Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2026-01-13 @ 7:48 AM
Study NCT ID:
NCT02781051
Status:
COMPLETED
Last Update Posted:
2019-02-22
First Post:
2016-05-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Increasing Physical Activity Among Breast Cancer Survivors With Depression
Sponsor:
Organization:
Raw JSON
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Topics covered include: benefits of exercise; recommendations on type, duration, frequency and intensity of exercise; goal-setting; and advice on overcoming barriers.\n\nFitbit: Subjects were provided a Fitbit and instructed to wear the device daily.\n\nActive Living counseling: The Active Living counseling program consisted of 12 weekly group educational sessions, facilitated by project interventionists. Discussions will involve topics related to increasing physical activity, such as identifying and overcoming barriers, setting goals, and time management.\n\nFacility Access: Subjects will have access to the exercise lab in the UT Southwestern Depression Center consisting of equipment for aerobic exercise (treadmills, stationary bikes, etc.).', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Moderate-to-vigorous Physical Activity Measured by Actigraph Accelerometer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Physical Activity Intervention', 'description': 'Participants will participate in a multi-component physical activity intervention for 12 weeks with a 6 month follow up.\n\nPrint-based education: Subjects were given a copy of Exercise for Health: An Exercise Guide for Breast Cancer Survivors. Topics covered within the book include benefits of exercise; recommendations on type, duration, frequency and intensity of exercise; goal-setting; and advice on overcoming barriers.\n\nFitbit: Subjects were provided with a Fitbit and instructed to wear the device daily.\n\nActive Living counseling: The Active Living counseling program consists of 12 weekly group educational sessions. These sessions involved discussion of topics related to increasing physical activity, including: identifying and overcoming barriers, setting goals, and time management.\n\nFacility Access: Subjects will have access to the exercise lab in the UT Southwestern Depression Center consisting of equipment for aerobic exercise (treadmills, stationary bikes, etc.).'}], 'classes': [{'categories': [{'measurements': [{'value': '56.2', 'spread': '23.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Assess changes in physical activity at 6 months following physical activity intervention.', 'unitOfMeasure': 'minutes per week', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '12 participants provided valid baseline and follow-up data.'}, {'type': 'SECONDARY', 'title': 'Depressive Symptoms Measured by the Quick Inventory of Depressive Symptomatology - Self Report(QIDS-SR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Physical Activity Intervention', 'description': 'Participants will participate in a multi-component physical activity intervention for 12 weeks with a 6 month follow up.\n\nPrint-based education: Subjects received the book, Exercise for Health: An Exercise Guide for Breast Cancer Survivors. Topics covered include: benefits of exercise; recommendations on type, duration, frequency and intensity of exercise; goal-setting; and advice on overcoming barriers.\n\nFitbit: Subjects were provided a Fitbit and instructed to wear the device daily.\n\nActive Living counseling: The Active Living counseling program consisted of 12 weekly group educational sessions, facilitated by project interventionists. Discussions will involve topics related to increasing physical activity, such as identifying and overcoming barriers, setting goals, and time management.\n\nFacility Access: Subjects will have access to the exercise lab in the UT Southwestern Depression Center consisting of equipment for aerobic exercise (treadmills, stationary bikes, etc.).'}], 'classes': [{'categories': [{'measurements': [{'value': '9.7', 'spread': '4.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Assess changes in depressive symptoms at 6 months following physical activity intervention.\n\nTitle: Quick Inventory of Depressive Symptomatology - Self Report(QIDS-SR) Scoring: ranges from 0-27, higher scores indicate more severe symptomatology', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '14 participants provided follow-up data'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Physical Activity Intervention', 'description': 'Participants receive a multi-component physical activity intervention for 12 weeks.\n\nPrint-based education: All subjects will be given a copy of Exercise for Health: An Exercise Guide for Breast Cancer Survivors. Topics covered within the book include benefits of exercise in breast cancer survivors; recommendations on type, duration, frequency and intensity of exercise; goal-setting; and advice on overcoming barriers.\n\nFitbit: Subjects were provided with a Fitbit and instructed to wear the device daily.\n\nActive Living Every Day: 12 weekly group educational sessions, facilitated by project interventionists. Topics included: identifying and overcoming barriers, setting goals, and time management.\n\nFacility Access: Subjects had access to the exercise lab in the UT Southwestern Depression Center consisting of equipment for aerobic exercise (treadmills, stationary bikes, etc.).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Physical Activity Intervention', 'description': 'Participants will participate in a multi-component physical activity intervention for 12 weeks with a 6 month follow up.\n\nPrint-based education: Subjects received the book, Exercise for Health: An Exercise Guide for Breast Cancer Survivors. Topics covered include: benefits of exercise; recommendations on type, duration, frequency and intensity of exercise; goal-setting; and advice on overcoming barriers.\n\nFitbit: Subjects were provided a Fitbit and instructed to wear the device daily.\n\nActive Living counseling: The Active Living counseling program consisted of 12 weekly group educational sessions, facilitated by project interventionists. Discussions will involve topics related to increasing physical activity, such as identifying and overcoming barriers, setting goals, and time management.