Ignite Creation Date:
2025-12-24 @ 3:42 PM
Ignite Modification Date:
2026-03-04 @ 10:25 PM
Study NCT ID:
NCT00220792
Status:
COMPLETED
Last Update Posted:
2024-08-26
First Post:
2005-09-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Group Therapy for Primary 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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'count': 480}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1993-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '1998-06'}, 'lastUpdateSubmitDate': '2024-08-23', 'studyFirstSubmitDate': '2005-09-15', 'studyFirstSubmitQcDate': '2005-09-15', 'lastUpdatePostDateStruct': {'date': '2024-08-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-09-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of change in mood disturbance assessed by the Profile of Mood States at baseline, 3 mo, 6 mo, 12 mo, 18 mo and 24 mo.'}]}, 'conditionsModule': {'keywords': ['Primary breast cancer', 'support groups', 'mood disturbance'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '15386762', 'type': 'BACKGROUND', 'citation': "Han WT, Collie K, Koopman C, Azarow J, Classen C, Morrow GR, Michel B, Brennan-O'Neill E, Spiegel D. Breast cancer and problems with medical interactions: relationships with traumatic stress, emotional self-efficacy, and social support. Psychooncology. 2005 Apr;14(4):318-30. doi: 10.1002/pon.852."}, {'pmid': '12228876', 'type': 'BACKGROUND', 'citation': "Fobair P, Koopman C, DiMiceli S, O'Hanlan K, Butler LD, Classen C, Drooker N, Davids HR, Loulan J, Wallsten D, Spiegel D. Psychosocial intervention for lesbians with primary breast cancer. Psychooncology. 2002 Sep-Oct;11(5):427-38. doi: 10.1002/pon.624."}, {'pmid': '12224799', 'type': 'BACKGROUND', 'citation': 'Koopman C, Butler LD, Classen C, Giese-Davis J, Morrow GR, Westendorf J, Banerjee T, Spiegel D. Traumatic stress symptoms among women with recently diagnosed primary breast cancer. J Trauma Stress. 2002 Aug;15(4):277-87. doi: 10.1023/A:1016295610660.'}, {'pmid': '11180576', 'type': 'BACKGROUND', 'citation': "Fobair P, O'Hanlan K, Koopman C, Classen C, Dimiceli S, Drooker N, Warner D, Davids H, Loulan J, Wallsten D, Goffinet D, Morrow G, Spiegel D. Comparison of lesbian and heterosexual women's response to newly diagnosed breast cancer. Psychooncology. 2001 Jan-Feb;10(1):40-51. doi: 10.1002/1099-1611(200101/02)10:13.0.co;2-s."}, {'pmid': '10607981', 'type': 'BACKGROUND', 'citation': 'Spiegel D, Morrow GR, Classen C, Raubertas R, Stott PB, Mudaliar N, Pierce HI, Flynn PJ, Heard L, Riggs G. Group psychotherapy for recently diagnosed breast cancer patients: a multicenter feasibility study. Psychooncology. 1999 Nov-Dec;8(6):482-93. doi: 10.1002/(sici)1099-1611(199911/12)8:63.0.co;2-w.'}, {'pmid': '9185066', 'type': 'BACKGROUND', 'citation': "Classen C, Abramson S, Angell K, Atkinson A, Desch C, Vinciguerra VP, Rosenbluth RJ, Kirshner JJ, Hart R, Morrow G, Spiegel D. Effectiveness of a training program for enhancing therapists' understanding of the supportive-expressive treatment model for breast cancer groups. J Psychother Pract Res. 1997 Summer;6(3):211-8."}, {'type': 'BACKGROUND', 'citation': 'Spiegel, D., Morrow, G.R., Classen, C., Riggs, G., Stott, P.B., Mudaliar, N., Pierce, H.I., Flynn, P.J., & Heard, L. (1996). Effects of group therapy on women with primary breast cancer. The Breast Journal, 2(1), 104-106.'}, {'type': 'BACKGROUND', 'citation': "Azarow, J., Han W.T., Koopman, C., Classen C., Morrow G.R., & Spiegel, D. (2001) Traumatic stress, pain, and self-efficacy are related to breast cancer patients' satisfaction with care. Psychosomatic Medicine, 63, 1, 1130"}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether women with primary breast cancer who were randomly assigned to receive a brief group therapy would show a greater reduction in mood disturbance over time compared to those randomized to the control condition. We also hypothesized that women who were highly distressed at baseline would show the greatest benefit from participating in a support group, and that therapists with more training and experience would be most effective in reducing distress.', 'detailedDescription': 