Ignite Creation Date:
2025-12-24 @ 3:17 PM
Ignite Modification Date:
2026-01-05 @ 6:38 PM
Study NCT ID:
NCT02688192
Status:
COMPLETED
Last Update Posted:
2021-04-09
First Post:
2015-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Mobile Health Fitness Program for Adolescent and Young Adult Childhood Cancer Survivors
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005221', 'term': 'Fatigue'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008991', 'term': 'Monitoring, Physiologic'}], 'ancestors': [{'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'katie.devine@rutgers.edu', 'phone': '7322357549', 'title': 'Dr. Katie Devine', 'organization': 'Rutgers Cancer Inst. of NJ'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'From the time first participant signed consent form until completion of all study related procedures. 3 years, 8 months.', 'description': 'Project Coordinator maintains the adverse event log. All unexpected and/or serious adverse events occurring during the active portion of the intervention or up to 30 days after the last fitness program session, are reported to the Rutgers Cancer Institute of New Jersey Human Research Services and the Institutional Review Board. Adverse even log is also presented to Data Safety Monitoring Board for review.', 'eventGroups': [{'id': 'EG000', 'title': 'Arm I (FitSurvivor Intervention)', 'description': 'Assessment including\n\n1. Wear an electronic accelerometer\n2. Quality of life assessment\n3. Physical fitness evaluation\n4. Participate in a fitness program which includes:\n\n * 8 group meetings of 90 minutes weekly\n * Behavioral internet based intervention engage in private social support messaging within the app and Facebook private groups and mobile app\n\nExercise Intervention: Participate in fitness program\n\nInternet-Based Intervention: Engage in private social support messaging and Use the mobile app\n\nMonitoring Device: Wear an electronic accelerometer\n\nQuality-of-Life Assessment: Ancillary studies', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Arm II (Waitlist Control [WLC])', 'description': 'Assessment including\n\n1. Wear an electronic accelerometer\n2. Quality of life assessment\n3. Physical fitness evaluation\n\nAfter waiting 6 months they will begin the fitness program as described in Arm I\n\nExercise Intervention: Participate in fitness program\n\nInternet-Based Intervention: Engage in private social support messaging and Use the mobile app\n\nMonitoring Device: Wear an electronic accelerometer\n\nQuality-of-Life Assessment: Ancillary studies', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 0, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Feasibility of the Technology-enhanced Fitness Program', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Intervention)', 'description': 'Assessment including\n\n1. Wear an electronic accelerometer\n2. Quality of life assessment\n3. Physical fitness evaluation\n4. Participate in a fitness program which includes:\n\n * 8 group meetings of 90 minutes weekly\n * Behavioral internet based intervention engage in private social support messaging within the app and Facebook private groups and mobile app\n\nExercise Intervention: Participate in fitness program\n\nInternet-Based Intervention: Engage in private social support messaging and Use the mobile app\n\nMonitoring Device: Wear an electronic accelerometer\n\nQuality-of-Life Assessment: Ancillary studies'}, {'id': 'OG001', 'title': 'Arm II (Waitlist Control [WLC])', 'description': 'Assessment including\n\n1. Wear an electronic accelerometer\n2. Quality of life assessment\n3. Physical fitness evaluation\n\nAfter waiting 6 months they will begin the fitness program as described in Arm I\n\nExercise Intervention: Participate in fitness program\n\nInternet-Based Intervention: Engage in private social support messaging and Use the mobile app\n\nMonitoring Device: Wear an electronic accelerometer\n\nQuality-of-Life Assessment: Ancillary studies'}], 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline', 'description': 'Feasibility will be evaluated by the number of participants who enroll and complete baseline assessment for the randomized trial. In total, 354 participants were mailed letters; 68 were contacted/screened, of which 56 were eligible and 49 enrolled (88% of those screened eligible, 14% of total potentially eligible pool).