Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-27 @ 10:09 PM
Study NCT ID:
NCT03952767
Status:
COMPLETED
Last Update Posted:
2022-10-25
First Post:
2019-05-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The STEPP Study: Sensors To Evaluate Physical Performance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-21', 'studyFirstSubmitDate': '2019-05-13', 'studyFirstSubmitQcDate': '2019-05-14', 'lastUpdatePostDateStruct': {'date': '2022-10-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Amount of mean steps per day recorded at home', 'timeFrame': '18 months', 'description': 'At-home record of mean steps per day'}, {'measure': 'Amount of mean sedentary activity time recorded at home', 'timeFrame': '18 months', 'description': 'At-home record of minutes per day of mean sedentary activity time'}, {'measure': 'Amount of Light activity time recorded at home', 'timeFrame': '18 months', 'description': 'At-home record of minutes per day of light activity time per day'}, {'measure': 'Amount of moderate activity time recorded at home', 'timeFrame': '18 months', 'description': 'At-home record of minutes per day of moderate activity time'}, {'measure': 'Amount of vigorous activity time recorded at home', 'timeFrame': '18 months', 'description': 'At-home record of minutes per day of vigorous activity time'}, {'measure': 'Self-Reported Karnofsky Performance Score (KPS)', 'timeFrame': '18 months', 'description': 'The validated 1 question Self-reported Karnofsky Performance Score (KPS) score 0 to 100 will be measured. Scores closer to 100 indicate high performance of the patient'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Oncology']}, 'referencesModule': {'references': [{'pmid': '40399391', 'type': 'DERIVED', 'citation': 'Karahanoglu FI, Jensen CE, Cai X, Santamaria M, Psaltos D, Messere A, Demanuele C, Stone J, Tarachandani A, Adamowicz L, Muss H, Wood WA. Improved functional assessment in cancer patients using home-based digital technologies. Sci Rep. 2025 May 21;15(1):17638. doi: 10.1038/s41598-025-02401-4.'}]}, 'descriptionModule': {'briefSummary': 'This study assesses the association between digital functional measures of physical and patient-reported standard onocological assessments, like Karnofsky Performance Score (KPS).', 'detailedDescription': 'This study assess the association between digital functional measures from physical monitoring devices (devices like a watch tracking steps, a heart rate monitor) and patient-reported standard oncological assessments. The study will also test the feasibility of obtaining the measures in clinic and at home from the monitoring devices in participants with cancer. Participants will be asked to spend 1 hour in clinic performing simple tasks such as walking and standing with 7 digital devices recording movement data. The participants will also be asked to fill out survey data regarding their health. At-home data will be collected for 14 days. During this time participants will wear a watch to collect movement and step data, and a lumbar belt to collect movement data.\n\nPrimary Objective:\n\n1\\. Assess the association of 5 main digital physical functional measures (mean steps per day, mean sedentary activity time, light activity time, moderate activity time, and vigorous activity time (in minutes) per day) recorded at home with patient-reported standard oncological assessment (e.g. KPS)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. All genders aged ≥ 18 years of age\n2. Patients being seen at UNCCH for treatment of cancer.\n3. English-speakers\n4. Able to understand and cooperate with study procedures.\n5. Patients with solid tumors or hematological malignancies, and self-reported KPS ≤70 to ≥ 100.\n\nSigned and dated informed consent and HIPPA.\n\nExclusion Criteria:\n\n1. Subjects using investigational/experimental products.\n2. Has dementia, altered mental status, or any psychiatric or co-morbid condition prohibiting the understanding or rending of informed consent.\n3. Unable or unwilling to complete physical performance assessments including the at-home wearable device for 14 days.\n4. Unable to speak English.\n5. Subjects who report any other medical condition, recreational substance use, or medication use which would prevent them from completing study tasks or impair the providing of informed consent.\n6. Subjects who are allergic to silicone or adhesives. Subjects with cardiac pacemakers, electronic pumps or any other implanted medical devices.'}, 'identificationModule': {'nctId': 'NCT03952767', 'acronym': 'STEPP', 'briefTitle': 'The STEPP Study: Sensors To Evaluate Physical Performance', 'organization': {'class': 'OTHER', 'fullName': 'UNC Lineberger Comprehensive Cancer Center'}, 'officialTitle': 'The STEPP Study: Sensors To Evaluate Physical Performance', 'orgStudyIdInfo': {'id': 'LCCC 1851'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Digital Physical Measures and Survey Assessments', 'description': 'Digital physical measure data will be collected in clinic and at home and survey assessments will be collected', 'interventionNames': ['Other: Digital Physical Measures and Survey Assessments']}], 'interventions': [{'name': 'Digital Physical Measures and Survey Assessments', 'type': 'OTHER', 'description': 'Data from at home and in clinic visits will assess physical function and survey data will be collected', 'armGroupLabels': ['Digital Physical Measures and Survey Assessments']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'UNC Lineberger Comprehensive Cancer Center', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UNC Lineberger Comprehensive Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}