Ignite Creation Date:
2025-12-25 @ 4:28 AM
Ignite Modification Date:
2025-12-26 @ 3:31 AM
Study NCT ID:
NCT01450020
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-18
First Post:
2011-10-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Peer Navigator Education in Improving Survivorship Care in African American Breast Cancer Survivors
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018479', 'term': 'Early Intervention, Educational'}, {'id': 'D008722', 'term': 'Methods'}, {'id': 'D003376', 'term': 'Counseling'}], 'ancestors': [{'id': 'D002662', 'term': 'Child Health Services'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D008605', 'term': 'Mental Health Services'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 145}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-16', 'studyFirstSubmitDate': '2011-10-06', 'studyFirstSubmitQcDate': '2011-10-11', 'lastUpdatePostDateStruct': {'date': '2025-07-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-10-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ability of peer navigation to improve understanding of SCP', 'timeFrame': 'At 6 months', 'description': 'Chi-square and t-tests will be used to compare the baseline characteristics of subjects randomized to PN intervention vs control. For subjects in the intervention arm, the number of navigation sessions received will be reported, and correlated factors will be explored. The number of subjects navigated per PN will also be reported. Nonevaluable and evaluable subjects (defined at 6 and 12 months) will be compared. Site of care will be handled as a cluster level variable in generalized linear mixed (GLM) regression models.'}, {'measure': 'Adherence to the SCP schedule of follow-up examinations', 'timeFrame': 'At 12 months', 'description': 'Measured using a newly created, 50-point scale that gives equal weight to completion of the recommended: physical exams, imaging, pelvic exam, annual oncology visit, and breast self-exams.'}], 'secondaryOutcomes': [{'measure': 'Effect of PN on change in medical efficacy', 'timeFrame': 'Baseline to 6 months', 'description': "Exploratory analyses will analyze the effect of PN intervention actually received, using the number of PN sessions completed and the quality of the subject's PN as measured by PN's post-training level of acuity and utility."}, {'measure': 'Preparedness for life as new survivor (PLANS)', 'timeFrame': 'At 6 months', 'description': "PLANS consists of two subscales that measure patients' knowledge and self efficacy with regards to their Access and Quality of Survivorship Care Plan (SCP) and adherence with regard to following these tasks. The knowledge subscale (Cronbach's alpha 0.90) and adherence subscale (Cronbach's alpha 0.70) have good reliability."}, {'measure': 'Physical and health related QOL', 'timeFrame': 'At 6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['cancer survivor'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This randomized clinical trial studies peer navigator education in improving survivorship care in African American breast cancer survivors. An educational intervention involving peer groups may help to improve the well-being and quality of life (QOL) in breast cancer survivors', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To evaluate the ability of peer navigation (PN) to improve understanding of survivorship care planning (SCP) at 6 months.\n\nII. To promote adherence to the SCP schedule of follow-up examinations at 12 months.\n\nSECONDARY OBJECTIVES:\n\nI. To evaluate the effect of PN on change from baseline in medical efficacy, preparedness for life as new survivor, and physical and health related QOL at 6 months.\n\nOUTLINE: PNs are trained on medical issues and resources, and SCP. Participants are then randomized to 1 of 2 treatment arms.\n\nARM I: Participants receive 4 PN sessions tailored to their needs followed by a 6 month booster session and American Cancer Society (ACS) materials.\n\nARM II: Participants receive ACS materials.\n\nAfter completion of study treatment, patients are followed up at 6 and 12 months.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* TRIAL SUBJECTS:\n* Patient age 18 years or older who self-identifies as African-American\n* In early survivorship phase, defined as being 1-12 months post completion of treatment for stage 0-3 breast cancer\n* Receiving health care primarily through an health maintenance organization (HMO)\n* Patients with metastatic cancer or a second primary cancer, because their medical characteristics (e.g. disease progression) are significantly different\n* Breast cancer survivors (BCS) with other major disabling medical, psychiatric, or substance abuse conditions (e.g., anxiety, depression, alcohol/tobacco problems) will be excluded\n* PEER NAVIGATORS:\n* At least 25 years of age who self-identifies as African-American\n* Previously participated in any type of research study\n* Has at least high school education\n* Has been diagnosed with breast cancer, currently in remission or eradicated\n* Belongs to a breast cancer support group\n* Has a valid driver's license\n* Owns an operational vehicle\n* Has access to a personal computer with internet access"}, 'identificationModule': {'nctId': 'NCT01450020', 'briefTitle': 'Peer Navigator Education in Improving Survivorship Care in African American Breast Cancer Survivors', 'organization': {'class': 'OTHER', 'fullName': 'City of Hope Medical Center'}, 'officialTitle': 'Sister Survivor: Improving the Survivorship Care of African-American Women With Breast Cancer', 'orgStudyIdInfo': {'id': '11115'}, 'secondaryIdInfos': [{'id': 'NCI-2011-03229', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm I (PN and ACS material)', 'description': 'Participants receive 4 PN sessions tailored to their needs followed by a 6 month booster session and ACS materials.', 'interventionNames': ['Other: educational intervention', 'Other: questionnaire administration', 'Other: counseling intervention', 'Other: survey administration', 'Procedure: quality-of-life assessment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm II (ACS material)', 'description': 'Participants receive ACS materials only.', 'interventionNames': ['Other: educational intervention', 'Other: questionnaire administration', 'Other: survey administration', 'Procedure: quality-of-life assessment']}], 'interventions': [{'name': 'educational intervention', 'type': 'OTHER', 'otherNames': ['intervention, educational'], 'description': 'Receive ACS material', 'armGroupLabels': ['Arm I (PN and ACS material)', 'Arm II (ACS material)']}, {'name': 'questionnaire administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Arm I (PN and ACS material)', 'Arm II (ACS material)']}, {'name': 'counseling intervention', 'type': 'OTHER', 'otherNames': ['counseling and communications studies'], 'description': 'Undergo PN session', 'armGroupLabels': ['Arm I (PN and ACS material)']}, {'name': 'survey administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Arm I (PN and ACS material)', 'Arm II (ACS material)']}, {'name': 'quality-of-life assessment', 'type': 'PROCEDURE', 'otherNames': ['quality of life assessment'], 'description': 'Ancillary studies', 'armGroupLabels': ['Arm I (PN and ACS material)', 'Arm II (ACS material)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91010', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope Medical Center', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}], 'overallOfficials': [{'name': 'Kimlin Ashing-Giwa', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'City of Hope Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'City of Hope Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}