Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2026-03-02 @ 4:01 PM
Study NCT ID:
NCT00027118
Status:
COMPLETED
Last Update Posted:
2019-12-16
First Post:
2001-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Morbidity After Diagnosis and Treatment of Breast Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D008209', 'term': 'Lymphedema'}, {'id': 'D005221', 'term': 'Fatigue'}], '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': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 326}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-11-16'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08-17', 'completionDateStruct': {'date': '2016-08-17'}, 'lastUpdateSubmitDate': '2019-12-13', 'studyFirstSubmitDate': '2001-11-20', 'studyFirstSubmitQcDate': '2001-11-20', 'lastUpdatePostDateStruct': {'date': '2019-12-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2001-11-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Upper limb strength', 'timeFrame': '1,3,6,9, 12, 18 24 months'}, {'measure': 'Upper limb range of motion', 'timeFrame': '1,3,6,9, 12, 18 24 months'}, {'measure': 'Upper limb volume', 'timeFrame': '1,3,6,9, 12, 18 24 months'}, {'measure': 'Arm disability questionnaire', 'timeFrame': '0, 12, 18, 24 months'}, {'measure': 'Quality of life questionnaire', 'timeFrame': '0, 12, 18, 24 months'}, {'measure': 'Physical activity questionnaire', 'timeFrame': '0, 12, 18, 24 months'}]}, 'conditionsModule': {'keywords': ['Shoulder', 'Breast Cancer', 'Physical Therapy', 'Lymphedema', 'Quality of Life', 'Breast Cancer Surgery', 'Healthy Volunteer', 'HV', 'Normal Control'], 'conditions': ['Breast Cancer', 'Shoulder', 'Lymphedema', 'Fatigue']}, 'referencesModule': {'references': [{'pmid': '3847996', 'type': 'BACKGROUND', 'citation': "King KB, Nail LM, Kreamer K, Strohl RA, Johnson JE. Patients' descriptions of the experience of receiving radiation therapy. Oncol Nurs Forum. 1985 Jul-Aug;12(4):55-61. No abstract available."}, {'pmid': '6549885', 'type': 'BACKGROUND', 'citation': 'Meyerowitz BE, Watkins IK, Sparks FC. Quality of life for breast cancer patients receiving adjuvant chemotherapy. Am J Nurs. 1983 Feb;83(2):232-5. No abstract available.'}, {'pmid': '9201739', 'type': 'BACKGROUND', 'citation': "Carter BJ. Women's experiences of lymphedema. Oncol Nurs Forum. 1997 Jun;24(5):875-82."}]}, 'descriptionModule': {'briefSummary': 'This study will examine the frequency and severity of problems in women with breast cancer for 2 years following initial medical treatment, including:\n\n* Physical impairments, such as loss of strength or flexibility, increased weight and swelling.\n* Symptom distress, such as pain, fatigue and weakness.\n* Functional limitations and disabilities, such as loss of independence in activities of daily living (e.g., grooming, bathing, dressing, driving a car), work and social and recreational activities.\n\nIt will identify factors associated with these problems and try to determine their relationship to them.\n\nPatients 18 years of age and older with stage I, II, III or IV breast cancer may be eligible for this study. Women who have a breast biopsy negative for cancer will also be enrolled as control subjects. Participants will be drawn from patients referred to the National Naval Medical Center for diagnosis and treatment during 2001-2003.\n\nParticipants will be evaluated over a 2-year period during an initial baseline visit (before medical treatment or biopsy) and follow-up visits at 1, 3, 6, 12, 18 and 24 months following procedures:\n\n* Interview about past medical history and present illness, social and recreational activities, functional independence at work and during activities of daily living.\n* Completion of questionnaires including health survey, upper limb disability questionnaire, and physical activity questionnaire. (Questionnaires are completed only at baseline and 12 and 24 months after medical treatment begins.) The questionnaires take about 30 to 40 minutes to complete.\n* Upper body examination, including pain measurement using a 10-point scale, active and passive range of motion measures, manual muscle testing measures using a 10-point scale, timed upper limb lift test, and measures of upper limb volume and girth.', 'detailedDescription': 'Patients and healthy participants will undergo an interview at the beginning of the study and 1,3,6,9, 12, 18 and 24 months and answer questions about their medical history; family history; current problem and treatment; pain history; and social, physical and recreational activities. At the visit, they will also undergo an upper body physical exam by a physical therapist. Patients and the healthy participants will also fill out questionnaires about arm disability, quality of life, and physical activity at the beginning of the study and at 12, 18, and 24 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': '* INCLUSION CRITERIA:\n\nPopulation/Subjects: Individuals with breast cancer are identified among the patient population at National Naval Medical Center (NNMC). Patients referred to the NNMC Breast Care Center) NNMC-BCC for diagnosis and management (surgical treatment and radiation treatment or chemotherapy) of histologically established breast cancer (stage I, II, III, or IV) during 2001-2003, are eligible to participate in the study.\n\nHealthy female individuals will be controls.\n\nSubjects must be over 18 years of age and post-puberty as breast cancer does not occur prior to puberty; and been seen pre-surgical or medical intervention for baseline measurements and agree to participate in six follow-up visits of 30-45 minutes in duration during the next two-years.\n\nEXCLUSION CRITERIA:\n\nSubject chooses to not participate in the study.\n\nSubjects are unable to complete the clinical examination tests.\n\nSubjects are unable to complete the questionnaires/surveys.\n\nSubjects are under age 18.'}, 'identificationModule': {'nctId': 'NCT00027118', 'briefTitle': 'Morbidity After Diagnosis and Treatment of Breast Cancer Patients', 'nctIdAliases': ['NCT00513838'], 'organization': {'class': 'NIH', 'fullName': 'National Institutes of Health Clinical Center (CC)'}, 'officialTitle': 'A Prospective (Cohort) Study to Identify Factors Affecting Morbidity Following the Diagnosis and Treatment of Patients With Breast Cancer: A Multi-Institutional Study Between the National Institutes of Health (NIH) Rehabilitation Medicine Department (RMD) and the Walter Reed National Military Medical Center (WRNMMC) Breast Care Center (BCC)', 'orgStudyIdInfo': {'id': '020045'}, 'secondaryIdInfos': [{'id': '02-CC-0045'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20889', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'National Naval Medical Center', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}], 'overallOfficials': [{'name': 'Minal Jain, R.P.T.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Institutes of Health Clinical Center (CC)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institutes of Health Clinical Center (CC)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}