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Psychosocial Treatment Effects on Cancer Survival


Phase 3
18 Years
N/A
Not Enrolling
Female
Metastatic/Recurrent Breast Cancer

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Trial Information

Psychosocial Treatment Effects on Cancer Survival


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

David Spiegel, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University

Authority:

United States: Federal Government

Study ID:

R01 MH47226

NCT ID:

NCT00226928

Start Date:

Completion Date:

July 2005

Related Keywords:

  • Metastatic/Recurrent Breast Cancer
  • Breast Neoplasms

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