Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-01-07 @ 10:22 AM
Study NCT ID:
NCT05942560
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-11-22
First Post:
2023-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of CBT-Based Intervention Among Patients With Liver Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': '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.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The study will be a parallel, multicenter, randomized controlled trial.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-12-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2029-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-21', 'studyFirstSubmitDate': '2023-06-25', 'studyFirstSubmitQcDate': '2023-07-05', 'lastUpdatePostDateStruct': {'date': '2023-11-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Depression symptoms at baseline', 'timeFrame': 'T0(Baseline)', 'description': "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."}, {'measure': 'Change in depression symptoms at 3 months', 'timeFrame': 'T1(3 months)', 'description': "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."}, {'measure': 'Change in depression symptoms at 6 months', 'timeFrame': 'T2(6 months)', 'description': "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."}, {'measure': 'Change in depression symptoms at 12 months', 'timeFrame': 'T3(12 months)', 'description': "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."}, {'measure': 'Anxiety symptoms at baseline', 'timeFrame': 'T0(Baseline)', 'description': "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."}, {'measure': 'Change in anxiety symptoms at 3 months', 'timeFrame': 'T1(3 months)', 'description': "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."}, {'measure': 'Change in anxiety symptoms at 6 months', 'timeFrame': 'T2(6 months)', 'description': "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."}, {'measure': 'Change in anxiety symptoms at 12 months', 'timeFrame': 'T3(12 months)', 'description': "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."}], 'secondaryOutcomes': [{'measure': 'Quality of life score (The EORTC QLQ-C30) at baseline', 'timeFrame': 'T0(Baseline)', 'description': 'The European Organization for Research and Treatment of Cancer(EORTC) Quality of Life Questionnaire results.\n\nScores range from 0 to 100. A higher score represents a higher ("better") level of functioning, or a higher ("worse") level of symptoms.'}, {'measure': 'Change in Quality of life score (The EORTC QLQ-C30) at 3 months', 'timeFrame': 'T1(3 months)', 'description': 'The European Organization for Research and Treatment of Cancer(EORTC) Quality of Life Questionnaire results.\n\nScores range from 0 to 100. A higher score represents a higher ("better") level of functioning, or a higher ("worse") level of symptoms.'}, {'measure': 'Change in Quality of life score (The EORTC QLQ-C30) at 6 months', 'timeFrame': 'T2(6 months)', 'description': 'The European Organization for Research and Treatment of Cancer(EORTC) Quality of Life Questionnaire results.\n\nScores range from 0 to 100. A higher score represents a higher ("better") level of functioning, or a higher ("worse") level of symptoms.'}, {'measure': 'Change in Quality of life score (The EORTC QLQ-C30) at 12 months', 'timeFrame': 'T3(12 months)', 'description': 'The European Organization for Research and Treatment of Cancer(EORTC) Quality of Life Questionnaire results.\n\nScores range from 0 to 100. A higher score represents a higher ("better") level of functioning, or a higher ("worse") level of symptoms.'}, {'measure': 'Quality of life score (The EORTC QLQ-HCC18) at baseline', 'timeFrame': 'T0(Baseline)', 'description': '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.'}, {'measure': 'Change in Quality of life score (The EORTC QLQ-HCC18) at 3 months', 'timeFrame': 'T1(3 months)', 'description': '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.'}, {'measure': 'Change in Quality of life score (The EORTC QLQ-HCC18) at 6 months', 'timeFrame': 'T2(6 months)', 'description': '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.'}, {'measure': 'Change in Quality of life score (The EORTC QLQ-HCC18) at 12 months', 'timeFrame': 'T3(12 months)', 'description': '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.'}, {'measure': 'Immune variables 1 at baseline', 'timeFrame': 'T0(Baseline)', 'description': 'Total lymphocyte count. Collected from daily medical records.'}, {'measure': 'Change in Immune variables 1 at 3 months', 'timeFrame': 'T1(3 months)', 'description': 'Total lymphocyte count. Collected from daily medical records.'}, {'measure': 'Change in Immune variables 1 at 6 months', 'timeFrame': 'T2(6 months)', 'description': 'Total lymphocyte count. Collected from daily medical records.'}, {'measure': 'Immune variables 2 at baseline', 'timeFrame': 'T0(Baseline)', 'description': 'Level of IFN-γ. Collected from blood sample.'