higher score represents a higher ("better") level of functioning, or a higher ("worse") level of symptoms.	T2(6 months)
Change in Quality of life score (The EORTC QLQ-C30) at 12 months	The European Organization for Research and Treatment of Cancer(EORTC) Quality of Life Questionnaire results. Scores range from 0 to 100. A higher score represents a higher ("better") level of functioning, or a higher ("worse") level of symptoms.	T3(12 months)
Quality of life score (The EORTC QLQ-HCC18) at baseline	The Hepatocellular Carcinoma Module of The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire. Scores range from 0 to 100. A higher score represents a high level of symptomatology or problems.	T0(Baseline)
Change in Quality of life score (The EORTC QLQ-HCC18) at 3 months	The Hepatocellular Carcinoma Module of The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire. Scores range from 0 to 100. A higher score represents a high level of symptomatology or problems.	T1(3 months)
Change in Quality of life score (The EORTC QLQ-HCC18) at 6 months	The Hepatocellular Carcinoma Module of The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire. Scores range from 0 to 100. A higher score represents a high level of symptomatology or problems.	T2(6 months)
Change in Quality of life score (The EORTC QLQ-HCC18) at 12 months	The Hepatocellular Carcinoma Module of The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire. Scores range from 0 to 100. A higher score represents a high level of symptomatology or problems.	T3(12 months)
Immune variables 1 at baseline	Total lymphocyte count. Collected from daily medical records.	T0(Baseline)
Change in Immune variables 1 at 3 months	Total lymphocyte count. Collected from daily medical records.	T1(3 months)
Change in Immune variables 1 at 6 months	Total lymphocyte count. Collected from daily medical records.	T2(6 months)
Immune variables 2 at baseline	Level of IFN-γ. Collected from blood sample.	T0(Baseline)
Change in Immune variables 2 at 3 months	Level of IFN-γ. Collected from blood sample.	T1(3 months)
Change in Immune variables 2 at 6 months	Level of IFN-γ. Collected from blood sample.	T2(6 months)
Immune variables 3 at baseline	IL-2. Collected from blood sample.	T0(Baseline)
Change in Immune variables 3 at 3 months	IL-2. Collected from blood sample.	T1(3 months)
Change in Immune variables 3 at 6 months	IL-2. Collected from blood sample.	T2(6 months)
Immune variables 4 at baseline	IL-4. Collected from blood sample.	T0(Baseline)
Change in Immune variables 4 at 3 months	IL-4. Collected from blood sample.	T1(3 months)
Change in Immune variables 4 at 6 months	IL-4. Collected from blood sample.	T2(6 months)
Immune variables 5 at baseline	IL-6. Collected from blood sample.	T0(Baseline)
Change in Immune variables 5 at 3 months	IL-6. Collected from blood sample.	T1(3 months)
Change in Immune variables 5 at 6 months	IL-6. Collected from blood sample.	T2(6 months)
Overall survival	Survival status form follow-up	T3 (12 months) and later till the end of life.

Collaborators and Investigators

• Sponsor: The Nethersole School of Nursing
• Collaborators: ZhuHai Hospital
• Investigators: Principal Investigator: Hua Yin, Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Estimated): December 30, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2029

Study Registration Dates

• First Submitted: June 25, 2023
• First Submitted That Met QC Criteria: July 5, 2023
• First Posted (Actual): July 12, 2023

Study Record Updates

• Last Update Posted (Actual): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 21, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: quality of life; depression; survival; immune; anxiety; cognitive behavioural therapy; liver cancer
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Digestive System Diseases; Mood Disorders; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Liver Diseases; Depression; Depressive Disorder; Anxiety Disorders; Liver Neoplasms
• Other Study ID Numbers: CREC2022.328

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No