Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2026-02-22 @ 4:10 AM
Study NCT ID:
NCT02341235
Status:
COMPLETED
Last Update Posted:
2024-07-31
First Post:
2015-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Self-monitoring Activity: a Randomized Trial of Game-oriented Applications
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D033262', 'term': 'Narration'}, {'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': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003142', 'term': 'Communication'}, {'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': 'Please interpret numerical outcomes with caution due to large amounts of drop out and low adherence in this pilot trial. All pre-specified PROMIS outcomes that were collected are provided, but note that these measures in particular faced a large amount of missing data.'}}, 'adverseEventsModule': {'timeFrame': '1 year', 'eventGroups': [{'id': 'EG000', 'title': 'Game Intervention', 'description': 'Participants will receive narrative-based games on a mobile device and telephone counseling (weekly for the first 12 weeks, then once per month until 6 months)\n\nGame intervention: The game will target motivation via narrative and game mechanics. It will also encourage self-regulation by providing monitoring and feedback of activity. Counseling will be adapted to specifically reference concepts related to narrative and games.', 'otherNumAtRisk': 45, 'deathsNumAtRisk': 45, 'otherNumAffected': 3, 'seriousNumAtRisk': 45, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Standard Intervention', 'description': 'Participants will receive an electronic activity monitor with a mobile device and telephone counseling (weekly for the first 12 weeks, then once per month until 6 months)\n\nStandard intervention: The electronic activity monitor will monitor steps, and the mobile device will provide basic feedback on progress toward goals. Counseling will be standard and concentrate on self-regulatory skill-building.', 'otherNumAtRisk': 45, 'deathsNumAtRisk': 45, 'otherNumAffected': 2, 'seriousNumAtRisk': 45, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Broken toe', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Shingles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Achilles tendon tear', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Hospitalization', 'notes': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization', 'notes': 'Breast reconstruction surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization', 'notes': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Minutes Per Day of Physical Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Game Intervention', 'description': 'Participants will receive narrative-based games on a mobile device and telephone counseling (weekly for the first 12 weeks, then once per month until 6 months)\n\nGame intervention: The game will target motivation via narrative and game mechanics. It will also encourage self-regulation by providing monitoring and feedback of activity. Counseling will be adapted to specifically reference concepts related to narrative and games.'}, {'id': 'OG001', 'title': 'Standard Intervention', 'description': 'Participants will receive an electronic activity monitor with a mobile device and telephone counseling (weekly for the first 12 weeks, then once per month until 6 months)\n\nStandard intervention: The electronic activity monitor will monitor steps, and the mobile device will provide basic feedback on progress toward goals. Counseling will be standard and concentrate on self-regulatory skill-building.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.87', 'spread': '3.29', 'groupId': 'OG000'}, {'value': '15.82', 'spread': '3.54', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.35', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 6 months', 'description': 'Minutes of moderate-vigorous physical activity per day (averaged over a 7 day period) at baseline and 6 months.', 'unitOfMeasure': 'minutes per day', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Physical Fitness From Baseline to 6 Months, as Measured by 6 Minute Walk Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Game Intervention', 'description': 'Participants will receive narrative-based games on a mobile device and telephone counseling (weekly for the first 12 weeks, then once per month until 6 months)\n\nGame intervention: The game will target motivation via narrative and game mechanics. It will also encourage self-regulation by providing monitoring and feedback of activity. Counseling will be adapted to specifically reference concepts related to narrative and games.'}, {'id': 'OG001', 'title': 'Standard Intervention', 'description': 'Participants will receive an electronic activity monitor with a mobile device and telephone counseling (weekly for the first 12 weeks, then once per month until 6 months)\n\nStandard intervention: The electronic activity monitor will monitor steps, and the mobile device will provide basic feedback on progress toward goals. Counseling will be standard and concentrate on self-regulatory skill-building.'}], 'classes': [{'categories': [{'measurements': [{'value': '-44.35', 'spread': '106.92', 'groupId': 'OG000'}, {'value': '71.74', 'spread': '88.64', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.22', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'baseline to 6 months', 'description': 'We will use a 6 minute walk test to measure fitness, measured in feet walked in six minutes on a pre-marked indoor course', 'unitOfMeasure': 'feet', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Change in Physical Function From Baseline to 6 Months as Measured by the Senior Fitness Test's Chair Stand Measure", 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Game Intervention', 'description': 'Participants will receive narrative-based games on a mobile device and telephone counseling (weekly for the first 12 weeks, then once per month until 6 months)\n\nGame intervention: The game will target motivation via narrative and game mechanics. It will also encourage self-regulation by providing monitoring and feedback of activity. Counseling will be adapted to specifically reference concepts related to narrative and games.'}, {'id': 'OG001', 'title': 'Standard Intervention', 'description': 'Participants will receive an electronic activity monitor with a mobile device and telephone counseling (weekly for the first 12 weeks, then once per month until 6 months)\n\nStandard intervention: The electronic activity monitor will monitor steps, and the mobile device will provide basic feedback on progress toward goals. Counseling will be standard and concentrate on self-regulatory skill-building.'}], 'classes': [{'categories': [{'measurements': [{'value': '.33', 'spread': '1.35', 'groupId': 'OG000'}, {'value': '.4', 'spread': '1.02', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.97', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'baseline to 6 months', 'description': 'We will use the Senior Fitness Test to measure physical function, specifically in regards to the number of chair stands that can be completed within 30 seconds. A higher number indicates better function in this area.', 'unitOfMeasure': 'number of chair stands', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Weight From Baseline to 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Game Intervention', 'description': 'Participants will receive narrative-based games on a mobile device and telephone counseling (weekly for the first 12 weeks, then once per month until 6 months)\n\nGame intervention: The game will target motivation via narrative and game mechanics. It will also encourage self-regulation by providing monitoring and feedback of activity. Counseling will be adapted to specifically reference concepts related to narrative and games.'}, {'id': 'OG001', 'title': 'Standard Intervention', 'description': 'Participants will receive an electronic activity monitor with a mobile device and telephone counseling (weekly for the first 12 weeks, then once per month until 6 months)\n\nStandard intervention: The electronic activity monitor will monitor steps, and the mobile device will provide basic feedback on progress toward goals. Counseling will be standard and concentrate on self-regulatory skill-building.'