Ignite Creation Date:
2025-12-24 @ 9:10 PM
Ignite Modification Date:
2026-02-22 @ 6:44 PM
Study NCT ID:
NCT03671304
Status:
TERMINATED
Last Update Posted:
2023-02-02
First Post:
2018-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Mobile Intervention - Physical Activity in Cancer Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'muhammad.beg@utsouthwestern.edu', 'phone': '214-648-4180', 'title': 'Dr. Muhammad Beg', 'organization': 'UT Southwestern Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '8 weeks', 'description': 'Adverse events were collected only for approx. 8 weeks because the application utilized with the fitbit was no longer supported and the study did not complete and was terminated.', 'eventGroups': [{'id': 'EG000', 'title': 'Just-in-time Adaptive Intervention', 'description': 'Participants will receive a Fitbit Versa and instructions on its use. The study design is not a traditional randomized controlled trial in which participants are randomized to either the intervention or control group. Instead the study utilizes a microrandomized design. This is a within-subjects design in which participants will receive affective framing messages and intention planning prompts on a randomized schedule, such that participants will receive each message type on 50% of days.\n\nFitbit Versa: Participants will receive a Fitbit Versa and instructions on its use. Participants will be asked to wear the device for eight weeks, removing it only for charging and when engaging in activities in which the device could be submerged in water (bathing, swimming, etc.).\n\nAt enrollment, participants will indicate a preferred time to receive affective framing messages and EMA prompts (morning), and intention planning prompts (evenings). Participants will receive affective framing messages and intention planning prompts on a randomized schedule, such that participants will receive each message type on 50% of days.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Physical Activity (Daily Step Count)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Just-in-time Adaptive Intervention', 'description': 'Participants will receive a Fitbit Versa and instructions on its use. The study design is not a traditional randomized controlled trial in which participants are randomized to either the intervention or control group. Instead the study utilizes a microrandomized design. This is a within-subjects design in which participants will receive affective framing messages and intention planning prompts on a randomized schedule, such that participants will receive each message type on 50% of days.\n\nFitbit Versa: Participants will receive a Fitbit Versa and instructions on its use. Participants will be asked to wear the device for eight weeks, removing it only for charging and when engaging in activities in which the device could be submerged in water (bathing, swimming, etc.).\n\nAt enrollment, participants will indicate a preferred time to receive affective framing messages and EMA prompts (morning), and intention planning prompts (evenings). Participants will receive affective framing messages and intention planning prompts on a randomized schedule, such that participants will receive each message type on 50% of days.'}], 'timeFrame': '8 weeks', 'description': 'Physical Activity (daily step count) will be measured with the Fitbit.', 'reportingStatus': 'POSTED', 'populationDescription': 'Collected data was not considered valid to be analyzed as the application utilized with the fitbit was no longer supported and the study did not complete and was terminated.'}, {'type': 'SECONDARY', 'title': 'Fitbit Wear Compliance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Just-in-time Adaptive Intervention', 'description': 'Participants will receive a Fitbit Versa and instructions on its use. The study design is not a traditional randomized controlled trial in which participants are randomized to either the intervention or control group. Instead the study utilizes a microrandomized design. This is a within-subjects design in which participants will receive affective framing messages and intention planning prompts on a randomized schedule, such that participants will receive each message type on 50% of days.\n\nFitbit Versa: Participants will receive a Fitbit Versa and instructions on its use. Participants will be asked to wear the device for eight weeks, removing it only for charging and when engaging in activities in which the device could be submerged in water (bathing, swimming, etc.).\n\nAt enrollment, participants will indicate a preferred time to receive affective framing messages and EMA prompts (morning), and intention planning prompts (evenings). Participants will receive affective framing messages and intention planning prompts on a randomized schedule, such that participants will receive each message type on 50% of days.'}], 'timeFrame': '8 weeks', 'description': 'Assessment of participant compliance with the intervention (days wearing the Fitbit) to determine feasibility for future trials.', 'reportingStatus': 'POSTED', 'populationDescription': 'Collected data was not considered valid to be analyzed as the application utilized with the fitbit was no longer supported and the study did not complete and was terminated.'