Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-25 @ 9:34 PM
Study NCT ID:
NCT01422551
Status:
COMPLETED
Last Update Posted:
2011-08-24
First Post:
2011-08-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Facilitating Positive Adaptation to Breast Cancer
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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 240}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-22', 'studyFirstSubmitDate': '2011-08-21', 'studyFirstSubmitQcDate': '2011-08-22', 'lastUpdatePostDateStruct': {'date': '2011-08-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change from baseline to 12 month follow-up in psychosocial adaptation (less negative affect and social disruption; more benefit finding and positive affect)', 'timeFrame': 'baseline and 6 and 12 month follow-up', 'description': 'changes in a composite composed of negative affect measures plus a measure of social disruption plus a measure of benefit finding plus a measure of positive affect'}], 'secondaryOutcomes': [{'measure': 'change from baseline to 12 months in physiological adaptation (decreased serum cortisol and increased Th1 cytokine production)', 'timeFrame': 'baseline and 6 and 12 months follow-up', 'description': 'decreased PM levels of serum cortisol and increased Th1 (interleukin-2, interferon-gamma) cytokine production following anti-CD3 stimulation of peripheral blood mononuclear cells (PBMCs)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['stress management intervention', 'breast cancer', 'quality of life', 'psychosocial adaptation'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '17012691', 'type': 'RESULT', 'citation': 'Antoni MH, Wimberly SR, Lechner SC, Kazi A, Sifre T, Urcuyo KR, Phillips K, Smith RG, Petronis VM, Guellati S, Wells KA, Blomberg B, Carver CS. Reduction of cancer-specific thought intrusions and anxiety symptoms with a stress management intervention among women undergoing treatment for breast cancer. Am J Psychiatry. 2006 Oct;163(10):1791-7. doi: 10.1176/ajp.2006.163.10.1791.'}, {'pmid': '17154743', 'type': 'RESULT', 'citation': 'Antoni MH, Lechner SC, Kazi A, Wimberly SR, Sifre T, Urcuyo KR, Phillips K, Gluck S, Carver CS. How stress management improves quality of life after treatment for breast cancer. J Consult Clin Psychol. 2006 Dec;74(6):1143-52. doi: 10.1037/0022-006X.74.6.1152.'}, {'pmid': '18835434', 'type': 'RESULT', 'citation': 'Antoni MH, Lechner S, Diaz A, Vargas S, Holley H, Phillips K, McGregor B, Carver CS, Blomberg B. Cognitive behavioral stress management effects on psychosocial and physiological adaptation in women undergoing treatment for breast cancer. Brain Behav Immun. 2009 Jul;23(5):580-91. doi: 10.1016/j.bbi.2008.09.005. Epub 2008 Sep 20.'}, {'pmid': '18842742', 'type': 'RESULT', 'citation': 'Phillips KM, Antoni MH, Lechner SC, Blomberg BB, Llabre MM, Avisar E, Gluck S, DerHagopian R, Carver CS. Stress management intervention reduces serum cortisol and increases relaxation during treatment for nonmetastatic breast cancer. Psychosom Med. 2008 Nov;70(9):1044-9. doi: 10.1097/PSY.0b013e318186fb27. Epub 2008 Oct 8.'}, {'pmid': '19837199', 'type': 'RESULT', 'citation': 'Blomberg BB, Alvarez JP, Diaz A, Romero MG, Lechner SC, Carver CS, Holley H, Antoni MH. Psychosocial adaptation and cellular immunity in breast cancer patients in the weeks after surgery: An exploratory study. J Psychosom Res. 2009 Nov;67(5):369-76. doi: 10.1016/j.jpsychores.2009.05.016. Epub 2009 Sep 24.'}, {'pmid': '28560656', 'type': 'DERIVED', 'citation': 'Jutagir DR, Blomberg BB, Carver CS, Lechner SC, Timpano KR, Bouchard LC, Gudenkauf LM, Jacobs JM, Diaz A, Lutgendorf SK, Cole SW, Heller AS, Antoni MH. Social well-being is associated with less pro-inflammatory and pro-metastatic leukocyte gene expression in women after surgery for breast cancer. Breast Cancer Res Treat. 2017 Aug;165(1):169-180. doi: 10.1007/s10549-017-4316-3. Epub 2017 May 30.'}, {'pmid': '27689900', 'type': 'DERIVED', 'citation': 'Antoni MH, Bouchard LC, Jacobs JM, Lechner SC, Jutagir DR, Gudenkauf LM, Carver CS, Lutgendorf S, Cole SW, Lippman M, Blomberg BB. Stress management, leukocyte transcriptional changes and breast cancer recurrence in a randomized trial: An exploratory analysis. Psychoneuroendocrinology. 2016 Dec;74:269-277. doi: 10.1016/j.psyneuen.2016.09.012. Epub 2016 Sep 24.'}, {'pmid': '26569533', 'type': 'DERIVED', 'citation': 'Bouchard LC, Antoni MH, Blomberg BB, Stagl JM, Gudenkauf LM, Jutagir DR, Diaz A, Lechner S, Gluck S, Derhagopian RP, Carver CS. Postsurgical Depressive Symptoms and Proinflammatory Cytokine Elevations in Women Undergoing Primary Treatment for Breast Cancer. Psychosom Med. 2016 Jan;78(1):26-37. doi: 10.1097/PSY.0000000000000261.'