Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2025-12-25 @ 11:22 PM
Study NCT ID:
NCT05376293
Status:
COMPLETED
Last Update Posted:
2025-04-24
First Post:
2022-05-06
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Be-Active Study - Increasing Physical Activity in Cancer Survivors
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'junick@brownhealth.org', 'phone': '401-793-7966', 'title': 'Dr. Jessica Unick', 'organization': 'The Miriam Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Data were collected over the 3-month intervention period.', 'description': 'Participants were instructed to inform the research staff if they had any injury or illnesses throughout the intervention period. Further, at the 3-month assessment visit, participants were queried regarding any potential adverse events over the past 3 months.', 'eventGroups': [{'id': 'EG000', 'title': 'Behavioral Internet Program', 'description': 'Participants randomized to the Internet program received a 12-week behavioral Internet program designed to increase physical activity to recommended levels.\n\nBehavioral Internet program: The 12-week behavioral Internet program is designed to increase physical activity to recommended levels. Participants are asked to plan and report aerobic exercise weekly, watch weekly video lessons, and complete brief weekly homework assignments.', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 0, 'seriousNumAtRisk': 23, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Informational Newsletter Condition', 'description': 'Participants randomized to the newsletter condition receive 6 newsletters, delivered every other week during the 3-month program.\n\nInformational newsletter condition: Newsletters focus on the health benefits of regular physical activity, exercise safety, and provide information on national exercise guidelines.', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 0, 'seriousNumAtRisk': 23, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Physical Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Behavioral Internet Program', 'description': 'Participants randomized to the Internet program received a 12-week behavioral Internet program designed to increase physical activity to recommended levels.\n\nBehavioral Internet program: The 12-week behavioral Internet program is designed to increase physical activity to recommended levels. Participants are asked to plan and report aerobic exercise weekly, watch weekly video lessons, and complete brief weekly homework assignments.'}, {'id': 'OG001', 'title': 'Informational Newsletter Condition', 'description': 'Participants randomized to the newsletter condition receive 6 newsletters, delivered every other week during the 3-month program.\n\nInformational newsletter condition: Newsletters focus on the health benefits of regular physical activity, exercise safety, and provide information on national exercise guidelines.'}], 'classes': [{'categories': [{'measurements': [{'value': '49.3', 'spread': '90.5', 'groupId': 'OG000'}, {'value': '15.1', 'spread': '100.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline to 3 months', 'description': 'Change in minutes/week of moderate-to-vigorous intensity physical activity from baseline to 3 months as assessed by Actigraph accelerometers. Positive number indicates an increase in physical activity', 'unitOfMeasure': 'minutes per week', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Intervention Engagement - Planning of Physical Activity (Internet Program Only)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Behavioral Internet Program', 'description': 'Participants randomized to the Internet program received a 12-week behavioral Internet program designed to increase physical activity to recommended levels.\n\nBehavioral Internet program: The 12-week behavioral Internet program is designed to increase physical activity to recommended levels. Participants are asked to plan and report aerobic exercise weekly, watch weekly video lessons, and complete brief weekly homework assignments.'}], 'classes': [{'categories': [{'measurements': [{'value': '82.6', 'spread': '25.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'weekly from weeks 2-12', 'description': 'Participants were asked to submit an exercise plan (i.e., when they intended to exercise that week) at the beginning of weeks 2-12. This is the percentage of weeks that an exercise plan was submitted on the study website by the participant.', 'unitOfMeasure': 'percentage of weeks', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Intervention Engagement - Self-monitoring of Physical Activity (Internet Program Only)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Behavioral Internet Program', 'description': 'Participants randomized to the Internet program received a 12-week behavioral Internet program designed to increase physical activity to recommended levels.\n\nBehavioral Internet program: The 12-week behavioral Internet program is designed to increase physical activity to recommended levels. Participants are asked to plan and report aerobic exercise weekly, watch weekly video lessons, and complete brief weekly homework assignments.'