'Breast cancer patients often experience significant psychological distress after diagnosis and during initial treatment. Group interventions for cancer patients have been shown to improve psychological adjustment. The tests of efficacy for these interventions have typically taken place in university settings using highly developed models of intervention. Our aim was to test our supportive-expressive model in community oncology practices utilizing personnel already working with these populations. To conduct this study of group therapy for primary breast cancer patients, we developed a brief version of the supportive-expressive model (Classen et al., 1993). Our first aim was to test the efficacy of this intervention for reducing mood disturbance for women who received the intervention compared to a control group. A second aim was to examine who was most likely to benefit from the intervention. A third aim was to see if this method could be taught efficiently and effectively to oncology nurses and mental health professionals.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* : 1) diagnosis of primary, biopsy-proven breast cancer, stages I through IIIA; 2) diagnosis occurred no more than 12 months prior to recruitment; 3) completion of initial surgical treatment; and 4) no detectable disease present.\n\nExclusion Criteria:\n\n* 1\\) evidence of metastases beyond adjacent lymph nodes, including chest wall involvement, bone or viscera; 2) recurrence of the cancer prior to randomization; 3) diagnosis of other cancers (except for basal cell or squamous cell carcinoma of the skin or in situ cervical cancer) within the past 10 years; 4) any other major medical problems likely to limit life expectancy to less than 10 years; 5) a history of major psychiatric illness for which the patient was hospitalized or medicated, except for a diagnosis of depression or anxiety treated for a period of less than one year; and 6) attendance at a cancer support group for more than two months.'}, 'identificationModule': {'nctId': 'NCT00220792', 'briefTitle': 'Group Therapy for Primary Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'A Multicenter Trial of Group Therapy for Breast Cancer', 'orgStudyIdInfo': {'id': 'CA61309'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Brief supportive-expressive group therapy', 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '67202', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'Social Work Consultants, Inc', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '49007', 'city': 'Kalamazoo', 'state': 'Michigan', 'country': 'United States', 'facility': 'Kalamazoo Community Clinical Oncology Program', 'geoPoint': {'lat': 42.29171, 'lon': -85.58723}}, {'zip': '55416', 'city': 'Saint Louis Park', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Metro-Minnesota CCOP', 'geoPoint': {'lat': 44.9483, 'lon': -93.34801}}, {'zip': '07601', 'city': 'Hackensack', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Northern New Jersey CCOP', 'geoPoint': {'lat': 40.88593, 'lon': -74.04347}}, {'zip': '11030', 'city': 'Manhasset', 'state': 'New York', 'country': 'United States', 'facility': 'North Shore University Hospital CCOP', 'geoPoint': {'lat': 40.79788, 'lon': -73.69957}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'University of Rochester CCOP', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '13210', 'city': 'Syracuse', 'state': 'New York', 'country': 'United States', 'facility': 'Syracuse Hem/Onc CCOP', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}, {'zip': '98405', 'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'facility': 'Northwest CCOP', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}, {'zip': '54449', 'city': 'Marshfield', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Marshfield Medical Research Foundation', 'geoPoint': {'lat': 44.66885, 'lon': -90.1718}}, {'zip': '53215', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Milwaukee CCOP', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'overallOfficials': [{'name': 'David Spiegel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, {'name': 'Cummings Foundation', 'class': 'UNKNOWN'}]}}}