\n\nFacility Access: Subjects will have access to the exercise lab in the UT Southwestern Depression Center consisting of equipment for aerobic exercise (treadmills, stationary bikes, etc.).'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.19', 'spread': '8.70', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', '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': '14', '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': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Quick Inventory of Depressive Symptomatology - Self-Rated', 'classes': [{'categories': [{'measurements': [{'value': '13.63', 'spread': '4.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Range: 0-27 Lower scores indicate less depressive symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Moderate-to-Vigorous Physical Activity', 'classes': [{'categories': [{'measurements': [{'value': '52.4', 'spread': '19.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Minutes per week', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-12-29', 'size': 321617, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-11-30T15:13', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-21', 'studyFirstSubmitDate': '2016-05-03', 'resultsFirstSubmitDate': '2018-12-03', 'studyFirstSubmitQcDate': '2016-05-23', 'lastUpdatePostDateStruct': {'date': '2019-02-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-02-21', 'studyFirstPostDateStruct': {'date': '2016-05-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-02-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Moderate-to-vigorous Physical Activity Measured by Actigraph Accelerometer', 'timeFrame': '6 months', 'description': 'Assess changes in physical activity at 6 months following physical activity intervention.'}], 'secondaryOutcomes': [{'measure': 'Depressive Symptoms Measured by the Quick Inventory of Depressive Symptomatology - Self Report(QIDS-SR)', 'timeFrame': '6 months', 'description': 'Assess changes in depressive symptoms at 6 months following physical activity intervention.\n\nTitle: Quick Inventory of Depressive Symptomatology - Self Report(QIDS-SR) Scoring: ranges from 0-27, higher scores indicate more severe symptomatology'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Depression', 'Physical Activity', 'Breast Cancer']}, 'descriptionModule': {'briefSummary': 'Pilot study to assess a multi-component intervention to increase physical activity among breast cancer survivors with depression.', 'detailedDescription': 'The research project is a pilot study to assess the effects of a multi-component intervention in increasing physical activity among breast cancer survivors with depression. Individuals meeting inclusion/exclusion criteria will be enrolled in the 12-week intervention with a 6 month follow up. Intervention components will include print-based education, self-monitoring, Active Living counseling, and facility access. Blood samples will be collected at baseline. Assessments (anxiety, stress, sleep) and sample collection will also occur at 3 time points during the intervention (Weeks 7, 13, and 25). Changes in physical activity will be assessed using Fitbits to measure weekly minutes of moderate/vigorous activity.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Positive depression screen (PHQ-9) or current antidepressant treatment\n* Report \\<150 minutes of weekly moderate-to-vigorous physical activity (MVPA) on the GPAQ\n* Physically able to engage in physical activity\n* Written and verbal fluency in English\n\nExclusion Criteria:\n\n* Medical condition contraindicating physical activity participation\n* Recurrence of breast cancer\n* Ductal carcinoma in situ (DCIS) diagnosis\n* Cognitively unable to give informed consent\n* Non-English speaking'}, 'identificationModule': {'nctId': 'NCT02781051', 'briefTitle': 'Increasing Physical Activity Among Breast Cancer Survivors With Depression', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas Southwestern Medical Center'}, 'officialTitle': 'Increasing Physical Activity Among Breast Cancer Survivors With Depression', 'orgStudyIdInfo': {'id': 'STU 122015-072'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Physical Activity Intervention', 'description': 'Participants will participate in a multi-component physical activity intervention for 12 weeks with a 6 month follow up.', 'interventionNames': ['Behavioral: Print-based education', 'Device: Fitbit', 'Behavioral: Active Living counseling', 'Other: Facility Access']}], 'interventions': [{'name': 'Print-based education', 'type': 'BEHAVIORAL', 'description': 'All subjects will be given a copy of Exercise for Health: An Exercise Guide for Breast Cancer Survivors. Topics covered within the book include benefits of exercise in breast cancer survivors; recommendations on type, duration, frequency and intensity of exercise; goal-setting; and advice on overcoming barriers.', 'armGroupLabels': ['Physical Activity Intervention']}, {'name': 'Fitbit', 'type': 'DEVICE', 'description': 'Subjects will be provided with a commercially available activity monitor (i.e., Fitbit) and instructed to wear the device daily.', 'armGroupLabels': ['Physical Activity Intervention']}, {'name': 'Active Living counseling', 'type': 'BEHAVIORAL', 'description': 'The Active Living counseling program consists of 12 weekly group educational sessions, facilitated by project interventionists. These sessions will involve discussion of topics related to increasing physical activity, including: identifying and overcoming barriers, setting goals, and time management.', 'armGroupLabels': ['Physical Activity Intervention']}, {'name': 'Facility Access', 'type': 'OTHER', 'description': 'Subjects will have access to the exercise lab in the UT Southwestern Depression Center consisting of equipment for aerobic exercise (treadmills, stationary bikes, etc.).', 'armGroupLabels': ['Physical Activity Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'UT Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Texas Southwestern Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Cancer Society, Inc.', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}