Ignite Creation Date:
2025-12-24 @ 10:54 PM
Ignite Modification Date:
2025-12-30 @ 11:17 AM
Study NCT ID:
NCT00390169
Status:
UNKNOWN
Last Update Posted:
2012-01-19
First Post:
2006-10-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized Controlled Trial Comparing MBSR to SET in Breast Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2006-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2009-07'}, 'lastUpdateSubmitDate': '2012-01-18', 'studyFirstSubmitDate': '2006-10-18', 'studyFirstSubmitQcDate': '2006-10-18', 'lastUpdatePostDateStruct': {'date': '2012-01-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-10-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Psychological:mood, stress, post-traumatic growth, social support, quality of life, spirituality'}, {'measure': 'Physical:cortisol levels (stress hormone)'}], 'secondaryOutcomes': [{'measure': 'emotional repression'}, {'measure': 'personality'}, {'measure': 'emotional suppression'}]}, 'conditionsModule': {'keywords': ['breast neoplasms', 'stress', 'personality', 'psychology'], 'conditions': ['Breast Neoplasms']}, 'referencesModule': {'references': [{'pmid': '16262547', 'type': 'BACKGROUND', 'citation': 'Carlson LE, Garland SN. Impact of mindfulness-based stress reduction (MBSR) on sleep, mood, stress and fatigue symptoms in cancer outpatients. Int J Behav Med. 2005;12(4):278-85. doi: 10.1207/s15327558ijbm1204_9.'}, {'pmid': '14749092', 'type': 'BACKGROUND', 'citation': 'Carlson LE, Speca M, Patel KD, Goodey E. Mindfulness-based stress reduction in relation to quality of life, mood, symptoms of stress and levels of cortisol, dehydroepiandrosterone sulfate (DHEAS) and melatonin in breast and prostate cancer outpatients. Psychoneuroendocrinology. 2004 May;29(4):448-74. doi: 10.1016/s0306-4530(03)00054-4.'}, {'pmid': '12883107', 'type': 'BACKGROUND', 'citation': 'Carlson LE, Speca M, Patel KD, Goodey E. Mindfulness-based stress reduction in relation to quality of life, mood, symptoms of stress, and immune parameters in breast and prostate cancer outpatients. Psychosom Med. 2003 Jul-Aug;65(4):571-81. doi: 10.1097/01.psy.0000074003.35911.41.'}, {'pmid': '27193737', 'type': 'DERIVED', 'citation': 'Carlson LE, Tamagawa R, Stephen J, Drysdale E, Zhong L, Speca M. Randomized-controlled trial of mindfulness-based cancer recovery versus supportive expressive group therapy among distressed breast cancer survivors (MINDSET): long-term follow-up results. Psychooncology. 2016 Jul;25(7):750-9. doi: 10.1002/pon.4150. Epub 2016 May 18.'}, {'pmid': '25367403', 'type': 'DERIVED', 'citation': 'Carlson LE, Beattie TL, Giese-Davis J, Faris P, Tamagawa R, Fick LJ, Degelman ES, Speca M. Mindfulness-based cancer recovery and supportive-expressive therapy maintain telomere length relative to controls in distressed breast cancer survivors. Cancer. 2015 Feb 1;121(3):476-84. doi: 10.1002/cncr.29063. Epub 2014 Nov 3.'}]}, 'descriptionModule': {'briefSummary': 'This study will compare three standard treatment programs commonly offered to patients with breast cancer. The three programs being compared are 1) Mindfulness Meditation-Based Stress Reduction (MBSR), 2)Supportive- Expressive Group Therapy (SET), and 3) A one day stress-management seminar. The purpose of this study is to determine if these three treatments have different effects on psychological well-being, the immune system, and the amount of stress hormones in the bloodstream.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Study participants must be women diagnosed with Stage I, II, or III breast cancer within the previous 18 months, have completed all treatments with the exception of hormonal therapy at least three months previously, over the age of 18, and have a score of 13 or higher on the BSI-18. Previous meditation/yoga experience is allowed but will be recorded.\n\nExclusion Criteria:\n\n* Participants must not have a concurrent DSM-IV diagnosis of psychosis, substance abuse, bipolar disorder, or active suicidality (as assessed by structured clinical interview), must not be currently using psychotropic medications (antipsychotics, antidepressants, anxiolytics), have a concurrent autoimmune disorder, or have participated previously in MBSR or SET group.'}, 'identificationModule': {'nctId': 'NCT00390169', 'briefTitle': 'Randomized Controlled Trial Comparing MBSR to SET in Breast Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'AHS Cancer Control Alberta'}, 'officialTitle': 'Randomized Controlled Trial Comparing Mindfulness-Based Stress Reduction (MBSR) to Supportive-Expressive Therapy (SET) on Psychological and Biological Outcomes in Breast Cancer Patients', 'orgStudyIdInfo': {'id': '20444'}, 'secondaryIdInfos': [{'id': 'CBCRA #017728'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Mindfulness Meditation-Based Stress Reduction', 'type': 'BEHAVIORAL'}, {'name': 'Supportive-Expressive Group Therapy', 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T2N 4N2', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Tom Baker Cancer Centre', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}], 'overallOfficials': [{'name': 'Linda E Carlson, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AHS Cancer Control Alberta'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Canadian Breast Cancer Research Alliance', 'class': 'OTHER'}, 'collaborators': [{'name': 'British Columbia Cancer Agency', 'class': 'OTHER'}]}}}