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Feasibility - Retention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Intervention)', 'description': 'Assessment including\n\n1. Wear an electronic accelerometer\n2. Quality of life assessment\n3. Physical fitness evaluation\n4. Participate in a fitness program which includes:\n\n * 8 group meetings of 90 minutes weekly\n * Behavioral internet based intervention engage in private social support messaging within the app and Facebook private groups and mobile app\n\nExercise Intervention: Participate in fitness program\n\nInternet-Based Intervention: Engage in private social support messaging and Use the mobile app\n\nMonitoring Device: Wear an electronic accelerometer\n\nQuality-of-Life Assessment: Ancillary studies'}, {'id': 'OG001', 'title': 'Arm II (Waitlist Control [WLC])', 'description': 'Assessment including\n\n1. Wear an electronic accelerometer\n2. Quality of life assessment\n3. Physical fitness evaluation\n\nAfter waiting 6 months they will begin the fitness program as described in Arm I\n\nExercise Intervention: Participate in fitness program\n\nInternet-Based Intervention: Engage in private social support messaging and Use the mobile app\n\nMonitoring Device: Wear an electronic accelerometer\n\nQuality-of-Life Assessment: Ancillary studies'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to post-intervention (3 months)', 'description': 'Percentage of participants who compete the 3 month assessment', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Fatigue Measured Using the PedsQL Multidimensional Fatigue Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Intervention)', 'description': 'Assessment including\n\n1. Wear an electronic accelerometer\n2. Quality of life assessment\n3. Physical fitness evaluation\n4. Participate in a fitness program which includes:\n\n * 8 group meetings of 90 minutes weekly\n * Behavioral internet based intervention engage in private social support messaging within the app and Facebook private groups and mobile app\n\nExercise Intervention: Participate in fitness program\n\nInternet-Based Intervention: Engage in private social support messaging and Use the mobile app\n\nMonitoring Device: Wear an electronic accelerometer\n\nQuality-of-Life Assessment: Ancillary studies'}, {'id': 'OG001', 'title': 'Arm II (Waitlist Control [WLC])', 'description': 'Assessment including\n\n1. Wear an electronic accelerometer\n2. Quality of life assessment\n3. Physical fitness evaluation\n\nAfter waiting 6 months they will begin the fitness program as described in Arm I\n\nExercise Intervention: Participate in fitness program\n\nInternet-Based Intervention: Engage in private social support messaging and Use the mobile app\n\nMonitoring Device: Wear an electronic accelerometer\n\nQuality-of-Life Assessment: Ancillary studies'}], 'classes': [{'title': 'Fatigue general (baseline)', 'categories': [{'measurements': [{'value': '60.12', 'spread': '25.72', 'groupId': 'OG000'}, {'value': '71.02', 'spread': '12.76', 'groupId': 'OG001'}]}]}, {'title': 'Fatigue general (post-intervention)', 'categories': [{'measurements': [{'value': '65.18', 'spread': '23.60', 'groupId': 'OG000'}, {'value': '71.40', 'spread': '13.44', 'groupId': 'OG001'}]}]}, {'title': 'Fatigue Sleep/Rest (baseline)', 'categories': [{'measurements': [{'value': '55.95', 'spread': '20.78', 'groupId': 'OG000'}, {'value': '62.88', 'spread': '15.90', 'groupId': 'OG001'}]}]}, {'title': 'Fatigue Sleep/Rest (post-intervention))', 'categories': [{'measurements': [{'value': '63.10', 'spread': '24.78', 'groupId': 'OG000'}, {'value': '65.72', 'spread': '17.95', 'groupId': 'OG001'}]}]}, {'title': 'Fatigue Cognitive (baseline)', 'categories': [{'measurements': [{'value': '57.74', 'spread': '24.78', 'groupId': 'OG000'}, {'value': '70.08', 'spread': '22.59', 'groupId': 'OG001'}]}]}, {'title': 'Fatigue Cognitive (post-intervention)', 'categories': [{'measurements': [{'value': '63.69', 'spread': '26.27', 'groupId': 'OG000'}, {'value': '75.38', 'spread': '20.45', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.39', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Effects of the intervention on changes in the General Subscale from baseline to post-intervention (3 months) were evaluated using group x time in a repeated measures analysis of variance performed in SAS using PROC GLM for participants with complete data.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'df = 33'}, {'pValue': '.49', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Effects of the intervention on changes in the Sleep/Rest Subscale from baseline to post-intervention (3 months) were evaluated using group x time in a repeated measures analysis of variance performed in SAS using PROC GLM for participants with complete data.