Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2026-02-23 @ 2:14 PM
Study NCT ID:
NCT02050620
Status:
COMPLETED
Last Update Posted:
2015-12-03
First Post:
2014-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Self-Reported Exercise Behavior and Short-Term Patient Outcomes in Women Undergoing Radiation Treatment for Operable Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D009043', 'term': 'Motor Activity'}], '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': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-01', 'studyFirstSubmitDate': '2014-01-23', 'studyFirstSubmitQcDate': '2014-01-30', 'lastUpdatePostDateStruct': {'date': '2015-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To measure in composite the association between self reported exercise behaviour and patient reported outcomes of quality of life.', 'timeFrame': '24 months', 'description': 'Quality of life outcomes will be measured by patient self reported levels of fatigue, sleep, pain and depression. Patient-Reported Outcomes will include QOL, fatigue, depression, pain and sleep. QOL will be assessed using the Functional Assessment of Cancer Therapy (FACT) scale. Fatigue will be assessed using the 13-item FACT-fatigue scale. Beck depression inventory (BDI) will be used to evaluate for underlying depressive symptoms. We will use the revised version (BDI-II) and the scores will range from 0 (no depression) to 63 (severe depression) (Beck et al., 1996) Pain will be assessed using the previously validated shortened Brief Pain Inventory (BPI) (Cleeland \\& Ryan, 1994). Sleep will be measured using the previously validated Pittsburgh Sleep Inventory (Buysse, Reynolds, Monk, Berman, \\& Kupfer, 1989).'}], 'secondaryOutcomes': [{'measure': 'To measure in composite the association between self-reported exercise behavior and acute radiation related toxicities.', 'timeFrame': '24 months', 'description': 'Acute radiation related toxicities will include assessments of radiation dermatitis , range of motion and lymphedema.Skin toxicity will be defined as radiation dermatitis, pruritus, and pain. It will be evaluated using the National Cancer Institute Common Terminology Criteria of Adverse Events v4.0 (NCI, 2010).\n\nLymphedema will be assessed by measuring limb girth. Measurements will be taken by first marking both limbs while patient is lying supine, starting at the ulnar styloid at 5cm intervals on the length of the arms. The diameter of the limb will then be measured at these markings. Based on these measurements, the affected limb will be compared to the unaffected limb. Lymphedema will be classified according to the American System: Mild 1.5-3.0 cm; Moderate 3.1-5.0 cm; Severe \\> 5.0 cm.(Markowski, Wilcox, \\& Helm, 1981) Range of motion will be defined as reduced abduction compared to the contralateral shoulder . All measurements will be taken with a goniometer.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Breast cancer, exercise and quality of life'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'Using an observational prospective design, potential subjects will be identified and screened for eligibility via medical record review of breast cancer patients scheduled for radiation therapy at Duke Radiation Oncology Clinic. Subjects who agree to participate will be asked to complete study questionaires prior to the start of radiation therapy and again during the last week of therapy.', 'detailedDescription': 'Exercise behavior will be defined as patient reported mean total minutes (frequency x duration) of mild, moderate, and vigorous-intensity physical exercise per week over the past month at baseline (prior to enrollment in the study). In addition we will collect patient reported mean total minutes per week of mild, moderate, and vigorous-intensity physical exercise over the course of radiation therapy.Baseline characteristics including demographic data (age, education, employment) as well as BMI, waist to hip ratio, and health comorbidities (including smoking status, cardiovascular disease, and diabetes) will also be collected. BMI and health comorbidities will be extracted from the chart. Patient-Reported Outcomes will include QOL, fatigue, depression, pain and sleep. QOL will be assessed using the Functional Assessment of Cancer Therapy (FACT) scale developed for the assessment of patient symptoms and QOL in cancer patients. Fatigue will be assessed using the 13-item FACT-fatigue scale for the assessment of fatigue in cancer patients.Skin toxicity will be defined as radiation dermatitis, pruritus, and pain.\n\nLymphedema will be assessed by measuring limb girth. Measurements will be taken by first marking both limbs while patient is lying supine, starting at the ulnar styloid at 5cm intervals on the length of the arms. The diameter of the limb will then be measured at these markings. Based on these measurements, the affected limb will be compared to the unaffected limb. Range of motion will be defined as reduced abduction compared to the contralateral shoulder . All measurements will be taken with a goniometer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects with biopsy proven ductal carcinoma in situ or invasive breast carcinoma scheduled to receive definitive treatment in the Department of Radiation Oncology at Duke will be potentially eligible for this study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women with a biopsy-proven diagnosis of ductal carcinoma in situ or invasive breast carcinoma\n* Definitive radiation treatment planned to the chest and/or regional nodes\n* 18 years of age or older\n* Signed study-specific informed consent\n\nExclusion Criteria:\n\n* Significant mental disorders making informed consent difficult or mental impairment leading to inability to cooperate\n* Karnofsky Performance Status (KPS) \\< 70%'}, 'identificationModule': {'nctId': 'NCT02050620', 'briefTitle': 'Self-Reported Exercise Behavior and Short-Term Patient Outcomes in Women Undergoing Radiation Treatment for Operable Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'A Pilot Study to Examine the Association Between Self-Reported Exercise Behavior and Short-Term Patient Outcomes in Women Undergoing Radiation Treatment for Operable Breast Cancer', 'orgStudyIdInfo': {'id': 'Pro00050716'}}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Cancer Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Janet K Horton, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}