}], 'classes': [{'categories': [{'measurements': [{'value': '85.9', 'spread': '22.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'weekly during weeks 1-12', 'description': 'Participants were asked to log their exercise minutes each week on the study website. This is the percentage of weeks that exercise minutes were reported on the study website by the participant over the 12-week period.', 'unitOfMeasure': 'percentage of weeks', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Program Satisfaction Via Likert Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Behavioral Internet Program', 'description': 'Participants randomized to the Internet program received a 12-week behavioral Internet program designed to increase physical activity to recommended levels.\n\nBehavioral Internet program: The 12-week behavioral Internet program is designed to increase physical activity to recommended levels. Participants are asked to plan and report aerobic exercise weekly, watch weekly video lessons, and complete brief weekly homework assignments.'}, {'id': 'OG001', 'title': 'Informational Newsletter Condition', 'description': 'Participants randomized to the newsletter condition receive 6 newsletters, delivered every other week during the 3-month program.\n\nInformational newsletter condition: Newsletters focus on the health benefits of regular physical activity, exercise safety, and provide information on national exercise guidelines.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.81', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '3.23', 'spread': '1.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'Participants used a 1-7 Likert scale to answer \'how satisfied are you with the program received?" (higher score indicates greater satisfaction)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Note: one participant who was randomized to the Internet program only completed the primary outcome measure (physical activity), resulting in a sample of n=21 instead of n=22 for this measure.'}, {'type': 'SECONDARY', 'title': 'Fatigue Measured Via the Brief Fatigue Inventory (BFI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Behavioral Internet Program', 'description': 'Participants randomized to the Internet program received a 12-week behavioral Internet program designed to increase physical activity to recommended levels.\n\nBehavioral Internet program: The 12-week behavioral Internet program is designed to increase physical activity to recommended levels. Participants are asked to plan and report aerobic exercise weekly, watch weekly video lessons, and complete brief weekly homework assignments.'}, {'id': 'OG001', 'title': 'Informational Newsletter Condition', 'description': 'Participants randomized to the newsletter condition receive 6 newsletters, delivered every other week during the 3-month program.\n\nInformational newsletter condition: Newsletters focus on the health benefits of regular physical activity, exercise safety, and provide information on national exercise guidelines.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.32', 'spread': '1.93', 'groupId': 'OG000'}, {'value': '-0.38', 'spread': '1.91', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline to 3 months', 'description': 'The Brief Fatigue Inventory (BFI) assesses the severity of fatigue and the impact of fatigue on daily functioning. An overall fatigue score was calculated as the average of all answered items (range: 0-10) , with higher scores indicating more severe fatigue. Change in BFI score from baseline to 3 months was then calculated (a negative change scores indicates a reduction in fatigue).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Note: one participant who was randomized to the Internet program only completed the primary outcome measure (physical activity), resulting in a sample of n=21 instead of n=22 for this measure.'}, {'type': 'SECONDARY', 'title': 'Health-related Quality of Life (General Health Subscale) Measured Via the SF-36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Behavioral Internet Program', 'description': 'Participants randomized to the Internet program received a 12-week behavioral Internet program designed to increase physical activity to recommended levels.\n\nBehavioral Internet program: The 12-week behavioral Internet program is designed to increase physical activity to recommended levels. Participants are asked to plan and report aerobic exercise weekly, watch weekly video lessons, and complete brief weekly homework assignments.'}, {'id': 'OG001', 'title': 'Informational Newsletter Condition', 'description': 'Participants randomized to the newsletter condition receive 6 newsletters, delivered every other week during the 3-month program.\n\nInformational newsletter condition: Newsletters focus on the health benefits of regular physical activity, exercise safety, and provide information on national exercise guidelines.