}], 'classes': [{'categories': [{'measurements': [{'value': '-.14', 'spread': '4.37', 'groupId': 'OG000'}, {'value': '-.04', 'spread': '2.94', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.98', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'baseline to 6 months', 'description': 'We will measure weight using a calibrated scale', 'unitOfMeasure': 'pounds', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Physical Quality of Life From Baseline to 6 Months as Measured by Functional Assessment of Cancer Therapy - Breast Measure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Game Intervention', 'description': 'Participants will receive narrative-based games on a mobile device and telephone counseling (weekly for the first 12 weeks, then once per month until 6 months)\n\nGame intervention: The game will target motivation via narrative and game mechanics. It will also encourage self-regulation by providing monitoring and feedback of activity. Counseling will be adapted to specifically reference concepts related to narrative and games.'}, {'id': 'OG001', 'title': 'Standard Intervention', 'description': 'Participants will receive an electronic activity monitor with a mobile device and telephone counseling (weekly for the first 12 weeks, then once per month until 6 months)\n\nStandard intervention: The electronic activity monitor will monitor steps, and the mobile device will provide basic feedback on progress toward goals. Counseling will be standard and concentrate on self-regulatory skill-building.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.11', 'spread': '.93', 'groupId': 'OG000'}, {'value': '-1.39', 'spread': '.88', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.83', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'baseline to 6 months', 'description': "We will use the Functional Assessment of Cancer Therapy - Breast measure's physical subscale. This scale has a range of 0-28 and 7 items measured on a 5 point scale (not at all to very much). A higher score indicates greater physical quality of life.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Intrinsic Motivation From Baseline to 6 Months, Measured by Intrinsic Motivation Specific to Physical Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Game Intervention', 'description': 'Participants will receive narrative-based games on a mobile device and telephone counseling (weekly for the first 12 weeks, then once per month until 6 months)\n\nGame intervention: The game will target motivation via narrative and game mechanics. It will also encourage self-regulation by providing monitoring and feedback of activity. Counseling will be adapted to specifically reference concepts related to narrative and games.'}, {'id': 'OG001', 'title': 'Standard Intervention', 'description': 'Participants will receive an electronic activity monitor with a mobile device and telephone counseling (weekly for the first 12 weeks, then once per month until 6 months)\n\nStandard intervention: The electronic activity monitor will monitor steps, and the mobile device will provide basic feedback on progress toward goals. Counseling will be standard and concentrate on self-regulatory skill-building.'}], 'classes': [{'categories': [{'measurements': [{'value': '.11', 'spread': '.23', 'groupId': 'OG000'}, {'value': '.62', 'spread': '.22', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.055', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'baseline to 6 months', 'description': 'The Behavioral Regulation in Exercise Questionnaire-2 intrinsic regulation subscale will be used. This subscale includes 4 items measured using a 5 point scale (not true for me to very true for me), with a range of scores from 0-12. A higher number indicates higher intrinsic motivation.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Change in Social/Family Quality of Life From Baseline to 6 Months as Measured by Functional Assessment of Cancer Therapy - Breast Measure's Social/Family Well-Being Subscale", 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Game Intervention', 'description': 'Participants will receive narrative-based games on a mobile device and telephone counseling (weekly for the first 12 weeks, then once per month until 6 months)\n\nGame intervention: The game will target motivation via narrative and game mechanics. It will also encourage self-regulation by providing monitoring and feedback of activity. Counseling will be adapted to specifically reference concepts related to narrative and games.'}, {'id': 'OG001', 'title': 'Standard Intervention', 'description': 'Participants will receive an electronic activity monitor with a mobile device and telephone counseling (weekly for the first 12 weeks, then once per month until 6 months)\n\nStandard intervention: The electronic activity monitor will monitor steps, and the mobile device will provide basic feedback on progress toward goals. Counseling will be standard and concentrate on self-regulatory skill-building.'}], 'classes': [{'categories': [{'measurements': [{'value': '-.74', 'spread': '1.27', 'groupId': 'OG000'}, {'value': '-1.53', 'spread': '1.11', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.71', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'baseline to 6 months', 'description': "We will use the Functional Assessment of Cancer Therapy - Breast measure's social/family subscale. This scale has a range of 0-28 and 7 items measured on a 5-point scale (not at all to very much). A higher score indicates greater social/family quality of life.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Change in Emotional Quality of Life From Baseline to 6 Months as Measured by Functional Assessment of Cancer Therapy - Breast Measure's Emotional Well-Being Subscale", 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Game Intervention', 'description': 'Participants will receive narrative-based games on a mobile device and telephone counseling (weekly for the first 12 weeks, then once per month until 6 months)\n\nGame intervention: The game will target motivation via narrative and game mechanics. It will also encourage self-regulation by providing monitoring and feedback of activity. Counseling will be adapted to specifically reference concepts related to narrative and games.'}, {'id': 'OG001', 'title': 'Standard Intervention', 'description': 'Participants will receive an electronic activity monitor with a mobile device and telephone counseling (weekly for the first 12 weeks, then once per month until 6 months)\n\nStandard intervention: The electronic activity monitor will monitor steps, and the mobile device will provide basic feedback on progress toward goals. Counseling will be standard and concentrate on self-regulatory skill-building.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.76', 'spread': '1.16', 'groupId': 'OG000'}, {'value': '-.27', 'spread': '.95', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.33', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'baseline to 6 Months', 'description': "We will use the Functional Assessment of Cancer Therapy - Breast measure's emotional subscale. This scale has a range of 0-24 and 6 items measured on a 5-point scale (not at all to very much). A higher score indicates greater emotional quality of life", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Change in Functional Quality of Life From Baseline to 6 Months as Measured by Functional Assessment of Cancer Therapy - Breast Measure's Functional Well-Being Subscale", 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Game Intervention', 'description': 'Participants will receive narrative-based games on a mobile device and telephone counseling (weekly for the first 12 weeks, then once per month until 6 months)\n\nGame intervention: The game will target motivation via narrative and game mechanics. It will also encourage self-regulation by providing monitoring and feedback of activity. Counseling will be adapted to specifically reference concepts related to narrative and games.'