Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2026-02-27 @ 11:57 AM
Study NCT ID:
NCT02238951
Status:
COMPLETED
Last Update Posted:
2018-11-16
First Post:
2014-09-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cancer Care Coordination for Chemotherapy Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017216', 'term': 'Telemedicine'}], 'ancestors': [{'id': 'D003695', 'term': 'Delivery of Health Care'}, {'id': 'D010346', 'term': 'Patient Care Management'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-15', 'studyFirstSubmitDate': '2014-09-10', 'studyFirstSubmitQcDate': '2014-09-10', 'lastUpdatePostDateStruct': {'date': '2018-11-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in Patient Health Outcomes', 'timeFrame': 'Baseline, 3 months, 6 months', 'description': '* Treatment related symptoms\n* Psychological Distress\n* Quality of Life'}, {'measure': 'Change in Healthcare Outcomes', 'timeFrame': 'Baseline, 6 months', 'description': '* Processes of care coordination\n* Patient engagement\n* Patient satisfaction'}, {'measure': 'Change in Healthcare Utilization', 'timeFrame': 'Baseline, 3 months, 6 months', 'description': '* Emergency department visits\n* Unplanned hospitalizations\n* Unplanned clinic visits'}, {'measure': 'Mobile health usability overtime', 'timeFrame': '2 weeks, 8 weeks', 'description': 'Guided interviews with technology group to assess understanding and usability of the mobile technology platform to communicate and coordinate care'}], 'primaryOutcomes': [{'measure': 'Change in Patient Health Outcome', 'timeFrame': 'Baseline, 3 months, 6 months', 'description': 'Pain'}], 'secondaryOutcomes': [{'measure': 'Demonstration of a HIPAA-compliant platform to coordinate care overtime', 'timeFrame': 'Baseline, 6 months', 'description': '* Technology Usability and Acceptance\n* Patient engagement with technology\n* Use of electronic medical record features to communicate with providers'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['care coordination, mobile health, chemotherapy, technology'], 'conditions': ['Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare nurse-led care coordination for persons receiving cancer chemotherapy treatment incorporating mobile health technology to nurse-led care coordination without any mobile health enhancements.', 'detailedDescription': 'This study will randomize sixty (60) participants receiving cancer chemotherapy treatment to receive nurse-led care coordination using a HIPAA-compliant mobile health platform compared to no technology-enhanced care coordination.\n\nAll participants receive nurse-led care coordination throughout chemotherapy treatment.\n\nRESEARCH AIMS:\n\n* Demonstration of a HIPAA-compliant social networking platform;\n* Facilitate communication and collaboration among patients with cancer and their care team;\n* Assess patient health outcomes (chemotherapy-related physical and psychological side effects; pain, quality of life and patient satisfaction)\n* Assessment of healthcare utilization including emergency department visits, unplanned clinic visits and hospitalization;\n* For patients assigned to the mobile health care coordination, understanding their experience of use of the technology'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or older\n* Newly diagnosed cancer - any site or stage\n* Initiating chemotherapy\n* Ability to read and write English\n* Manual dexterity sufficient to use a tablet technology\n* Cognitive capacity to participate\n* Preferential recruitment of publicly insured and/or living in rural communities\n\nExclusion Criteria:\n\n* Oral chemotherapy'}, 'identificationModule': {'nctId': 'NCT02238951', 'acronym': '4CP', 'briefTitle': 'Cancer Care Coordination for Chemotherapy Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Davis'}, 'officialTitle': 'Use of mHealth to Support Nurse-directed Care Coordination for Chemotherapy Patients: Improving Health, Healthcare Delivery, and Healthcare Utilization.', 'orgStudyIdInfo': {'id': '551190'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mobile Health (mHealth)', 'description': 'Care coordination using mHealth technology enhancements', 'interventionNames': ['Other: Mobile Health (mHealth)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'No mHealth', 'description': 'Care coordination without mHealth enhancements', 'interventionNames': ['Other: No mHealth']}], 'interventions': [{'name': 'Mobile Health (mHealth)', 'type': 'OTHER', 'otherNames': ['Android-based device', 'Mobile health', 'Patient Health Network'], 'description': 'Participants receive care coordination throughout their chemotherapy treatment using mHealth technology', 'armGroupLabels': ['Mobile Health (mHealth)']}, {'name': 'No mHealth', 'type': 'OTHER', 'description': 'Participants receive the same evidence-based care coordination without mHealth technology', 'armGroupLabels': ['No mHealth']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'UC Davis Comprehensive Cancer Care Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}], 'overallOfficials': [{'name': 'Jill G Joseph, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Davis Betty Irene Moore School of Nursing'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Davis', 'class': 'OTHER'}, 'collaborators': [{'name': 'McKesson Foundation', 'class': 'OTHER'}, {'name': 'Boston University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}