Ignite Creation Date:
2025-12-26 @ 11:07 AM
Ignite Modification Date:
2025-12-31 @ 8:30 PM
Study NCT ID:
NCT03574012
Status:
COMPLETED
Last Update Posted:
2024-01-23
First Post:
2018-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SmART Heart: Study of mHealth Apps to Reduce Cancer-Treatment Effects on the Heart
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008223', 'term': 'Lymphoma'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008991', 'term': 'Monitoring, Physiologic'}], 'ancestors': [{'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-06-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-22', 'studyFirstSubmitDate': '2018-06-19', 'studyFirstSubmitQcDate': '2018-06-19', 'lastUpdatePostDateStruct': {'date': '2024-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Enrollment rate among participants approached', 'timeFrame': 'Up to 1 year'}, {'measure': 'Retention rate among participants enrolled', 'timeFrame': 'Up to 1 year', 'description': 'Retention is defined as completion of patient questionnaire and in-person assessment after 4-month intervention'}, {'measure': 'Participation in Facebook group', 'timeFrame': 'Up to 1 year', 'description': 'Number of participants who log onto the group page and participate at least one time (e.g., view a post, post something themselves, respond to a post \\[e.g., "like" a post\\], etc.)'}, {'measure': 'Participation in Fitbit physical activity tracking', 'timeFrame': 'Up to 1 year', 'description': 'Number of participants who submit step count data on at least 50% of eligible days'}, {'measure': 'Participation in Healthwatch diet tracking', 'timeFrame': 'Up to 1 year', 'description': 'Number of participants who provide dietary data on at least 75% of eligible days'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Leukemia in Remission', 'Hematopoietic Cell Transplantation Recipient', 'Lymphoma']}, 'referencesModule': {'references': [{'pmid': '33037989', 'type': 'RESULT', 'citation': 'Chow EJ, Doody DR, Di C, Armenian SH, Baker KS, Bricker JB, Gopal AK, Hagen AM, Ketterl TG, Lee SJ, Reding KW, Schenk JM, Syrjala KL, Taylor SA, Wang G, Neuhouser ML, Mendoza JA. Feasibility of a behavioral intervention using mobile health applications to reduce cardiovascular risk factors in cancer survivors: a pilot randomized controlled trial. J Cancer Surviv. 2021 Aug;15(4):554-563. doi: 10.1007/s11764-020-00949-w. Epub 2020 Oct 10.'}]}, 'descriptionModule': {'briefSummary': 'This pilot trial studies how well education and mobile health applications work in reducing the effects of cancer treatment on the heart in participants with blood cancers that are in remission. Education and mobile health applications may be effective ways to manage heart health and to reduce future heart disease risk in participants with blood cancers.', 'detailedDescription': "PRIMARY OBJECTIVES:\n\nI. Determine the feasibility of recruiting and retaining hematologic malignancy and hematopoietic cell transplantation (HCT) survivors in a randomized cardiovascular (CV) risk reduction mobile health (mHealth) counseling intervention.\n\nII. Develop and refine a protocol to engage participants using an existing social medial platform and commercially available mHealth tools to reinforce lifestyle goals.\n\nOUTLINE: Participants are randomized to 1 of 2 groups.\n\nINTERVENTION GROUP: Participants receive individualized goal-setting and coaching in relation to physical activity and diet, supplemented with peer support through the study's social media platform, over 4 months. They also have access to mHealth apps including Fitbit and Healthwatch that provide feedback on physical activity and diet.\n\nCONTROL GROUP: Participants receive general information about physical activity and diet, and access to Fitbit and Healthwatch.\n\nAfter completion of study treatment, participants are followed up at 2 months and at 1 year."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Prior diagnosis of an acute leukemia or lymphoma or any receipt of HCT for a malignant condition.\n* At time of approach, \\>= 5 years from initial cancer diagnosis or \\>= 5 years from first HCT, whichever is later.\n* Currently in remission and not on any active anti-cancer therapies (survivors receiving maintenance tyrosine kinase inhibitors are NOT eligible).\n* Able to read, write, and speak English.\n* Access to smart phone or computer with internet access.\n* Presence of at least 1 CV risk factor:\n\n * Currently on medication for hypertension, or\n * Currently on medication for cholesterol or triglyceride, or\n * Currently on medication for diabetes, or\n * Currently not physically active (self-reported average \\< 30 minutes/day), or\n * Currently smoking.\n* Ability to understand and the willingness to provide informed consent.\n\nExclusion Criteria:\n\n* Pre-existing ischemic heart disease (includes angina if documented in electronic medical record \\[EMR\\]) or ongoing symptomatic cardiomyopathy (those with asymptomatic cardiomyopathy may be allowed to participate if they do not have any current activity restrictions, but we will seek physician clearance for any submaximal exercise testing).\n* Active systemic treatment for graft versus host disease.\n* Currently pregnant. However, participants enrolled who become pregnant after randomization can remain on the study.'}, 'identificationModule': {'nctId': 'NCT03574012', 'briefTitle': 'SmART Heart: Study of mHealth Apps to Reduce Cancer-Treatment Effects on the Heart', 'organization': {'class': 'OTHER', 'fullName': 'Fred Hutchinson Cancer Center'}, 'officialTitle': 'SmART Heart: Study of mHealth Apps to Reduce Cancer-Treatment Effects on the Heart', 'orgStudyIdInfo': {'id': '10037'}, 'secondaryIdInfos': [{'id': 'NCI-2018-01168', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '10037', 'type': 'OTHER', 'domain': 'Fred Hutch/University of Washington Cancer Consortium'}, {'id': 'P30CA015704', 'link': 'https://reporter.nih.gov/quickSearch/P30CA015704', 'type': 'NIH'}, {'id': 'RG1001769', 'type': 'OTHER', 'domain': 'Fred Hutch/University of Washington Cancer Consortium'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group (general health information, fitness tracker)', 'description': 'Participants receive general information about physical activity and diet, and access to Fitbit and Healthwatch.', 'interventionNames': ['Device: Monitoring Device', 'Other: Informational Intervention', 'Other: Questionnaire Administration']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention Group (individualized information, tracker)', 'description': "Participants receive individualized goal-setting and coaching in relation to physical activity and diet, supplemented with peer support through the study's social media platform, over 4 months. They also have access to mHealth apps including Fitbit and Healthwatch that provide feedback on physical activity and diet.", 'interventionNames': ['Device: Monitoring Device', 'Other: Informational Intervention', 'Other: Questionnaire Administration']}], 'interventions': [{'name': 'Monitoring Device', 'type': 'DEVICE', 'description': 'Use Fitbit tracker', 'armGroupLabels': ['Control Group (general health information, fitness tracker)', 'Intervention Group (individualized information, tracker)']}, {'name': 'Informational Intervention', 'type': 'OTHER', 'description': "Receive individualized health and fitness information from clinician, supplemented with peer support through the study's social media platform", 'armGroupLabels': ['Intervention Group (individualized information, tracker)']}, {'name': 'Informational Intervention', 'type': 'OTHER', 'description': 'Receive general health and fitness information from clinician', 'armGroupLabels': ['Control Group (general health information, fitness tracker)']}, {'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Control Group (general health information, fitness tracker)', 'Intervention Group (individualized information, tracker)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Fred Hutch/University of Washington Cancer Consortium', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Eric Chow', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fred Hutch/University of Washington Cancer Consortium'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fred Hutchinson Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}