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Does a Peer Navigator Improve Quality of Life at Diagnosis for Women With Breast Cancer?

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ClinicalTrials.gov Identifier: NCT00186602
Recruitment Status : Unknown
Verified September 2005 by Stanford University.
Recruitment status was:  Active, not recruiting
First Posted : September 16, 2005
Last Update Posted : October 5, 2006
Sponsor:
Collaborators:
California Breast Cancer Research Program
Genentech, Inc.
Amgen
Johnson & Johnson
Google Inc.
Information provided by:
Stanford University

September 14, 2005
September 16, 2005
October 5, 2006
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Complete list of historical versions of study NCT00186602 on ClinicalTrials.gov Archive Site
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Does a Peer Navigator Improve Quality of Life at Diagnosis for Women With Breast Cancer?
Does a Peer Navigator Improve Quality of Life at Diagnosis?

Women indicate the greatest needs for counseling at the time of initial diagnosis for primary breast cancer. The time of initial diagnosis is also often the time of greatest need for information for women and their families. However, this is the time when a woman, overwhelmed by shock and trauma, is least likely to absorb information provided or seek new sources of information. An informed peer navigator with carefully trained communication skills can judge the level of information to disclose and pace that information in a way that can be easily absorbed and understood. She will also provide support. WomenCARE, a well-established Santa Cruz agency providing free support services for women with cancer, and the Psychosocial Treatment Lab at Stanford therefore ask whether women newly diagnosed with breast cancer will improve their quality of life by participating in a peer navigator program. WomenCARE's peer navigators provide emotional support, good listening skills, and information on resources for women just diagnosed with breast cancer. Having a peer counselor while a woman goes through treatment may reduce the magnitude of distress or shorten its time course. It may also reduce distress in family members, and improve relationships with medical personnel.

This study is designed to evaluate the effectiveness of a peer navigator program where a woman newly diagnosed with breast cancer is carefully matched for 3 to 6 months after diagnosis with a trained volunteer who is herself a breast cancer survivor. Navigators and Sojourners (newly diagnosed women) are matched on things that are important to them. Women often want to be matched on the type of surgery or treatment they have received. We assign half of the women (by a process similar to a coin toss) to our peer navigator program and half to a group that receives standard medical care but no peer navigator. In this way we can compare the groups to see whether those matched with a peer navigator have better quality of life over the 3 to 6 month period. All women who join our study, regardless of the group to which they are assigned, get an extra consultation with a nurse specialist at a local hospital. In this consultation, the nurse reviews the cancer resources available to the woman in Santa Cruz County. This meeting is tailored to the woman’s individual diagnosis and situation.

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Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Educational/Counseling/Training
Breast Cancer
Behavioral: Peer counseling
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
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Inclusion Criteria:

women within 2 months of diagnosis of breast cancer can read English within the catchment area of Watsonville and Santa Cruz California -

Exclusion Criteria:

women who have previously had a peer navigator intervention women who have a chronic history of hospitalization for psychiatric reason

Sexes Eligible for Study: Female
20 Years to 85 Years   (Adult, Older Adult)
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Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00186602
7BB-2400
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Stanford University
  • California Breast Cancer Research Program
  • Genentech, Inc.
  • Amgen
  • Johnson & Johnson
  • Google Inc.
Principal Investigator: David Spiegel, M.D. Stanford University
Principal Investigator: Caroline Bliss-Isberg, Ph.D. Cabrillo College
Study Director: Janine Giese-Davis, Ph.D. Stanford University
Stanford University
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP