Ignite Creation Date:
2025-12-25 @ 12:06 AM
Ignite Modification Date:
2026-01-02 @ 10:42 PM
Study NCT ID:
NCT01558258
Status:
COMPLETED
Last Update Posted:
2015-04-10
First Post:
2012-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Mindfulness Meditation-Based Intervention for Younger Breast Cancer Survivors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 71}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-08', 'studyFirstSubmitDate': '2012-02-17', 'studyFirstSubmitQcDate': '2012-03-16', 'lastUpdatePostDateStruct': {'date': '2015-04-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of Mindful Awareness Practices on daily living.', 'timeFrame': '6 weeks', 'description': 'Participants meet for 6 weekly, 2hr group sessions that include presentation of theoretical materials on mindfulness,relaxation,and mind-body connection;experiential practice of meditation and gentle yoga;psycho-educational component for cancer survivors,and group process focused on solving problems concerning impediments to effective practice.Participants will be instructed to practice mindfulness techniques on a daily basis. Daily diaries will be kept by participants to record practice time, mood assessments, and self-reported questions on benefits and barriers to practicing.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Younger Breast Cancer Survivors']}, 'descriptionModule': {'briefSummary': 'Younger women with breast cancer experience substantially greater distress and depressive symptoms than older women. These symptoms can hamper recovery and healthy behaviors that can reduce the risk of recurrence and/or other chronic diseases. The primary objective of this study is to evaluate the feasibility and preliminary efficacy of a mindfulness meditation-based intervention for this at-risk group of women. The investigators hypothesize that a structured program of mindfulness meditation will lead to significant improvements in psychological well-being (i.e., depression, stress), with corresponding improvements in health behaviors and biomarkers of cancer risk, in women diagnosed with breast cancer, prior to age 50. The investigators will also examine mechanisms for intervention effects, including increased mindfulness and ability to relax.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women diagnosed with early, resectable breast cancer (Stage 0, I, II, or III) prior to age 50\n* have completed treatment with surgery, radiation, and/or chemotherapy at least 3 months previously.\n\nExclusion Criteria:\n\n* have a breast cancer recurrence, metastasis, or another cancer diagnosis (excluding non-melanoma skin cancer\n* unable to commit to intervention schedule.'}, 'identificationModule': {'nctId': 'NCT01558258', 'briefTitle': 'A Mindfulness Meditation-Based Intervention for Younger Breast Cancer Survivors', 'organization': {'class': 'OTHER', 'fullName': 'Jonsson Comprehensive Cancer Center'}, 'officialTitle': 'A Mindfulness Meditation-Based Intervention for Younger Breast Cancer Survivors', 'orgStudyIdInfo': {'id': '10-001799'}, 'secondaryIdInfos': [{'id': 'SAC110009', 'type': 'OTHER', 'domain': 'Susan G. Komen Foundation'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mindfullness Meditation-based Intervention', 'description': 'Mindfulness meditation-based intervention, is a 6-week program adapted from an existing program at Mindfulness Awareness Research Center(MARC),UCLA.', 'interventionNames': ['Behavioral: Mindful Awareness practices (MAPs)']}, {'type': 'NO_INTERVENTION', 'label': 'Wait-list control group', 'description': 'The wait-list control condition will control for naturally occurring changes in stress and other outcomes over the six-week intervention period. After the post-treatment assessments have been completed, those assigned to the wait-list control group will be able to participate in the MAP classes.'}], 'interventions': [{'name': 'Mindful Awareness practices (MAPs)', 'type': 'BEHAVIORAL', 'description': 'Mindfulness meditation-based intervention, is a 6-week program adapted from an existing program at Mindfulness Awareness Research Center(MARC),UCLA.', 'armGroupLabels': ['Mindfullness Meditation-based Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Patricia Ganz, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jonsson Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jonsson Comprehensive Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Susan G. Komen Breast Cancer Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}