Ignite Creation Date:
2025-12-25 @ 2:56 AM
Ignite Modification Date:
2025-12-30 @ 1:30 PM
Study NCT ID:
NCT04557033
Status:
COMPLETED
Last Update Posted:
2022-08-25
First Post:
2020-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
My Mindful Moments: A Mindfulness Meditation and Digital Art Activity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-08-16', 'size': 125475, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-08-22T10:27', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-22', 'studyFirstSubmitDate': '2020-09-15', 'studyFirstSubmitQcDate': '2020-09-15', 'lastUpdatePostDateStruct': {'date': '2022-08-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participation-Feasibility', 'timeFrame': '1 year', 'description': '≥50% of staff choose to participate=Feasibility. This measure of feasibility will be evaluated by calculating index scores of the percentage of clinical staff who choose to participate'}, {'measure': 'Percentage Completion of Full Activity-Feasibility', 'timeFrame': '1 year', 'description': '\\> 80% of those who participate complete the activity=Feasibility. This measure of feasibility will be evaluated by index scores of the percentage of clinical staff who complete the full activity'}, {'measure': 'Mean Completion Time-Feasibility', 'timeFrame': '1 year', 'description': 'The activity is completed by the group in 40 minutes or less-Feasibility. This measure of feasibility will be evaluatedby individual group completions times and overall analysis of descriptive statistics on the time for completion of the activity by all groups.'}], 'secondaryOutcomes': [{'measure': 'Change in Anxiety Score', 'timeFrame': '1 Year', 'description': 'Changes in participant state anxiety will be evaluated using the visual analogue scale in measuring state anxiety. The electronic scale displays a horizontal line divided into 30 equal-sized partitions. The left edge of the scale is marked "calm" and the right edge is marked "anxious." A sliding locator is positioned at the midpoint of the scale. The participant is instructed to use the computer mouse to place the locator at the scale position representing their current level of anxiety. The score is automatically calculated by rounding the relative distance of the locator from the left edge of the scale to the nearest integer value between 0 and 30. A higher score indicates greater anxiety. A comparison of scores pre- and post- intervention by calculating a paired t-test comparison of means'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mindfulness', 'Meditation'], 'conditions': ['Mindfulness', 'Meditation']}, 'descriptionModule': {'briefSummary': 'The purpose of this evidence-based practice project is to evaluate the feasibility of providing a relaxation mindfulness meditation and an expressive digital arts activity among clinical staff at Dana Farber Cancer Institute .', 'detailedDescription': 'This project provides an opportunity for patient care staff in an ambulatory oncology setting to participate in and evaluate an activity that includes a mindfulness meditation technique and an expressive digital arts activity.\n\nThis study will be conducted to evaluate the feasibility of providing a mindfulness meditation and digital imagery activity.\n\n* The activity will include a guided mindfulness meditation and the creation of a digital image on an iPad.\n* Participants will be asked to complete brief surveys before and after the intervention activity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults ≥18 years of age\n* Currently employed at Dana Farber Cancer Institute\n* Providing patient care on Yawkey\n\nExclusion Criteria:\n\n* Not an employee of Dana Farber Cancer Institute\n* Not providing Patient Care on Yawkey'}, 'identificationModule': {'nctId': 'NCT04557033', 'briefTitle': 'My Mindful Moments: A Mindfulness Meditation and Digital Art Activity', 'organization': {'class': 'OTHER', 'fullName': 'Dana-Farber Cancer Institute'}, 'officialTitle': 'My Mindful Moments: A Mindfulness Meditation and Digital Art Activity', 'orgStudyIdInfo': {'id': '20-420'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mindful Meditation', 'description': '* The activity will include a guided mindfulness meditation and the creation of a digital image on an iPad.\n* The My Moments® application (app) is a tool used to facilitate expressive art creation in a digital photography media\n* Participants will be asked to complete brief surveys before and after the intervention activity.', 'interventionNames': ['Other: Mindfulness intervention']}], 'interventions': [{'name': 'Mindfulness intervention', 'type': 'OTHER', 'description': 'My Moments® application (app) is a tool used to facilitate expressive art creation in a digital photography media', 'armGroupLabels': ['Mindful Meditation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Terri Jabaley, Ph.D, RN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dana-Farber Cancer Institute'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Data can be shared no earlier than 1 year following the date of publication', 'ipdSharing': 'YES', 'description': 'The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.', 'accessCriteria': 'DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dana-Farber Cancer Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Theresa Jabaley', 'investigatorAffiliation': 'Dana-Farber Cancer Institute'}}}}