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'df = 33'}, {'pValue': '.83', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Effect of the intervention on changes in the Cognitive Subscale from baseline to post-intervention (3 months) were evaluated using group x time in a repeated measures analysis of variance performed in SAS using PROC GLM for participants with complete data.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'df = 33'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to post-intervention (3 months)', 'description': 'Fatigue measured using the PedsQL Multidimensional Fatigue Scale. The PedsQL Multidimensional Fatigue Scale yields three subscales: general, sleep/rest, and cognitive fatigue. Scores are transformed on a 0-100 scale, with higher scores indicating better functioning.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants with complete data were included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Health Related Quality of Life (HRQL) Measured Using the Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Intervention)', 'description': 'Assessment including\n\n1. Wear an electronic accelerometer\n2. Quality of life assessment\n3. Physical fitness evaluation\n4. Participate in a fitness program which includes:\n\n * 8 group meetings of 90 minutes weekly\n * Behavioral internet based intervention engage in private social support messaging within the app and Facebook private groups and mobile app\n\nExercise Intervention: Participate in fitness program\n\nInternet-Based Intervention: Engage in private social support messaging and Use the mobile app\n\nMonitoring Device: Wear an electronic accelerometer\n\nQuality-of-Life Assessment: Ancillary studies'}, {'id': 'OG001', 'title': 'Arm II (Waitlist Control [WLC])', 'description': 'Assessment including\n\n1. Wear an electronic accelerometer\n2. Quality of life assessment\n3. Physical fitness evaluation\n\nAfter waiting 6 months they will begin the fitness program as described in Arm I\n\nExercise Intervention: Participate in fitness program\n\nInternet-Based Intervention: Engage in private social support messaging and Use the mobile app\n\nMonitoring Device: Wear an electronic accelerometer\n\nQuality-of-Life Assessment: Ancillary studies'}], 'classes': [{'title': 'HRQOL: Physical Summary (baseline)', 'categories': [{'measurements': [{'value': '72.10', 'spread': '21.10', 'groupId': 'OG000'}, {'value': '79.75', 'spread': '8.32', 'groupId': 'OG001'}]}]}, {'title': 'HRQOL: Physical Summary (post-intervention)', 'categories': [{'measurements': [{'value': '74.11', 'spread': '20.74', 'groupId': 'OG000'}, {'value': '81.68', 'spread': '9.56', 'groupId': 'OG001'}]}]}, {'title': 'HRQOL: Psycho social Summary (baseline)', 'categories': [{'measurements': [{'value': '72.64', 'spread': '12.28', 'groupId': 'OG000'}, {'value': '77.92', 'spread': '12.14', 'groupId': 'OG001'}]}]}, {'title': 'HRQOL: Psycho social Summary (post-intervention)', 'categories': [{'measurements': [{'value': '70.00', 'spread': '16.17', 'groupId': 'OG000'}, {'value': '75.92', 'spread': '11.98', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.98', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Effects of the intervention on changes in the PedsQL Physical Summary score were evaluated using group x time in a repeated measures analysis of variance performed in SAS using PROC GLM for participants with complete data.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'df = 33'}, {'pValue': '.85', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Effects of the intervention on changes in the PedsQL Psychosocial Summary score were evaluated using group x time in a repeated measures analysis of variance performed in SAS using PROC GLM for participants with complete data.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'df = 29'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to post-intervention (3 months)', 'description': 'The PedsQL Generic Core Scale is a well-validated measure of HRQOL with physical, emotional, social, and cognitive functioning domains. The PedsQL Generic Core yields two summary scores - Physical Summary and Psychosocial Summary. Scores are transformed on a 0-100 scale, with higher scores indicating better functioning.