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Effects of CBT-Based Intervention Among Patients With Liver Cancer

NCT ID: NCT05942560

Last Updated: 2023-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-30

Study Completion Date

2029-06-30

Brief Summary

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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

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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.

Conditions

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Depression Anxiety Liver Cancer CBT

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study will be a parallel, multicenter, randomized controlled trial.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors
We will ensure that the assessors are unaware of the treatment assignments or intervention details for each participant. We will use anonymized coded data that does not reveal the group allocation during the outcome assessment. The data will be presented in a standardized format that prevents any identification of treatment groups.

Study Groups

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Cognitive behavioural therapy-based(CBT-based) intervention group

A specifically designed CBT-based intervention consisting of 8 weekly sessions will be conducted in a group format.

Group Type EXPERIMENTAL

Cognitive behavioural therapy-based intervention

Intervention Type 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.

Control group

Participants will receive eight health education sessions simultaneously with the CBT-based intervention group.

Group Type ACTIVE_COMPARATOR

Educational group

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ZhuHai Hospital

OTHER

Sponsor Role collaborator

The Nethersole School of Nursing

OTHER

Sponsor Role lead

Responsible Party

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Hua Yin

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hua Yin

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

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Zhuhai People's Hospital

Zhuhai, Guangdong, China

Site Status

Countries

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China

Central Contacts

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Hua Yin

Role: CONTACT

[email protected]
+8613823013393

Other Identifiers

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CREC2022.328

Identifier Type: -

Identifier Source: org_study_id