Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2026-02-24 @ 2:58 PM
Study NCT ID:
NCT01404520
Status:
COMPLETED
Last Update Posted:
2015-12-02
First Post:
2011-05-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patient Activation, Counseling and Exercise - Acute Leukemia (PACE-AL)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-30', 'studyFirstSubmitDate': '2011-05-10', 'studyFirstSubmitQcDate': '2011-07-27', 'lastUpdatePostDateStruct': {'date': '2015-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Six Minute Walk Distance 6MWD', 'timeFrame': 'Change from baseline in 6MWD at 12 weeks', 'description': 'Change in distance in meter'}], 'secondaryOutcomes': [{'measure': 'Estimated VO2 max Aastrand test', 'timeFrame': 'Change from baseline in VO2 Aastrand test at 12 weeks', 'description': 'Change in l/m'}, {'measure': 'Timed chair stand', 'timeFrame': 'Change from baseline in timed chair stand at 12 weeks', 'description': 'Change in number of repetitions'}, {'measure': 'Timed biceps curl', 'timeFrame': 'Change from baseline in timed bicep curl at 12 weeks', 'description': 'Change in number of repetitions'}, {'measure': 'EORTC QLQ-C30', 'timeFrame': 'Change from baseline in EORTC QLQ-C30 at 12 weeks', 'description': 'Change in scores for quality of life'}, {'measure': 'FACT-An', 'timeFrame': 'Change from baseline in FACT-An at 12 weeks', 'description': 'Change in scores for quality of life/function'}, {'measure': 'HADS', 'timeFrame': 'Change from baseline in HADS at 12 weeks', 'description': 'Change in scores for emotional wellbeing'}, {'measure': 'SF36', 'timeFrame': 'Change from baseline in SF36 at 12 weeks', 'description': 'Change in scores for general health'}, {'measure': 'MDASI', 'timeFrame': 'Change from baseline over time (1,2,3,4,5,6,7,8,9,10,11,12 weeks)', 'description': 'Change in scores for symptom burden'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['#14 Cancer Related fatigue', '#13 Quality of Life', '#12 "Psychosocial Intervention"[ti/ab]', '#11 Rehabilitation[tw]', '#10 "Physical Fitness"[tw]', '#9 "Physical Activity"[tw]', '#8 "Exercise Therapy"[tw]', '#7 Exercise[tw]', '#6 Hematologic[tw]', '#5 Hematological[tw]', '#4 Leukemia, Myeloid, Acute[mh]', '#3 "Acute Myeloid Leukemia"[tw]', '#2 "Acute Lymphoblastic Leukemia"[tw]', '#1 "Acute Leukemia"[tw]'], 'conditions': ['Acute Leukemia']}, 'referencesModule': {'references': [{'pmid': '27036163', 'type': 'DERIVED', 'citation': "Jarden M, Moller T, Christensen KB, Kjeldsen L, Birgens HS, Adamsen L. Multimodal intervention integrated into the clinical management of acute leukemia improves physical function and quality of life during consolidation chemotherapy: a randomized trial 'PACE-AL'. Haematologica. 2016 Jul;101(7):e316-9. doi: 10.3324/haematol.2015.140152. Epub 2016 Apr 1. No abstract available."}, {'pmid': '24083543', 'type': 'DERIVED', 'citation': 'Jarden M, Moller T, Kjeldsen L, Birgens H, Christensen JF, Bang Christensen K, Diderichsen F, Hendriksen C, Adamsen L. Patient Activation through Counseling and Exercise--Acute Leukemia (PACE-AL)--a randomized controlled trial. BMC Cancer. 2013 Oct 2;13:446. doi: 10.1186/1471-2407-13-446.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to test a new preventive and restorative intervention for patients with acute leukaemia undergoing consolidation chemotherapy, to measure and delineate the patients' treatment related symptom burden and to explore the effect of the intervention on length of hospital stay, duration of sick leave and return to work status. Further, to examine the relationship of the symptom profile with clinical indicators, physiological response, physical performance and survival."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients that are able to speak Danish \\> 18 years and newly diagnosed with acute leukæmia (MDS, AML, CMML, APL or ALL)\n* Normal EKG, blood pressure and pulse\n* Signed informed written consent\n\nExclusion Criteria:\n\n* Medical reason that contraindicates physical activity\n* Patients diagnosed with a symptomatic cardial disease\n* Documented bone metastasis\n* Cognitively or emotionally unstable\n* Unable to read or write in Danish\n* Patients unable to carry out baseline tests'}, 'identificationModule': {'nctId': 'NCT01404520', 'acronym': 'PACE-AL', 'briefTitle': 'Patient Activation, Counseling and Exercise - Acute Leukemia (PACE-AL)', 'organization': {'class': 'OTHER', 'fullName': 'Universitetshospitalernes Center for Sygepleje'}, 'officialTitle': 'Patient Activation, Counseling and Exercise - Acute Leukemia (PACE-AL) Health Promoting Rehabilitation. A Multimodal Exercise-based Intervention in Patients With Acute Leukaemia Undergoing Re-induction or Consolidation Chemotherapy', 'orgStudyIdInfo': {'id': 'H-4-2010-046'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exercise based multimodal intervention', 'description': 'The intervention is initiated early, during treatment (consolidation) in the intra-hospital setting and continues for two successive treatment series (12 weeks). The intervention is a three hour/wk supervised in-hospital programme of aerobic (stationary cycle) and functional muscle training, progressive relaxation training, nutrition supplement (protein and carbohydrate) immediately after training and health-promoting consultation combined with an unsupervised in-home walking and progressive relaxation programme', 'interventionNames': ['Other: Exercise based multimodal intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Control group receives usual care'}], 'interventions': [{'name': 'Exercise based multimodal intervention', 'type': 'OTHER', 'description': 'The intervention is initiated early, during treatment (consolidation) in the intra-hospital setting and continues for two successive treatment series (12 weeks). The intervention is a three hour/wk supervised in-hospital programme of aerobic (stationary cycle) and functional muscle training, progressive relaxation training, nutrition supplement (protein and carbohydrate) immediately after training and health-promoting consultation combined with an unsupervised in-home walking and progressive relaxation programme.', 'armGroupLabels': ['Exercise based multimodal intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DK 2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Copenhagen University Hospital Rigshospital', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'zip': 'DK 2730', 'city': 'Herlev', 'country': 'Denmark', 'facility': 'Herlev Hospital', 'geoPoint': {'lat': 55.72366, 'lon': 12.43998}}], 'overallOfficials': [{'name': 'Mary Jarden, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UCSF and CIRE'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitetshospitalernes Center for Sygepleje', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Copenhagen', 'class': 'OTHER'}, {'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}, {'name': 'Danish Cancer Society', 'class': 'OTHER'}, {'name': 'Lundbeck Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Fellow', 'investigatorFullName': 'Mary Jarden', 'investigatorAffiliation': 'Universitetshospitalernes Center for Sygepleje'}}}}