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

Primary Purpose

Breast Cancer

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Peer counseling
Sponsored by
Stanford University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Breast Cancer

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)Female

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 -

Sites / Locations

  • WomenCARE

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 14, 2005
Last Updated
November 20, 2019
Sponsor
Stanford University
Collaborators
California Breast Cancer Research Program, Genentech, Inc., Amgen, Johnson & Johnson, Google LLC.
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1. Study Identification

Unique Protocol Identification Number
NCT00186602
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?
Study Type
Observational

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
July 1, 2000 (Actual)
Primary Completion Date
November 30, 2006 (Actual)
Study Completion Date
November 30, 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stanford University
Collaborators
California Breast Cancer Research Program, Genentech, Inc., Amgen, Johnson & Johnson, Google LLC.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Peer counseling

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
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 -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Spiegel, M.D.
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Caroline Bliss-Isberg, Ph.D.
Organizational Affiliation
Cabrillo College
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Janine Giese-Davis, Ph.D.
Organizational Affiliation
Stanford University
Official's Role
Study Director
Facility Information:
Facility Name
WomenCARE
City
Santa Cruz
State/Province
California
ZIP/Postal Code
95061
Country
United States

12. IPD Sharing Statement

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

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