}, {'id': 'OG001', 'title': 'Standard Intervention', 'description': 'Participants will receive an electronic activity monitor with a mobile device and telephone counseling (weekly for the first 12 weeks, then once per month until 6 months)\n\nStandard intervention: The electronic activity monitor will monitor steps, and the mobile device will provide basic feedback on progress toward goals. Counseling will be standard and concentrate on self-regulatory skill-building.'}], 'classes': [{'categories': [{'measurements': [{'value': '.72', 'spread': '1.14', 'groupId': 'OG000'}, {'value': '.6', 'spread': '.87', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.94', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'baseline to 6 Months', 'description': "We will use the Functional Assessment of Cancer Therapy - Breast measure's functional subscale. This scale has a range of 0-28 and 7 items measured on a 5-point scale (not at all to very much). A higher score indicates greater functional quality of life", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Change in Breast Cancer-Specific Quality of Life From Baseline to 6 Months as Measured by Functional Assessment of Cancer Therapy - Breast Measure's Breast Cancer Subscale", 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Game Intervention', 'description': 'Participants will receive narrative-based games on a mobile device and telephone counseling (weekly for the first 12 weeks, then once per month until 6 months)\n\nGame intervention: The game will target motivation via narrative and game mechanics. It will also encourage self-regulation by providing monitoring and feedback of activity. Counseling will be adapted to specifically reference concepts related to narrative and games.'}, {'id': 'OG001', 'title': 'Standard Intervention', 'description': 'Participants will receive an electronic activity monitor with a mobile device and telephone counseling (weekly for the first 12 weeks, then once per month until 6 months)\n\nStandard intervention: The electronic activity monitor will monitor steps, and the mobile device will provide basic feedback on progress toward goals. Counseling will be standard and concentrate on self-regulatory skill-building.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.03', 'spread': '1.16', 'groupId': 'OG000'}, {'value': '-.96', 'spread': '1.34', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.57', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'baseline to 6 Months', 'description': "We will use the Functional Assessment of Cancer Therapy - Breast measure's breast cancer subscale. This scale has a range of 0-40 and 10 items measured on a 5-point scale (not at all to very much). A higher score indicates greater breast cancer-related quality of life", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Identified Regulation From Baseline to 6 Months, Measured by Identified Regulation Specific to Physical Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Game Intervention', 'description': 'Participants will receive narrative-based games on a mobile device and telephone counseling (weekly for the first 12 weeks, then once per month until 6 months)\n\nGame intervention: The game will target motivation via narrative and game mechanics. It will also encourage self-regulation by providing monitoring and feedback of activity. Counseling will be adapted to specifically reference concepts related to narrative and games.'}, {'id': 'OG001', 'title': 'Standard Intervention', 'description': 'Participants will receive an electronic activity monitor with a mobile device and telephone counseling (weekly for the first 12 weeks, then once per month until 6 months)\n\nStandard intervention: The electronic activity monitor will monitor steps, and the mobile device will provide basic feedback on progress toward goals. Counseling will be standard and concentrate on self-regulatory skill-building.'}], 'classes': [{'categories': [{'measurements': [{'value': '.01', 'spread': '.19', 'groupId': 'OG000'}, {'value': '.30', 'spread': '.21', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.30', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'baseline to 6 Months', 'description': 'The Behavioral Regulation in Exercise Questionnaire-2 identified regulation subscale will be used. This subscale includes 4 items measured using a 5 point scale (not true for me to very true for me), with a range of scores from 0-12. A higher number indicates a greater amount of identified regulation.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Integrated Regulation From Baseline to 6 Months, Measured by Integrated Regulation Specific to Physical Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Game Intervention', 'description': 'Participants will receive narrative-based games on a mobile device and telephone counseling (weekly for the first 12 weeks, then once per month until 6 months)\n\nGame intervention: The game will target motivation via narrative and game mechanics. It will also encourage self-regulation by providing monitoring and feedback of activity. Counseling will be adapted to specifically reference concepts related to narrative and games.'}, {'id': 'OG001', 'title': 'Standard Intervention', 'description': 'Participants will receive an electronic activity monitor with a mobile device and telephone counseling (weekly for the first 12 weeks, then once per month until 6 months)\n\nStandard intervention: The electronic activity monitor will monitor steps, and the mobile device will provide basic feedback on progress toward goals. Counseling will be standard and concentrate on self-regulatory skill-building.'}], 'classes': [{'categories': [{'measurements': [{'value': '.32', 'spread': '.27', 'groupId': 'OG000'}, {'value': '.53', 'spread': '.18', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.44', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'baseline to 6 Months', 'description': "We will use items from P.M. Wilson and colleague's expansion of the Behavioral Regulation in Exercise Questionnaire-2 to include integrated regulation. This subscale includes 4 items measured using a 5 point scale (not true for me to very true for me), with a range of scores from 0-12. A higher number indicates a greater amount of identified regulation.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Change in Physical Function From Baseline to 6 Months as Measured by the Senior Fitness Test's Arm Curl Measure", 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Game Intervention', 'description': 'Participants will receive narrative-based games on a mobile device and telephone counseling (weekly for the first 12 weeks, then once per month until 6 months)\n\nGame intervention: The game will target motivation via narrative and game mechanics. It will also encourage self-regulation by providing monitoring and feedback of activity. Counseling will be adapted to specifically reference concepts related to narrative and games.'}, {'id': 'OG001', 'title': 'Standard Intervention', 'description': 'Participants will receive an electronic activity monitor with a mobile device and telephone counseling (weekly for the first 12 weeks, then once per month until 6 months)\n\nStandard intervention: The electronic activity monitor will monitor steps, and the mobile device will provide basic feedback on progress toward goals. Counseling will be standard and concentrate on self-regulatory skill-building.'}], 'classes': [{'categories': [{'measurements': [{'value': '.39', 'spread': '1.34', 'groupId': 'OG000'}, {'value': '1.04', 'spread': '.83', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.62', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'baseline to 6 Months', 'description': 'We will use the Senior Fitness Test to measure physical function, specifically in regards to the number of arm curls that can be completed within 30 seconds. A higher number indicates better function in this area.', 'unitOfMeasure': 'number of arm curls', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Change in Physical Function From Baseline to 6 Months as Measured by the Senior Fitness Test's Sit and Reach Measure", 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Game Intervention', 'description': 'Participants will receive narrative-based games on a mobile device and telephone counseling (weekly for the first 12 weeks, then once per month until 6 months)\n\nGame intervention: The game will target motivation via narrative and game mechanics. It will also encourage self-regulation by providing monitoring and feedback of activity. Counseling will be adapted to specifically reference concepts related to narrative and games.'