Ignite Creation Date:
2025-12-25 @ 12:53 AM
Ignite Modification Date:
2026-01-06 @ 3:51 AM
Study NCT ID:
NCT02756767
Status:
COMPLETED
Last Update Posted:
2021-06-07
First Post:
2016-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessing the Impact of Electronic Capture of Patient Reported Outcomes in Radiation Oncology
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2021-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-04', 'studyFirstSubmitDate': '2016-04-28', 'studyFirstSubmitQcDate': '2016-04-28', 'lastUpdatePostDateStruct': {'date': '2021-06-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Surveys completed', 'timeFrame': 'five years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Patients With Lung, Breast, Head and Neck, or Pelvic Malignancies']}, 'descriptionModule': {'briefSummary': 'The goals of this study are to assess the feasibility of weekly administration of site specific patient reported assessments using an electronic platform and to explore the correlation between patient reported outcomes as well as known dosimetric prognostic factors in patients with lung, breast, head and neck, or pelvic malignancies'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with breast cancer, lung cancer, head and neck cancer, or gynecologic cancer receiving definitive external beam radiotherapy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with breast cancer, lung cancer, head and neck cancer, or gynecologic cancer receiving definitive external beam radiotherapy.\n* Must be ≥ 18 years of age\n* Able to read, write, and speak English in order to complete patient reported outcomes.\n\nPatients will be approached about the study at the time of consultation or at the time of simulation by their treating physicians or by a research coordinator. All patients must sign a study-specific informed consent to participate. All patients, including those who do not choose to consent to the study, will be provided with a short survey to assess health literacy using the eHealth Literacy Scale (eHEALS).\n\nFor those not consenting to the study, the survey will be de-identified and will also ask for basic demographic information including age grouping, race, education level, and type of cancer.'}, 'identificationModule': {'nctId': 'NCT02756767', 'briefTitle': 'Assessing the Impact of Electronic Capture of Patient Reported Outcomes in Radiation Oncology', 'organization': {'class': 'OTHER', 'fullName': 'Abramson Cancer Center at Penn Medicine'}, 'officialTitle': 'Assessing the Impact of Electronic Capture of Patient Reported Outcomes in Radiation Oncology', 'orgStudyIdInfo': {'id': 'UPCC 24915'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Completed subjects', 'description': 'Subjects will complete patient-reported outcomes assessments during and after radiation therapy.', 'interventionNames': ['Other: Survey']}], 'interventions': [{'name': 'Survey', 'type': 'OTHER', 'armGroupLabels': ['Completed subjects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Abramson Cancer Center of the University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Lilie Lin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Abramson Cancer Center at Penn Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abramson Cancer Center at Penn Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}