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants with complete data were included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Change in Cardiorespiratory Fitness Measured Using Submaximal Treadmill Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Intervention)', 'description': 'Assessment including\n\n1. Wear an electronic accelerometer\n2. Quality of life assessment\n3. Physical fitness evaluation\n4. Participate in a fitness program which includes:\n\n * 8 group meetings of 90 minutes weekly\n * Behavioral internet based intervention engage in private social support messaging within the app and Facebook private groups and mobile app\n\nExercise Intervention: Participate in fitness program\n\nInternet-Based Intervention: Engage in private social support messaging and Use the mobile app\n\nMonitoring Device: Wear an electronic accelerometer\n\nQuality-of-Life Assessment: Ancillary studies'}, {'id': 'OG001', 'title': 'Arm II (Waitlist Control [WLC])', 'description': 'Assessment including\n\n1. Wear an electronic accelerometer\n2. Quality of life assessment\n3. Physical fitness evaluation\n\nAfter waiting 6 months they will begin the fitness program as described in Arm I\n\nExercise Intervention: Participate in fitness program\n\nInternet-Based Intervention: Engage in private social support messaging and Use the mobile app\n\nMonitoring Device: Wear an electronic accelerometer\n\nQuality-of-Life Assessment: Ancillary studies'}], 'classes': [{'title': 'estimated VO2 max (baseline)', 'categories': [{'measurements': [{'value': '36.67', 'spread': '7.03', 'groupId': 'OG000'}, {'value': '40.61', 'spread': '9.60', 'groupId': 'OG001'}]}]}, {'title': 'estimated VO2 max (post-intervention)', 'categories': [{'measurements': [{'value': '39.08', 'spread': '9.48', 'groupId': 'OG000'}, {'value': '39.80', 'spread': '9.27', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.29', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'df = 29'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to post-intervention (3 months)', 'description': 'Cardiorespiratory fitness was measured via submaximal treadmill testing using a modified Bruce protocol. This standardized graded treadmill test adds two warm-up stages, with the first performed at a 1.7 mph and 0% grade and the second at 1.7 mph and 5% grade. Participants performed the graded exercise test until they reached 85% of their age-predicted maximum heart rate, which was measured using a chest-worn Polar heart rate monitor. Estimated VO2 max was calculated for each participant using the multi-stage model and American College of Sports Medicine metabolic equations.', 'unitOfMeasure': 'ml/kg/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants with complete data were included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Change in Muscle Strength/Endurance Measured Using 10-repetition Maximum Strength Tests (Upper and Lower Body)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Intervention)', 'description': 'Assessment including\n\n1. Wear an electronic accelerometer\n2. Quality of life assessment\n3. Physical fitness evaluation\n4. Participate in a fitness program which includes:\n\n * 8 group meetings of 90 minutes weekly\n * Behavioral internet based intervention engage in private social support messaging within the app and Facebook private groups and mobile app\n\nExercise Intervention: Participate in fitness program\n\nInternet-Based Intervention: Engage in private social support messaging and Use the mobile app\n\nMonitoring Device: Wear an electronic accelerometer\n\nQuality-of-Life Assessment: Ancillary studies'}, {'id': 'OG001', 'title': 'Arm II (Waitlist Control [WLC])', 'description': 'Assessment including\n\n1. Wear an electronic accelerometer\n2. Quality of life assessment\n3. Physical fitness evaluation\n\nAfter waiting 6 months they will begin the fitness program as described in Arm I\n\nExercise Intervention: Participate in fitness program\n\nInternet-Based Intervention: Engage in private social support messaging and Use the mobile app\n\nMonitoring Device: Wear an electronic accelerometer\n\nQuality-of-Life Assessment: Ancillary studies'}], 'classes': [{'title': 'Lower Body 1-RM (baseline)', 'categories': [{'measurements': [{'value': '191.93', 'spread': '80.76', 'groupId': 'OG000'}, {'value': '199.78', 'spread': '84.56', 'groupId': 'OG001'}]}]}, {'title': 'Lower Body 1-RM (post-intervention)', 'categories': [{'measurements': [{'value': '247.23', 'spread': '109.76', 'groupId': 'OG000'}, {'value': '219.71', 'spread': '89.85', 'groupId': 'OG001'}]}]}, {'title': 'Upper Body 1-RM (baseline)', 'categories': [{'measurements': [{'value': '35.78', 'spread': '22.76', 'groupId': 'OG000'}, {'value': '45.51', 'spread': '25.83', 'groupId': 'OG001'}]}]}, {'title': 'Upper Body 1-RM (post-intervention)', 'categories': [{'measurements': [{'value': '40.50', 'spread': '24.26', 'groupId': 