Ignite Creation Date:
2025-12-24 @ 1:52 PM
Ignite Modification Date:
2026-01-07 @ 1:56 PM
Study NCT ID:
NCT03523195
Status:
COMPLETED
Last Update Posted:
2019-07-22
First Post:
2018-05-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exercise Intervention After Cancer Treatment for Improving Health in Stage II-III Breast Cancer Survivors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057185', 'term': 'Sedentary Behavior'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008991', 'term': 'Monitoring, Physiologic'}, {'id': 'D005080', 'term': 'Exercise Test'}], 'ancestors': [{'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D012129', 'term': 'Respiratory Function Tests'}, {'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}, {'id': 'D016552', 'term': 'Ergometry'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2019-07-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-19', 'studyFirstSubmitDate': '2018-05-01', 'studyFirstSubmitQcDate': '2018-05-01', 'lastUpdatePostDateStruct': {'date': '2019-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adherence', 'timeFrame': 'Up to 26 weeks', 'description': 'Will assess the percent of expected onsite sessions attended by participants as determined by Prevention Center attendance log.'}, {'measure': 'Differential micro ribonucleic acid expression', 'timeFrame': 'At baseline, 13, and 26 weeks', 'description': 'Will compare between arms. Descriptive statistics will be provided. Will calculate the log-fold change between baseline measure and post-baseline measure, and the difference in the log-fold change will be calculated between the two arms.'}], 'secondaryOutcomes': [{'measure': 'Percent of expected home exercise sessions completed as determined by the home exercise logs for those choosing to not come in for a third weekly session', 'timeFrame': 'Up to 26 weeks'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anatomic Stage II Breast Cancer AJCC v8', 'Anatomic Stage IIA Breast Cancer AJCC v8', 'Anatomic Stage IIB Breast Cancer AJCC v8', 'Anatomic Stage III Breast Cancer AJCC v8', 'Anatomic Stage IIIA Breast Cancer AJCC v8', 'Anatomic Stage IIIB Breast Cancer AJCC v8', 'Anatomic Stage IIIC Breast Cancer AJCC v8', 'Cancer Survivor', 'Estrogen Receptor Positive', 'HER2/Neu Negative', 'Progesterone Receptor Positive', 'Prognostic Stage II Breast Cancer AJCC v8', 'Prognostic Stage IIA Breast Cancer AJCC v8', 'Prognostic Stage IIB Breast Cancer AJCC v8', 'Prognostic Stage III Breast Cancer AJCC v8', 'Prognostic Stage IIIA Breast Cancer AJCC v8', 'Prognostic Stage IIIB Breast Cancer AJCC v8', 'Prognostic Stage IIIC Breast Cancer AJCC v8', 'Sedentary Lifestyle']}, 'descriptionModule': {'briefSummary': 'This pilot trial studies how well exercise intervention after cancer treatment works in improving physical activity in stage II-III breast cancer survivors. An exercise intervention may promote regular physical activity.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. Estimate the adherence rate of the experimental exercise program, and deem as feasible if at least 80% of participants complete 80% or more of a 12-week, 180 minute aerobic+resistance training program that combines structured, individualized onsite exercise at the Fred Hutch Prevention Center with at-home exercise.\n\nII. Identify up to 5 circulating micro ribonucleic acid (c-miRNA) biomarkers that show the largest differential change from baseline when comparing levels in the exercise program to those in the Fitbit-activity control condition.\n\nSECONDARY OBJECTIVES:\n\nI. Explore associations between changes in miRNAs and serum biomarkers (IL-6, lipids, adiponectin and leptin, C-reactive protein \\[CRP\\]) and physiological outcomes (resting heart rate, blood pressure, 1 repetition max, 6 minute walk, timed up and go test) of the exercise program.\n\nII. Explore changes in the patient-reported outcomes (PRO) in response to the exercise intervention relative to the control group, and finalize measures to use in the design of the phase III clinical trial based on descriptive changes from baseline to follow-ups in the intervention versus (vs.) control groups.\n\nOUTLINE: Participants are randomized into 1 of 2 arms.\n\nARM 0: Participants wear Fitbit and receive written information on healthy exercise and diet recommendations.\n\nARM 1: Participants complete exercise program including aerobic and resistance exercises over 60 minutes 3 times per week for 12 weeks. Exercise is supervised all 3 times during weeks 1-2. During weeks 3-12, exercise is supervised 2 times a week, with home-based coaching for an additional 60 minutes a week.