Ignite Creation Date:
2025-12-24 @ 10:20 PM
Ignite Modification Date:
2026-02-22 @ 9:37 AM
Study NCT ID:
NCT01727635
Status:
COMPLETED
Last Update Posted:
2012-11-16
First Post:
2009-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Long-term Effects of Body-mind-spirit Group Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011615', 'term': 'Psychotherapy, Group'}], 'ancestors': [{'id': 'D012960', 'term': 'Socioenvironmental Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-12', 'studyFirstSubmitDate': '2009-10-21', 'studyFirstSubmitQcDate': '2012-11-12', 'lastUpdatePostDateStruct': {'date': '2012-11-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-11-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diurnal Cortisol patterns', 'timeFrame': 'pre, post, 3months, 6months and 1year after end of treatment'}], 'secondaryOutcomes': [{'measure': 'The Experiences in Close Relationships-Revised questionnaire', 'timeFrame': 'pre, post, 3months, 6months and 1year after end of treatment'}, {'measure': 'Beck Depression Inventory', 'timeFrame': 'pre, post, 3months, 6months and 1year after end of treatment'}, {'measure': 'Quality of life', 'timeFrame': 'pre, post, 3months, 6months and 1year after end of treatment'}, {'measure': 'MOS sleep scale', 'timeFrame': 'pre, post, 3months, 6months and 1year after end of treatment'}, {'measure': 'Meaning in Life Questionnaire', 'timeFrame': 'pre, post, 3months, 6months and 1year after end of treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Breast cancer, survivors, partners, group therapy'], 'conditions': ['Depression', 'Sleep']}, 'descriptionModule': {'briefSummary': 'Aims and objectives: This study aims to examine the effects of the body-mind-spirit group therapy on marital close relationships, sleeping quality, depression, quality of life, meaning of life, and salivary cortisol levels in metastatic breast cancer survivors and partners.\n\nMethods: The design adopts the randomized controlled trial (RCT). The metastatic breast cancer survivors will be recruited from outpatient department of surgical at hospital. The partners will be invited to participate in this study through the survivors. The 120 dyad survivors and spouse will be randomly assigned into an experimental group or a control group. Survivors and spouse partners in an experimental group will receive 2 months time body-mind-spirit group therapy while those in a control will receive usual care in the same period of time. The outcome measures include Experiences in close relationships scale, Moss sleeping scale, Short-form 12 health-related quality of life questionnaires, Meaning of life questionnaire, BDI-II depression scale and salivary cortisol levels. Measurement time-points include pre intervention, post intervention (after 8 weekly group therapy), \\& then 3, 6, 12 months after the end of intervention for the maintenance effect. Univariate analyses will be performed to explore the basic characteristics of participants. The hierarchical linear model will be used to test the hypothesis the improvement is higher in intervention group than the control group in the effects of marital close relationships, sleeping quality, depression, meaning of life, quality of life, and salivary cortisol levels in metastatic breast cancer survivors and partners.', 'detailedDescription': 'Aims and objectives: This study aims to examine the effects of the body-mind-spirit group therapy on marital close relationships, sleeping quality, depression, quality of life, meaning of life, and salivary cortisol levels in metastatic breast cancer survivors and partners. Methods: The design adopts the randomized controlled trial (RCT). The metastatic breast cancer survivors will be recruited from outpatient department of surgical at hospital. The partners will be invited to participate in this study through the survivors. The 120 dyad survivors and spouse will be randomly assigned into an experimental group or a control group. Survivors and spouse partners in an experimental group will receive 2 months time body-mind-spirit group therapy while those in a control will receive usual care in the same period of time. The outcome measures include Experiences in close relationships scale, Moss sleeping scale, Short-form 12 health-related quality of life questionnaires, Meaning of life questionnaire, BDI-II depression scale and salivary cortisol levels. Measurement time-points include pre intervention, post intervention (after 8 weekly group therapy), \\& then 3, 6, 12 months after the end of intervention for the maintenance effect. Univariate analyses will be performed to explore the basic characteristics of participants. The hierarchical linear model will be used to test the hypothesis the improvement is higher in intervention group than the control group in the effects of marital close relationships, sleeping quality, depression, meaning of life, quality of life, and salivary cortisol levels in metastatic breast cancer survivors and partners.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nInclusion criteria of Survivors:\n\n1. breast cancer patients who complete active treatments,\n2. those who are willing to participate in the research,\n3. those who currently do not receive any individual or group psychotherapy, AND\n4. aged between 18 and 65.\n\nInclusion criteria of Spouse partners:\n\n1. partners of breast cancer patient who complete active treatments,\n2. those who are willing to participate in the research,\n3. those who currently do not receive any individual or group psychotherapy, AND\n4. aged between 18 and 65.\n\nExclusion Criteria:\n\nExclusion criteria of Survivors:\n\n1. diagnosed as both breast cancer and other types of cancers,\n2. those with adrenal function disorders (for example, Cushing syndrome, Addison's disease, adrenal tumor, pituitary tumor), OR\n3. those who currently use antidepressants.\n\nExclusion criteria of Survivors:\n\n1. diagnosed as adrenal function disorders (for example, Cushing syndrome, Addison's disease, adrenal tumor, pituitary tumor), OR\n2. those who currently use antidepressants."}, 'identificationModule': {'nctId': 'NCT01727635', 'briefTitle': 'The Long-term Effects of Body-mind-spirit Group Therapy', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'The Long-term Effects of Body-mind-spirit Group Therapy on Close Relationships, Sleeping Quality, Depression, Quality of Life, Meaning of Life, and Saliva Cortisol Responses in Breast Cancer Survivors and Partners', 'orgStudyIdInfo': {'id': '200909010R'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'counseling', 'description': 'body-mind-spirit group therapy', 'interventionNames': ['Other: body-mind-spirit group therapy']}], 'interventions': [{'name': 'body-mind-spirit group therapy', 'type': 'OTHER', 'otherNames': ['group therapy'], 'description': '8-session therapy', 'armGroupLabels': ['counseling']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10051', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Department of Nursing, College of Medicine, National Taiwan University', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Fei Hsiao, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taiwan University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}