NCT00186602

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.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Jul 2000

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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 Start

First participant enrolled

July 1, 2000

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2006

Completed
Last Updated

November 22, 2019

Status Verified

September 1, 2005

Enrollment Period

6.4 years

First QC Date

September 14, 2005

Last Update Submit

November 20, 2019

Conditions

Interventions

Peer counselingBEHAVIORAL

Eligibility Criteria

Age20 Years - 85 Years
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

WomenCARE

Santa Cruz, California, 95061, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • David Spiegel, M.D.

    Stanford University

    PRINCIPAL INVESTIGATOR
  • Caroline Bliss-Isberg, Ph.D.

    Cabrillo College

    PRINCIPAL INVESTIGATOR
  • Janine Giese-Davis, Ph.D.

    Stanford University

    STUDY DIRECTOR

Study Design

Study Type
observational
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2005

First Posted

September 16, 2005

Study Start

July 1, 2000

Primary Completion

November 30, 2006

Study Completion

November 30, 2006

Last Updated

November 22, 2019

Record last verified: 2005-09

Locations