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.05', 'spread': '10.54', 'groupId': 'OG000'}, {'value': '3.64', 'spread': '11.57', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline to 3 months', 'description': "The 'General Health' subscale of the Short Form Health Survey (SF-36) evaluates a person's overall perception of their health. Scores range from 0 to 100, with higher scores indicating better perceived general health. Change scores from baseline to 3 months were then calculated (positive change scores indicate improved general health).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Note: one participant who was randomized to the Internet program only completed the primary outcome measure (physical activity), resulting in a sample of n=21 instead of n=22 for this measure.'}, {'type': 'SECONDARY', 'title': "Psychological Distress Measured Via the 'Global Severity Index' Scale of the Brief Symptom Inventory-18 (BSI-18)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Behavioral Internet Program', 'description': 'Participants randomized to the Internet program received a 12-week behavioral Internet program designed to increase physical activity to recommended levels.\n\nBehavioral Internet program: The 12-week behavioral Internet program is designed to increase physical activity to recommended levels. Participants are asked to plan and report aerobic exercise weekly, watch weekly video lessons, and complete brief weekly homework assignments.'}, {'id': 'OG001', 'title': 'Informational Newsletter Condition', 'description': 'Participants randomized to the newsletter condition receive 6 newsletters, delivered every other week during the 3-month program.\n\nInformational newsletter condition: Newsletters focus on the health benefits of regular physical activity, exercise safety, and provide information on national exercise guidelines.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.1', 'spread': '9.71', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '5.18', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline to 3 months', 'description': "Psychological distress was assessed using the 'Global Severity Index' of the Brief Symptom Inventory-18 (BFI-18). Scores range from 0 to 72, with greater scores indicating greater psychological distress. Change in psychological distress from baseline to 3 months was then calculated, with positive change scores indicating increased severity of symptoms such as somatization, depression, and anxiety.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Note: one participant who was randomized to the Internet program only completed the primary outcome measure (physical activity), resulting in a sample of n=21 instead of n=22 for this measure.'}, {'type': 'SECONDARY', 'title': 'Fear of Recurrence Measured Via the Fear of Cancer Recurrence Inventory (FCRI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Behavioral Internet Program', 'description': 'Participants randomized to the Internet program received a 12-week behavioral Internet program designed to increase physical activity to recommended levels.\n\nBehavioral Internet program: The 12-week behavioral Internet program is designed to increase physical activity to recommended levels. Participants are asked to plan and report aerobic exercise weekly, watch weekly video lessons, and complete brief weekly homework assignments.'}, {'id': 'OG001', 'title': 'Informational Newsletter Condition', 'description': 'Participants randomized to the newsletter condition receive 6 newsletters, delivered every other week during the 3-month program.\n\nInformational newsletter condition: Newsletters focus on the health benefits of regular physical activity, exercise safety, and provide information on national exercise guidelines.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.67', 'spread': '4.55', 'groupId': 'OG000'}, {'value': '-1.41', 'spread': '4.33', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline to 3 months', 'description': 'A total score from the Fear of Recurrence Inventory - Short Form was used to assess the intensity of fear related to the possibility of cancer returning. Scores range from 0 to 36, with higher scores reflecting a greater severity of fear of cancer recurrence. Change scores from baseline to 3 months were then calculated (negative change scores indicates reduced fear of cancer recurrence)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Note: one participant who was randomized to the Internet program only completed the primary outcome measure (physical activity), resulting in a sample of n=21 instead of n=22 for this measure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Behavioral Internet Program', 'description': 'Participants randomized to the Internet program received a 12-week behavioral Internet program designed to increase physical activity to recommended levels.\n\nBehavioral Internet program: The 12-week behavioral Internet program is designed to increase physical activity to recommended levels. Participants are asked to plan and report aerobic exercise weekly, watch weekly video lessons, and complete brief weekly homework assignments.'