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.
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
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
160
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.
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.
Zhuhai People's Hospital
Zhuhai, Guangdong, China
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Time frame: 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.
Time frame: 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.
Time frame: T3(12 months)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: T3(12 months)
Immune variables 1 at baseline
Total lymphocyte count. Collected from daily medical records.
Time frame: T0(Baseline)
Change in Immune variables 1 at 3 months
Total lymphocyte count. Collected from daily medical records.
Time frame: T1(3 months)
Change in Immune variables 1 at 6 months
Total lymphocyte count. Collected from daily medical records.
Time frame: T2(6 months)
Immune variables 2 at baseline
Level of IFN-γ. Collected from blood sample.
Time frame: T0(Baseline)
Change in Immune variables 2 at 3 months
Level of IFN-γ. Collected from blood sample.
Time frame: T1(3 months)
Change in Immune variables 2 at 6 months
Level of IFN-γ. Collected from blood sample.
Time frame: T2(6 months)
Immune variables 3 at baseline
IL-2. Collected from blood sample.
Time frame: T0(Baseline)
Change in Immune variables 3 at 3 months
IL-2. Collected from blood sample.
Time frame: T1(3 months)
Change in Immune variables 3 at 6 months
IL-2. Collected from blood sample.
Time frame: T2(6 months)
Immune variables 4 at baseline
IL-4. Collected from blood sample.
Time frame: T0(Baseline)
Change in Immune variables 4 at 3 months
IL-4. Collected from blood sample.
Time frame: T1(3 months)
Change in Immune variables 4 at 6 months
IL-4. Collected from blood sample.
Time frame: T2(6 months)
Immune variables 5 at baseline
IL-6. Collected from blood sample.
Time frame: T0(Baseline)
Change in Immune variables 5 at 3 months
IL-6. Collected from blood sample.
Time frame: T1(3 months)
Change in Immune variables 5 at 6 months
IL-6. Collected from blood sample.
Time frame: T2(6 months)
Overall survival
Survival status form follow-up
Time frame: T3 (12 months) and later till the end of life.