Effects of CBT-Based Intervention Among Patients With Liver Cancer

Official title

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

Overview

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.

Interventions

• 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.
• 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.

Primary outcome measures

• Depression symptoms at baseline [Time frame: T0(Baseline)]
• Change in depression symptoms at 3 months [Time frame: T1(3 months)]
• Change in depression symptoms at 6 months [Time frame: T2(6 months)]
• Change in depression symptoms at 12 months [Time frame: T3(12 months)]
• Anxiety symptoms at baseline [Time frame: T0(Baseline)]
• Change in anxiety symptoms at 3 months [Time frame: T1(3 months)]
• Change in anxiety symptoms at 6 months [Time frame: T2(6 months)]
• Change in anxiety symptoms at 12 months [Time frame: T3(12 months)]

Secondary outcome measures (12)

• Quality of life score (The EORTC QLQ-C30) at baseline [Time frame: T0(Baseline)]
• Change in Quality of life score (The EORTC QLQ-C30) at 3 months [Time frame: T1(3 months)]
• Change in Quality of life score (The EORTC QLQ-C30) at 6 months [Time frame: T2(6 months)]
• Change in Quality of life score (The EORTC QLQ-C30) at 12 months [Time frame: T3(12 months)]
• Quality of life score (The EORTC QLQ-HCC18) at baseline [Time frame: T0(Baseline)]
• Change in Quality of life score (The EORTC QLQ-HCC18) at 3 months [Time frame: T1(3 months)]
• Change in Quality of life score (The EORTC QLQ-HCC18) at 6 months [Time frame: T2(6 months)]
• Change in Quality of life score (The EORTC QLQ-HCC18) at 12 months [Time frame: T3(12 months)]
• Immune variables 1 at baseline [Time frame: T0(Baseline)]
• Change in Immune variables 1 at 3 months [Time frame: T1(3 months)]
• Change in Immune variables 1 at 6 months [Time frame: T2(6 months)]
• Immune variables 2 at baseline [Time frame: T0(Baseline)]

Eligibility criteria

Inclusion criteria

• 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).

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Supportive care

Study locations

China · 1 center

• Zhuhai People's Hospital — Zhuhai

Identifiers

NCT: NCT05942560 · CREC2022.328

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