'OG000'}, {'value': '48.48', 'spread': '25.40', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.019', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Effect of the intervention on changes in lower body estimated 1-RM was evaluated using group x time in a repeated measures analysis of variance performed in SAS using PROC GLM for participants with complete data', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'df = 32'}, {'pValue': '.34', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Effect of the intervention on changes in upper body estimated 1-RM was evaluated using group x time in a repeated measures analysis of variance performed in SAS using PROC GLM for participants with complete data.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'df = 32'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to post-intervention (3 months)', 'description': 'Lower and upper body muscular strength/endurance were measured via 10-repetition maximum (10-RM) tests following National Strength and Conditioning Association guidelines (leg press machine for lower body and barbell bench press for upper body). Weight was increased until participants executed 10 repetitions in good form for both exercises. Estimates of 1-RM leg and bench press were made using a linear prediction equation. Higher scores indicate greater muscular strength/endurance.', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participant with complete data were included.'}, {'type': 'SECONDARY', 'title': 'Feasibility - Engagement With the App', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ALL: Arm I (Intervention) and Arm II (WLC)', 'description': 'All participants from Arm I and Arm II who started the 12-week intervention.'}], 'classes': [{'title': '# In-app workouts', 'categories': [{'measurements': [{'value': '6.50', 'spread': '10.69', 'groupId': 'OG000'}]}]}, {'title': 'Total in-app points earned', 'categories': [{'measurements': [{'value': '165.48', 'spread': '287.74', 'groupId': 'OG000'}]}]}, {'title': '# Achievements unlocked', 'categories': [{'measurements': [{'value': '8.50', 'spread': '4.63', 'groupId': 'OG000'}]}]}, {'title': '# of Likes/Comments posted', 'categories': [{'measurements': [{'value': '0.62', 'spread': '1.51', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Duration of the FitSurvivor intervention (12 weeks)', 'description': 'Engagement with the app was measured by 1) number of in-app exercises completed; 2) points earned (more active = more points); 3) achievements unlocked; and 4) number of likes and comments posted within the social feed. These are count data. Achievements unlocked has possible range of 0 to 20. Number of in-app exercises completed, points earned, and number of likes and comments posted within the social feed have a possible lower limit of 0 and no upper limit; higher numbers indicate more instances of each. The full range of participant data are: number of in-app exercises completed = 0-44; points earned = 0-1,195; number of achievements unlocked = 1-20; number of likes/comments posted = 0-8.', 'unitOfMeasure': 'counts', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants from Arm I and Arm II who started the intervention were included. Those who dropped out prior to starting any sessions (n=7) were excluded from this analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm I (Intervention)', 'description': 'Assessment including\n\n1. Wear an electronic accelerometer\n2. Quality of life assessment\n3. Physical fitness evaluation\n4. Participate in a fitness program which includes:\n\n * 8 group meetings over 90 minutes weekly\n * Behavioral internet based intervention engage in private social support messaging within the app and Facebook private groups and mobile app\n\nExercise Intervention: Participate in fitness program\n\nInternet-Based Intervention: Engage in private social support messaging and Use the mobile app\n\nMonitoring Device: Wear an electronic accelerometer\n\nQuality-of-Life Assessment: Ancillary studies'}, {'id': 'FG001', 'title': 'Arm II (Waitlist Control [WLC])', 'description': 'Assessment including\n\n1. Wear an electronic accelerometer\n2. Quality of life assessment\n3. Physical fitness evaluation\n\nAfter waiting 6 months they will begin the fitness program as described in Arm I\n\nExercise Intervention: Participate in fitness program\n\nInternet-Based Intervention: Engage in private social support messaging and Use the mobile app\n\nMonitoring Device: Wear an electronic accelerometer\n\nQuality-of-Life Assessment: Ancillary studies'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'In total, 354 participants were mailed letters; 68 were contacted/screened, of which 56 were eligible and 49 enrolled (88% of those screened eligible, 14% of total potentially eligible pool).