Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-31 @ 10:56 AM
Study NCT ID:
NCT04259905
Status:
COMPLETED
Last Update Posted:
2023-06-08
First Post:
2020-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pink Warrior 2: Teleconference-based Gaming Support
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'esmartin@utmb.edu', 'phone': '409-266-9643', 'title': 'Eloisa Martinez', 'organization': 'The University of Texas Medical Branch'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Due to COVID-19 restrictions, we were unable to complete collection of Senior Fitness Test or hand grip measures. These were moved from secondary to other pre-specified outcomes. Other objective measures were collected via videoconference.'}}, 'adverseEventsModule': {'timeFrame': '12 weeks', 'description': 'PI review of screening call logs, group session documentation, and data collection was used to systematically assess instances of adverse events.', 'eventGroups': [{'id': 'EG000', 'title': 'Active Video Game Teleconference Support Group', 'description': 'Participants will attend enhanced support group meetings via zoom teleconferencing software. Support group meetings will include group play of active video games and discussion of survivorship topics. Participants will self-monitor physical activity using Fitbit wearable activity monitors and will receive a water bottle and tote bag.\n\nActive video game teleconference support group: 12 sessions of teleconferenced support group meetings, including active video game play + self-paced walking monitored by Fitbit wearable device', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Standard Support Group + Pedometer', 'description': 'Participants will attend standard in-person support groups currently offered by the UTMB Breast Health Center. They will also receive a standard pedometer and a water bottle and tote bag.\n\nStandard support group + pedometer: 3 monthly sessions of in-person standard support group meetings + self-paced walking monitored by pedometer', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Walking Physical Activity as Measured by Change in Daily Steps From Baseline to 14 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Video Game Teleconference Support Group', 'description': 'Participants will attend enhanced support group meetings via zoom teleconferencing software. Support group meetings will include group play of active video games and discussion of survivorship topics. Participants will self-monitor physical activity using Fitbit wearable activity monitors and will receive a water bottle and tote bag.\n\nActive video game teleconference support group: 12 sessions of teleconferenced support group meetings, including active video game play + self-paced walking monitored by Fitbit wearable device'}, {'id': 'OG001', 'title': 'Standard Support Group + Pedometer', 'description': 'Participants will attend standard in-person support groups currently offered by the UTMB Breast Health Center. They will also receive a standard pedometer and a water bottle and tote bag.\n\nStandard support group + pedometer: 3 monthly sessions of in-person standard support group meetings + self-paced walking monitored by pedometer'}], 'classes': [{'categories': [{'measurements': [{'value': '-229.52', 'spread': '1905.94', 'groupId': 'OG000'}, {'value': '1570.17', 'spread': '2355.59', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG001'], 'paramType': "Cohen's d", 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.85', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 14 weeks', 'description': 'Difference in mean of daily steps taken from Actigraph accelerometer worn for 7 day period from baseline assessment to 14 week assessment', 'unitOfMeasure': 'steps', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One person dropped out of the study shortly after randomization in the standard group and did not have a baseline step value'}, {'type': 'SECONDARY', 'title': 'Quality of Life as Measured by the Change in FACT-B Scores From Baseline to 14 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Video Game Teleconference Support Group', 'description': 'Participants will attend enhanced support group meetings via zoom teleconferencing software. Support group meetings will include group play of active video games and discussion of survivorship topics. Participants will self-monitor physical activity using Fitbit wearable activity monitors and will receive a water bottle and tote bag.\n\nActive video game teleconference support group: 12 sessions of teleconferenced support group meetings, including active video game play + self-paced walking monitored by Fitbit wearable device'}, {'id': 'OG001', 'title': 'Standard Support Group + Pedometer', 'description': 'Participants will attend standard in-person support groups currently offered by the UTMB Breast Health Center. They will also receive a standard pedometer and a water bottle and tote bag.