[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654342":3},{"organization":4,"outcomesModule":7,"designInfo":52,"detailedDescription":63,"studyPopulation":57,"armGroups":64,"interventions":77,"overallOfficials":57,"centralContacts":85,"locations":93,"responsibleParty":109,"collaborators":57,"id":111,"slug":112,"hasResults":113,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":117,"eligibilityCriteria":118,"healthyVolunteers":113,"sex":119,"minAge":120,"maxAge":57,"enrollmentInfo":121,"targetDuration":57,"studyType":124,"phases":125,"briefSummary":127,"conditions":128,"keywords":134,"overallStatus":139,"whyStopped":57,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":149},{"fullName":5,"class":6},"Tianjin Medical University Cancer Institute and Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":30},[9],{"measure":10,"description":11,"timeFrame":12},"Change in the Hospital Anxiety and Depression Scale-Anxiety Score","Anxiety assessed using the Hospital Anxiety and Depression Scale-Anxiety subscale (HADS-A). Score ranges from 0 to 21, with higher scores indicating worse anxiety. The primary analysis is non-inferiority of Ziwu Liuzhu Five-Element Music Therapy compared to Mindfulness-Based Stress Reduction at week 8.","Baseline, Week 4, Week 8",[14,17,20,23,27],{"measure":15,"description":16,"timeFrame":12},"Change in the Hospital Anxiety and Depression Scale-Depression Score","Depression assessed using the Hospital Anxiety and Depression Scale-Depression subscale (HADS-D). Score ranges from 0 to 21, with higher scores indicating worse depression.",{"measure":18,"description":19,"timeFrame":12},"Change in Global Health Status\u002FQoL Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30","Quality of life assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30. Global Health Status\u002FQoL scale score ranges from 0 to 100, with higher scores indicating better quality of life.",{"measure":21,"description":22,"timeFrame":12},"Change in Functional Subscales and Symptom Scores on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30","Functional subscales (physical, role, emotional, cognitive, social) and symptom scales (fatigue, nausea\u002Fvomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea) of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30. Each scale score ranges from 0 to 100; higher functional scores indicate better functioning, higher symptom scores indicate worse symptoms.",{"measure":24,"description":25,"timeFrame":26},"Adherence: Practice Check-in Rate","Adherence measured by the proportion of days with completed music listening sessions (check-in rate), weekly online group session attendance (for Mindfulness-Based Stress Reduction group), and practice log completion rate.","Daily, summarized at Week 4, Week 8",{"measure":28,"description":29,"timeFrame":26},"Incidence of Adverse Events","Safety assessed by the incidence and severity of adverse events graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, including but not limited to: neutropenia, leukopenia, thrombocytopenia, anemia, diarrhea, nausea, vomiting, and fatigue. Grade ≥3 events are reported within 24 hours.",[31,34,37,40,43,46,49],{"measure":32,"description":33,"timeFrame":12},"Change in Neutrophil-to-Lymphocyte Ratio (NLR)","NLR is calculated as absolute neutrophil count divided by absolute lymphocyte count from peripheral blood. Higher NLR indicates greater systemic inflammation.",{"measure":35,"description":36,"timeFrame":12},"Change in Monocyte-to-Lymphocyte Ratio (MLR)","Change in Monocyte-to-Lymphocyte Ratio (MLR) is calculated as absolute monocyte count divided by absolute lymphocyte count from peripheral blood. Higher MLR indicates greater systemic inflammation.",{"measure":38,"description":39,"timeFrame":12},"Change in White Blood Cell Count(WBC)","White