Ignite Creation Date:
2025-12-24 @ 5:59 PM
Ignite Modification Date:
2025-12-31 @ 2:51 AM
Study NCT ID:
NCT01053468
Status:
UNKNOWN
Last Update Posted:
2011-07-01
First Post:
2010-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Facilitating Physical Activity Behavior and Health Outcomes in Breast Cancer Patients Receiving Chemotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'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': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-01', 'completionDateStruct': {'date': '2013-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-06-30', 'studyFirstSubmitDate': '2010-01-20', 'studyFirstSubmitQcDate': '2010-01-20', 'lastUpdatePostDateStruct': {'date': '2011-07-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Self-reported physical activity', 'timeFrame': 'Baseline, post intervention, 6 months follow up'}], 'secondaryOutcomes': [{'measure': 'Cancer specific health related quality of life', 'timeFrame': 'Baseline, post intervention, 6 months follow up'}, {'measure': 'Psychosocial health outcomes', 'timeFrame': 'Baseline, post intervention, 6 months follow up'}, {'measure': 'Objective step counts (pedometer)', 'timeFrame': 'Baseline, post intervention, 6 months follow up'}, {'measure': 'Chemotherapy completion rate', 'timeFrame': 'Baseline, post intervention, 6 months follow up'}, {'measure': 'Determinants of physical activity', 'timeFrame': 'Baseline, post intervention, 6 months follow up'}, {'measure': 'Physical functioning', 'timeFrame': 'Baseline, post intervention, 6 months follow up'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['breast cancer', 'physical activity', 'quality of life', 'theory of planned behavior', 'behavior change', 'health promotion'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'Breast cancer and its treatments can take a toll on the physical and psychosocial well-being of cancer survivors. Few interventions can help breast cancer patients improve their physical strength, stamina, and overall well-being. Developing ways to facilitate PA behavior during chemotherapy for breast cancer are necessary. This trial explores ways that breast cancer patients receiving chemotherapy can learn about and engage in PA during chemotherapy. This trial will also give Southern Alberta breast cancer survivors an opportunity to participate in evidence-based programs designed to facilitate their health, breast cancer recovery, and disease-free survival.\n\nThe investigators primary hypothesis is that women receiving the PA intervention resource kit will report a more positive change in self-reported PA at the end of chemotherapy treatments when compared to the group receiving standard materials.', 'detailedDescription': 'Primary Objective:\n\nTo compare the effects of an evidence-based intervention consisting of targeted breast-cancer specific PA print materials (i.e., Exercise for health), a step pedometer, a step-walking guidebook (i.e., Step into survivorship), and a physical activity and step journal (INT) to a comparison group receiving a generic, two-page public health PA resource (Standard Material: SM).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* are diagnosed with stage I -IIIA breast cancer\n* are scheduled to receive neoadjuvant or adjuvant chemotherapy\n* did not receive transabdominal rectus abdominus muscle (TRAM) reconstructive surgery\n* are \\>18 years of age\n* receive approval from their treating oncologist to participate\n* do not have uncontrolled hypertension, cardiac illness, or psychiatric conditions (i.e., indicated in patient medical charts).'}, 'identificationModule': {'nctId': 'NCT01053468', 'acronym': 'PROACTIVE', 'briefTitle': 'Facilitating Physical Activity Behavior and Health Outcomes in Breast Cancer Patients Receiving Chemotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Athabasca University'}, 'officialTitle': 'Facilitating Physical Activity Behavior and Health Outcomes in Breast Cancer Patients Receiving Chemotherapy', 'orgStudyIdInfo': {'id': 'PROACTIVE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PA Behavior Intervention', 'description': 'Physical Activity Resource Kit', 'interventionNames': ['Behavioral: Physical Activity Resource Kit']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Materials', 'description': 'Receive physical activity handout from the Canadian Public Health Agency', 'interventionNames': ['Behavioral: Standard Materials']}], 'interventions': [{'name': 'Physical Activity Resource Kit', 'type': 'BEHAVIORAL', 'description': 'The Intervention group (INT) will receive a Physical Activity Resource Kit which includes a step pedometer, a breast cancer-specific Physical Activity Guidebook (Exercise for health), a step pedometer resource (Step into survivorship), and a physical activity and step journal to record their daily step totals and daily physical activities.\n\nParticipants will be instructed to wear their pedometer for the entire duration of the study (i.e., chemotherapy duration).', 'armGroupLabels': ['PA Behavior Intervention']}, {'name': 'Standard Materials', 'type': 'BEHAVIORAL', 'description': 'Participants in this usual care group will receive a generic physical activity leaflet from the Canadian Public Health Agency', 'armGroupLabels': ['Standard Materials']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Calgary', 'state': 'Alberta', 'status': 'RECRUITING', 'country': 'Canada', 'facility': 'Tom Baker Cancer Centre', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'city': 'Grande Prairie', 'state': 'Alberta', 'status': 'RECRUITING', 'country': 'Canada', 'facility': 'Grande Prairie Cancer Centre', 'geoPoint': {'lat': 55.16667, 'lon': -118.80271}}, {'city': 'Lethbridge', 'state': 'Alberta', 'status': 'RECRUITING', 'country': 'Canada', 'facility': 'Lethbridge Cancer Centre', 'geoPoint': {'lat': 49.69999, 'lon': -112.81856}}, {'city': 'Medicine Hat', 'state': 'Alberta', 'status': 'RECRUITING', 'country': 'Canada', 'facility': 'Medicine Hat Cancer Centre', 'geoPoint': {'lat': 50.03928, 'lon': -110.67661}}, {'city': 'Red Deer', 'state': 'Alberta', 'status': 'RECRUITING', 'country': 'Canada', 'facility': 'Central Alberta Cancer Centre', 'geoPoint': {'lat': 52.26682, 'lon': -113.802}}], 'centralContacts': [{'name': 'Jeff Vallance, PhD', 'role': 'CONTACT', 'email': 'jeffv@athabascau.ca', 'phone': '403-488-7179'}, {'name': 'Celeste Lavallee, BSc, RD', 'role': 'CONTACT', 'email': 'clavallee@athabascau.ca'}], 'overallOfficials': [{'name': 'Jeff Vallance, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Athabasca University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Athabasca University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Alberta', 'class': 'OTHER'}, {'name': 'University of Calgary', 'class': 'OTHER'}, {'name': 'Alberta Health services', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Jeff Vallance, PhD', 'oldOrganization': 'Athabasca University'}}}}