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

NCT ID: NCT00186602

Last Updated: 2019-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Study Classification

OBSERVATIONAL

Study Start Date

2000-07-01

Study Completion Date

2006-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Peer counseling

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

\-
Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

California Breast Cancer Research Program

OTHER

Sponsor Role collaborator

Genentech, Inc.

INDUSTRY

Sponsor Role collaborator

Amgen

INDUSTRY

Sponsor Role collaborator

Johnson & Johnson

INDUSTRY

Sponsor Role collaborator

Google LLC.

INDUSTRY

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

David Spiegel, M.D.

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Caroline Bliss-Isberg, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Cabrillo College

Janine Giese-Davis, Ph.D.

Role: STUDY_DIRECTOR

Stanford University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

WomenCARE

Santa Cruz, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

12382

Identifier Type: OTHER

Identifier Source: secondary_id

7BB-2400

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Group Interventions for Breast Cancer Survivors
NCT01775085 ACTIVE_NOT_RECRUITING NA