\n\nStandard support group + pedometer: 3 monthly sessions of in-person standard support group meetings + self-paced walking monitored by pedometer'}], 'classes': [{'categories': [{'measurements': [{'value': '8.72', 'spread': '10.07', 'groupId': 'OG000'}, {'value': '-1.69', 'spread': '2.84', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': "Cohen's d", 'ciNumSides': 'TWO_SIDED', 'paramValue': '1.29', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 14 weeks', 'description': 'Quality of life score as measured by the Functional Assessment of Cancer Therapy-Breast measure at follow-up, scored for physical, social, emotional, functional, and breast well-being (here we report the total score of these subscales). The range for this scale is 0-123, with 0 indicating a better outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One person dropped out of the standard group shortly after randomization. An additional person in each group had missing values at baseline.'}, {'type': 'SECONDARY', 'title': 'Physical Performance as Measured by the Change in Short Physical Performance Battery Scores From Baseline to 14 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Video Game Teleconference Support Group', 'description': 'Participants will attend enhanced support group meetings via zoom teleconferencing software. Support group meetings will include group play of active video games and discussion of survivorship topics. Participants will self-monitor physical activity using Fitbit wearable activity monitors and will receive a water bottle and tote bag.\n\nActive video game teleconference support group: 12 sessions of teleconferenced support group meetings, including active video game play + self-paced walking monitored by Fitbit wearable device'}, {'id': 'OG001', 'title': 'Standard Support Group + Pedometer', 'description': 'Participants will attend standard in-person support groups currently offered by the UTMB Breast Health Center. They will also receive a standard pedometer and a water bottle and tote bag.\n\nStandard support group + pedometer: 3 monthly sessions of in-person standard support group meetings + self-paced walking monitored by pedometer'}], 'classes': [{'categories': [{'measurements': [{'value': '1.6', 'spread': '1.17', 'groupId': 'OG000'}, {'value': '0.44', 'spread': '1.01', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG001'], 'paramType': "Cohen's d", 'ciNumSides': 'TWO_SIDED', 'paramValue': '1.06', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 14 weeks', 'description': 'Difference in physical performance as measured by Short Physical Performance Battery from baseline to 14 weeks. The numbers reported here are the sum of scores from the subscales. The range for this measure is between 0-12, with lower scores indicating better outcomes.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One person in the standard group dropped out of the study shortly after randomization.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Walking Skills in Daily Life', 'timeFrame': 'Baseline to 14 weeks', 'description': 'Walking skills as measured by the Figure-of-8 Walk test', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Hand Grip Strength', 'timeFrame': 'Baseline to 14 weeks', 'description': 'Flexor muscle strength of hand and forearm measured by dynamometer', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Physical Function as Measured by the Senior Fitness Test', 'timeFrame': 'Baseline to 14 weeks', 'description': 'Physical function scores on six components: chair stands, arm curls, chair sit and reach, back scratch, 8 foot up and go, and 2 minute step in place test', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Body Weight in kg', 'timeFrame': 'Baseline to 14 weeks', 'description': 'Mean body weight as measured by a calibrated scale in a cancer clinic setting', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Waist Circumference in cm', 'timeFrame': 'Baseline to 14 weeks', 'description': 'Mean waist circumference as measured by Seca-203 measuring tape', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Dietary Pattern', 'timeFrame': 'Baseline to 14 weeks', 'description': 'Dietary pattern change measured by the National Health and Nutrition Examination Survey (2009-10) measuring fruits, vegetables, dairy/calcium, added sugar, whole grains/fiber, red meat, and processed meat consumption within the past 30 days', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Self-reported Physical Activity Minutes', 'timeFrame': 'Baseline to 14 weeks', 'description': 'Minutes of physical activity as self-reported using the Community Healthy Activities Model Program for Seniors questionnaire', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Self-reported Physical Function', 'timeFrame': 'Baseline to 14 weeks', 'description': 'Physical function score as measured by the PROMIS cancer-specific instrument (PROMIS-CA Bank v1.1-Physical Function)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Fatigue', 'timeFrame': 'Baseline to 14 weeks', 'description': 'Fatigue score as measured by the PROMIS cancer-specific instrument (PROMIS-Ca Bank v1.1-Fatigue)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Exercise Motivation Measured as Autonomous Regulation', 'timeFrame': 'Baseline to 14 weeks', 'description': 'Autonomous regulation as measured by the Behavioral Regulation in Exercise Questionnaire-2', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Psychological Feelings Related to Exercise', 'timeFrame': 'Baseline to 14 weeks', 'description': 'Perceptions of autonomy, competence, and relatedness as measured by the Basic Psychological Needs in Exercise scale. 