Ignite Creation Date:
2025-12-24 @ 3:18 PM
Ignite Modification Date:
2026-02-24 @ 5:46 AM
Study NCT ID:
NCT02619292
Status:
COMPLETED
Last Update Posted:
2017-07-14
First Post:
2015-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mindful Movement for Breast Cancer Survivors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-12', 'studyFirstSubmitDate': '2015-11-06', 'studyFirstSubmitQcDate': '2015-11-30', 'lastUpdatePostDateStruct': {'date': '2017-07-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Fear of Recurrence', 'timeFrame': '18 weeks', 'description': 'Fear of recurrence as measured on Fear of Recurrence (FOR) scale'}, {'measure': 'Mindfulness attention', 'timeFrame': '18 weeks', 'description': 'Improvement in mindfulness attitude as measured with the Mindful Attention Awareness Scale (MAAS)'}, {'measure': 'Mindfulness attitude', 'timeFrame': '18 weeks', 'description': 'Improvement in mindfulness attitude as measured with the Experiences Questionnaire (EQ)'}], 'primaryOutcomes': [{'measure': 'Immune markers', 'timeFrame': '18 weeks', 'description': 'Improvement in serum markers of immune cell phenotype at week 18'}], 'secondaryOutcomes': [{'measure': 'Mindful Movement Intervention Experience', 'timeFrame': '18 weeks', 'description': 'Improvement in mindfulness attitude as measured on Meditative Movement Inventory (MMI)'}, {'measure': 'Mindful Movement Intervention Experience', 'timeFrame': '18 weeks', 'description': 'Improvement in mindfulness attitude as measured on Perceived Exertion Scale (PES)'}, {'measure': 'Mindful Movement Intervention Experience - Mindfulness Intention', 'timeFrame': '18 weeks', 'description': 'Improvement in mindfulness attitude as measured on Mindfulness Intention (modified from Segal, 1-item)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cancer survivor', 'immune function'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to determine if participating in a Mindful Movement Program (MMP) (learning how to be mindful in one's movement), positively affects the body's immune functions improves mindfulness and reduces worries about cancer returning. All participants will be in this study about three months.", 'detailedDescription': "Breast cancer survivors (BCS) may experience psychological and physical effects long after treatment is over. Some research shows that practicing mindfulness, and movement types of activities such as qi gong or yoga may lead to improvements in emotional and physical well-being, including improved immune function. Immune function can be negatively affected by stress and worry, and this has an unknown effect on the risk of cancer recurrence. Psychological and physical interventions that help enhance an individual's wellbeing and reduce stress and worry may have a positive influence on immune function and in turn, reduce the risk of cancer recurrence. While there is limited research in this area, and none with dance therapy, little attention has been given to older BCS. However, understanding of immune function suggests that older women may be the best group to target for such interventions. Previous research with BCS age 50 or older who participated in a 12-week program combining mindfulness practice with dance/movement therapy (Mindful Movement Program) demonstrated positive effects: participants were more mindful in their day-to-day living and had less worry about the cancer coming back. Participants also reported through focus groups that the Mindful Movement Program (MMP) had improved their overall well-being. No laboratory tests of the body's immune response to MMP were included."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosed at age 50 or older with stage 0-III disease\n* 6 months or more since completion of primary breast cancer treatment\n* have a medical release from their physician\n* English-speaking\n* not pregnant\n* no weekly practice of yoga, qi gong, tai chi, dance/movement therapy, or mindfulness meditation practice\n\nExclusion Criteria:\n\n* Males with breast cancer'}, 'identificationModule': {'nctId': 'NCT02619292', 'briefTitle': 'Mindful Movement for Breast Cancer Survivors', 'organization': {'class': 'OTHER', 'fullName': "Saint John's Cancer Institute"}, 'officialTitle': 'Mindful Movement for Breast Cancer Survivors', 'orgStudyIdInfo': {'id': 'MMP-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mindful Movement Program', 'description': 'Mindfulness is "moment-to-moment, present-centered, purposive non-judgmental awareness"; Dance/movement therapy is a multidimensional approach that integrates body awareness, expression and acceptance to facilitate physical, emotional, cognitive, social and spiritual integration of individuals', 'interventionNames': ['Behavioral: Mindful Movement Program']}], 'interventions': [{'name': 'Mindful Movement Program', 'type': 'BEHAVIORAL', 'description': "Mindfulness is turning one's awareness to the present moment. Movement-dance therapy is the expression of thoughts or feelings through body movement, under the supervision of a licensed professional.", 'armGroupLabels': ['Mindful Movement Program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': "Margie Petersen Breast Center at Providence Saint John's Health Center", 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}], 'overallOfficials': [{'name': 'Rebecca Crane-Okada, PhD, RN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Saint John's Cancer Institute"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Saint John's Cancer Institute", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}