Effects of CBT-Based Intervention Among Patients With Liver Cancer
- Conditions
- DepressionCBTLiver CancerAnxiety
- Interventions
- Behavioral: Cognitive behavioural therapy-based interventionBehavioral: Educational group
- Registration Number
- NCT05942560
- Lead Sponsor
- The Nethersole School of Nursing
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 160
- Adults (aged ≥18);
- Diagnosed with liver cancer based on pathological findings or imaging findings in the medical record;
- 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).
- 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
- Patients with active immunological diseases, such as autoimmune diseases, and inflammatory diseases.
- Patients accepting hormone therapy or taking long-term antibiotic drugs.
- Patients who lack the basic ability of understanding and expression and are incompetent in giving consent.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cognitive behavioural therapy-based(CBT-based) intervention group Cognitive behavioural therapy-based intervention A specifically designed CBT-based intervention consisting of 8 weekly sessions will be conducted in a group format. Control group Educational group Participants will receive eight health education sessions simultaneously with the CBT-based intervention group.
- Primary Outcome Measures
Name Time Method Change in depression symptoms at 6 months T2(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.
Change in depression symptoms at 12 months T3(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.
Change in anxiety symptoms at 3 months T1(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.
Change in depression symptoms at 3 months T1(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.
Anxiety symptoms at baseline T0(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.
Change in anxiety symptoms at 12 months T3(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.
Depression symptoms at baseline T0(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.
Change in anxiety symptoms at 6 months T2(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.
- Secondary Outcome Measures
Name Time Method Overall survival T3 (12 months) and later till the end of life. Survival status form follow-up
Change in Quality of life score (The EORTC QLQ-HCC18) at 3 months T1(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.
Change in Quality of life score (The EORTC QLQ-HCC18) at 12 months T3(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.
Change in Immune variables 4 at 6 months T2(6 months) IL-4. Collected from blood sample.
Immune variables 5 at baseline T0(Baseline) IL-6. Collected from blood sample.
Quality of life score (The EORTC QLQ-C30) at baseline T0(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.Change in Quality of life score (The EORTC QLQ-C30) at 6 months T2(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.Change in Quality of life score (The EORTC QLQ-HCC18) at 6 months T2(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.
Change in Quality of life score (The EORTC QLQ-C30) at 3 months T1(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.Change in Quality of life score (The EORTC QLQ-C30) at 12 months T3(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.Quality of life score (The EORTC QLQ-HCC18) at baseline T0(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.
Immune variables 1 at baseline T0(Baseline) Total lymphocyte count. Collected from daily medical records.
Immune variables 3 at baseline T0(Baseline) IL-2. Collected from blood sample.
Change in Immune variables 3 at 3 months T1(3 months) IL-2. Collected from blood sample.
Change in Immune variables 5 at 6 months T2(6 months) IL-6. Collected from blood sample.
Change in Immune variables 1 at 3 months T1(3 months) Total lymphocyte count. Collected from daily medical records.
Change in Immune variables 2 at 3 months T1(3 months) Level of IFN-γ. Collected from blood sample.
Change in Immune variables 2 at 6 months T2(6 months) Level of IFN-γ. Collected from blood sample.
Change in Immune variables 4 at 3 months T1(3 months) IL-4. Collected from blood sample.
Change in Immune variables 1 at 6 months T2(6 months) Total lymphocyte count. Collected from daily medical records.
Immune variables 2 at baseline T0(Baseline) Level of IFN-γ. Collected from blood sample.
Change in Immune variables 3 at 6 months T2(6 months) IL-2. Collected from blood sample.
Immune variables 4 at baseline T0(Baseline) IL-4. Collected from blood sample.
Change in Immune variables 5 at 3 months T1(3 months) IL-6. Collected from blood sample.
Trial Locations
- Locations (1)
Zhuhai People's Hospital
🇨🇳Zhuhai, Guangdong, China