11 items on a 5-point Likert scale. Range: 1 (I do not agree at all) to 5 (I completely agree) for each of the constructs-autonomy (1-20), competence (1-20), and relatedness (1-15). The higher the score means more autonomy, more competence, and relatedness.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Self-regulation: Exercise Goal-Setting (EGS) and Exercise Planning and Scheduling Scale (EPS)', 'timeFrame': 'Baseline to 14 weeks', 'description': 'Goal-setting and planning measures, adapted from a published, untitled series of items created by Rovniak et al for evaluation of technology-mediated health promotion content. 10 EGS and 10 EPS items on a 5-point Likert scale. Range: 1 (does not describe) to 5 (describes completely) of the goal setting and planning strategies. The higher the score means more exercise goal-setting and planning behavior. (Rovniak et al. Annals of Behavioral Medicine, 2002, 24(2): 149-156.)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Feasibility - Adherence', 'timeFrame': 'Baseline to 14 weeks', 'description': 'Adherence as measured by number of participants who complete at least 80% of program activities', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Feasibility - Attrition', 'timeFrame': 'Baseline to 14 weeks', 'description': 'Attrition as measured by percentage of people who drop out of the program', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Feasibility - Technological Issues', 'timeFrame': 'Baseline to 14 weeks', 'description': 'Technological issues will be measured by counting the number of reported occurrences', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Feasibility - Adverse Events', 'timeFrame': 'Baseline to 14 weeks', 'description': 'Adverse events will be measured by counting the number of occurrences', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Acceptability Scale', 'timeFrame': 'Baseline to 14 weeks', 'description': 'Acceptability and satisfaction will be assessed via Vandelanotte questionnaire with 5-point scale responses, measures are adapted from a published, untitled series of items created by Vandelanotte et al for evaluation of technology-mediated health promotion content. Acceptability and feasibility of 3 components on a 5-point Likert scale-activity monitor (7-item), program team (6-item), and the program itself (15-item). Ranged: 1 (strongly disagree) to 5 (strongly agree). The higher the score means that it is more acceptable and feasible.\n\n(Vandelanotte, C. and I. De Bourdeaudhuij (2003). "Acceptability and feasibility of a computer-tailored physical activity intervention using stages of change: project FAITH." Health Educ Res 18(3): 304-317 and Vandelanotte, C., et al. (2004). "Acceptability and feasibility of an interactive computer-tailored fat intake intervention in Belgium." Health Promot Int 19(4): 463-470.)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Active Video Game Teleconference Support Group', 'description': 'Participants will attend enhanced support group meetings via zoom teleconferencing software. Support group meetings will include group play of active video games and discussion of survivorship topics. Participants will self-monitor physical activity using Fitbit wearable activity monitors and will receive a water bottle and tote bag.\n\nActive video game teleconference support group: 12 sessions of teleconferenced support group meetings, including active video game play + self-paced walking monitored by Fitbit wearable device'}, {'id': 'FG001', 'title': 'Standard Support Group + Pedometer', 'description': 'Participants will attend standard in-person support groups currently offered by the UTMB Breast Health Center. They will also receive a standard pedometer and a water bottle and tote bag.\n\nStandard support group + pedometer: 3 monthly sessions of in-person standard support group meetings + self-paced walking monitored by pedometer'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Active Video Game Teleconference Support Group', 'description': 'Participants will attend enhanced support group meetings via zoom teleconferencing software. Support group meetings will include group play of active video games and discussion of survivorship topics. Participants will self-monitor physical activity using Fitbit wearable activity monitors and will receive a water bottle and tote bag.