}, {'id': 'FG001', 'title': 'Informational Newsletter Condition', 'description': 'Participants randomized to the newsletter condition receive 6 newsletters, delivered every other week during the 3-month program.\n\nInformational newsletter condition: Newsletters focus on the health benefits of regular physical activity, exercise safety, and provide information on national exercise guidelines.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Behavioral Internet Program', 'description': 'Participants randomized to the Internet program received a 12-week behavioral Internet program designed to increase physical activity to recommended levels.\n\nBehavioral Internet program: The 12-week behavioral Internet program is designed to increase physical activity to recommended levels. Participants are asked to plan and report aerobic exercise weekly, watch weekly video lessons, and complete brief weekly homework assignments.'}, {'id': 'BG001', 'title': 'Informational Newsletter Condition', 'description': 'Participants randomized to the newsletter condition receive 6 newsletters, delivered every other week during the 3-month program.\n\nInformational newsletter condition: Newsletters focus on the health benefits of regular physical activity, exercise safety, and provide information on national exercise guidelines.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.4', 'spread': '7.9', 'groupId': 'BG000'}, {'value': '56.0', 'spread': '8.8', 'groupId': 'BG001'}, {'value': '55.2', 'spread': '8.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '41', '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': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', '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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-10-28', 'size': 244830, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-02-24T17:43', 'hasProtocol': True}, {'date': '2024-10-01', 'size': 113286, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-02-24T17:50', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-04-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-22', 'studyFirstSubmitDate': '2022-05-06', 'resultsFirstSubmitDate': '2025-02-25', 'studyFirstSubmitQcDate': '2022-05-16', 'lastUpdatePostDateStruct': {'date': '2025-04-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-04-22', 'studyFirstPostDateStruct': {'date': '2022-05-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Physical Activity', 'timeFrame': 'baseline to 3 months', 'description': 'Change in minutes/week of moderate-to-vigorous intensity physical activity from baseline to 3 months as assessed by Actigraph accelerometers. Positive number indicates an increase in physical activity'}, {'measure': 'Intervention Engagement - Planning of Physical Activity (Internet Program Only)', 'timeFrame': 'weekly from weeks 2-12', 'description': 'Participants were asked to submit an exercise plan (i.e., when they intended to exercise that week) at the beginning of weeks 2-12. This is the percentage of weeks that an exercise plan was submitted on the study website by the participant.'}, {'measure': 'Intervention Engagement - Self-monitoring of Physical Activity (Internet Program Only)', 'timeFrame': 'weekly during weeks 1-12', 'description': 'Participants were asked to log their exercise minutes each week on the study website. This is the percentage of weeks that exercise minutes were reported on the study website by the participant over the 12-week period.'}, {'measure': 'Program Satisfaction Via Likert Scale', 'timeFrame': '3 months', 'description': 'Participants used a 1-7 Likert scale to answer \'how satisfied are you with the program received?" (higher score indicates greater satisfaction)'}], 'secondaryOutcomes': [{'measure': 'Fatigue Measured Via the Brief Fatigue Inventory (BFI)', 'timeFrame': 'baseline to 3 months', 'description': 'The Brief Fatigue Inventory (BFI) assesses the severity of fatigue and the impact of fatigue on daily functioning. An overall fatigue score was calculated as the average of all answered items (range: 0-10) , with higher scores indicating more severe fatigue. Change in BFI score from baseline to 3 months was then calculated (a negative change scores indicates a reduction in fatigue).'}, {'measure': 'Health-related Quality of Life (General Health Subscale) Measured Via the SF-36', 'timeFrame': 'baseline to 3 months', 'description': "The 'General Health' subscale of the Short Form Health Survey (SF-36) evaluates a person's overall perception of their health. Scores range from 0 to 100, with higher scores indicating better perceived general health. Change scores from baseline to 3 months were then calculated (positive change scores indicate improved general health)."