Effects of CBT-Based Intervention Among Patients With Liver Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Nethersole School of Nursing
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Cognitive behavioural therapy-based intervention
BehavioralA 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
BehavioralThe 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.
Treatment groups
160 Participants
are divided into 2 treatment groupsGroup A: Cognitive behavioural therapy-based(CBT-based) intervention groupExperimental treatment 1 intervention
Group B: Control groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
T0(Baseline)2
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.
Time frame
T1(3 months)3
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.
Time frame
T2(6 months)4
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.
Time frame
T3(12 months)Secondary outcomes
1
Quality of life score (The EORTC QLQ-C30) at 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.
Time frame
T0(Baseline)2
Change in Quality of life score (The EORTC QLQ-C30) at 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.
Time frame
T1(3 months)3
Change in Quality of life score (The EORTC QLQ-C30) at 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.
Time frame
T2(6 months)4
Change in Quality of life score (The EORTC QLQ-C30) at 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.
Time frame
T3(12 months)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
The Nethersole School of Nursing
Lead sponsor
ZhuHai Hospital
Collaborator
Source ClinicalTrials.gov
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