\n\nActive video game teleconference support group: 12 sessions of teleconferenced support group meetings, including active video game play + self-paced walking monitored by Fitbit wearable device'}, {'id': 'BG001', 'title': 'Standard Support Group + Pedometer', 'description': 'Participants will attend standard in-person support groups currently offered by the UTMB Breast Health Center. They will also receive a standard pedometer and a water bottle and tote bag.\n\nStandard support group + pedometer: 3 monthly sessions of in-person standard support group meetings + self-paced walking monitored by pedometer'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.90', 'spread': '8.03', 'groupId': 'BG000'}, {'value': '62.60', 'spread': '4.20', 'groupId': 'BG001'}, {'value': '63.75', 'spread': '6.35', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-12-19', 'size': 509077, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-03-20T16:36', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2022-03-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-12', 'studyFirstSubmitDate': '2020-01-30', 'resultsFirstSubmitDate': '2023-03-27', 'studyFirstSubmitQcDate': '2020-02-04', 'lastUpdatePostDateStruct': {'date': '2023-06-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-05-12', 'studyFirstPostDateStruct': {'date': '2020-02-07', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-06-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Walking Skills in Daily Life', 'timeFrame': 'Baseline to 14 weeks', 'description': 'Walking skills as measured by the Figure-of-8 Walk test'}, {'measure': 'Hand Grip Strength', 'timeFrame': 'Baseline to 14 weeks', 'description': 'Flexor muscle strength of hand and forearm measured by dynamometer'}, {'measure': 'Physical Function as Measured by the Senior Fitness Test', 'timeFrame': 'Baseline to 14 weeks', 'description': 'Physical function scores on six components: chair stands, arm curls, chair sit and reach, back scratch, 8 foot up and go, and 2 minute step in place test'}, {'measure': 'Body Weight in kg', 'timeFrame': 'Baseline to 14 weeks', 'description': 'Mean body weight as measured by a calibrated scale in a cancer clinic setting'}, {'measure': 'Waist Circumference in cm', 'timeFrame': 'Baseline to 14 weeks', 'description': 'Mean waist circumference as measured by Seca-203 measuring tape'}, {'measure': 'Dietary Pattern', 'timeFrame': 'Baseline to 14 weeks', 'description': 'Dietary pattern change measured by the National Health and Nutrition Examination Survey (2009-10) measuring fruits, vegetables, dairy/calcium, added sugar, whole grains/fiber, red meat, and processed meat consumption within the past 30 days'}, {'measure': 'Self-reported Physical Activity Minutes', 'timeFrame': 'Baseline to 14 weeks', 'description': 'Minutes of physical activity as self-reported using the Community Healthy Activities Model Program for Seniors questionnaire'}, {'measure': 'Self-reported Physical Function', 'timeFrame': 'Baseline to 14 weeks', 'description': 'Physical function score as measured by the PROMIS cancer-specific instrument (PROMIS-CA Bank v1.1-Physical Function)'}, {'measure': 'Fatigue', 'timeFrame': 'Baseline to 14 weeks', 'description': 'Fatigue score as measured by the PROMIS cancer-specific instrument (PROMIS-Ca Bank v1.1-Fatigue)'}, {'measure': 'Exercise Motivation Measured as Autonomous Regulation', 'timeFrame': 'Baseline to 14 weeks', 'description': 'Autonomous regulation as measured by the Behavioral Regulation in Exercise Questionnaire-2'}, {'measure': 'Psychological Feelings Related to Exercise', 'timeFrame': 'Baseline to 14 weeks', 'description': 'Perceptions of autonomy, competence, and relatedness as measured by the Basic Psychological Needs in Exercise scale. 11 items on a 5-point Likert scale. Range: 1 (I do not agree at all) to 5 (I completely agree) for each of the constructs-autonomy (1-20), competence (1-20), and relatedness (1-15). The higher the score means more autonomy, more competence, and relatedness.'}, {'measure': 'Self-regulation: Exercise Goal-Setting (EGS) and Exercise Planning and Scheduling Scale (EPS)', 'timeFrame': 'Baseline to 14 weeks', 'description': 'Goal-setting and planning measures, adapted from a published, untitled series of items created by Rovniak et al for evaluation of technology-mediated health promotion content. 10 EGS and 10 EPS items on a 5-point Likert scale. Range: 1 (does not describe) to 5 (describes completely) of the goal setting and planning strategies. The higher the score means more exercise goal-setting and planning behavior. (Rovniak et al. Annals of Behavioral Medicine, 2002, 24(2): 149-156.)'