}, {'measure': 'Change in Immune variables 2 at 3 months', 'timeFrame': 'T1(3 months)', 'description': 'Level of IFN-γ. Collected from blood sample.'}, {'measure': 'Change in Immune variables 2 at 6 months', 'timeFrame': 'T2(6 months)', 'description': 'Level of IFN-γ. Collected from blood sample.'}, {'measure': 'Immune variables 3 at baseline', 'timeFrame': 'T0(Baseline)', 'description': 'IL-2. Collected from blood sample.'}, {'measure': 'Change in Immune variables 3 at 3 months', 'timeFrame': 'T1(3 months)', 'description': 'IL-2. Collected from blood sample.'}, {'measure': 'Change in Immune variables 3 at 6 months', 'timeFrame': 'T2(6 months)', 'description': 'IL-2. Collected from blood sample.'}, {'measure': 'Immune variables 4 at baseline', 'timeFrame': 'T0(Baseline)', 'description': 'IL-4. Collected from blood sample.'}, {'measure': 'Change in Immune variables 4 at 3 months', 'timeFrame': 'T1(3 months)', 'description': 'IL-4. Collected from blood sample.'}, {'measure': 'Change in Immune variables 4 at 6 months', 'timeFrame': 'T2(6 months)', 'description': 'IL-4. Collected from blood sample.'}, {'measure': 'Immune variables 5 at baseline', 'timeFrame': 'T0(Baseline)', 'description': 'IL-6. Collected from blood sample.'}, {'measure': 'Change in Immune variables 5 at 3 months', 'timeFrame': 'T1(3 months)', 'description': 'IL-6. Collected from blood sample.'}, {'measure': 'Change in Immune variables 5 at 6 months', 'timeFrame': 'T2(6 months)', 'description': 'IL-6. Collected from blood sample.'}, {'measure': 'Overall survival', 'timeFrame': 'T3 (12 months) and later till the end of life.', 'description': 'Survival status form follow-up'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cognitive behavioural therapy', 'depression', 'anxiety', 'immune', 'quality of life', 'survival', 'liver cancer'], 'conditions': ['Depression', 'Anxiety', 'Liver Cancer', 'CBT']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nA 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.\n\nBy 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adults (aged ≥18);\n2. Diagnosed with liver cancer based on pathological findings or imaging findings in the medical record;\n3. 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).\n\nExclusion Criteria:\n\n1. 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\n2. Patients with active immunological diseases, such as autoimmune diseases, and inflammatory diseases.\n3. Patients accepting hormone therapy or taking long-term antibiotic drugs.\n4. Patients who lack the basic ability of understanding and expression and are incompetent in giving consent.'}, 'identificationModule': {'nctId': 'NCT05942560', 'briefTitle': 'Effects of CBT-Based Intervention Among Patients With Liver Cancer', 'organization': {'class': 'OTHER', 'fullName': 'The Nethersole School of Nursing'}, 'officialTitle': 'Effects of Cognitive Behavioral Therapy-Based Intervention on Depression, Anxiety, Quality of Life, Immune Indicators, and Survival Among Patients With Liver Cancer', 'orgStudyIdInfo': {'id': 'CREC2022.328'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cognitive behavioural therapy-based(CBT-based) intervention group', 'description': 'A specifically designed CBT-based intervention consisting of 8 weekly sessions will be conducted in a group format.', 'interventionNames': ['Behavioral: Cognitive behavioural therapy-based intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Participants will receive eight health education sessions simultaneously with the CBT-based intervention group.', 'interventionNames': ['Behavioral: Educational group']}], 'interventions': [{'name': 'Cognitive behavioural therapy-based intervention', 'type': 'BEHAVIORAL', 'description': "A specifically designed CBT-based intervention consisting of 8 weekly sessions with group format.\n\nEach group will be comprised of 4-10 participants, and each session will last 1.5 hours.\n\nThe content of the weekly sessions will be based on Beck's cognitive theory and the cognitive therapy in groups guidelines.\n\nThe framework of every session will follow a pre-determined structure.", 'armGroupLabels': ['Cognitive behavioural therapy-based(CBT-based) intervention group']}, {'name': 'Educational group', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '519000', 'city': 'Zhuhai', 'state': 'Guangdong', 'country': 'China', 'facility': "Zhuhai People's Hospital", 'geoPoint': {'lat': 22.27694, 'lon': 113.56778}}], 'centralContacts': [{'name': 'Hua Yin', 'role': 'CONTACT', 'email': 'huayin0408@163.com', 'phone': '+8613823013393'}], 'overallOfficials': [{'name': 'Hua Yin', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese University of Hong Kong'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Nethersole School of Nursing', 'class': 'OTHER'}, 'collaborators': [{'name': 'ZhuHai Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Hua Yin', 'investigatorAffiliation': 'The Nethersole School of Nursing'}}}}