Ignite Creation Date:
2025-12-26 @ 4:02 PM
Ignite Modification Date:
2026-03-11 @ 11:16 PM
Study NCT ID:
NCT03211806
Status:
COMPLETED
Last Update Posted:
2021-05-24
First Post:
2017-01-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Detecting Activity to Support Healing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D057185', 'term': 'Sedentary Behavior'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomized to the sedentary behavior intervention or the monitoring-only control group'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2021-05-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-21', 'studyFirstSubmitDate': '2017-01-23', 'studyFirstSubmitQcDate': '2017-07-05', 'lastUpdatePostDateStruct': {'date': '2021-05-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Retention', 'timeFrame': '30 days post-discharge', 'description': 'Percentage of those enrolled who completed the program'}, {'measure': 'Acceptability', 'timeFrame': '30-days post-discharge', 'description': 'Post-intervention interviews will be conducted to assess acceptability of the program'}, {'measure': 'Adherence', 'timeFrame': '30-days post-discharge', 'description': 'Percentages of assessments completed and prompts after which steps were detected'}], 'secondaryOutcomes': [{'measure': 'Total objective sedentary behavior', 'timeFrame': 'Change from baseline to 30 days post-discharge', 'description': 'A Bluetooth enabled activity monitor worn throughout the study will estimate the total amount of time spent in sedentary behavior per day'}, {'measure': 'Objective physical activity', 'timeFrame': 'Change from baseline to 30 days post-discharge', 'description': 'A Bluetooth enabled activity monitor worn throughout the study will estimate of number of steps/day.'}, {'measure': 'Patient-reported symptoms', 'timeFrame': 'Change from baseline to 30 days post-discharge', 'description': 'Depressive (CES-D) and physical symptom severity (adapted from the MD Anderson Symptom Inventory)'}, {'measure': 'Patient-reported quality of life', 'timeFrame': 'Change from baseline to 30 days post-discharge', 'description': 'Quality of life (FACT)'}, {'measure': 'Inflammatory biomarkers', 'timeFrame': '2 weeks post-discharge', 'description': 'Plasma levels of IL-6 and CRP'}, {'measure': 'Morbidity', 'timeFrame': '30 days post-discharge', 'description': 'Grade 3-4 surgical complications within 30 days after index hospital discharge will be extracted from medical records'}, {'measure': 'Mean sedentary behavior bout', 'timeFrame': 'Change from baseline to 30 days post-discharge', 'description': 'A Bluetooth enabled activity monitor will be used to estimate mean daily sedentary bout'}, {'measure': 'Maximum sedentary behavior bout', 'timeFrame': 'Change from baseline to 30 days post-discharge', 'description': 'A Bluetooth enabled activity monitor will be used to estimate maximum daily sedentary bout'}, {'measure': 'Readmission', 'timeFrame': '30 days post-discharge', 'description': 'Readmissions within 30 days after index hospital discharge will be extracted from medical records'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colorectal Cancer', 'Peritoneal Cancer', 'Sedentary Lifestyle']}, 'referencesModule': {'references': [{'pmid': '36633893', 'type': 'DERIVED', 'citation': 'Low CA, Danko M, Durica KC, Vega J, Li M, Kunta AR, Mulukutla R, Ren Y, Sereika SM, Bartlett DL, Bovbjerg DH, Dey AK, Jakicic JM. A Real-Time Mobile Intervention to Reduce Sedentary Behavior Before and After Cancer Surgery: Pilot Randomized Controlled Trial. JMIR Perioper Med. 2023 Jan 12;6:e41425. doi: 10.2196/41425.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this research is to develop and test a technology-supported intervention to reduce sedentary behavior before and after cancer surgery. Surgical oncology patients are at elevated risk for postoperative complications and readmissions. Sedentary behavior increases markedly after surgery and hospitalization, and reducing sedentary behavior around the time of cancer surgery could reduce risk while also empowering cancer patients to take a more active role in their recovery.', 'detailedDescription': 'Colorectal or peritoneal cancer patients scheduled for surgical resection (n=60) will be randomized to either the sedentary behavior intervention or monitoring only. The intervention will use a Bluetooth-enabled activity monitor to detect prolonged sedentary bouts, which will prompt a message delivered via smartphone suggesting that patients walk. The intervention will begin at least two weeks prior to scheduled surgery and will continue through the first 30 days at home following hospital discharge. Outcomes will include objective activity and sedentary behavior, patient-reported symptoms and quality of life using standardized instruments, inflammatory biomarkers, and morbidity and hospital readmission 30-days after index discharge.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Scheduled for curative surgical treatment of metastatic colorectal or peritoneal cancer at UPMC Shadyside\n* Ability to stand and walk unassisted prior to surgery\n* Identified at least two weeks prior to their scheduled surgery date\n\nExclusion Criteria:\n\n* Unable to read and write in English'}, 'identificationModule': {'nctId': 'NCT03211806', 'acronym': 'DASH', 'briefTitle': 'Detecting Activity to Support Healing', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Technology to Reduce Sedentary Behavior Before and After Cancer Surgery', 'orgStudyIdInfo': {'id': '16-075'}, 'secondaryIdInfos': [{'id': 'K07CA204380', 'link': 'https://reporter.nih.gov/quickSearch/K07CA204380', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sedentary behavior intervention group', 'description': 'This group will wear an activity monitor linked to a smartphone app that will send prompts aimed at interrupting prolonged sedentary bouts', 'interventionNames': ['Behavioral: Sedentary Behavior', 'Device: Bluetooth-enabled activity monitor']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Monitoring-only group', 'description': 'This group will wear a bluetooth-enabled activity monitor but will not be prompted to change behavior', 'interventionNames': ['Device: Bluetooth-enabled activity monitor']}], 'interventions': [{'name': 'Sedentary Behavior', 'type': 'BEHAVIORAL', 'description': 'Messages delivered via smartphone prompting patients to walk after prolonged sedentary behavior bouts are detected via Bluetooth-enabled activity monitor', 'armGroupLabels': ['Sedentary behavior intervention group']}, {'name': 'Bluetooth-enabled activity monitor', 'type': 'DEVICE', 'description': 'Monitoring activity using a Bluetooth-enabled activity monitor', 'armGroupLabels': ['Monitoring-only group', 'Sedentary behavior intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15232', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'UPMC Shadyside', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Carissa Low', 'investigatorAffiliation': 'University of Pittsburgh'}}}}