Clinical trial NCT05942560: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Depression
Anxiety
Liver Cancer
CBT
Keywords: cognitive behavioural therapy
depression
anxiety
immune
quality of life
survival
liver cancer
Lead sponsor: The Nethersole School of Nursing
Sponsor class: OTHER
Collaborators: name: ZhuHai Hospital
First posted: 2023-07-12
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will be a parallel, multicenter, randomized controlled trial.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Depression symptoms at baseline
timeFrame: T0(Baseline)
measure: Change in depression symptoms at 3 months
timeFrame: T1(3 months)
measure: Change in depression symptoms at 6 months
timeFrame: T2(6 months)
measure: Change in depression symptoms at 12 months
timeFrame: T3(12 months)
measure: Anxiety symptoms at baseline
timeFrame: T0(Baseline)
measure: Change in anxiety symptoms at 3 months
timeFrame: T1(3 months)
measure: Change in anxiety symptoms at 6 months
timeFrame: T2(6 months)
measure: Change in anxiety symptoms at 12 months
timeFrame: T3(12 months)
Secondary outcomes:
measure: Quality of life score (The EORTC QLQ-C30) at baseline
timeFrame: T0(Baseline)
measure: Change in Quality of life score (The EORTC QLQ-C30) at 3 months
timeFrame: T1(3 months)
measure: Change in Quality of life score (The EORTC QLQ-C30) at 6 months
timeFrame: T2(6 months)
measure: Change in Quality of life score (The EORTC QLQ-C30) at 12 months
timeFrame: T3(12 months)
measure: Quality of life score (The EORTC QLQ-HCC18) at baseline
timeFrame: T0(Baseline)
measure: Change in Quality of life score (The EORTC QLQ-HCC18) at 3 months
timeFrame: T1(3 months)
measure: Change in Quality of life score (The EORTC QLQ-HCC18) at 6 months
timeFrame: T2(6 months)
measure: Change in Quality of life score (The EORTC QLQ-HCC18) at 12 months
timeFrame: T3(12 months)
measure: Immune variables 1 at baseline
timeFrame: T0(Baseline)
measure: Change in Immune variables 1 at 3 months
timeFrame: T1(3 months)
measure: Change in Immune variables 1 at 6 months
timeFrame: T2(6 months)
measure: Immune variables 2 at baseline
timeFrame: T0(Baseline)
measure: Change in Immune variables 2 at 3 months
timeFrame: T1(3 months)
measure: Change in Immune variables 2 at 6 months
timeFrame: T2(6 months)
measure: Immune variables 3 at baseline
timeFrame: T0(Baseline)
measure: Change in Immune variables 3 at 3 months
timeFrame: T1(3 months)
measure: Change in Immune variables 3 at 6 months
timeFrame: T2(6 months)
measure: Immune variables 4 at baseline
timeFrame: T0(Baseline)
measure: Change in Immune variables 4 at 3 months
timeFrame: T1(3 months)
measure: Change in Immune variables 4 at 6 months
timeFrame: T2(6 months)
measure: Immune variables 5 at baseline
timeFrame: T0(Baseline)
measure: Change in Immune variables 5 at 3 months
timeFrame: T1(3 months)
measure: Change in Immune variables 5 at 6 months
timeFrame: T2(6 months)
measure: Overall survival
timeFrame: T3 (12 months) and later till the end of life.
Other outcomes:
Locations:
city: Zhuhai
country: China
facility: Zhuhai People's Hospital
state: Guangdong
Study officials:
affiliation: Chinese University of Hong Kong
name: Hua Yin
role: PRINCIPAL_INVESTIGATOR
References: