Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2025-12-27 @ 4:47 AM
Study NCT ID:
NCT06224504
Status:
COMPLETED
Last Update Posted:
2024-01-25
First Post:
2024-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Effectiveness of Combining Mindfulness-Based Stress Reduction With Exercise Interventione
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000099024', 'term': 'Mindfulness-Based Stress Reduction'}, {'id': 'D005081', 'term': 'Exercise Therapy'}], 'ancestors': [{'id': 'D064866', 'term': 'Mindfulness'}, {'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-16', 'studyFirstSubmitDate': '2024-01-16', 'studyFirstSubmitQcDate': '2024-01-16', 'lastUpdatePostDateStruct': {'date': '2024-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SAS score', 'timeFrame': 'one day before the intervention', 'description': 'Self-Rating Anxiety Scale (SAS)'}, {'measure': 'SAS score', 'timeFrame': 'at 6 weeks after the intervention', 'description': 'Self-Rating Anxiety Scale (SAS)'}, {'measure': 'SAS score', 'timeFrame': 'at 8 weeks after the intervention', 'description': 'Self-Rating Anxiety Scale (SAS)'}, {'measure': 'SDS score', 'timeFrame': 'one day before the intervention', 'description': 'Self-Rating Depression Scale (SDS)'}, {'measure': 'SDS score', 'timeFrame': 'at 6 weeks after the intervention', 'description': 'Self-Rating Depression Scale (SDS)'}, {'measure': 'SDS score', 'timeFrame': 'at 8 weeks after the intervention', 'description': 'Self-Rating Depression Scale (SDS)'}, {'measure': 'BSRS-5 score', 'timeFrame': 'one day before the intervention', 'description': 'the five-item Brief Symptom Rating Scale (BSRS-5)'}, {'measure': 'BSRS-5 score', 'timeFrame': 'at 6 weeks after the intervention', 'description': 'the five-item Brief Symptom Rating Scale (BSRS-5)'}, {'measure': 'BSRS-5 score', 'timeFrame': 'at 8 weeks after the intervention', 'description': 'the five-item Brief Symptom Rating Scale (BSRS-5)'}, {'measure': 'PSQI score', 'timeFrame': 'one day before the intervention', 'description': 'Pittsburgh Sleep Quality Index (PSQI)'}, {'measure': 'PSQI score', 'timeFrame': 'at 6 weeks after the intervention', 'description': 'Pittsburgh Sleep Quality Index (PSQI)'}, {'measure': 'PSQI score', 'timeFrame': 'at 8 weeks after the intervention', 'description': 'Pittsburgh Sleep Quality Index (PSQI)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lung cancer', 'Mindfulness-Based Stress Reduction', 'Exercise intervention', 'Anxiety', 'Depression'], 'conditions': ['Non-Small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'This study is to assess the clinical effectiveness of combining Mindfulness-Based Stress Reduction (MBSR) with exercise intervention in improving anxiety, depression, sleep quality, and mood regulation in Chinese patients with non-small cell lung cancer (NSCLC).The control group received conventional psychological nursing care, while the intervention group received a combination of MBSR and exercise therapy. Pre- and post-treatment scores of anxiety, depression, sleep quality, and the BSRS-5 were compared.', 'detailedDescription': 'To assess the clinical effectiveness of combining Mindfulness-Based Stress Reduction (MBSR) with exercise intervention in improving anxiety, depression, sleep quality, and mood regulation in Chinese patients with non-small cell lung cancer (NSCLC). A total of 60 lung cancer patients from a hospital in Shanxi Province were selected using convenience sampling and divided into an intervention group and a control group, with 30 patients in each group. The control group received conventional psychological nursing care, while the intervention group received a combination of MBSR and exercise therapy. The two group were evaluated by the questionnaire three times. One day before the intervention, the first questionnaire was conducted, and the basic data of the two groups of patients were collected. The second questionnaire evaluation of anxiety, depression, sleep quality, and the Brief Symptom Rating Scale (BSRS-5) was conducted 6 weeks after the end of the intervention, and the third questionnaire evaluation was conducted 8 weeks after the end of the intervention to evaluate the intervention effect of the two groups. Pre- and post-treatment scores of anxiety, depression, sleep quality, and the BSRS-5 were compared.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '44 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients diagnosed with non-small cell lung cancer\n* patients aged between 20 and 74 years, without gender limitation\n* a score of 4-14 on the Short Symptom Rating Scale (BSRS-5)\n* a clinical prognosis of at least 6 months\n* clear consciousness, good functional ability, and unrestricted language communication\n* written informed consent provided by the patient\n\nExclusion Criteria:\n\n* patients with severe physical illnesses or symptoms that impede learning and are considered life-threatening\n* patients with a BSRS-5 assessment score \\> 15 and suicidal ideation \\> 2\n* patients unable to accurately describe their symptoms\n* patients with limited cooperation ability\n* patients who have previously undergone MBSR or other positive-thinking-focused psychotherapy methods'}, 'identificationModule': {'nctId': 'NCT06224504', 'briefTitle': 'Clinical Effectiveness of Combining Mindfulness-Based Stress Reduction With Exercise Interventione', 'organization': {'class': 'OTHER', 'fullName': 'Shanxi Bethune Hospital'}, 'officialTitle': 'Combined Mindfulness-Based Stress Reduction and Exercise Intervention for Improving Psychological Well-being in Chinese Patients With Non-Small Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'SBH-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'the intervention group', 'description': 'routine health education ， psychological nursing， MBSR therapy ， exercise therapy', 'interventionNames': ['Behavioral: routine health education', 'Behavioral: psychological nursing', 'Behavioral: MBSR therapy', 'Behavioral: exercise therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'the control group', 'description': 'routine health education ， psychological nursing', 'interventionNames': ['Behavioral: routine health education', 'Behavioral: psychological nursing']}], 'interventions': [{'name': 'routine health education', 'type': 'BEHAVIORAL', 'description': 'guided the diet of patients, and introduced the knowledge of the disease in detail', 'armGroupLabels': ['the control group', 'the intervention group']}, {'name': 'psychological nursing', 'type': 'BEHAVIORAL', 'description': "hen the patient has negative emotions, patiently listen to the patient's expression, and timely provide language comfort and guidance to the negative psychological emotions", 'armGroupLabels': ['the control group', 'the intervention group']}, {'name': 'MBSR therapy', 'type': 'BEHAVIORAL', 'description': 'Conducted in small groups once a week for 8 weeks, with each session lasting approximately 1-1.5 hours, encompassed mindfulness-based breathing exercises, dietary interventions, and body scans', 'armGroupLabels': ['the intervention group']}, {'name': 'exercise therapy', 'type': 'BEHAVIORAL', 'description': 'Participants were assigned daily tasks for each session, requiring approximately 35-45 minutes per day', 'armGroupLabels': ['the intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '030032', 'city': 'Taiyuan', 'state': 'Shanxi', 'country': 'China', 'facility': 'Combined Mindfulness-Based Stress Reduction and Exercise Intervention for Improving Psychological Well-being in Chinese Patients with Non-Small Cell Lung Cancer', 'geoPoint': {'lat': 37.86944, 'lon': 112.56028}}], 'overallOfficials': [{'name': 'Wanling Li', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanxi Bethune Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanxi Bethune Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Wanling Li', 'investigatorAffiliation': 'Shanxi Bethune Hospital'}}}}