Effects of CBT-Based Intervention Among Patients With Liver Cancer

NCT05942560 | Not Yet Recruiting DMC

• 1 other identifier: CREC2022.328
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Anxiety; Liver Cancer; CBT

Keywords

cognitive behavioural therapy; depression; anxiety; immune; quality of life; survival; liver cancer

Outcome Measures

Primary Outcomes (8)

• Depression symptoms at 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.

  T0(Baseline)

• Change in depression symptoms at 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.

  T1(3 months)

• Change in depression symptoms at 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.

  T2(6 months)

• Change in depression symptoms at 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.

  T3(12 months)

• Anxiety symptoms at 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.

  T0(Baseline)

• Change in anxiety symptoms at 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.

  T1(3 months)

• Change in anxiety symptoms at 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.

  T2(6 months)

• Change in anxiety symptoms at 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.

  T3(12 months)

Secondary Outcomes (24)

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

  T0(Baseline)

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

  T1(3 months)

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

  T2(6 months)

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

  T3(12 months)

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

  T0(Baseline)

Study Arms (2)

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

EXPERIMENTAL

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

Behavioral: Cognitive behavioural therapy-based intervention

Control group

ACTIVE COMPARATOR

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

Behavioral: Educational group

Interventions

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.

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

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.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Nethersole School of Nursing: lead
• ZhuHai Hospital: collaborator

Study Sites (1)

Zhuhai People's Hospital

Zhuhai, Guangdong, 519000, China

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders; Liver Neoplasms

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Study Officials

• Hua Yin

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hua Yin

CONTACT

+8613823013393; huayin0408@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The study will be a parallel, multicenter, randomized controlled trial.

Study Record Dates

• First Submitted: June 25, 2023
• First Posted: July 12, 2023
• Study Start: December 30, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2029
• Last Updated: November 22, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)