}, {'type': 'SECONDARY', 'title': 'Fitbit Response Compliance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Just-in-time Adaptive Intervention', 'description': 'Participants will receive a Fitbit Versa and instructions on its use. The study design is not a traditional randomized controlled trial in which participants are randomized to either the intervention or control group. Instead the study utilizes a microrandomized design. This is a within-subjects design in which participants will receive affective framing messages and intention planning prompts on a randomized schedule, such that participants will receive each message type on 50% of days.\n\nFitbit Versa: Participants will receive a Fitbit Versa and instructions on its use. Participants will be asked to wear the device for eight weeks, removing it only for charging and when engaging in activities in which the device could be submerged in water (bathing, swimming, etc.).\n\nAt enrollment, participants will indicate a preferred time to receive affective framing messages and EMA prompts (morning), and intention planning prompts (evenings). Participants will receive affective framing messages and intention planning prompts on a randomized schedule, such that participants will receive each message type on 50% of days.'}], 'timeFrame': '8 weeks', 'description': 'Assessment of participant compliance with the intervention (response rate to intervention prompts) to determine feasibility for future trials.', 'reportingStatus': 'POSTED', 'populationDescription': 'Collected data was not considered valid to be analyzed as the application utilized with the fitbit was no longer supported and the study did not complete and was terminated.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Just-in-time Adaptive Intervention', 'description': 'Participants will receive a Fitbit Versa and instructions on its use. The study design is not a traditional randomized controlled trial in which participants are randomized to either the intervention or control group. Instead the study utilizes a microrandomized design. This is a within-subjects design in which participants will receive affective framing messages and intention planning prompts on a randomized schedule, such that participants will receive each message type on 50% of days.\n\nFitbit Versa: Participants will receive a Fitbit Versa and instructions on its use. Participants will be asked to wear the device for eight weeks, removing it only for charging and when engaging in activities in which the device could be submerged in water (bathing, swimming, etc.).\n\nAt enrollment, participants will indicate a preferred time to receive affective framing messages and EMA prompts (morning), and intention planning prompts (evenings). Participants will receive affective framing messages and intention planning prompts on a randomized schedule, such that participants will receive each message type on 50% of days.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'study terminated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Just-in-time Adaptive Intervention', 'description': 'Participants will receive a Fitbit Versa and instructions on its use. The study design is not a traditional randomized controlled trial in which participants are randomized to either the intervention or control group. Instead the study utilizes a microrandomized design. This is a within-subjects design in which participants will receive affective framing messages and intention planning prompts on a randomized schedule, such that participants will receive each message type on 50% of days.\n\nFitbit Versa: Participants will receive a Fitbit Versa and instructions on its use. Participants will be asked to wear the device for eight weeks, removing it only for charging and when engaging in activities in which the device could be submerged in water (bathing, swimming, etc.).\n\nAt enrollment, participants will indicate a preferred time to receive affective framing messages and EMA prompts (morning), and intention planning prompts (evenings). Participants will receive affective framing messages and intention planning prompts on a randomized schedule, such that participants will receive each message type on 50% of days.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65', 'groupId': 'BG000', 'lowerLimit': '41', 'upperLimit': '77'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-06-17', 'size': 657858, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-01-09T18:19', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This project will enroll 50 participants receiving treatment for RCC in an eight-week study. Using a microrandomized design, participants will receive affective framing messages and intention planning prompts on a randomized schedule, such that participants will receive each message type on 50% of days.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'whyStopped': 'The study was prematurely discontinued, the application utilized with the fitbit is no longer being supported.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-11-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2021-12-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-09', 'studyFirstSubmitDate': '2018-09-07', 'resultsFirstSubmitDate': '2023-01-09', 'studyFirstSubmitQcDate': '2018-09-12', 'lastUpdatePostDateStruct': {'date': '2023-02-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-01-09', 'studyFirstPostDateStruct': {'date': '2018-09-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-02-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Physical Activity (Daily Step Count)', 'timeFrame': '8 weeks', 'description': 'Physical Activity (daily step count) will be measured with the Fitbit.'