Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2026-04-20 @ 8:03 AM
Study NCT ID:
NCT02468050
Status:
COMPLETED
Last Update Posted:
2015-06-10
First Post:
2012-06-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Exercise to Manage Distress During Breast Screening
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D004194', 'term': 'Disease'}], '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': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}, {'id': 'D000073278', 'term': 'Self-Management'}, {'id': 'D017009', 'term': 'Professional Autonomy'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D011364', 'term': 'Professional Practice'}, {'id': 'D009934', 'term': 'Organization and Administration'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-05', 'studyFirstSubmitDate': '2012-06-25', 'studyFirstSubmitQcDate': '2015-06-05', 'lastUpdatePostDateStruct': {'date': '2015-06-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-06-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Symptoms of anxiety will be assessed using patient reported anxiety inventory', 'timeFrame': 'Change in baseline (within 1 week of breast biopsy) at Week 3 and at Week 6', 'description': 'Spielberger State-Trait Anxiety Inventory - State Form (STAI; Spielberger, Gorsuch, \\& Lushene, 1970).'}], 'secondaryOutcomes': [{'measure': 'Symptoms of subclinical depression will be assessed using a patient reported inventory', 'timeFrame': 'Within 1 week of breast biopsy, Week 3, Week 6', 'description': 'Centre for Epidemiologic Studies-Depression Scale (CES-D; Radloff, 1977).'}, {'measure': 'Exercise behaviour will be assessed using a patient reported inventory', 'timeFrame': 'Within 1 week of breast biopsy, Week 3, Week 6', 'description': 'Leisure Time Exercise Questionnaire (Godin \\& Shephard, 1985)'}, {'measure': 'Body composition: Dual X-Ray Absorptiometry scan (GE Lunar iDXA)', 'timeFrame': 'Baseline (within 1 week of breast biopsy), Week 6'}, {'measure': 'Self Efficacy: patient reported inventory assessing efficacy for self management of exercise', 'timeFrame': '1 week post breast biopsy, Week 3, Week 6'}, {'measure': 'Optimism: patient reported inventory assessing dispositional optimism', 'timeFrame': 'Baseline (within 1 week of core breast biopsy)', 'description': 'Life Orientation Test-Revised (LOT-R; Scheier, Carver, \\& Bridges, 1994).'}, {'measure': 'Symptoms of dispositional anxiety will be assessed using patient reported anxiety inventory', 'timeFrame': 'Within 1 week of breast biopsy', 'description': 'STAI - Trait Form'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Anxiety', 'Depression', 'Exercise', 'Breast Cancer', 'Biopsy', 'Screening', 'Diagnosis'], 'conditions': ['Breast Cancer', 'Anxiety', 'Depression']}, 'descriptionModule': {'briefSummary': 'The breast cancer screening and diagnostic period is associated with heightened symptoms of anxiety and depression. Physical exercise has been found to effectively decrease these symptoms in healthy and diseased populations. This study aims to determine if a pre treatment exercise intervention can minimize symptoms of anxiety and depression in women undergoing screening for breast cancer.', 'detailedDescription': 'The breast cancer diagnostic process is associated with anxiety and depression. Physical exercise has emerged as an attractive non-pharmacologic approach to mitigating the psychological and physical sequelae of breast cancer and its treatments, however pre treatment interventions are not integrated into current practice. This study aims to determine the effectiveness and feasibility of a pre treatment exercise intervention in attenuating levels of anxiety and depression following breast biopsy and throughout the diagnostic period.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* undergoing breast biopsy at St. Joseph's Health Care, London Ontario\n* minimum BI-RADS 4a\n* physically inactive\n\nExclusion Criteria:\n\n* meeting Health Canada Guidelines for Physical Activity for past 6 months\n* medical contraindications to exercise\n* unable to participate in moderate intensity exercise program"}, 'identificationModule': {'nctId': 'NCT02468050', 'briefTitle': 'Study of Exercise to Manage Distress During Breast Screening', 'organization': {'class': 'OTHER', 'fullName': 'University of Western Ontario, Canada'}, 'officialTitle': 'Effectiveness of Exercise Training and Self Management in the Attenuation of Anxiety and Depressive Symptoms Following Breast Biopsy', 'orgStudyIdInfo': {'id': '17796'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Self Management', 'description': 'In addition to the weekly supervised exercise session, participants in this arm will view an instructional video. The video will deliver theory driven training of cognitive behavioural strategies for self management of exercise. It is expected that this will improve adherence to the exercise program.', 'interventionNames': ['Behavioral: Moderate intensity exercise training', 'Behavioral: Self Management of exercise']}, {'type': 'EXPERIMENTAL', 'label': 'Exercise', 'description': 'Personalized 6 week moderate intensity (50 - 75% of heart rate reserve) facility and home based exercise program including cardiovascular and muscular conditioning.', 'interventionNames': ['Behavioral: Moderate intensity exercise training']}, {'type': 'NO_INTERVENTION', 'label': 'Prospective Cohort Control', 'description': 'Eligible, consented participants who are unable to attend the weekly exercise sessions will serve as a cohort control group. Participants will be asked to complete patient reported measures of anxiety, depression, and exercise behaviour within 3 days of biopsy, and 6 weeks post biopsy.'}], 'interventions': [{'name': 'Moderate intensity exercise training', 'type': 'BEHAVIORAL', 'otherNames': ['Exercise', 'Treatment Group 1'], 'description': '6 weeks of moderate intensity exercise training (50 - 75% of heart rate reserve). Sessions are facility and home based and include cardiovascular warm-up, cardiovascular training, muscular conditioning, and flexibility exercises.', 'armGroupLabels': ['Exercise', 'Self Management']}, {'name': 'Self Management of exercise', 'type': 'BEHAVIORAL', 'otherNames': ['Self Management', 'Self Regulation', 'Adherence', 'Treatment Group 2'], 'description': 'In addition to the 6 week exercise program (refer to Exercise Treatment Group), participants randomly assigned to the Self Management Group will learn strategies for the self management of exercise.', 'armGroupLabels': ['Self Management']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N6A 3K7', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Exercise and Health Psychology Laboratory, Western University', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}], 'overallOfficials': [{'name': 'Muriel Brackstone, MD PhD FRCSC', 'role': 'STUDY_DIRECTOR', 'affiliation': 'London Regional Cancer Program'}, {'name': 'Anita G Cramp, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Western University'}, {'name': 'Amy Kossert, MHK', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Western University'}, {'name': 'Harry Prapavessis, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Western University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Western Ontario, Canada', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}