Ignite Creation Date:
2025-12-25 @ 5:07 AM
Ignite Modification Date:
2026-02-25 @ 7:07 PM
Study NCT ID:
NCT02469727
Status:
COMPLETED
Last Update Posted:
2016-10-13
First Post:
2015-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
mHealth Intervention to Promote Cancer Survivors' Physical Activity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-12', 'studyFirstSubmitDate': '2015-06-08', 'studyFirstSubmitQcDate': '2015-06-09', 'lastUpdatePostDateStruct': {'date': '2016-10-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-06-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-intervention physical activity (measured by accelerometers)', 'timeFrame': 'up to week 10'}], 'secondaryOutcomes': [{'measure': 'Post-intervention health related quality of life (measured by questionnaire)', 'timeFrame': 'up to week 10'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Physical Activity', 'Quality of Life']}, 'descriptionModule': {'briefSummary': "The Primary Goal is to conduct a 5-10 week randomized controlled trial (RCT) of the Fitbit Flex, a popular, affordable, wearable physical activity tracking device, and the Fitbit mHealth app. The target population will be childhood cancer survivors 14-18 years old recruited from Seattle Children's Hospital. For the intervention group, peer influences will be engaged via a private, social network (e.g. a Facebook group) customized for survivors. Measurements will be completed (1) at baseline, prior to randomization, and (2) during the final week of the intervention period (follow-up measure). This study will provide initial proof of concept and allow for further customization of the intervention for childhood cancer survivors in anticipation of a future, larger proposal to study physical activity and related outcomes over a multi-year period."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '14 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* in remission for childhood cancer and previously treated for childhood cancer at Seattle Children's Hospital\n* ≥1-year post-cancer therapy\n* ambulatory without any known medical contraindications to participation\n* able to complete surveys in English\n* agree to install and share data from the FitBit smart phone app with the investigators\n\nExclusion Criteria:\n\n* currently or previously used a wearable physical activity sensing device to improve physical activity"}, 'identificationModule': {'nctId': 'NCT02469727', 'briefTitle': "mHealth Intervention to Promote Cancer Survivors' Physical Activity", 'organization': {'class': 'OTHER', 'fullName': "Seattle Children's Hospital"}, 'officialTitle': "mHealth Intervention to Promote Cancer Survivors' Physical Activity", 'orgStudyIdInfo': {'id': '15563'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fitbit + Facebook', 'description': 'Participants will use the Fitbit device and join the Facebook group.', 'interventionNames': ['Behavioral: Fitbit', 'Behavioral: Facebook group']}, {'type': 'NO_INTERVENTION', 'label': 'Usual care control', 'description': 'No intervention provided.'}], 'interventions': [{'name': 'Fitbit', 'type': 'BEHAVIORAL', 'description': 'Participants will use the FitBit device to track their physical activity', 'armGroupLabels': ['Fitbit + Facebook']}, {'name': 'Facebook group', 'type': 'BEHAVIORAL', 'description': 'Participants will receive and post messages and receive badges on the Facebook group', 'armGroupLabels': ['Fitbit + Facebook']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98145-5005', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': "Seattle Children's Research Institute", 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Seattle Children's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jason Mendoza', 'investigatorAffiliation': "Seattle Children's Hospital"}}}}