blood cell (WBC) count measured in ×10⁹\u002FL from peripheral blood. Abnormal WBC count indicates myelosuppression or infection.",{"measure":41,"description":42,"timeFrame":12},"Change in Serum Albumin","Serum albumin level measured in g\u002FL from peripheral blood. Higher albumin indicates better nutritional status.",{"measure":44,"description":45,"timeFrame":12},"Change in Total Protein","Serum total protein level measured in g\u002FL from peripheral blood.",{"measure":47,"description":48,"timeFrame":12},"Change in Hemoglobin","Hemoglobin level measured in g\u002FL from peripheral blood. Higher hemoglobin indicates better functional status.",{"measure":50,"description":51,"timeFrame":12},"Change in Fasting Blood Glucose","Fasting blood glucose level measured in mmol\u002FL from peripheral blood.",{"allocation":53,"interventionModel":54,"interventionModelDescription":55,"primaryPurpose":56,"observationalModel":57,"timePerspective":57,"maskingInfo":58},"RANDOMIZED","PARALLEL","This study employs a parallel-group, non-inferiority design. Participants are randomly assigned in a 1:1 ratio to either the Ziwu Liuzhu Five-Element Music Therapy group or the Mindfulness-Based Stress Reduction group. Both groups are conducted concurrently across four study centers. No crossover between groups is permitted.","TREATMENT",null,{"masking":59,"maskingDescription":60,"whoMasked":61},"SINGLE","The statistician responsible for data analysis is also masked to group allocation. Data are coded with randomization numbers and analyzed under blinded conditions.",[62],"OUTCOMES_ASSESSOR","Background Pancreatic cancer patients have a high prevalence of anxiety and depression, with rates reaching 70% for depression and 80% for anxiety after diagnosis; however, 73% of those with Psychological Distress do not receive effective intervention. Psychological Distress promotes pancreatic cancer progression through sympathetic-exosome pathways, establishing an \"emotion-tumor\" vicious cycle. Although the NALIRIFOX or AG regimen extends survival, the incidence of grade ≥3 adverse events reaches 73.1%, and chemotherapy toxicities interact bidirectionally with Psychological Distress. Music therapy has been recommended by NCCN and other guidelines for improving Psychological Distress in cancer patients. Ziwu Liuzhu Five-Element Music Therapy integrates five-element music with chronomedicine, delivering music at specific time periods to enhance therapeutic efficacy; however, high-level evidence is lacking for pancreatic cancer patients undergoing chemotherapy.\n\nStudy Objectives This study aims to: (1) demonstrate that Ziwu Liuzhu Five-Element Music Therapy is non-inferior to Mindfulness-Based Stress Reduction in reducing anxiety in pancreatic cancer patients during chemotherapy; (2) evaluate its effects on depression, quality of life, and biomarkers.\n\nStudy Design This is a multicenter, prospective, parallel-group, non-inferiority randomized controlled trial with a 1:1 allocation ratio to either the Ziwu Liuzhu Five-Element Music Therapy group or the MBSR group.\n\nParticipants Inclusion criteria: age ≥18 years; histologically confirmed pancreatic cancer; first-line chemotherapy with NALIRIFOX or AG (nab-paclitaxel + gemcitabine) regimen; ECOG PS ≤2; life expectancy \\>3 months; HAMA score 7-23 (mild-to-moderate anxiety); voluntary signed informed consent. A total of 320 participants (160 per group) are planned for enrollment.\n\nExclusion criteria: severe psychiatric disorders, cognitive impairment, suicidal ideation, or unstable antipsychotic medication dosage; chemotherapy-related acute unstable conditions; severe hearing impairment or intolerance to music; concurrent participation in other clinical trials; regular mindfulness or yoga practice history (≥2 times\u002Fweek for ≥3 months).