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NCT Number: NCT05942560

Effects of CBT-Based Intervention Among Patients With Liver Cancer

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.

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Key information

Conditions

Depression Anxiety Anxiety Disorders Behavior Behavioral Symptoms CBT Digestive System Diseases Digestive System Neoplasms Liver Cancer Liver Diseases Liver Neoplasms Mental Disorders Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhuhai People's Hospital

Zhuhai, Guangdong, 519000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cognitive behavioural therapy-based intervention

Behavioral

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

Behavioral

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 outcomes

  1. Depression symptoms at baseline

    Time frame: 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.

  2. Change in depression symptoms at 3 months

    Time frame: 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.

  3. Change in depression symptoms at 6 months

    Time frame: 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.

  4. Change in depression symptoms at 12 months

    Time frame: 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.

  5. Anxiety symptoms at baseline

    Time frame: 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.

  6. Change in anxiety symptoms at 3 months

    Time frame: 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.

  7. Change in anxiety symptoms at 6 months

    Time frame: 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.

  8. Change in anxiety symptoms at 12 months

    Time frame: 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.

Secondary outcomes

  1. Quality of life score (The EORTC QLQ-C30) at baseline

    Time frame: 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.

  2. Change in Quality of life score (The EORTC QLQ-C30) at 3 months

    Time frame: 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.

  3. Change in Quality of life score (The EORTC QLQ-C30) at 6 months

    Time frame: 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.

  4. Change in Quality of life score (The EORTC QLQ-C30) at 12 months

    Time frame: 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.

  5. Quality of life score (The EORTC QLQ-HCC18) at baseline

    Time frame: 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.

  6. Change in Quality of life score (The EORTC QLQ-HCC18) at 3 months

    Time frame: 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.

  7. Change in Quality of life score (The EORTC QLQ-HCC18) at 6 months

    Time frame: 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.

  8. Change in Quality of life score (The EORTC QLQ-HCC18) at 12 months

    Time frame: 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.

  9. Immune variables 1 at baseline

    Time frame: T0(Baseline)

    Total lymphocyte count. Collected from daily medical records.

  10. Change in Immune variables 1 at 3 months

    Time frame: T1(3 months)

    Total lymphocyte count. Collected from daily medical records.

  11. Change in Immune variables 1 at 6 months

    Time frame: T2(6 months)

    Total lymphocyte count. Collected from daily medical records.

  12. Immune variables 2 at baseline

    Time frame: T0(Baseline)

    Level of IFN-γ. Collected from blood sample.

  13. Change in Immune variables 2 at 3 months

    Time frame: T1(3 months)

    Level of IFN-γ. Collected from blood sample.

  14. Change in Immune variables 2 at 6 months

    Time frame: T2(6 months)

    Level of IFN-γ. Collected from blood sample.

  15. Immune variables 3 at baseline

    Time frame: T0(Baseline)

    IL-2. Collected from blood sample.

  16. Change in Immune variables 3 at 3 months

    Time frame: T1(3 months)

    IL-2. Collected from blood sample.

  17. Change in Immune variables 3 at 6 months

    Time frame: T2(6 months)

    IL-2. Collected from blood sample.

  18. Immune variables 4 at baseline

    Time frame: T0(Baseline)

    IL-4. Collected from blood sample.

  19. Change in Immune variables 4 at 3 months

    Time frame: T1(3 months)

    IL-4. Collected from blood sample.

  20. Change in Immune variables 4 at 6 months

    Time frame: T2(6 months)

    IL-4. Collected from blood sample.

  21. Immune variables 5 at baseline

    Time frame: T0(Baseline)

    IL-6. Collected from blood sample.

  22. Change in Immune variables 5 at 3 months

    Time frame: T1(3 months)

    IL-6. Collected from blood sample.

  23. Change in Immune variables 5 at 6 months

    Time frame: T2(6 months)

    IL-6. Collected from blood sample.

  24. Overall survival

    Time frame: T3 (12 months) and later till the end of life.

    Survival status form follow-up

Study contacts

Contact information is provided by the study sponsor or research team.

Hua Yin

CONTACT

[email protected]

+8613823013393

Sponsors and collaborators

Lead sponsor

The Nethersole School of Nursing

Other

Collaborators

  • ZhuHai Hospital

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2029
First posted
Jul 12, 2023
Registry last updated
Nov 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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