}, {'measure': "Psychological Distress Measured Via the 'Global Severity Index' Scale of the Brief Symptom Inventory-18 (BSI-18)", 'timeFrame': 'baseline to 3 months', 'description': "Psychological distress was assessed using the 'Global Severity Index' of the Brief Symptom Inventory-18 (BFI-18). Scores range from 0 to 72, with greater scores indicating greater psychological distress. Change in psychological distress from baseline to 3 months was then calculated, with positive change scores indicating increased severity of symptoms such as somatization, depression, and anxiety."}, {'measure': 'Fear of Recurrence Measured Via the Fear of Cancer Recurrence Inventory (FCRI)', 'timeFrame': 'baseline to 3 months', 'description': 'A total score from the Fear of Recurrence Inventory - Short Form was used to assess the intensity of fear related to the possibility of cancer returning. Scores range from 0 to 36, with higher scores reflecting a greater severity of fear of cancer recurrence. Change scores from baseline to 3 months were then calculated (negative change scores indicates reduced fear of cancer recurrence)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Physical Activity', 'Exercise', 'Cancer Survivors']}, 'descriptionModule': {'briefSummary': 'Rates of cancer survivorship are on the rise and cancer survivors face unique health challenges that are common across cancer types that last well beyond the cessation of cancer treatment (e.g., increased fatigue, anxiety/depression, fear of recurrence, risk of cardiovascular disease, and lower health-related quality of life). While physical activity (PA) has favorable effects on these health parameters and is highly recommended for cancer survivors, this population engages in lower-than-average levels of PA. Effective PA interventions with high translation potential are important for improving the health of this population. The Internet overcome barriers to traditional face-to-face treatment programs (e.g., high cost, participant burden, geographical constraints) and represents a disseminable intervention approach. While behaviorally-based Internet programs significantly increase PA in other health domains, the application of these programs to cancer survivors is relatively new. This study will randomize 50 cancer survivors to a 12-week Internet PA program or usual-care newsletter condition. Primary outcomes include intervention engagement and program satisfaction related to the Internet program and changes in PA by intervention arm at post-treatment (3 months). Secondary aims include comparison of intervention arms on changes in sleep, weight, fatigue, anxiety/depression, health-related quality of life, and fear of recurrence.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed cancer diagnosis and have either completed all cancer-directed treatment in the past 3-12 months or be on a maintenance/continuous treatment regimen for which they have been stable for at least 3 months\n* Inactive - defined as engaging in \\<60 min/week of moderate-intensity PA over the past 3 months\n* BMI between 18.5 and 45 kg/m2\n* English speaking\n* Daily Internet access\n\nExclusion Criteria:\n\n* Any medical condition for which physical activity is contraindicated\n* Unable to attend assessment visits in Providence RI'}, 'identificationModule': {'nctId': 'NCT05376293', 'briefTitle': 'Be-Active Study - Increasing Physical Activity in Cancer Survivors', 'organization': {'class': 'OTHER', 'fullName': 'The Miriam Hospital'}, 'officialTitle': 'Web-based Intervention for Increasing Physical Activity in Cancer Survivors', 'orgStudyIdInfo': {'id': '1850077'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Behavioral internet program', 'description': 'Participants randomized to the Internet program will receive a 12-week behavioral Internet program designed to increase physical activity to recommended levels.', 'interventionNames': ['Behavioral: Behavioral Internet program']}, {'type': 'SHAM_COMPARATOR', 'label': 'Informational newsletter condition', 'description': 'Participants randomized to the newsletter condition will receive 6 newsletters, delivered every other week during the 3-month program.', 'interventionNames': ['Behavioral: Informational newsletter condition']}], 'interventions': [{'name': 'Behavioral Internet program', 'type': 'BEHAVIORAL', 'description': 'The 12-week behavioral Internet program is designed to increase physical activity to recommended levels. Participants will be asked to plan and report aerobic exercise weekly, watch weekly video lessons, and complete brief weekly homework assignments.', 'armGroupLabels': ['Behavioral internet program']}, {'name': 'Informational newsletter condition', 'type': 'BEHAVIORAL', 'description': 'Newsletters will focus on the health benefits of regular physical activity, exercise safety, and will provide information on national exercise guidelines.', 'armGroupLabels': ['Informational newsletter condition']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02903', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': "The Miriam Hospital's Weight Control and Diabetes Research Center", 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Miriam Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Brown University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}