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

Stage IIIB, IV, Recurrent, and Metastatic Breast Cancer Clinical Trial

Official title:

Psychosocial Treatment Effects on Cancer Survival

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00226928
• Other study ID #: R01MH047226
• Secondary ID: R01MH047226DAHBR
• Status: Completed
• Phase: N/A
• First received: September 12, 2005
• Last updated: December 2, 2013
• Est. completion date: July 2005

Study information

• Verified date: December 2013
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stage IIIB, IV, Recurrent, and Metastatic Breast Cancer

Intervention

Behavioral:
• Supportive-Expressive Group Therapy plus education

• Education

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Institute of Mental Health (NIMH)

References & Publications (14)

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. — View Citation

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. — View Citation

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):55 — View Citation

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. — View Citation

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 G — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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) — View Citation

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. — View Citation

* Note: There are 14 references in all — Click here to view all references