\n\nIntervention\n\nThe intervention group receives an 8-week Ziwu Liuzhu Five-Element Music Therapy program:\n\nSi Period (9:00-11:00, Spleen meridian): Gong mode (e.g., \"Spring River Moonlight\"), 20 minutes after breakfast, once daily, 20 minutes per session.\n\nWu Period (11:00-13:00, Heart meridian): Zhi mode (e.g., \"Purple Bamboo Tune\"), before lunchtime rest, once daily, 20 minutes per session.\n\nYou Period (17:00-19:00, Kidney meridian): Yu mode (e.g., \"Three Variations of Plum Blossom\"), during dinner, once daily, 20 minutes per session.\n\nDuring hospitalization, bedside guidance is provided by the responsible nurse. At home, exercises are supervised via video, with daily check-in recording.\n\nThe control group receives an 8-week standard Mindfulness-Based Stress Reduction program: weekly online group sessions (60 minutes\u002Fsession) + twice-daily home audio-guided practice (20 minutes\u002Fsession)..\n\nOutcome Measures Primary outcome: HADS-Anxiety score (T0, T1, T2). Secondary outcomes: HADS-Depression score, EORTC QLQ-C30 quality of life score (T0, T1, T2).\n\nExploratory outcomes: NLR, MLR, albumin, total protein, hemoglobin, glucose (prior to each chemotherapy cycle).\n\nStatistical Analysis Non-inferiority testing with one-sided α = 0.025. Linear mixed-effects models are used to analyze HADS-A change scores. Non-inferiority is claimed if the upper bound of the 97.5% confidence interval for the between-group difference is less than the prespecified non-inferiority margin (1.225 points). Intention-to-treat analysis is primary; per-protocol analysis is sensitivity.\n\nEthics and Registration This study has been approved by the Medical Ethics Committee of Tianjin Medical University Cancer Institute \\& Hospital. All participants will provide written informed consent.",[65,71],{"label":66,"type":67,"description":68,"interventionNames":69},"Ziwu Liuzhu Five-Element Music Therapy","EXPERIMENTAL","Participants receive an 8-week Ziwu Liuzhu Five-Element Music Therapy program: three 20-minute sessions daily (Si period: Gong mode; Wu period: Zhi mode; You period: Yu mode). Delivered via bedside instruction during hospitalization and video supervision at home.",[70],"Behavioral: Ziwu Liuzhu Five-Element Music Therapy",{"label":72,"type":73,"description":74,"interventionNames":75},"Mindfulness-Based Stress Reduction","ACTIVE_COMPARATOR","Participants receive an 8-week standard Mindfulness-Based Stress Reduction program: weekly online group sessions (60 min) + twice-daily home audio-guided practice (20 min).",[76],"Behavioral: Mindfulness-Based Stress Reduction",[78,82],{"type":79,"name":66,"description":80,"armGroupLabels":81,"otherNames":57},"BEHAVIORAL","An 8-week program delivering Gong, Zhi, and Yu musical modes at Si, Wu, and You periods respectively, 20 min per session, 3 sessions daily. Music selected from a curated library based on patient preference.",[66],{"type":79,"name":72,"description":83,"armGroupLabels":84,"otherNames":57},"An 8-week standard Mindfulness-Based Stress Reduction program consisting of weekly 60-minute online group sessions and twice-daily 20-minute home audio-guided practice sessions.",[72],[86,91],{"name":87,"role":88,"phone":89,"phoneExt":57,"email":90},"Ying Wang","CONTACT","82+022-23340123","wangying3046@tjmuch.com",{"name":92,"role":88,"phone":57,"phoneExt":57,"email":57},"Jihui Hao",[94],{"facility":95,"status":57,"city":96,"state":97,"zip":98,"country":99,"countryCode":100,"cosmosGeoPoint":101,"geoPoint":106,"contacts":107},"Tianjin Medical University Cancer Institute & Hospital","Tianjin","Tianjin