}, {'id': 'OG001', 'title': 'Standard Intervention', 'description': 'Participants will receive an electronic activity monitor with a mobile device and telephone counseling (weekly for the first 12 weeks, then once per month until 6 months)\n\nStandard intervention: The electronic activity monitor will monitor steps, and the mobile device will provide basic feedback on progress toward goals. Counseling will be standard and concentrate on self-regulatory skill-building.'}], 'classes': [{'categories': [{'measurements': [{'value': '-.05', 'spread': '.73', 'groupId': 'OG000'}, {'value': '.29', 'spread': '.63', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.70', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'baseline to 6 Months', 'description': 'We will use the Senior Fitness Test to measure physical function, specifically in regards to the distance an individual can reach from their toes when bending forward. A higher number indicates better function in this area.', 'unitOfMeasure': 'inches', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Change in Physical Function From Baseline to 6 Months as Measured by the Senior Fitness Test's Back Scratch Measure", 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Game Intervention', 'description': 'Participants will receive narrative-based games on a mobile device and telephone counseling (weekly for the first 12 weeks, then once per month until 6 months)\n\nGame intervention: The game will target motivation via narrative and game mechanics. It will also encourage self-regulation by providing monitoring and feedback of activity. Counseling will be adapted to specifically reference concepts related to narrative and games.'}, {'id': 'OG001', 'title': 'Standard Intervention', 'description': 'Participants will receive an electronic activity monitor with a mobile device and telephone counseling (weekly for the first 12 weeks, then once per month until 6 months)\n\nStandard intervention: The electronic activity monitor will monitor steps, and the mobile device will provide basic feedback on progress toward goals. Counseling will be standard and concentrate on self-regulatory skill-building.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.32', 'spread': '1.98', 'groupId': 'OG000'}, {'value': '-.57', 'spread': '.91', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.41', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'baseline to 6 Months', 'description': "We will use the Senior Fitness Test to measure physical function, specifically in regards to the distance between an individual's arms when they reach them behind their back (one higher above the shoulder and one lower). A higher number indicates better function in this area.", 'unitOfMeasure': 'inches', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Change in Physical Function From Baseline to 6 Months as Measured by the Senior Fitness Test's 8 Foot Up and Go Test", 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Game Intervention', 'description': 'Participants will receive narrative-based games on a mobile device and telephone counseling (weekly for the first 12 weeks, then once per month until 6 months)\n\nGame intervention: The game will target motivation via narrative and game mechanics. It will also encourage self-regulation by providing monitoring and feedback of activity. Counseling will be adapted to specifically reference concepts related to narrative and games.'}, {'id': 'OG001', 'title': 'Standard Intervention', 'description': 'Participants will receive an electronic activity monitor with a mobile device and telephone counseling (weekly for the first 12 weeks, then once per month until 6 months)\n\nStandard intervention: The electronic activity monitor will monitor steps, and the mobile device will provide basic feedback on progress toward goals. Counseling will be standard and concentrate on self-regulatory skill-building.'}], 'classes': [{'categories': [{'measurements': [{'value': '.68', 'spread': '.85', 'groupId': 'OG000'}, {'value': '.26', 'spread': '.85', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.72', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'baseline to 6 Months', 'description': 'We will use the Senior Fitness Test to measure physical function, specifically in regards to the time in which an individual can sit up, walk 8 feet around a cone, and sit back down. A lower number indicates better function in this area.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Maintenance of Physical Fitness From 6 Months to 1 Year, Measured by a 6 Minute Walk Test', 'timeFrame': 'baseline to 6 months', 'description': 'We will use a 6 minute walk test to measure fitness, measured in feet walked in six minutes on a pre-marked indoor course', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Maintenance of Physical Function From 6 Months to 1 Year, Measured by the Senior Fitness Test', 'timeFrame': 'baseline to 6 months', 'description': 'We will use the Senior Fitness Test to measure physical function, with a higher number indicating greater function', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Sleep From 6 Months to 1 Year', 'timeFrame': 'baseline to 6 months', 'description': 'We will use a computerized PROMIS measure specific to cancer survivors', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Weight From 6 Months to 1 Year', 'timeFrame': 'baseline to 6 months', 'description': 'Weight will be measured using a calibrated scale', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Adherence, Measured by Objective Measures to Investigate Adherence to Study Protocols', 'timeFrame': '1 year', 'description': 'We will use objective measures to investigate adherence to study protocols (game usage, monitor usage, phone calls completed, assessments attended, etc.)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants Who Report Adverse Events', 'timeFrame': '1 year', 'description': 'We will inquire about potential adverse events during counseling calls and assessment visits. Discrete events will be summed, and the number of participants with events will be summed.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Anxiety From Baseline to 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Game Intervention', 'description': 'Participants will receive narrative-based games on a mobile device and telephone counseling (weekly for the first 12 weeks, then once per month until 6 months)\n\nGame intervention: The game will target motivation via narrative and game mechanics. It will also encourage self-regulation by providing monitoring and feedback of activity. Counseling will be adapted to specifically reference concepts related to narrative and games.'}, {'id': 'OG001', 'title': 'Standard Intervention', 'description': 'Participants will receive an electronic activity monitor with a mobile device and telephone counseling (weekly for the first 12 weeks, then once per month until 6 months)\n\nStandard intervention: The electronic activity monitor will monitor steps, and the mobile device will provide basic feedback on progress toward goals. Counseling will be standard and concentrate on self-regulatory skill-building.'}], 'classes': [{'categories': [{'measurements': [{'value': '51.34', 'spread': '0.90', 'groupId': 'OG000'}, {'value': '49.09', 'spread': '0.90', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.084', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'baseline to 6 months', 'description': 'We will use a computerized PROMIS measure to investigate anxiety (Patient Reported Outcomes Measurement Information System PROMIS-Ca Bank 1.0 - Anxiety). The result shown is a t-score, where a score of 50 would be equivalent to the mean in the population of cancer survivors. Because the standard deviation is 10, a score of 10 higher or lower would indicate that the score is 1 standard deviation higher or lower (more/less anxiety) than the population.', 'unitOfMeasure': 't-score', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Depression From 6 Months to 1 Year', 'timeFrame': 'baseline to 6 months', 'description': 'We will use a computerized PROMIS measure specific to cancer patients/survivors (Patient Reported Outcomes Measurement Information System PROMIS-Ca Bank 1.0 - Depression)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Fatigue From Baseline to 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Game Intervention', 'description': 'Participants will receive narrative-based games on a mobile device and telephone counseling (weekly for the first 12 weeks, then once per month until 6 months)\n\nGame intervention: The game will target motivation via narrative and game mechanics. It will also encourage self-regulation by providing monitoring and feedback of activity. Counseling will be adapted to specifically reference concepts related to narrative and games.'