Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 2:59 AM
Study NCT ID:
NCT00186602
Status:
COMPLETED
Last Update Posted:
2019-11-22
First Post:
2005-09-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Does a Peer Navigator Improve Quality of Life at Diagnosis for Women With Breast Cancer?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-09', 'completionDateStruct': {'date': '2006-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-20', 'studyFirstSubmitDate': '2005-09-14', 'studyFirstSubmitQcDate': '2005-09-14', 'lastUpdatePostDateStruct': {'date': '2019-11-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-11-30', 'type': 'ACTUAL'}}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': "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.\n\nThis 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."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '20 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\nwomen within 2 months of diagnosis of breast cancer can read English within the catchment area of Watsonville and Santa Cruz California -\n\nExclusion Criteria:\n\nwomen who have previously had a peer navigator intervention women who have a chronic history of hospitalization for psychiatric reason\n\n\\-'}, 'identificationModule': {'nctId': 'NCT00186602', 'briefTitle': 'Does a Peer Navigator Improve Quality of Life at Diagnosis for Women With Breast Cancer?', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Does a Peer Navigator Improve Quality of Life at Diagnosis?', 'orgStudyIdInfo': {'id': '7BB-2400'}, 'secondaryIdInfos': [{'id': '12382', 'type': 'OTHER', 'domain': 'Stanford-IRB'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Peer counseling', 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '95061', 'city': 'Santa Cruz', 'state': 'California', 'country': 'United States', 'facility': 'WomenCARE', 'geoPoint': {'lat': 36.97412, 'lon': -122.0308}}], 'overallOfficials': [{'name': 'David Spiegel, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}, {'name': 'Caroline Bliss-Isberg, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cabrillo College'}, {'name': 'Janine Giese-Davis, Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Stanford University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'collaborators': [{'name': 'California Breast Cancer Research Program', 'class': 'OTHER'}, {'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}, {'name': 'Amgen', 'class': 'INDUSTRY'}, {'name': 'Johnson & Johnson', 'class': 'INDUSTRY'}, {'name': 'Google LLC.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}