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm I (Intervention)', 'description': 'Assessment including\n\n1. Wear an electronic accelerometer\n2. Quality of life assessment\n3. Physical fitness evaluation\n4. Participate in a fitness program which includes:\n\n * 8 group meetings over 90 minutes weekly\n * Behavioral internet based intervention engage in private social support messaging within the app and Facebook private groups and mobile app\n\nExercise Intervention: Participate in fitness program\n\nInternet-Based Intervention: Engage in private social support messaging and Use the mobile app\n\nMonitoring Device: Wear an electronic accelerometer\n\nQuality-of-Life Assessment: Ancillary studies'}, {'id': 'BG001', 'title': 'Arm II (Waitlist Control [WLC])', 'description': 'Assessment including\n\n1. Wear an electronic accelerometer\n2. Quality of life assessment\n3. Physical fitness evaluation\n\nAfter waiting 6 months they will begin the fitness program as described in Arm I\n\nExercise Intervention: Participate in fitness program\n\nInternet-Based Intervention: Engage in private social support messaging and Use the mobile app\n\nMonitoring Device: Wear an electronic accelerometer\n\nQuality-of-Life Assessment: Ancillary studies'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '18.88', 'groupId': 'BG000', 'lowerLimit': '13', 'upperLimit': '25'}, {'value': '18.25', 'groupId': 'BG001', 'lowerLimit': '13', 'upperLimit': '25'}, {'value': '18.56', 'groupId': 'BG002', 'lowerLimit': '13', 'upperLimit': '25'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '39', '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': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', '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': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Participants in Group Qualitative, Group RCT ARM I and Group RCT Arm II, who completed any study activities after signing the consent form, are included. We excluded 2 participants (from Group Qualitative) who signed the consent form, but never completed qualitative interview.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-10-04', 'size': 414533, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-05-10T11:52', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2018-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-07', 'studyFirstSubmitDate': '2015-11-30', 'resultsFirstSubmitDate': '2019-05-10', 'studyFirstSubmitQcDate': '2016-02-17', 'lastUpdatePostDateStruct': {'date': '2021-04-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-03-24', 'studyFirstPostDateStruct': {'date': '2016-02-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-03-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of the Technology-enhanced Fitness Program', 'timeFrame': 'Baseline', 'description': 'Feasibility will be evaluated by the number of participants who enroll and complete baseline assessment for the randomized trial. In total, 354 participants were mailed letters; 68 were contacted/screened, of which 56 were eligible and 49 enrolled (88% of those screened eligible, 14% of total potentially eligible pool).'}], 'secondaryOutcomes': [{'measure': 'Feasibility - Retention', 'timeFrame': 'Baseline to post-intervention (3 months)', 'description': 'Percentage of participants who compete the 3 month assessment'}, {'measure': 'Fatigue Measured Using the PedsQL Multidimensional Fatigue Scale', 'timeFrame': 'Baseline to post-intervention (3 months)', 'description': 'Fatigue measured using the PedsQL Multidimensional Fatigue Scale. The PedsQL Multidimensional Fatigue Scale yields three subscales: general, sleep/rest, and cognitive fatigue. Scores are transformed on a 0-100 scale, with higher scores indicating better functioning.'}, {'measure': 'Health Related Quality of Life (HRQL) Measured Using the Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale', 'timeFrame': 'Baseline to post-intervention (3 months)', 'description': 'The PedsQL Generic Core Scale is a well-validated measure of HRQOL with physical, emotional, social, and cognitive functioning domains. The PedsQL Generic Core yields two summary scores - Physical Summary and Psychosocial Summary. Scores are transformed on a 0-100 scale, with higher scores indicating better functioning.'