Ignite Creation Date:
2025-12-24 @ 12:32 PM
Ignite Modification Date:
2026-02-21 @ 9:48 PM
Study NCT ID:
NCT02824861
Status:
COMPLETED
Last Update Posted:
2019-04-17
First Post:
2016-07-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bemobile Intervention to Support Physical Activity in Cancer Survivors
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': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-15', 'studyFirstSubmitDate': '2016-07-02', 'studyFirstSubmitQcDate': '2016-07-06', 'lastUpdatePostDateStruct': {'date': '2019-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline in Step counts', 'timeFrame': '8 weeks', 'description': 'Mean daily step counts as assessed by Actigraph Accelerometer'}, {'measure': 'Change from Baseline in Moderate to Vigorous Physical Activity (MVPA)', 'timeFrame': '8 weeks', 'description': 'Weekly accumulated minutes spent in MVPA as assessed by Actigraph Accelerometer'}], 'secondaryOutcomes': [{'measure': 'Change in Weekly average of mean daily step counts', 'timeFrame': '8 weeks', 'description': 'Step counts assessed during the intervention with the Fitbit One'}, {'measure': 'Change from Baseline in Self-efficacy to perform exercise', 'timeFrame': '8 weeks', 'description': 'Scale developed by Garcia and King'}, {'measure': 'Change from Baseline in Self-regulation', 'timeFrame': '8 weeks', 'description': 'Scale Developed R. Umstattd'}, {'measure': 'Change from Baseline in Fatigue', 'timeFrame': '8 weeks', 'description': 'Fatigue Symptom Inventory (FSI)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cancer']}, 'descriptionModule': {'briefSummary': 'This study evaluates a technology based intervention (physical activity tracker, text messages, health coach, global positioning system enabled location based feedback on physical activity) to support physical activity in cancer survivors after completing oncology rehabilitation. In Phase 1 all participants received the full intervention. In phase II participants are randomly assigned to receive the full intervention or a fitbit only.', 'detailedDescription': 'This intervention, offered to participants after completing oncology rehabilitation, integrates known preferences and determinants of physical activity participation in women and breast cancers survivors including social support, professional guidance, self-efficacy, goal setting, self-regulation, and environmental awareness delivered through accessible technology. For the iteration phase, the investigators will conduct an initial, abbreviated intervention wave lasting 4 weeks; the investigators will then incorporate participant input and feedback on the specific components to refine the intervention prior to a pilot trial. Means of delivering the components include communication and support through tailored text messaging, health coaching phone calls, self-monitoring of physical activity through a wearable sensor, and environmental assessment of community physical activity options (e.g., parks, fitness centers, trails) based on global positioning system information.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cancer diagnosis\n* Impending graduation from oncology rehabilitation\n\nExclusion Criteria:\n\n* Metastatic cancer\n* Concurrent radiation or chemotherapy\n* No cell phone\n* Inability to read or speak English.'}, 'identificationModule': {'nctId': 'NCT02824861', 'briefTitle': 'Bemobile Intervention to Support Physical Activity in Cancer Survivors', 'organization': {'class': 'OTHER', 'fullName': 'University of Vermont'}, 'officialTitle': 'Bemobile: A Text Intervention to Support Physical Activity in Cancer Survivors', 'orgStudyIdInfo': {'id': 'CHRMS15-405'}, 'secondaryIdInfos': [{'id': 'VCC1504', 'type': 'OTHER', 'domain': 'Vermont Cancer Center'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Text Intervention', 'description': 'Participants receive text messages to a personal cell phone over 8 weeks, wear a fitbit to monitor physical activity, and communicate with a health coach intermittently over 2 weeks', 'interventionNames': ['Behavioral: Bemobile']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active Control', 'description': 'Participants receive and wear a fitbit only for 8 weeks', 'interventionNames': ['Behavioral: Bemobile']}], 'interventions': [{'name': 'Bemobile', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Active Control', 'Text Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05405', 'city': 'Burlington', 'state': 'Vermont', 'country': 'United States', 'facility': 'University of Vermont', 'geoPoint': {'lat': 44.47588, 'lon': -73.21207}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No plan to make individual participant data available'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Vermont', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Nancy Gell', 'investigatorAffiliation': 'University of Vermont'}}}}