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

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. Identifier: NCT00226928
Recruitment Status : Completed
First Posted : September 27, 2005
Last Update Posted : December 4, 2013
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
David Spiegel, Stanford University

Brief Summary:
This study will investigate the influence of psychosocial treatment on psychological outcomes and survival among women with metastatic or recurrent breast cancer.

Condition or disease Intervention/treatment Phase
Stage IIIB, IV, Recurrent, and Metastatic Breast Cancer Behavioral: Supportive-Expressive Group Therapy plus education Behavioral: Education Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 125 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Psychosocial Treatment Effects on Cancer Survival
Actual Study Completion Date : July 2005

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Information from the National Library of Medicine

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

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.

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 identifier (NCT number): NCT00226928

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

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: David Spiegel, Jack, Lulu & Sam Willson Professor, Stanford University Identifier: NCT00226928    
Other Study ID Numbers: R01MH047226 ( U.S. NIH Grant/Contract )
R01MH047226 ( U.S. NIH Grant/Contract )
First Posted: September 27, 2005    Key Record Dates
Last Update Posted: December 4, 2013
Last Verified: December 2013
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases