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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 : Completed
First Posted : September 16, 2005
Last Update Posted : November 22, 2019
Sponsor:
Collaborators:
California Breast Cancer Research Program
Genentech, Inc.
Amgen
Johnson & Johnson
Google LLC.
Information provided by (Responsible Party):
Stanford University

Tracking Information
First Submitted Date September 14, 2005
First Posted Date September 16, 2005
Last Update Posted Date November 22, 2019
Actual Study Start Date July 1, 2000
Actual Primary Completion Date November 30, 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Does a Peer Navigator Improve Quality of Life at Diagnosis for Women With Breast Cancer?
Official Title Does a Peer Navigator Improve Quality of Life at Diagnosis?
Brief Summary

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.

Detailed Description Not Provided
Study Type Observational
Study Design Not Provided
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition Breast Cancer
Intervention Behavioral: Peer counseling
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Enrollment Not Provided
Original Enrollment Not Provided
Actual Study Completion Date November 30, 2006
Actual Primary Completion Date November 30, 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria

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

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Sex/Gender
Sexes Eligible for Study: Female
Ages 20 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00186602
Other Study ID Numbers 7BB-2400
12382 ( Other Identifier: Stanford-IRB )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Stanford University
Study Sponsor Stanford University
Collaborators
  • California Breast Cancer Research Program
  • Genentech, Inc.
  • Amgen
  • Johnson & Johnson
  • Google LLC.
Investigators
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
PRS Account Stanford University
Verification Date September 2005