- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00226928
Psychosocial Treatment for Improving Chances of Survival in Women With Breast Cancer
Psychosocial Treatment Effects on Cancer Survival
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Women were eligible for the study if they had documented metastatic or recurrent breast cancer, were proficient enough in English to be able to complete questionnaires and participate in a support group, were living in the Greater San Francisco Bay Area, and had a Karnofsky score of at least 70%.19 Exclusion Criteria:
Women were excluded if they had any of the following risk factors: positive supraclavicular lymph nodes as the only metastatic lesion at the time of initial diagnosis; active non-breast cancers within the past 10 years; or other concurrent medical conditions likely to influence short-term survival. Basal cell or squamous cell carcinomas of the skin, in situ cancer of the cervix, or melanoma with a Breslow depth less than 0.76 mm were allowed.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: David Spiegel, M.D., Stanford University
Publications and helpful links
General Publications
- Butler LD, Field NP, Busch AL, Seplaki JE, Hastings TA, Spiegel D. Anticipating loss and other temporal stressors predict traumatic stress symptoms among partners of metastatic/recurrent breast cancer patients. Psychooncology. 2005 Jun;14(6):492-502. doi: 10.1002/pon.865.
- Giese-Davis J, Sephton SE, Abercrombie HC, Duran RE, Spiegel D. Repression and high anxiety are associated with aberrant diurnal cortisol rhythms in women with metastatic breast cancer. Health Psychol. 2004 Nov;23(6):645-50. doi: 10.1037/0278-6133.23.6.645.
- Turner-Cobb JM, Koopman C, Rabinowitz JD, Terr AI, Sephton SE, Spiegel D. The interaction of social network size and stressful life events predict delayed-type hypersensitivity among women with metastatic breast cancer. Int J Psychophysiol. 2004 Nov;54(3):241-9. doi: 10.1016/j.ijpsycho.2004.05.010.
- Blake-Mortimer JS, Sephton SE, Carlson RW, Stites D, Spiegel D. Cytotoxic T lymphocyte count and survival time in women with metastatic breast cancer. Breast J. 2004 May-Jun;10(3):195-9. doi: 10.1111/j.1075-122X.2004.21290.x.
- Butler LD, Koopman C, Cordova MJ, Garlan RW, DiMiceli S, Spiegel D. Psychological distress and pain significantly increase before death in metastatic breast cancer patients. Psychosom Med. 2003 May-Jun;65(3):416-26. doi: 10.1097/01.psy.0000041472.77692.c6.
- Koopman C, Nouriani B, Erickson V, Anupindi R, Butler LD, Bachmann MH, Sephton SE, Spiegel D. Sleep disturbances in women with metastatic breast cancer. Breast J. 2002 Nov-Dec;8(6):362-70. doi: 10.1046/j.1524-4741.2002.08606.x.
- Giese-Davis J, Koopman C, Butler LD, Classen C, Cordova M, Fobair P, Benson J, Kraemer HC, Spiegel D. Change in emotion-regulation strategy for women with metastatic breast cancer following supportive-expressive group therapy. J Consult Clin Psychol. 2002 Aug;70(4):916-25. doi: 10.1037//0022-006x.70.4.916.
- Sephton SE, Koopman C, Schaal M, Thoresen C, Spiegel D. Spiritual expression and immune status in women with metastatic breast cancer: an exploratory study. Breast J. 2001 Sep-Oct;7(5):345-53. doi: 10.1046/j.1524-4741.2001.20014.x.
- Classen C, Butler LD, Koopman C, Miller E, DiMiceli S, Giese-Davis J, Fobair P, Carlson RW, Kraemer HC, Spiegel D. Supportive-expressive group therapy and distress in patients with metastatic breast cancer: a randomized clinical intervention trial. Arch Gen Psychiatry. 2001 May;58(5):494-501. doi: 10.1001/archpsyc.58.5.494.
- Turner-Cobb JM, Sephton SE, Koopman C, Blake-Mortimer J, Spiegel D. Social support and salivary cortisol in women with metastatic breast cancer. Psychosom Med. 2000 May-Jun;62(3):337-45. doi: 10.1097/00006842-200005000-00007.
- Butler LD, Koopman C, Classen C, Spiegel D. Traumatic stress, life events, and emotional support in women with metastatic breast cancer: cancer-related traumatic stress symptoms associated with past and current stressors. Health Psychol. 1999 Nov;18(6):555-60. doi: 10.1037//0278-6133.18.6.555.
- Koopman C, Hermanson K, Diamond S, Angell K, Spiegel D. Social support, life stress, pain and emotional adjustment to advanced breast cancer. Psychooncology. 1998 Mar-Apr;7(2):101-11. doi: 10.1002/(SICI)1099-1611(199803/04)7:23.0.CO;2-3.
- Classen C, Koopman C, Angell K, Spiegel D. Coping styles associated with psychological adjustment to advanced breast cancer. Health Psychol. 1996 Nov;15(6):434-7. doi: 10.1037//0278-6133.15.6.434.
- Sephton SE, Sapolsky RM, Kraemer HC, Spiegel D. Diurnal cortisol rhythm as a predictor of breast cancer survival. J Natl Cancer Inst. 2000 Jun 21;92(12):994-1000. doi: 10.1093/jnci/92.12.994.
- Butler LD, Koopman C, Neri E, Giese-Davis J, Palesh O, Thorne-Yocam KA, Dimiceli S, Chen XH, Fobair P, Kraemer HC, Spiegel D. Effects of supportive-expressive group therapy on pain in women with metastatic breast cancer. Health Psychol. 2009 Sep;28(5):579-87. doi: 10.1037/a0016124.
- Spiegel D, Butler LD, Giese-Davis J, Koopman C, Miller E, DiMiceli S, Classen CC, Fobair P, Carlson RW, Kraemer HC. Effects of supportive-expressive group therapy on survival of patients with metastatic breast cancer: a randomized prospective trial. Cancer. 2007 Sep 1;110(5):1130-8. doi: 10.1002/cncr.22890.
Study record dates
Study Major Dates
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01MH047226 (U.S. NIH Grant/Contract)
- DAHBR HB-C
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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