}, {'measure': 'Feasibility - Adherence', 'timeFrame': 'Baseline to 14 weeks', 'description': 'Adherence as measured by number of participants who complete at least 80% of program activities'}, {'measure': 'Feasibility - Attrition', 'timeFrame': 'Baseline to 14 weeks', 'description': 'Attrition as measured by percentage of people who drop out of the program'}, {'measure': 'Feasibility - Technological Issues', 'timeFrame': 'Baseline to 14 weeks', 'description': 'Technological issues will be measured by counting the number of reported occurrences'}, {'measure': 'Feasibility - Adverse Events', 'timeFrame': 'Baseline to 14 weeks', 'description': 'Adverse events will be measured by counting the number of occurrences'}, {'measure': 'Acceptability Scale', 'timeFrame': 'Baseline to 14 weeks', 'description': 'Acceptability and satisfaction will be assessed via Vandelanotte questionnaire with 5-point scale responses, measures are adapted from a published, untitled series of items created by Vandelanotte et al for evaluation of technology-mediated health promotion content. Acceptability and feasibility of 3 components on a 5-point Likert scale-activity monitor (7-item), program team (6-item), and the program itself (15-item). Ranged: 1 (strongly disagree) to 5 (strongly agree). The higher the score means that it is more acceptable and feasible.\n\n(Vandelanotte, C. and I. De Bourdeaudhuij (2003). "Acceptability and feasibility of a computer-tailored physical activity intervention using stages of change: project FAITH." Health Educ Res 18(3): 304-317 and Vandelanotte, C., et al. (2004). "Acceptability and feasibility of an interactive computer-tailored fat intake intervention in Belgium." Health Promot Int 19(4): 463-470.)'}], 'primaryOutcomes': [{'measure': 'Walking Physical Activity as Measured by Change in Daily Steps From Baseline to 14 Weeks', 'timeFrame': 'Baseline to 14 weeks', 'description': 'Difference in mean of daily steps taken from Actigraph accelerometer worn for 7 day period from baseline assessment to 14 week assessment'}], 'secondaryOutcomes': [{'measure': 'Quality of Life as Measured by the Change in FACT-B Scores From Baseline to 14 Weeks', 'timeFrame': 'Baseline to 14 weeks', 'description': 'Quality of life score as measured by the Functional Assessment of Cancer Therapy-Breast measure at follow-up, scored for physical, social, emotional, functional, and breast well-being (here we report the total score of these subscales). The range for this scale is 0-123, with 0 indicating a better outcome.'}, {'measure': 'Physical Performance as Measured by the Change in Short Physical Performance Battery Scores From Baseline to 14 Weeks', 'timeFrame': 'Baseline to 14 weeks', 'description': 'Difference in physical performance as measured by Short Physical Performance Battery from baseline to 14 weeks. The numbers reported here are the sum of scores from the subscales. The range for this measure is between 0-12, with lower scores indicating better outcomes.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['active video game', 'telemedicine', 'cancer survivor', "women's health", 'support group', 'survivorship', 'mhealth'], 'conditions': ['Breast Cancer', 'Physical Activity']}, 'descriptionModule': {'briefSummary': 'Breast cancer survivors, from diagnosis until the end of life, go through many transitions. One major transition is the significant decrease of physical activity immediately after diagnosis. Despite the known benefits of physical activity-speeding recovery time and reduced cancer recurrence risk-only 1 in 3 survivors met physical activity recommendations of 150 minutes of moderate-intensity activity per week. Physical activity interventions have shown effectiveness in helping breast cancer survivors increase physical activity during treatment, but limited evidence-based physical activity interventions have been incorporated into the clinic and community. To address this limitation, the investigators are partnering with the UTMB breast cancer support group to conduct a 12-week physical activity intervention, Pink Warrior.\n\nThe goal of this study is to compare an intervention that uses active games versus an intervention uses pedometer to encourage physical activity such as walking within breast cancer survivors in active cancer treatment. The study will include breast cancer survivor between the ages of 18 - 70 whom currently gets less than 150 minutes of planned physical activity per week and received a breast cancer diagnosis within 0 to 6 months. Participants will be randomized to participate in the support group using the active video game-based physical activity intervention (Wii and Xbox active games) or to participate in the existing UTMB breast cancer support group with pedometers (Digi-Walker CW-700/701). The investigators hypothesize that by engaging in active video gaming, breast cancer survivors will be motivated to initiate and maintain physical activity during treatment. This will ultimately increase functional capacity and prevent functional disability in breast cancer survivors.', 'detailedDescription': "Increasing and maintaining physical activity among female breast cancer (BC) survivors during treatment remains an unresolved problem in BC survivorship care. BC survivors, from diagnosis until the end of life, go through many transitions. One major transition is the significant decline of physical activity immediately after diagnosis. Despite the known benefits of physical activity-speeding recovery time and reduced cancer recurrence risk-less than 30% of survivors