Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:12 AM
Study NCT ID:
NCT00903305
Status:
WITHDRAWN
Last Update Posted:
2013-02-01
First Post:
2009-05-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Nurse-Provided Care or Standard Care in Treating Patients With Stage I, Stage II, or Stage III Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D005221', 'term': 'Fatigue'}, {'id': 'D009325', 'term': 'Nausea'}, {'id': 'D014839', 'term': 'Vomiting'}, {'id': 'D010146', 'term': 'Pain'}], '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'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D000067250', 'term': 'Psychiatric Rehabilitation'}], 'ancestors': [{'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-30', 'studyFirstSubmitDate': '2009-05-15', 'studyFirstSubmitQcDate': '2009-05-15', 'lastUpdatePostDateStruct': {'date': '2013-02-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of life, psychological distress, symptom relief, geriatric assessment outcome, and resource use at 3 months'}, {'measure': 'Long-term impact at 6 months'}]}, 'conditionsModule': {'keywords': ['pain', 'fatigue', 'nausea and vomiting', 'stage I breast cancer', 'stage II breast cancer', 'stage IIIA breast cancer', 'stage IIIB breast cancer', 'stage IIIC breast cancer'], 'conditions': ['Breast Cancer', 'Fatigue', 'Nausea and Vomiting', 'Pain']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Meeting with a nurse to assess symptoms and quality of life may be more effective than standard care in treating patients with breast cancer.\n\nPURPOSE: This clinical trial is studying nurse-provided care to see how well it works compared with standard care in treating patients with stage I, stage II, or stage III breast cancer.', 'detailedDescription': "OBJECTIVES:\n\n* To compare the effects of an advanced practice nurse, standardized nursing intervention protocol (SNIP) model vs usual care on overall quality of life and psychological distress of patients with stage I-III breast cancer, from initial treatment to 6 months post diagnosis.\n* To compare symptom control in these two groups.\n* To compare geriatric assessment outcomes in these two groups.\n* To test the effects of the SNIP intervention as compared to the usual care group on resource use by these patients.\n* To test the effects of SNIP on patients' and clinicians' satisfaction with care.\n* To describe the effects of SNIP on patients' management of transitions from one phase of chronic illness to another.\n* To identify subgroups of these patients who benefit most from the SNIP in relation to sociodemographic characteristics, disease/treatment factors, and geriatric assessment predictors.\n* To obtain feedback from clinicians regarding interpretation of findings and application to the routine care of breast cancer patients.\n\nOUTLINE: Patients are enrolled sequentially to 1 of 2 groups. Group 1 is enrolled during months 4-21 and group 2 is enrolled during months 25-54.\n\n* Group 1 (usual care): Patient questionnaires are administered at baseline and at 3 and 6 months. The clinicians' satisfaction with care is also evaluated.\n* Group 2 (advanced practice nurse \\[APN\\] intervention): Patients are accrued by an APN. Patients meet with the APN periodically to assess their physical well-being including ambulatory care needed, care of physical symptoms (i.e., pain, fatigue, nausea and vomiting), and psychological well-being. Questionnaires are administered at baseline and at 3 and 6 months.\n\nIn both groups, questionnaires include the FACT-Breast, Memorial Symptom Assessment Scale, Psychological Distress Thermometer, Comprehensive Geriatric Assessment, and Patient Satisfaction with Intervention. Clinicians also complete questionnaires. Patients' medical charts are also reviewed."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Diagnosis of stage I, II, or III breast cancer\n* Admitted to City of Hope National Medical Center\n\n * Resides within a 30-mile radius of the medical center\n* Hormone receptor status not specified\n\nPATIENT CHARACTERISTICS:\n\n* Menopausal status not specified\n* No prior cancer\n\nPRIOR CONCURRENT THERAPY:\n\n* Not specified'}, 'identificationModule': {'nctId': 'NCT00903305', 'briefTitle': 'Nurse-Provided Care or Standard Care in Treating Patients With Stage I, Stage II, or Stage III Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'City of Hope Medical Center'}, 'officialTitle': 'A Standard Nursing Intervention Protocol for Breast Cancer as a Chronic Illness', 'orgStudyIdInfo': {'id': 'CDR0000629408'}, 'secondaryIdInfos': [{'id': 'P30CA033572', 'link': 'https://reporter.nih.gov/quickSearch/P30CA033572', 'type': 'NIH'}, {'id': 'CHNMC-08031'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group II (SNIP)', 'description': 'Patients undergo SNIP comprising four visits over 2 months and four monthly telephone calls from the APN. The APN will provide 24 hour access during the study. Patients complete questionnaires about satisfaction with care, perceived preparedness with self-care, and helpfulness of patient teaching at baseline, 3 months and 6 months.', 'interventionNames': ['Other: medical chart review', 'Other: questionnaire administration', 'Procedure: fatigue assessment and management', 'Procedure: psychosocial assessment and care', 'Procedure: quality-of-life assessment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group I (usual care intervention)', 'description': 'Patients undergo usual care and complete questionnaires about satisfaction with care, perceived preparedness with self-care, and helpfulness of patient teaching at baseline, 3 months and 6 months.', 'interventionNames': ['Other: medical chart review', 'Other: questionnaire administration', 'Procedure: fatigue assessment and management', 'Procedure: quality-of-life assessment']}], 'interventions': [{'name': 'medical chart review', 'type': 'OTHER', 'armGroupLabels': ['Group I (usual care intervention)', 'Group II (SNIP)']}, {'name': 'questionnaire administration', 'type': 'OTHER', 'armGroupLabels': ['Group I (usual care intervention)', 'Group II (SNIP)']}, {'name': 'fatigue assessment and management', 'type': 'PROCEDURE', 'armGroupLabels': ['Group I (usual care intervention)', 'Group II (SNIP)']}, {'name': 'psychosocial assessment and care', 'type': 'PROCEDURE', 'armGroupLabels': ['Group II (SNIP)']}, {'name': 'quality-of-life assessment', 'type': 'PROCEDURE', 'armGroupLabels': ['Group I (usual care intervention)', 'Group II (SNIP)']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Marcia Grant, RN, DNSc, FAAN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'City of Hope Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'City of Hope Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}