}, {'id': 'OG001', 'title': 'Standard Intervention', 'description': 'Participants will receive an electronic activity monitor with a mobile device and telephone counseling (weekly for the first 12 weeks, then once per month until 6 months)\n\nStandard intervention: The electronic activity monitor will monitor steps, and the mobile device will provide basic feedback on progress toward goals. Counseling will be standard and concentrate on self-regulatory skill-building.'}], 'classes': [{'categories': [{'measurements': [{'value': '50.96', 'spread': '0.75', 'groupId': 'OG000'}, {'value': '50.37', 'spread': '0.75', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.580', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'baseline to 6 months', 'description': 'We will use a computerized PROMIS measure specific to cancer patients/survivors (Patient Reported Outcomes Measurement Information System PROMIS-Ca Bank 1.0 Fatigue). The result shown is a t-score, where a score of 50 would be equivalent to the mean in the population of cancer survivors. Because the standard deviation is 10, a score of 10 higher or lower would indicate that the score is 1 standard deviation higher or lower (more/less fatigued) than the population.', 'unitOfMeasure': 't-score', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Quality of Life From 6 Months to 1 Year', 'timeFrame': 'baseline to 6 months', 'description': 'We will use the Functional Assessment of Cancer Therapy - Breast measure', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Motivation From 6 Months to 1 Year, Measured by Autonomous Motivation Specific to Physical Activity', 'timeFrame': 'baseline to 6 months', 'description': "Behavioral Regulation in Exercise Questionnaire-2 will be used, specifically subscales for autonomous motivation (intrinsic, integrated, identified regulation). We will use items from P.M. Wilson and colleague's expansion of the Behavioral Regulation in Exercise Questionnaire-2 to include integrated regulation.", 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Acceptability, Measured Using Self-report Measures of Usability and Liking of the Apps', 'timeFrame': 'baseline to 6 months', 'description': 'Participants will report their perceptions of app usability and acceptability in the 6 month questionnaire', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Play Experience, Measured Using the Play Experience Questionnaire', 'timeFrame': 'Measured at 3 months', 'description': 'Participants will self-report their perceptions of the playfulness of the intervention apps', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Exercise Identity From Baseline to 6 Months', 'timeFrame': 'baseline to 6 months', 'description': 'We will use the Exercise Identity Scale to investigate exercise beliefs and exercise role identity', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Narrative Engagement (Measured in Narrative Group Only), Measured Using the Narrative Engagement Scale', 'timeFrame': 'Measured at 3 months', 'description': "We will measure the extent to which participants in the narrative group felt narratively engaged in the game's storyline", 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Character Identification (Measured in Narrative Group Only), Measured Using the Player Identification Scale', 'timeFrame': 'Measured at 3 months', 'description': 'We will measure the extent to which participants in the narrative group felt like they identified with their game character', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Depression From Baseline to 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Game Intervention', 'description': 'Participants will receive narrative-based games on a mobile device and telephone counseling (weekly for the first 12 weeks, then once per month until 6 months)\n\nGame intervention: The game will target motivation via narrative and game mechanics. It will also encourage self-regulation by providing monitoring and feedback of activity. Counseling will be adapted to specifically reference concepts related to narrative and games.'}, {'id': 'OG001', 'title': 'Standard Intervention', 'description': 'Participants will receive an electronic activity monitor with a mobile device and telephone counseling (weekly for the first 12 weeks, then once per month until 6 months)\n\nStandard intervention: The electronic activity monitor will monitor steps, and the mobile device will provide basic feedback on progress toward goals. Counseling will be standard and concentrate on self-regulatory skill-building.'}], 'classes': [{'categories': [{'measurements': [{'value': '49.32', 'spread': '0.77', 'groupId': 'OG000'}, {'value': '48.50', 'spread': '0.77', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.461', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'baseline to 6 months', 'description': 'We will use a computerized PROMIS measure specific to cancer patients/survivors (Patient Reported Outcomes Measurement Information System PROMIS-Ca Bank 1.0 - Depression). The result shown is a t-score, where a score of 50 would be equivalent to the mean in the population of cancer survivors. Because the standard deviation is 10, a score of 10 higher or lower would indicate that the score is 1 standard deviation higher or lower (more/less depressed) than the population.', 'unitOfMeasure': 't-score', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Fatigue From 6 Months to 1 Year', 'timeFrame': 'baseline to 6 months', 'description': 'We will use a computerized PROMIS measure specific to cancer patients/survivors', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Sleep From Baseline to 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Game Intervention', 'description': 'Participants will receive narrative-based games on a mobile device and telephone counseling (weekly for the first 12 weeks, then once per month until 6 months)\n\nGame intervention: The game will target motivation via narrative and game mechanics. It will also encourage self-regulation by providing monitoring and feedback of activity. Counseling will be adapted to specifically reference concepts related to narrative and games.'}, {'id': 'OG001', 'title': 'Standard Intervention', 'description': 'Participants will receive an electronic activity monitor with a mobile device and telephone counseling (weekly for the first 12 weeks, then once per month until 6 months)\n\nStandard intervention: The electronic activity monitor will monitor steps, and the mobile device will provide basic feedback on progress toward goals. Counseling will be standard and concentrate on self-regulatory skill-building.'}], 'classes': [{'categories': [{'measurements': [{'value': '52.35', 'spread': '0.48', 'groupId': 'OG000'}, {'value': '52.30', 'spread': '0.48', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.934', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'baseline to 6 months', 'description': 'We will use a computerized PROMIS measure (Patient Reported Outcomes Measurement Information System PROMIS Bank v1.0 - Sleep-Related Impairment). The result shown is a t-score, where a score of 50 would be equivalent to the mean in the population. Because the standard deviation is 10, a score of 10 higher or lower would indicate that the score is 1 standard deviation higher or lower than the population (more/less impairment).', 'unitOfMeasure': 't-score', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Maintenance of Physical Activity From 6 Months to 1 Year', 'timeFrame': 'baseline to 6 months', 'description': 'Minutes of moderate-vigorous physical activity measured over a 7 day period', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Game Intervention', 'description': 'Participants will receive narrative-based games on a mobile device and telephone counseling (weekly for the first 12 weeks, then once per month until 6 months)\n\nGame intervention: The game will target motivation via narrative and game mechanics. It will also encourage self-regulation by providing monitoring and feedback of activity. Counseling will be adapted to specifically reference concepts related to narrative and games.'