Municipality","300060","China","CN",{"type":102,"coordinates":103},"Point",[104,105],117.17667,39.14222,{"lat":105,"lon":104},[108],{"name":87,"role":88,"phone":89,"phoneExt":57,"email":90},{"type":110,"investigatorFullName":57,"investigatorTitle":57,"investigatorAffiliation":57,"oldNameTitle":57,"oldOrganization":57},"SPONSOR","100654342","five-element-music-therapy-for-psychological-distress-in-pancreatic-cancer-chemotherapy-100654342",false,"NCT07796906","Five-Element Music Therapy for Psychological Distress in Pancreatic Cancer Chemotherapy","Effect of Ziwu Liuzhu Five-Element Music Therapy on Psychological Distress in Patients With Pancreatic Cancer Undergoing Chemotherapy: A Multicenter, Non-Inferiority Randomized Controlled Trial","FEMT-PC","Inclusion Criteria:\n\n* Histologically or cytologically confirmed pancreatic cancer\n* Receiving first-line neoadjuvant or adjuvant chemotherapy with NALIRIFOX or AG regimen\n* ECOG performance status ≤ 2\n* Life expectancy \\> 3 months\n* HAMA score 7-23 (mild-to-moderate anxiety)\n* Ability to understand, communicate, and cooperate with the study; Voluntary signed informed consent\n\nExclusion Criteria:\n\n* Severe psychiatric disorders, cognitive impairment, suicidal ideation, or unstable antipsychotic medication dosage\n* Chemotherapy-related acute unstable conditions (severe myelosuppression, uncontrolled pain, active infection, or uncontrolled seizures)\n* Severe hearing impairment or intolerance to music intervention\n* Concurrent participation in other clinical trials\n* Regular mindfulness meditation or yoga practice history (≥2 times\u002Fweek for ≥3 months)","ALL","18 Years",{"count":122,"type":123},320,"ESTIMATED","INTERVENTIONAL",[126],"NA","Ziwu Liuzhu Five-Element Music Therapy is a non-pharmacological intervention grounded in the traditional Chinese medicine theory of \"five tones corresponding to the five viscera and five emotions,\" integrated with the chronomedicine framework of Ziwu Liuzhu (midnight-noon meridian flow). It delivers specific musical modes at designated two-hour intervals to resonate with meridian qi and blood, achieving the therapeutic goals of \"time-matched music for organ-specific regulation.\" Existing meta-analyses have confirmed that five-element music therapy significantly alleviates anxiety and depression and improves quality of life in cancer patients; however, no dedicated study has been conducted in pancreatic cancer patients undergoing chemotherapy.\n\nThis is a multicenter, prospective, parallel-group, non-inferiority randomized controlled trial. A total of 320 pancreatic cancer patients with mild-to-moderate anxiety receiving NALIRIFOX or AG (nab-paclitaxel + gemcitabine) chemotherapy will be enrolled and randomly assigned in a 1:1 ratio to either the Ziwu Liuzhu Five-Element Music Therapy group or the Mindfulness-Based Stress Reduction (MBSR) group. The intervention group receives 20-minute sessions, three times daily, for 8 weeks of Ziwu Liuzhu Five-Element Music listening. The control group receives an 8-week standard MBSR program consisting of twice-daily home practice and weekly online group sessions.\n\nThe primary outcome is the change in HADS-Anxiety score from baseline to week 8. Secondary outcomes include depression (HADS-D), quality of life (EORTC QLQ-C30), and biomarkers (NLR, MLR, albumin, etc.). This trial aims to demonstrate that Ziwu Liuzhu Five-Element Music Therapy is non-inferior to a standardized psychological intervention (MBSR) for improving Psychological Distress in pancreatic cancer patients during chemotherapy.",[129,130,131,132,133],"Pancreatic Neoplasms","Pancreatic Cancer","Anxiety","Depression and\u002For Anxiety Symptoms","Psychological Distress",[130,135,136,133,72,137,138],"Five-Element Music Therapy","Music Therapy","Randomized Controlled Trial","Non-Inferiority Trial","NOT_YET_RECRUITING","2026-09-11",{"date":142,"type":143},"2026-09-16","ACTUAL",{"date":145,"type":123},"2026-08-28",{"date":147,"type":123},"2027-01-31",{"name":5,"class":6},1]