Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2026-02-23 @ 1:53 PM
Study NCT ID:
NCT02649569
Status:
COMPLETED
Last Update Posted:
2018-05-25
First Post:
2016-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Continuous Activity Monitoring During Fractionated Radiotherapy in Patients With Head and Neck, Lung, or Gastrointestinal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008991', 'term': 'Monitoring, Physiologic'}], 'ancestors': [{'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-24', 'studyFirstSubmitDate': '2016-01-06', 'studyFirstSubmitQcDate': '2016-01-06', 'lastUpdatePostDateStruct': {'date': '2018-05-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-01-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients who complete most (>= 80%) of the protocol-specified assessments', 'timeFrame': 'Up to 4 weeks post-chemoradiation therapy', 'description': 'This pilot study will yield preliminary data on the feasibility of activity monitoring during radiotherapy as well as possible associations between activity level and various clinical and treatment-related variables. Data from the study will be summarized using standard descriptive statistics; means and standard deviations will be used for normally-distributed continuous variables, and frequencies and percentages will be used for categorical variables. Exploratory analyses for associations between activity levels and clinical and treatment-related variables will be performed using chi-square o'}, {'measure': 'Number of patients who successfully use the activity monitor (i.e. wearing the activity monitor throughout the treatment course)', 'timeFrame': 'Up to 4 weeks post-chemoradiation therapy', 'description': 'This pilot study will yield preliminary data on the feasibility of activity monitoring during radiotherapy as well as possible associations between activity level and various clinical and treatment-related variables. Data from the study will be summarized using standard descriptive statistics; means and standard deviations will be used for normally-distributed continuous variables, and frequencies and percentages will be used for categorical variables. Exploratory analyses for associations between activity levels and clinical and treatment-related variables will be performed using chi-square o'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Digestive System Carcinoma', 'Head and Neck Carcinoma', 'Lung Carcinoma']}, 'descriptionModule': {'briefSummary': "This pilot research trial studies continuous activity monitoring during fractionated radiotherapy in patients with head and neck, lung, or gastrointestinal cancer. This study explores the use of fitness trackers to study the activity levels of patients before, during, and after radiation therapy and the use of weekly assessments to measure the patients' quality of life during radiation therapy. This may allow doctors to see if there is any relationship between activity levels, quality of life, treatment interruptions, hospitalizations, and clinical outcomes.", 'detailedDescription': "PRIMARY OBJECTIVES:\n\nI. To demonstrate the feasibility of continuous, accelerometer-based evaluation of patient activity levels before, during, and after treatment with fractionated external beam radiotherapy.\n\nSECONDARY OBJECTIVES:\n\nI. To demonstrate the feasibility of performing weekly quality of life assessments during fractionated external beam radiotherapy.\n\nII. To explore how accelerometer-based metrics change throughout patients' treatment courses and if these changes are associated with quality of life assessments, treatment interruptions, hospitalizations, and clinical outcomes.\n\nOUTLINE:\n\nPatients wear an activity monitor throughout and up 4 weeks after completion of radiation therapy. Patients who are willing may continue to wear the monitor through routine follow up appointments. Patients also complete questionnaires at evaluations, which take place prior to radiotherapy initiation, weekly during radiotherapy, and then 2 and 4 weeks after the completion of radiotherapy."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Planned treatment with fractionated (\\>= 15 treatments) external beam radiotherapy with concurrent chemotherapy with curative intent', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n* Able to ambulate independently (without the assistance of a cane or walker)\n* Diagnosis of invasive malignancy of the head and neck region, lung, or gastrointestinal tract\n* Planned treatment with fractionated (\\>= 15 treatments) external beam radiotherapy with concurrent chemotherapy with curative intent\n* Women of childbearing potential must:\n\n * Have a negative serum or urine pregnancy test within 72 hours prior to the start of study therapy\n * Agree to utilize an adequate method of contraception throughout treatment and for at least 4 weeks after study therapy is completed\n * Be advised of the importance of avoiding pregnancy during trial participation and the potential risks of an unintentional pregnancy\n* All patients must sign study specific informed consent prior to study entry'}, 'identificationModule': {'nctId': 'NCT02649569', 'briefTitle': 'Continuous Activity Monitoring During Fractionated Radiotherapy in Patients With Head and Neck, Lung, or Gastrointestinal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Albert Einstein College of Medicine'}, 'officialTitle': 'Continuous Activity Monitoring During Fractionated Radiotherapy: A Pilot Study', 'orgStudyIdInfo': {'id': '2015-4873'}, 'secondaryIdInfos': [{'id': 'NCI-2015-02292', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '007067'}, {'id': '2015-4873', 'type': 'OTHER', 'domain': 'Albert Einstein College of Medicine'}, {'id': 'P30CA013330', 'link': 'https://reporter.nih.gov/quickSearch/P30CA013330', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Observational (continuous activity monitoring, questionnaires)', 'description': 'Patients wear an activity monitor throughout and up 4 weeks after completion of radiation therapy. Patients who are willing may continue to wear the monitor through routine follow up appointments. Patients also complete questionnaires at evaluations, which take place prior to radiotherapy initiation, weekly during radiotherapy, and then 2 and 4 weeks after the completion of radiotherapy.', 'interventionNames': ['Device: Monitoring Device', 'Other: Quality-of-Life Assessment']}], 'interventions': [{'name': 'Monitoring Device', 'type': 'DEVICE', 'otherNames': ['Monitor'], 'description': 'Wear activity monitor', 'armGroupLabels': ['Observational (continuous activity monitoring, questionnaires)']}, {'name': 'Quality-of-Life Assessment', 'type': 'OTHER', 'otherNames': ['Quality of Life Assessment'], 'description': 'Complete the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30', 'armGroupLabels': ['Observational (continuous activity monitoring, questionnaires)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10461', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Albert Einstein College of Medicine', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '10467-2490', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore Medical Center - Moses Campus', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}], 'overallOfficials': [{'name': 'Nitin Ohri', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Albert Einstein College of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Albert Einstein College of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Nitin Ohri', 'investigatorAffiliation': 'Albert Einstein College of Medicine'}}}}