}, {'id': 'FG001', 'title': 'Standard Intervention', 'description': 'Participants will receive an electronic activity monitor with a mobile device and telephone counseling (weekly for the first 12 weeks, then once per month until 6 months)\n\nStandard intervention: The electronic activity monitor will monitor steps, and the mobile device will provide basic feedback on progress toward goals. Counseling will be standard and concentrate on self-regulatory skill-building.'}], 'periods': [{'title': 'Baseline to 6 Months', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '45'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '31'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '14'}]}]}, {'title': '6 Months to 12 Months', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '31'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '10'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Game Intervention', 'description': 'Participants will receive narrative-based games on a mobile device and telephone counseling (weekly for the first 12 weeks, then once per month until 6 months)\n\nGame intervention: The game will target motivation via narrative and game mechanics. It will also encourage self-regulation by providing monitoring and feedback of activity. Counseling will be adapted to specifically reference concepts related to narrative and games.'}, {'id': 'BG001', 'title': 'Standard Intervention', 'description': 'Participants will receive an electronic activity monitor with a mobile device and telephone counseling (weekly for the first 12 weeks, then once per month until 6 months)\n\nStandard intervention: The electronic activity monitor will monitor steps, and the mobile device will provide basic feedback on progress toward goals. Counseling will be standard and concentrate on self-regulatory skill-building.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.48', 'spread': '6.78', 'groupId': 'BG000'}, {'value': '59.92', 'spread': '7.68', 'groupId': 'BG001'}, {'value': '61.22', 'spread': '7.31', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '90', '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': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '79', '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': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '70', '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': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Time since diagnosis', 'classes': [{'categories': [{'measurements': [{'value': '5.55', 'spread': '6.43', 'groupId': 'BG000'}, {'value': '6.84', 'spread': '5.29', 'groupId': 'BG001'}, {'value': '6.19', 'spread': '5.89', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-04-01', 'size': 766976, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-06-07T13:52', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-29', 'studyFirstSubmitDate': '2015-01-09', 'resultsFirstSubmitDate': '2022-06-17', 'studyFirstSubmitQcDate': '2015-01-13', 'lastUpdatePostDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-07-29', 'studyFirstPostDateStruct': {'date': '2015-01-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Maintenance of Physical Fitness From 6 Months to 1 Year, Measured by a 6 Minute Walk Test', 'timeFrame': 'baseline to 6 months', 'description': 'We will use a 6 minute walk test to measure fitness, measured in feet walked in six minutes on a pre-marked indoor course'}, {'measure': 'Maintenance of Physical Function From 6 Months to 1 Year, Measured by the Senior Fitness Test', 'timeFrame': 'baseline to 6 months', 'description': 'We will use the Senior Fitness Test to measure physical function, with a higher number indicating greater function'}, {'measure': 'Change in Sleep From 6 Months to 1 Year', 'timeFrame': 'baseline to 6 months', 'description': 'We will use a computerized PROMIS measure specific to cancer survivors'}, {'measure': 'Change in Weight From 6 Months to 1 Year', 'timeFrame': 'baseline to 6 months', 'description': 'Weight will be measured using a calibrated scale'}, {'measure': 'Adherence, Measured by Objective Measures to Investigate Adherence to Study Protocols', 'timeFrame': '1 year', 'description': 'We will use objective measures to investigate adherence to study protocols (game usage, monitor usage, phone calls completed, assessments attended, etc.)'}, {'measure': 'Number of Participants Who Report Adverse Events', 'timeFrame': '1 year', 'description': 'We will inquire about potential adverse events during counseling calls and assessment visits. Discrete events will be summed, and the number of participants with events will be summed.'}, {'measure': 'Change in Anxiety From Baseline to 6 Months', 'timeFrame': 'baseline to 6 months', 'description': 'We will use a computerized PROMIS measure to investigate anxiety (Patient Reported Outcomes Measurement Information System PROMIS-Ca Bank 1.0 - Anxiety). The result shown is a t-score, where a score of 50 would be equivalent to the mean in the population of cancer survivors. Because the standard deviation is 10, a score of 10 higher or lower would indicate that the score is 1 standard deviation higher or lower (more/less anxiety) than the population.'}, {'measure': 'Change in Depression From 6 Months to 1 Year', 'timeFrame': 'baseline to 6 months', 'description': 'We will use a computerized PROMIS measure specific to cancer patients/survivors (Patient Reported Outcomes Measurement Information System PROMIS-Ca Bank 1.0 - Depression)'}, {'measure': 'Change in Fatigue From Baseline to 6 Months', 'timeFrame': 'baseline to 6 months', 'description': 'We will use a computerized PROMIS measure specific to cancer patients/survivors (Patient Reported Outcomes Measurement Information System PROMIS-Ca Bank 1.0 Fatigue). The result shown is a t-score, where a score of 50 would be equivalent to the mean in the population of cancer survivors. Because the standard deviation is 10, a score of 10 higher or lower would indicate that the score is 1 standard deviation higher or lower (more/less fatigued) than the population.'}, {'measure': 'Change in Quality of Life From 6 Months to 1 Year', 'timeFrame': 'baseline to 6 months', 'description': 'We will use the Functional Assessment of Cancer Therapy - Breast measure'}, {'measure': 'Change in Motivation From 6 Months to 1 Year, Measured by Autonomous Motivation Specific to Physical Activity', 'timeFrame': 'baseline to 6 months', 'description': "Behavioral Regulation in Exercise Questionnaire-2 will be used, specifically subscales for autonomous motivation (intrinsic, integrated, identified regulation). We will use items from P.M. Wilson and colleague's expansion of the Behavioral Regulation in Exercise Questionnaire-2 to include integrated regulation."