}, {'measure': 'Change in Cardiorespiratory Fitness Measured Using Submaximal Treadmill Test', 'timeFrame': 'Baseline to post-intervention (3 months)', 'description': 'Cardiorespiratory fitness was measured via submaximal treadmill testing using a modified Bruce protocol. This standardized graded treadmill test adds two warm-up stages, with the first performed at a 1.7 mph and 0% grade and the second at 1.7 mph and 5% grade. Participants performed the graded exercise test until they reached 85% of their age-predicted maximum heart rate, which was measured using a chest-worn Polar heart rate monitor. Estimated VO2 max was calculated for each participant using the multi-stage model and American College of Sports Medicine metabolic equations.'}, {'measure': 'Change in Muscle Strength/Endurance Measured Using 10-repetition Maximum Strength Tests (Upper and Lower Body)', 'timeFrame': 'Baseline to post-intervention (3 months)', 'description': 'Lower and upper body muscular strength/endurance were measured via 10-repetition maximum (10-RM) tests following National Strength and Conditioning Association guidelines (leg press machine for lower body and barbell bench press for upper body). Weight was increased until participants executed 10 repetitions in good form for both exercises. Estimates of 1-RM leg and bench press were made using a linear prediction equation. Higher scores indicate greater muscular strength/endurance.'}, {'measure': 'Feasibility - Engagement With the App', 'timeFrame': 'Duration of the FitSurvivor intervention (12 weeks)', 'description': 'Engagement with the app was measured by 1) number of in-app exercises completed; 2) points earned (more active = more points); 3) achievements unlocked; and 4) number of likes and comments posted within the social feed. These are count data. Achievements unlocked has possible range of 0 to 20. Number of in-app exercises completed, points earned, and number of likes and comments posted within the social feed have a possible lower limit of 0 and no upper limit; higher numbers indicate more instances of each. The full range of participant data are: number of in-app exercises completed = 0-44; points earned = 0-1,195; number of achievements unlocked = 1-20; number of likes/comments posted = 0-8.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Survivorship', 'Fatigue']}, 'descriptionModule': {'briefSummary': 'This clinical trial studies a mobile health fitness program for adolescent and young adult childhood cancer survivors. Adolescent and young adult childhood cancer survivors are at risk to have negative late effects from treatment and to develop chronic health conditions. A sedentary lifestyle may increase the risk of cardiovascular disease, osteoporosis, and early mortality. Physical activity reduces the risk for cardiovascular disease and early mortality, improves cardiorespiratory fitness, muscular fitness, bone health, and body composition, and it is also positively associated with quality of life. Programs and technologies that promote physical activity are important because health behaviors adopted by adolescent and young adult childhood cancer survivors are likely to continue into adulthood. A mobile health fitness application may motivate adolescent and young adult childhood cancer survivors to engage and maintain physical activity.', 'detailedDescription': "PRIMARY OBJECTIVES:\n\nI. Evaluate the feasibility of the technology-enhanced (electronic accelerometer + app + 8 weekly group sessions) fitness program in a pilot randomized clinical trial.\n\nSECONDARY OBJECTIVES:\n\nI. Determine the effectiveness of the technology-enhanced fitness program on participants' cardiorespiratory fitness and muscular fitness.\n\nII. Examine the effects of the program on secondary outcomes of health related quality of life (HRQOL) and fatigue.\n\nOUTLINE:\n\nParticipants are randomized to 1 of 2 arms.\n\nARM I (Intervention): Participants attend 8 group meetings weekly, wear an electronic accelerometer, engage in private social support messaging within the app and Facebook private groups, and then use the mobile app for 4 weeks without in-person groups.\n\nARM II (WAITLIST CONTROL \\[WLC\\]): After the 6 month assessment, participants receive the FitSurvivor intervention as in arm I."