met physical activity recommendations. Physical activity interventions have shown effectiveness in helping BC survivors increase activity during treatment, but limited evidence-based activity interventions have been disseminated into the clinic and community. To address this limitation, we are partnering with the UTMB breast cancer support group to conduct a 12-week physical activity intervention, Pink Warrior, which will investigate the feasibility of implementing active video game-based physical activity intervention among BC survivors undergoing treatment within the support group setting. Participants (N = 60) will be randomized to participate in the support group using the active video game-based physical activity intervention or to participate in the existing UTMB breast cancer support group with pedometers. Our specific aims are:\n\nAim 1: Evaluate the feasibility and acceptability of active video game-based physical activity intervention among BC survivors undergoing treatment within the support group setting. Measures of feasibility will include weekly attendance records, number of completed home-based worksheets, number of participants completing the program activities, technological issues, and adverse events.\n\nAim 2: Compare the support group using the active video game-based physical activity intervention to the existing UTMB breast cancer support group with pedometer. Primary outcomes will be changes in physical activity. Secondary outcomes will be changes in physical function, dietary pattern, and quality of life.\n\nAim 3: Develop tools for implementation of the Pink Warrior intervention within the clinic and community settings. A trainer's manual for the Pink Warrior intervention will be developed and UTMB Breast Cancer Support Group facilitators will be trained by research staff to implement the program."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '55 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Provide informed consent\n2. Diagnosed with primary female breast cancer\n3. 55 years to 79\n4. Able to speak, read, and write in English\n5. Able to travel to UTMB locations and/or MD Anderson Victory Lakes\n6. Able to move arms and les as well as ambulate\n7. Has a smartphone, tablet or computer and daily access to a reliable internet\n\nExclusion Criteria:\n\n1. Pregnancy\n2. Diagnosed dementia\n3. Currently engage in 150 minutes or more of planned moderate intensity physical activity\n4. Currently involved in another physical activity intervention'}, 'identificationModule': {'nctId': 'NCT04259905', 'acronym': 'PW2', 'briefTitle': 'Pink Warrior 2: Teleconference-based Gaming Support', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Medical Branch, Galveston'}, 'officialTitle': 'Pink Warrior 2.0: Teleconference Support Group Toolkit for Breast Cancer Survivors', 'orgStudyIdInfo': {'id': '16-0040-02'}, 'secondaryIdInfos': [{'id': '5P30AG024832', 'link': 'https://reporter.nih.gov/quickSearch/5P30AG024832', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active video game teleconference support group', 'description': 'Participants will attend enhanced support group meetings via zoom teleconferencing software. Support group meetings will include group play of active video games and discussion of survivorship topics. Participants will self-monitor physical activity using Fitbit wearable activity monitors and will receive a water bottle and tote bag.', 'interventionNames': ['Behavioral: Active video game teleconference support group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard support group + pedometer', 'description': 'Participants will attend standard in-person support groups currently offered by the UTMB Breast Health Center. They will also receive a standard pedometer and a water bottle and tote bag.', 'interventionNames': ['Behavioral: Standard support group + pedometer']}], 'interventions': [{'name': 'Active video game teleconference support group', 'type': 'BEHAVIORAL', 'description': '12 sessions of teleconferenced support group meetings, including active video game play + self-paced walking monitored by Fitbit wearable device', 'armGroupLabels': ['Active video game teleconference support group']}, {'name': 'Standard support group + pedometer', 'type': 'BEHAVIORAL', 'description': '3 monthly sessions of in-person standard support group meetings + self-paced walking monitored by pedometer', 'armGroupLabels': ['Standard support group + pedometer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77555', 'city': 'Galveston', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Texas Medical Branch', 'geoPoint': {'lat': 29.30135, 'lon': -94.7977}}, {'zip': '77054', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'UT MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Elizabeth J Lyons, PhD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Medical Branch, Galveston', 'class': 'OTHER'}, 'collaborators': [{'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, {'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}