}], 'secondaryOutcomes': [{'measure': 'Fitbit Wear Compliance', 'timeFrame': '8 weeks', 'description': 'Assessment of participant compliance with the intervention (days wearing the Fitbit) to determine feasibility for future trials.'}, {'measure': 'Fitbit Response Compliance', 'timeFrame': '8 weeks', 'description': 'Assessment of participant compliance with the intervention (response rate to intervention prompts) to determine feasibility for future trials.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['renal call carcinoma', 'exercise', 'physical activity', 'mobile intervention', 'just-in-time adaptive intervention', 'affective framing', 'intention planning'], 'conditions': ['Carcinoma, Renal Cell']}, 'descriptionModule': {'briefSummary': 'Aim 1. Determine the feasibility and acceptability of the proposed mobile technology intervention to increase physical activity patients receiving treatment for renal cell carcinoma.\n\nAim 2. Evaluate the effect of the proposed intervention components (affective framing, intention planning, and goal-setting) on changes in physical activity.', 'detailedDescription': 'Recent analyses have indicated that physical activity reduces mortality risk among patients with RCC.1. Physical activity also provides additional benefits for patients undergoing treatment for cancer such as improved quality of life and sleep, and reduced treatment-related fatigue. However, individuals receiving treatment for renal cell carcinoma (RCC) often fail to engage in sufficient physical activity. Many cancer survivors experience a decrease in their physical activity after diagnosis2 and the majority of RCC survivors do not meet the recommended guidelines for physical activity.3 Traditional physical activity interventions require significant resources and present substantial barriers for participants (travel, time commitments, etc.). In contrast, mobile technologies enable delivery of interventions with significantly fewer resources. These technologies also facilitate the delivery of just-in-time adaptive interventions (JITAIs) in which intervention support is provided at only at times when an opportunity for positive changes exists.4 The purpose of this support the development of a JITAI in RCC patients. Evaluation of the acceptability and efficacy of three intervention strategies (affective framing, intention planning, goal-setting, and savoring) will determine their inclusion in the JITAI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Ages 18 years or older\n2. Diagnosed with RCC\n3. \\< 150 minutes of weekly moderate-to-vigorous physical activity\n4. Own a smartphone (required for syncing the Fitbit device).\n\nExclusion Criteria:\n\n1. Medical condition contraindicating exercise participation\n2. Cognitively unable to give informed consent.\n3. Unable to read and communicate in English'}, 'identificationModule': {'nctId': 'NCT03671304', 'briefTitle': 'Mobile Intervention - Physical Activity in Cancer Treatment', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas Southwestern Medical Center'}, 'officialTitle': 'Mobile Intervention - Physical Activity in Cancer Treatment', 'orgStudyIdInfo': {'id': 'STU 072018-088'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Just-in-time Adaptive Intervention', 'description': 'Participants will receive a Fitbit Versa and instructions on its use. The study design is not a traditional randomized controlled trial in which participants are randomized to either the intervention or control group. Instead the study utilizes a microrandomized design. This is a within-subjects design in which participants will receive affective framing messages and intention planning prompts on a randomized schedule, such that participants will receive each message type on 50% of days.', 'interventionNames': ['Device: Fitbit Versa']}], 'interventions': [{'name': 'Fitbit Versa', 'type': 'DEVICE', 'description': 'Participants will receive a Fitbit Versa and instructions on its use. Participants will be asked to wear the device for eight weeks, removing it only for charging and when engaging in activities in which the device could be submerged in water (bathing, swimming, etc.).\n\nAt enrollment, participants will indicate a preferred time to receive affective framing messages and EMA prompts (morning), and intention planning prompts (evenings). Participants will receive affective framing messages and intention planning prompts on a randomized schedule, such that participants will receive each message type on 50% of days.', 'armGroupLabels': ['Just-in-time Adaptive Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75063', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Chad Rethorst, BS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UT Southwestern'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Texas Southwestern Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Simmons Cancer Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'ASSOC PROFESSOR', 'investigatorFullName': 'Muhammad Beg', 'investigatorAffiliation': 'University of Texas Southwestern Medical Center'}}}}