}, {'pmid': '25809235', 'type': 'DERIVED', 'citation': 'Stagl JM, Bouchard LC, Lechner SC, Blomberg BB, Gudenkauf LM, Jutagir DR, Gluck S, Derhagopian RP, Carver CS, Antoni MH. Long-term psychological benefits of cognitive-behavioral stress management for women with breast cancer: 11-year follow-up of a randomized controlled trial. Cancer. 2015 Jun 1;121(11):1873-81. doi: 10.1002/cncr.29076. Epub 2015 Mar 23.'}, {'pmid': '24318654', 'type': 'DERIVED', 'citation': 'Vargas S, Antoni MH, Carver CS, Lechner SC, Wohlgemuth W, Llabre M, Blomberg BB, Gluck S, DerHagopian RP. Sleep quality and fatigue after a stress management intervention for women with early-stage breast cancer in southern Florida. Int J Behav Med. 2014 Dec;21(6):971-81. doi: 10.1007/s12529-013-9374-2.'}, {'pmid': '22088795', 'type': 'DERIVED', 'citation': 'Antoni MH, Lutgendorf SK, Blomberg B, Carver CS, Lechner S, Diaz A, Stagl J, Arevalo JM, Cole SW. Cognitive-behavioral stress management reverses anxiety-related leukocyte transcriptional dynamics. Biol Psychiatry. 2012 Feb 15;71(4):366-72. doi: 10.1016/j.biopsych.2011.10.007. Epub 2011 Nov 16.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test the effects of a 10-wk cognitive behavioral stress management (CBSM) intervention vs. a single-day psycho-educational seminar on psychosocial adaptation and physiological adaptation in women being treated for stage I-III breast cancer.', 'detailedDescription': 'The study tests the effects of a 10-wk group-based cognitive behavioral stress management (CBSM) intervention (relaxation, stress awareness, cognitive restructuring, coping skills training, interpersonal skills training) versus a single-day psycho-educational seminar (general information about stress and coping) in women who have recently had surgery for breast cancer but have not yet started adjuvant therapy. The study evaluates the effects of CBSM on psychosocial adaptation (includes measures of negative adaptation \\[distress and social disruption\\] and positive adaptation \\[benefit finding and positive affect\\]) at 6-month and 12-month follow-up. The study also evaluates the effects of CBSM on physiological adaptation (includes levels of PM serum cortisol and T-helper-type 1 (Th1) cytokine \\[interleukin-2, IL-2, and interferon-gamma, IFN-g, production after anti-CD3 stimulation of peripheral blood mononuclear cells (PBMC).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-women diagnosed with breast cancer at stage III or below who had recently undergone lumpectomy or mastectomy\n\nExclusion Criteria:\n\n* prior cancer,\n* prior psychiatric treatment for a serious disorder (e.g., psychosis, suicidality),\n* lack of fluency in English and had begun adjuvant therapy at time of first assessment'}, 'identificationModule': {'nctId': 'NCT01422551', 'briefTitle': 'Facilitating Positive Adaptation to Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'Facilitating Positive Adaptation to Breast Cancer', 'orgStudyIdInfo': {'id': '19930536'}, 'secondaryIdInfos': [{'id': 'R01CA064710', 'link': 'https://reporter.nih.gov/quickSearch/R01CA064710', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cognitive Behavioral Stress Management', 'description': '10 weekly 2-hour sessions of group-based cognitive behavioral stress management', 'interventionNames': ['Behavioral: Cognitive Behavioral Stress Management']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Psycho-educational Control', 'description': 'a single day group-based psycho-educational seminar', 'interventionNames': ['Behavioral: a psycho-educational control']}], 'interventions': [{'name': 'Cognitive Behavioral Stress Management', 'type': 'BEHAVIORAL', 'description': '10 weekly 2-hour sessions of group-based cognitive behavioral stress management', 'armGroupLabels': ['Cognitive Behavioral Stress Management']}, {'name': 'a psycho-educational control', 'type': 'BEHAVIORAL', 'description': 'a single-day psycho-educational seminar', 'armGroupLabels': ['Psycho-educational Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33124', 'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'facility': 'Department of Psychology University of Miami', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}], 'overallOfficials': [{'name': 'Michael Antoni, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Michael H. Antoni', 'investigatorAffiliation': 'University of Miami'}}}}