Effects of CBT-Based Intervention Among Patients With Liver Cancer

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05942560
• Other study ID #: CREC2022.328
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 30, 2023
• Est. completion date: June 30, 2029

Study information

• Verified date: November 2023
• Source: The Nethersole School of Nursing
• Contact: Hua Yin
• Phone: +8613823013393
• Email: huayin0408[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 160
• Est. completion date: June 30, 2029
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• CBT
• Depression
• Depressive Disorder
• Liver Cancer
• Liver Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Zhuhai People's Hospital	Zhuhai	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
The Nethersole School of Nursing	ZhuHai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Immune variables 1 at baseline	Total lymphocyte count. Collected from daily medical records.	T0(Baseline)
Secondary	Change in Immune variables 1 at 3 months	Total lymphocyte count. Collected from daily medical records.	T1(3 months)
Secondary	Change in Immune variables 1 at 6 months	Total lymphocyte count. Collected from daily medical records.	T2(6 months)
Secondary	Immune variables 2 at baseline	Level of IFN-?. Collected from blood sample.	T0(Baseline)
Secondary	Change in Immune variables 2 at 3 months	Level of IFN-?. Collected from blood sample.	T1(3 months)
Secondary	Change in Immune variables 2 at 6 months	Level of IFN-?. Collected from blood sample.	T2(6 months)
Secondary	Immune variables 3 at baseline	IL-2. Collected from blood sample.	T0(Baseline)
Secondary	Change in Immune variables 3 at 3 months	IL-2. Collected from blood sample.	T1(3 months)
Secondary	Change in Immune variables 3 at 6 months	IL-2. Collected from blood sample.	T2(6 months)
Secondary	Immune variables 4 at baseline	IL-4. Collected from blood sample.	T0(Baseline)
Secondary	Change in Immune variables 4 at 3 months	IL-4. Collected from blood sample.	T1(3 months)
Secondary	Change in Immune variables 4 at 6 months	IL-4. Collected from blood sample.	T2(6 months)
Secondary	Immune variables 5 at baseline	IL-6. Collected from blood sample.	T0(Baseline)
Secondary	Change in Immune variables 5 at 3 months	IL-6. Collected from blood sample.	T1(3 months)
Secondary	Change in Immune variables 5 at 6 months	IL-6. Collected from blood sample.	T2(6 months)
Secondary	Overall survival	Survival status form follow-up	T3 (12 months) and later till the end of life.