Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2026-02-21 @ 7:37 PM
Study NCT ID:
NCT03728205
Status:
WITHDRAWN
Last Update Posted:
2021-04-27
First Post:
2018-10-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Yoga for Solid Tumor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015013', 'term': 'Yoga'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026443', 'term': 'Spiritual Therapies'}, {'id': 'D026241', 'term': 'Exercise Movement Techniques'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Covid-19', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2018-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-01-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-23', 'studyFirstSubmitDate': '2018-10-29', 'studyFirstSubmitQcDate': '2018-11-01', 'lastUpdatePostDateStruct': {'date': '2021-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Long Term', 'timeFrame': '17 months', 'description': 'Examine the long term effect of yoga to be tested at the 6 months post radiation visit. We will use the BFI and distress thermometer to see if any positive results during yoga are sustained to the 6 month follow up visit.'}], 'primaryOutcomes': [{'measure': 'The feasibility of implementing Eischens yoga interventions for solid tumor cancer patients undergoing radiation therapy. This will be measured by the success rate of recruitment and retention for 10 subjects.', 'timeFrame': '12 months', 'description': 'Feasibility'}], 'secondaryOutcomes': [{'measure': 'Effects on fatigue', 'timeFrame': '12 months', 'description': 'Examine the effect of yoga on cancer and radiation related fatigue during radiation therapy. We will use the BFI results both before, during and after radiation therapy.'}, {'measure': 'Effects on Stress Level', 'timeFrame': '12 Months', 'description': 'Examine the effect of yoga on cancer and radiation related fatigue during radiation therapy. We will use the NCCN Distress thermometer results both before, during and after radiation therapy.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Solid Tumor, Adult']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to ascertain the effect of yoga interventions on radiation-related fatigue, and stress in cancer patients with stage I and II solid tumors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Stage I and II Cancer patients with solid tumors undergoing RT for 4-8 weeks (external beam radiation).\n2. Patients of age \\>18, and all races will be included in the study.\n3. All patients must sign an informed consent form approved for this purpose by the Institutional Review Board (IRB) of the University of Pennsylvania.\n4. Patients must be English speaking.\n5. Patients must be able to attend the schedule classes.\n\n Exclusion Criteria:\n6. Patients with medical restrictions that may interfere with or prevent them from taking part in the yoga interventions per their physician orders.\n7. Patients with metastatic disease.\n8. Active smokers. Smoking may interfere with relaxation and breathing modalities of the yoga interventions. (Self-reporting smokers that have been smoke free for 6 months may be included)\n9. Patients who currently practice or have recently practiced yoga (had not taken a yoga class on a regular bases in the last 6 months).'}, 'identificationModule': {'nctId': 'NCT03728205', 'briefTitle': 'Yoga for Solid Tumor', 'organization': {'class': 'OTHER', 'fullName': 'Abramson Cancer Center at Penn Medicine'}, 'officialTitle': 'A Pilot Study On The Effect Of Yoga On Fatigue, And Stress Levels In Solid Tumor Cancer Patients Undergoing Active Radiation Therapy', 'orgStudyIdInfo': {'id': 'UPCC 13918'}, 'secondaryIdInfos': [{'id': '831417', 'type': 'OTHER', 'domain': 'Penn Medicine'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Observational', 'description': 'All 10 pilot subjects will be taking yoga', 'interventionNames': ['Behavioral: Yoga']}], 'interventions': [{'name': 'Yoga', 'type': 'BEHAVIORAL', 'description': 'Twice weekly yoga sessions for 12 weeks', 'armGroupLabels': ['Observational']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abramson Cancer Center at Penn Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}