}, {'measure': 'Acceptability, Measured Using Self-report Measures of Usability and Liking of the Apps', 'timeFrame': 'baseline to 6 months', 'description': 'Participants will report their perceptions of app usability and acceptability in the 6 month questionnaire'}, {'measure': 'Play Experience, Measured Using the Play Experience Questionnaire', 'timeFrame': 'Measured at 3 months', 'description': 'Participants will self-report their perceptions of the playfulness of the intervention apps'}, {'measure': 'Change in Exercise Identity From Baseline to 6 Months', 'timeFrame': 'baseline to 6 months', 'description': 'We will use the Exercise Identity Scale to investigate exercise beliefs and exercise role identity'}, {'measure': 'Narrative Engagement (Measured in Narrative Group Only), Measured Using the Narrative Engagement Scale', 'timeFrame': 'Measured at 3 months', 'description': "We will measure the extent to which participants in the narrative group felt narratively engaged in the game's storyline"}, {'measure': 'Character Identification (Measured in Narrative Group Only), Measured Using the Player Identification Scale', 'timeFrame': 'Measured at 3 months', 'description': 'We will measure the extent to which participants in the narrative group felt like they identified with their game character'}, {'measure': 'Change in Depression From Baseline to 6 Months', 'timeFrame': 'baseline to 6 months', 'description': 'We will use a computerized PROMIS measure specific to cancer patients/survivors (Patient Reported Outcomes Measurement Information System PROMIS-Ca Bank 1.0 - Depression). The result shown is a t-score, where a score of 50 would be equivalent to the mean in the population of cancer survivors. Because the standard deviation is 10, a score of 10 higher or lower would indicate that the score is 1 standard deviation higher or lower (more/less depressed) than the population.'}, {'measure': 'Change in Fatigue From 6 Months to 1 Year', 'timeFrame': 'baseline to 6 months', 'description': 'We will use a computerized PROMIS measure specific to cancer patients/survivors'}, {'measure': 'Change in Sleep From Baseline to 6 Months', 'timeFrame': 'baseline to 6 months', 'description': 'We will use a computerized PROMIS measure (Patient Reported Outcomes Measurement Information System PROMIS Bank v1.0 - Sleep-Related Impairment). The result shown is a t-score, where a score of 50 would be equivalent to the mean in the population. Because the standard deviation is 10, a score of 10 higher or lower would indicate that the score is 1 standard deviation higher or lower than the population (more/less impairment).'}, {'measure': 'Maintenance of Physical Activity From 6 Months to 1 Year', 'timeFrame': 'baseline to 6 months', 'description': 'Minutes of moderate-vigorous physical activity measured over a 7 day period'}], 'primaryOutcomes': [{'measure': 'Change in Minutes Per Day of Physical Activity', 'timeFrame': 'baseline and 6 months', 'description': 'Minutes of moderate-vigorous physical activity per day (averaged over a 7 day period) at baseline and 6 months.'}], 'secondaryOutcomes': [{'measure': 'Change in Physical Fitness From Baseline to 6 Months, as Measured by 6 Minute Walk Test', 'timeFrame': 'baseline to 6 months', 'description': 'We will use a 6 minute walk test to measure fitness, measured in feet walked in six minutes on a pre-marked indoor course'}, {'measure': "Change in Physical Function From Baseline to 6 Months as Measured by the Senior Fitness Test's Chair Stand Measure", 'timeFrame': 'baseline to 6 months', 'description': 'We will use the Senior Fitness Test to measure physical function, specifically in regards to the number of chair stands that can be completed within 30 seconds. A higher number indicates better function in this area.'}, {'measure': 'Change in Weight From Baseline to 6 Months', 'timeFrame': 'baseline to 6 months', 'description': 'We will measure weight using a calibrated scale'}, {'measure': 'Change in Physical Quality of Life From Baseline to 6 Months as Measured by Functional Assessment of Cancer Therapy - Breast Measure', 'timeFrame': 'baseline to 6 months', 'description': "We will use the Functional Assessment of Cancer Therapy - Breast measure's physical subscale. This scale has a range of 0-28 and 7 items measured on a 5 point scale (not at all to very much). A higher score indicates greater physical quality of life."}, {'measure': 'Change in Intrinsic Motivation From Baseline to 6 Months, Measured by Intrinsic Motivation Specific to Physical Activity', 'timeFrame': 'baseline to 6 months', 'description': 'The Behavioral Regulation in Exercise Questionnaire-2 intrinsic regulation subscale will be used. This subscale includes 4 items measured using a 5 point scale (not true for me to very true for me), with a range of scores from 0-12. A higher number indicates higher intrinsic motivation.'}, {'measure': "Change in Social/Family Quality of Life From Baseline to 6 Months as Measured by Functional Assessment of Cancer Therapy - Breast Measure's Social/Family Well-Being Subscale", 'timeFrame': 'baseline to 6 months', 'description': "We will use the Functional Assessment of Cancer Therapy - Breast measure's social/family subscale. This scale has a range of 0-28 and 7 items measured on a 5-point scale (not at all to very much). A higher score indicates greater social/family quality of life."}, {'measure': "Change in Emotional Quality of Life From Baseline to 6 Months as Measured by Functional Assessment of Cancer Therapy - Breast Measure's Emotional Well-Being Subscale", 'timeFrame': 'baseline to 6 Months', 'description': "We will use the Functional Assessment of Cancer Therapy - Breast measure's emotional subscale. This scale has a range of 0-24 and 6 items measured on a 5-point scale (not at all to very much). A higher score indicates greater emotional quality of life"}, {'measure': "Change in Functional Quality of Life From Baseline to 6 Months as Measured by Functional Assessment of Cancer Therapy - Breast Measure's Functional Well-Being Subscale", 'timeFrame': 'baseline to 6 Months', 'description': "We will use the Functional Assessment of Cancer Therapy - Breast measure's functional subscale. This scale has a range of 0-28 and 7 items measured on a 5-point scale (not at all to very much). A higher score indicates greater functional quality of life"}, {'measure': "Change in Breast Cancer-Specific Quality of Life From Baseline to 6 Months as Measured by Functional Assessment of Cancer Therapy - Breast Measure's Breast Cancer Subscale", 'timeFrame': 'baseline to 6 Months', 'description': "We will use the Functional Assessment of Cancer Therapy - Breast measure's breast cancer subscale. This scale has a range of 0-40 and 10 items measured on a 5-point scale (not at all to very much). A higher score indicates greater breast cancer-related quality of life"}, {'measure': 'Change in Identified Regulation From Baseline to 6 Months, Measured by Identified Regulation Specific to Physical Activity', 'timeFrame': 'baseline to 6 Months', 'description': 'The Behavioral Regulation in Exercise Questionnaire-2 identified regulation subscale will be used. This subscale includes 4 items measured using a 5 point scale (not true for me to very true for me), with a range of scores from 0-12. A higher number indicates a greater amount of identified regulation.'}, {'measure': 'Change in Integrated Regulation From Baseline to 6 Months, Measured by Integrated Regulation Specific to Physical Activity', 'timeFrame': 'baseline to 6 Months', 'description': "We will use items from P.M. Wilson and colleague's expansion of the Behavioral Regulation in Exercise Questionnaire-2 to include integrated regulation. This subscale includes 4 items measured using a 5 point scale (not true for me to very true for me), with a range of scores from 0-12. A higher number indicates a greater amount of identified regulation."}, {'measure': "Change in Physical Function From Baseline to 6 Months as Measured by the Senior Fitness Test's Arm Curl Measure", 'timeFrame': 'baseline to 6 Months', 'description': 'We will use the Senior Fitness Test to measure physical function, specifically in regards to the number of arm curls that can be completed within 30 seconds. A higher number indicates better function in this area.'}, {'measure': "Change in Physical Function From Baseline to 6 Months as Measured by the Senior Fitness Test's Sit and Reach Measure", 'timeFrame': 'baseline to 6 Months', 'description': 'We will use the Senior Fitness Test to measure physical function, specifically in regards to the distance an individual can reach from their toes when bending forward. A higher number indicates better function in this area.'}, {'measure': "Change in Physical Function From Baseline to 6 Months as Measured by the Senior Fitness Test's Back Scratch Measure", 'timeFrame': 'baseline to 6 Months', 'description': "We will use the Senior Fitness Test to measure physical function, specifically in regards to the distance between an individual's arms when they reach them behind their back (one higher above the shoulder and one lower). A higher number indicates better function in this area."