NCT00226928

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P50-P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 27, 2005

Completed
Last Updated

December 4, 2013

Status Verified

December 1, 2013

First QC Date

September 12, 2005

Last Update Submit

December 2, 2013

Conditions

Stage IIIB, IV, Recurrent, and Metastatic Breast Cancer

Interventions

Supportive-Expressive Group Therapy plus educationBEHAVIORAL
EducationBEHAVIORAL

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (16)

  • 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.

    PMID: 15452896RESULT

  • 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.

    PMID: 15546233RESULT

  • 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.

    PMID: 15331215RESULT

  • 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.

    PMID: 15125744RESULT

  • 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.

    PMID: 12764215RESULT

  • 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.

    PMID: 12390359RESULT

  • 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.

    PMID: 12182275RESULT

  • 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.

    PMID: 11906445RESULT

  • 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.

    PMID: 11343530RESULT

  • 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.

    PMID: 10845347RESULT

  • 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.

    PMID: 10619528RESULT

  • 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.

    PMID: 9589508RESULT

  • 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.

    PMID: 8973923RESULT

  • 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.

    PMID: 10861311RESULT

  • 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.

    PMID: 19751084DERIVED

  • 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.

    PMID: 17647221DERIVED

MeSH Terms

Conditions

RecurrenceBreast Neoplasms

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • David Spiegel, M.D.

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Jack, Lulu & Sam Willson Professor

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 27, 2005

Study Completion

July 1, 2005

Last Updated

December 4, 2013

Record last verified: 2013-12