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Any diagnosis of cancer prior to age 21\n* Off treatment for at least 6 months\n* For patients \\< 18 years, parents must give informed consent and patient must give assent; patients \\>= 18 must give informed consent\n\nExclusion Criteria:\n\n* Any medical contraindication to exercise according to a physician or physician's designee\n* Non-English speaking\n* Current physical activity level exceeding Centers for Disease Control and Prevention (CDC) guidelines for activity (60 min of moderate-vigorous exercise/day for 5+ days/week (wk) including 3+ days of vigorous intensity activities and muscle-strengthening exercises on 3+ days/wk and bone strengthening exercises on 3+ days/wk for children \\< 18 and 150 min of moderate vigorous exercise or 75 min of vigorous exercise/wk and 2+ days of muscle strengthening activities for adults \\>= 18); the CDC guidelines are used to determine exercise prescription in our intervention; individuals already exceeding the guidelines would be unlikely to benefit from participating\n* Significant developmental delay per patient, parent, or physician report\n* Pregnant (per patient report); if participant becomes pregnant during the course of the study, she will be removed from further participation"}, 'identificationModule': {'nctId': 'NCT02688192', 'acronym': 'TLCFIT', 'briefTitle': 'Mobile Health Fitness Program for Adolescent and Young Adult Childhood Cancer Survivors', 'organization': {'class': 'OTHER', 'fullName': 'Rutgers, The State University of New Jersey'}, 'officialTitle': 'Teens Living With Cancer Fitness Improvement Training (TLCFIT): A Novel Mobile Health Fitness Program for Adolescent and Young Adult (AYA) Childhood Cancer Survivors', 'orgStudyIdInfo': {'id': 'Pro2013003658'}, 'secondaryIdInfos': [{'id': 'NCI-2015-01841', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '131323', 'type': 'OTHER', 'domain': 'Rutgers Cancer Institute of New Jersey'}, {'id': 'K07CA174728', 'link': 'https://reporter.nih.gov/quickSearch/K07CA174728', 'type': 'NIH'}, {'id': 'P30CA072720', 'link': 'https://reporter.nih.gov/quickSearch/P30CA072720', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm I (Intervention)', 'description': 'Assessment including\n\n1. Wear an electronic accelerometer\n2. Quality of life assessment\n3. Physical fitness evaluation\n4. Participate in a fitness program which includes:\n\n * 8 group meetings of 90 minutes weekly\n * Behavioral internet based intervention engage in private social support messaging within the app and Facebook private groups and mobile app', 'interventionNames': ['Behavioral: Exercise Intervention', 'Behavioral: Internet-Based Intervention', 'Device: Monitoring Device', 'Other: Quality-of-Life Assessment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm II (Waitlist Control [WLC])', 'description': 'Assessment including\n\n1. Wear an electronic accelerometer\n2. Quality of life assessment\n3. Physical fitness evaluation\n\nAfter waiting 6 months they will begin the fitness program as described in Arm I', 'interventionNames': ['Behavioral: Exercise Intervention', 'Behavioral: Internet-Based Intervention', 'Device: Monitoring Device', 'Other: Quality-of-Life Assessment']}], 'interventions': [{'name': 'Exercise Intervention', 'type': 'BEHAVIORAL', 'description': 'Participate in fitness program', 'armGroupLabels': ['Arm I (Intervention)', 'Arm II (Waitlist Control [WLC])']}, {'name': 'Internet-Based Intervention', 'type': 'BEHAVIORAL', 'description': 'Engage in private social support messaging and Use the mobile app', 'armGroupLabels': ['Arm I (Intervention)', 'Arm II (Waitlist Control [WLC])']}, {'name': 'Monitoring Device', 'type': 'DEVICE', 'otherNames': ['Monitor'], 'description': 'Wear an electronic accelerometer', 'armGroupLabels': ['Arm I (Intervention)', 'Arm II (Waitlist Control [WLC])']}, {'name': 'Quality-of-Life Assessment', 'type': 'OTHER', 'otherNames': ['Quality of Life Assessment'], 'description': 'Ancillary studies', 'armGroupLabels': ['Arm I (Intervention)', 'Arm II (Waitlist Control [WLC])']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07601', 'city': 'Hackensack', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Hackensack University Medical Center', 'geoPoint': {'lat': 40.88593, 'lon': -74.04347}}, {'zip': '08903', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Rutgers Cancer Institute of New Jersey', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}], 'overallOfficials': [{'name': 'Katie Devine', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rutgers Cancer Institute of New Jersey'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rutgers, The State University of New Jersey', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, {'name': 'Rutgers Cancer Institute of New Jersey', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Medicine', 'investigatorFullName': 'Katie Devine, PhD, MPH', 'investigatorAffiliation': 'Rutgers, The State University of New Jersey'}}}}