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Psychosocial Treatment for Improving Chances of Survival in Women With Breast Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00226928
First Posted: September 27, 2005
Last Update Posted: December 4, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
David Spiegel, Stanford University
  Purpose
This study will investigate the influence of psychosocial treatment on psychological outcomes and survival among women with metastatic or recurrent breast cancer.

Condition Intervention
Stage IIIB, IV, Recurrent, and Metastatic Breast Cancer Behavioral: Supportive-Expressive Group Therapy plus education Behavioral: Education

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Psychosocial Treatment Effects on Cancer Survival

Resource links provided by NLM:


Further study details as provided by David Spiegel, Stanford University:

Enrollment: 125
Study Completion Date: July 2005
Detailed Description:
The objective of this study is to investigate the influence of psychosocial treatment on psychological outcomes and survival among women with metastatic/recurrent breast cancer.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00226928


Sponsors and Collaborators
Stanford University
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: David Spiegel, M.D. Stanford University
  More Information

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.
Giese-Davis J, Sephton SE, Abercrombie HC, Durán 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: David Spiegel, Jack, Lulu & Sam Willson Professor, Stanford University
ClinicalTrials.gov Identifier: NCT00226928     History of Changes
Other Study ID Numbers: R01MH047226 ( U.S. NIH Grant/Contract )
DAHBR HB-C
First Submitted: September 12, 2005
First Posted: September 27, 2005
Last Update Posted: December 4, 2013
Last Verified: December 2013

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases


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