}, {'measure': "Change in Physical Function From Baseline to 6 Months as Measured by the Senior Fitness Test's 8 Foot Up and Go Test", 'timeFrame': 'baseline to 6 Months', 'description': 'We will use the Senior Fitness Test to measure physical function, specifically in regards to the time in which an individual can sit up, walk 8 feet around a cone, and sit back down. A lower number indicates better function in this area.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['video game', 'narrative', 'story', 'survivorship', 'cancer survivor', 'mhealth', 'physical activity', 'women', "women's health"], 'conditions': ['Breast Cancer', 'Obesity']}, 'referencesModule': {'references': [{'pmid': '26960972', 'type': 'DERIVED', 'citation': 'Lyons EJ, Baranowski T, Basen-Engquist KM, Lewis ZH, Swartz MC, Jennings K, Volpi E. Testing the effects of narrative and play on physical activity among breast cancer survivors using mobile apps: study protocol for a randomized controlled trial. BMC Cancer. 2016 Mar 9;16:202. doi: 10.1186/s12885-016-2244-y.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare an enhanced intervention that includes narrative and game components to a standard intervention that only targets self-monitoring. These approaches will be tested among postmenopausal breast cancer survivors who are sedentary and overweight.', 'detailedDescription': 'Habitual physical activity decreases risk of multiple negative health outcomes, including breast cancer recurrence and mortality. It is also associated with better quality of life and reducing negative effects of cancer and cancer treatment. However, most breast cancer survivors do not engage in sufficient physical activity. Behavior change interventions produce short-term increases in activity but have difficulty motivating sustained active lifestyles over longer periods and are not equally effective in women of different races/ethnicities. The purpose of this study is to test a novel intervention that uses video games and storytelling to increase motivation. Video game mechanics increase enjoyment and feelings of autonomy (control), competence, and relatedness to others. All of these feelings are associated with motivation for activity and, in turn, sustained activity over time. Additionally, narrative storytelling is an effective method of persuading individuals to change their behavior. We propose that play of active video games that include compelling storylines will increase physical activity among a diverse sample of postmenopausal breast cancer survivors.\n\nTo test this hypothesis, we will conduct a clinical trial that compares the enhanced intervention (story-based video games) to a standard intervention in 90 sedentary, overweight postmenopausal breast cancer survivors. Participants in the enhanced group will receive a mobile device and accessories with two story-based video game applications installed. The games incorporate behavior change strategies such as self-monitoring and feedback while also using game mechanics and a lengthy storyline to motivate physical activity. Participants in the standard group will receive the same mobile device with an electronic activity monitor and its companion feedback application. Both groups will receive brief weekly telephone counseling. By comparing two groups that both receive typical behavior change intervention components (counseling) and a novel electronic intervention, we will be able to investigate the specific effects of game mechanics and storytelling on motivation and physical activity. We will measure changes in physical activity, fitness, function, and quality of life from the beginning of the study to 6 months. We will also investigate further changes during an additional 6 month follow-up period in which participants keep their intervention tools but do not receive any counseling, to measure maintenance of activity. This project will develop and test a promising, innovative intervention that has the potential to be used on a widespread basis in clinical and community settings.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age between 45 and 75 years old\n2. Report a breast cancer diagnosis no more than 10 years prior to enrollment\n3. Cessation of menses for 12 months or more\n4. Able to read and understand English\n5. Able to read words in standard applications on a mobile device 3-4" large\n6. Able to walk for exercise\n7. Able to find transportation to the study location\n8. Willing to use a mobile device provided by the study to participate (or to use one of their own)\n9. Willing to be randomized to either group\n\nExclusion Criteria:\n\n1. Currently pregnant or nursing\n2. Surgery in the past six months\n3. Chemotherapy or radiation treatment in the past six months\n4. Evidence of disease recurrence\n5. Participant is active (90 minutes of moderate-vigorous intensity activity per week or more)\n6. BMI is under 25 kg/m2 or over 35 kg/m2\n7. Report a heart condition, chest pain during periods of activity or rest, loss of consciousness, etc. on the Physical Activity Readiness Questionnaire (PAR-Q), unless cleared by their physician\n8. Participant reports hospitalization within the past year due to psychiatric problem(s)\n9. Report current symptoms of alcohol or substance dependence\n10. Plans to move away from the Galveston-Houston area or to be out of town for more than 1 week during the study period\n11. Stroke, hip fracture, hip or knee replacement, or spinal surgery in the past 6 months\n12. Report a history of severe orthopedic complications that would prevent optimal participation in the physical activities prescribed (e.g., severe arthritis, leg amputations, etc.)\n13. Clinical judgment concerning safety\n14. Lost more than 5% body weight in the previous 6 months\n15. Currently participating in a physical activity or weight loss program\n16. Current smoker\n17. Participant already uses an electronic activity monitor (we will ask them to stop)\n18. Another member of the household is a participant or staff member on this trial'}, 'identificationModule': {'nctId': 'NCT02341235', 'acronym': 'SMARTGOAL', 'briefTitle': 'Self-monitoring Activity: a Randomized Trial of Game-oriented Applications', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Medical Branch, Galveston'}, 'officialTitle': 'Self-monitoring Activity: a Randomized Trial of Game-oriented Applications (SMARTGOAL)', 'orgStudyIdInfo': {'id': '14-0376'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Game intervention', 'description': 'Participants will receive narrative-based games on a mobile device and telephone counseling (weekly for the first 12 weeks, then once per month until 6 months)', 'interventionNames': ['Behavioral: Game intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard intervention', 'description': 'Participants will receive an electronic activity monitor with a mobile device and telephone counseling (weekly for the first 12 weeks, then once per month until 6 months)', 'interventionNames': ['Behavioral: Standard intervention']}], 'interventions': [{'name': 'Game intervention', 'type': 'BEHAVIORAL', 'description': 'The game will target motivation via narrative and game mechanics. It will also encourage self-regulation by providing monitoring and feedback of activity. Counseling will be adapted to specifically reference concepts related to narrative and games.', 'armGroupLabels': ['Game intervention']}, {'name': 'Standard intervention', 'type': 'BEHAVIORAL', 'description': 'The electronic activity monitor will monitor steps, and the mobile device will provide basic feedback on progress toward goals. Counseling will be standard and concentrate on self-regulatory skill-building.', 'armGroupLabels': ['Standard intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77550', 'city': 'Galveston', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Texas Medical Branch', 'geoPoint': {'lat': 29.30135, 'lon': -94.7977}}], 'overallOfficials': [{'name': 'Elizabeth Lyons, PhD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Medical Branch, Galveston', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Cancer Society, Inc.', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}