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Single malignancy with diagnosis of breast cancer diagnosis of stage II-III, estrogen and progesterone positive, HER-2neu negative, and on stable dose of aromatase inhibitor (AI) for past 3 months, with AI expected to be stable for the study duration\n* No evidence of disease\n* 1-5 years post active treatment for malignancy\n* Body mass index 19 to 35\n* Sedentary (\\< 100 minutes of moderate intensity exercise per week)\n* English adequate to complete assessments and follow exercise instructions\n* Able to independently use transportation to attend 2-day a week onsite exercise training\n* Access to a computer or smartphone\n\nExclusion Criteria:\n\n* Current tobacco use or electronic cigarette smoker\n* Pregnant\n* Diabetes requiring insulin injection\n* Lymphedema that restricts range of motion or with worsening symptoms in the past month, or without compression garment\n* Weight change of more than 10 pounds in previous 3 months will exclude from study participation at baseline\n* Medical or other issue impacting exercise ability or safety, or ability to comply with study procedures (e.g. significant vision or cognitive impairment, major illness, in hospital or other institution), and specifically:\n\n * Have been hospitalized within 3 months prior to screening for major atherosclerotic events (e.g. myocardial infarction, target-vessel revascularization, coronary bypass surgery, stroke or blood clot) or other major medical condition (as determined by an investigator) that may put the subject at risk because of his/her participation in the study;\n * Have an implanted cardiac pacemaker or other implanted cardiac device;\n * Have chronic, uncontrolled hypertension as judged by the investigator;\n * Have a creatinine clearance \\< 45 mL/min as calculated by the Cockcroft-Gault equation;\n * Subject's hand or legs have mobility impairment from fractures, arthritis, surgery, muscle disease or other injury that may interfere with any study procedure or ability to exercise"}, 'identificationModule': {'nctId': 'NCT03523195', 'acronym': 'PACT', 'briefTitle': 'Exercise Intervention After Cancer Treatment for Improving Health in Stage II-III Breast Cancer Survivors', 'organization': {'class': 'OTHER', 'fullName': 'Fred Hutchinson Cancer Center'}, 'officialTitle': 'Physical Activity After Cancer Treatment (PACT): Pilot Study of Exercise in Stage II-III Breast Cancer Survivors', 'orgStudyIdInfo': {'id': '9988'}, 'secondaryIdInfos': [{'id': 'NCI-2018-00544', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '9988', 'type': 'OTHER', 'domain': 'Fred Hutch/University of Washington Cancer Consortium'}, {'id': 'P30CA015704', 'link': 'https://reporter.nih.gov/quickSearch/P30CA015704', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 0 (written information)', 'description': 'Participants wear Fitbit and receive written information on healthy exercise and diet recommendations.', 'interventionNames': ['Other: Informational Intervention', 'Other: Laboratory Biomarker Analysis', 'Device: Monitoring Device', 'Other: Questionnaire Administration', 'Other: Physical Performance Testing']}, {'type': 'EXPERIMENTAL', 'label': 'Arm I (exercise program)', 'description': 'Participants complete exercise program including aerobic and resistance exercises over 60 minutes 3 times per week for 12 weeks. Exercise is supervised all 3 times during weeks 1-2. During weeks 3-12, exercise is supervised 2 times a week, with home-based coaching for an additional 60 minutes a week.', 'interventionNames': ['Behavioral: Exercise Intervention', 'Other: Laboratory Biomarker Analysis', 'Other: Questionnaire Administration', 'Other: Physical Performance Testing']}], 'interventions': [{'name': 'Exercise Intervention', 'type': 'BEHAVIORAL', 'description': 'Complete exercise program', 'armGroupLabels': ['Arm I (exercise program)']}, {'name': 'Informational Intervention', 'type': 'OTHER', 'description': 'Receive written information on healthy exercise and diet recommendations', 'armGroupLabels': ['Arm 0 (written information)']}, {'name': 'Laboratory Biomarker Analysis', 'type': 'OTHER', 'description': 'Blood tests', 'armGroupLabels': ['Arm 0 (written information)', 'Arm I (exercise program)']}, {'name': 'Monitoring Device', 'type': 'DEVICE', 'otherNames': ['Monitor'], 'description': 'Wear Fitbit', 'armGroupLabels': ['Arm 0 (written information)']}, {'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Arm 0 (written information)', 'Arm I (exercise program)']}, {'name': 'Physical Performance Testing', 'type': 'OTHER', 'otherNames': ['Physical Function Testing'], 'description': 'Performance of physical tests', 'armGroupLabels': ['Arm 0 (written information)', 'Arm I (exercise program)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Fred Hutch/University of Washington Cancer Consortium', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Karen Syrjala', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fred Hutch/University of Washington Cancer Consortium'}, {'name': 'Julie Gralow', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fred Hutch/University of Washington Cancer Consortium'}, {'name': 'Marie-Laure Crouch', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fred Hutch/University of Washington Cancer Consortium'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fred Hutchinson Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}