Patient Activation, Counseling and Exercise - Acute Leukemia (PACE-AL)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2012 by Universitetshospitalernes Center for Sygepleje
Sponsor:
Collaborators:
University of Copenhagen
Novo Nordisk A/S
Danish Cancer Society
Lundbeck Foundation
Information provided by (Responsible Party):
Mary Jarden, Universitetshospitalernes Center for Sygepleje
ClinicalTrials.gov Identifier:
NCT01404520
First received: May 10, 2011
Last updated: March 15, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Acute Leukemia
Other: Exercise based multimodal intervention
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Universitetshospitalernes Center for Sygepleje:

Primary Outcome Measures:
  • 6MWD [ Time Frame: Change from baseline in 6MWD at 12 weeks ] [ Designated as safety issue: Yes ]
    Change in distance in meter


Secondary Outcome Measures:
  • Estimated VO2 max Aastrand test [ Time Frame: Change from baseline in VO2 Aastrand test at 12 weeks ] [ Designated as safety issue: Yes ]
    Change in l/m

  • Timed chair stand [ Time Frame: Change from baseline in timed chair stand at 12 weeks ] [ Designated as safety issue: Yes ]
    Change in number of repetitions

  • Timed bicep curl [ Time Frame: Change from baseline in timed bicep curl at 12 weeks ] [ Designated as safety issue: Yes ]
    Change in number of repetitions

  • EORTC QLQ-C30 [ Time Frame: Change from baseline in EORTC QLQ-C30 at 12 weeks ] [ Designated as safety issue: No ]
    Change in scores for quality of life

  • FACT-Leukaemia [ Time Frame: Change from baseline in FACT-Leuk at 12 weeks ] [ Designated as safety issue: No ]
    Change in scores for quality of life/function

  • HADS [ Time Frame: Change from baseline in HADS at 12 weeks ] [ Designated as safety issue: No ]
    Change in scores for emotional wellbeing

  • SF36 [ Time Frame: Change from baseline in SF36 at 12 weeks ] [ Designated as safety issue: No ]
    Change in scores for general health

  • MDSAI [ Time Frame: Change from baseline over time (1,2,3,4,5,6,7,8,9,10,11,12 weeks) ] [ Designated as safety issue: No ]
    Change in scores for symtom burden


Estimated Enrollment: 106
Study Start Date: June 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exercise based multimodal intervention
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
Other: Exercise based multimodal intervention
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients that are able to speak Danish > 18 years and newly diagnosed with acute leukæmia (MDS, AML, CMML, APL or ALL)
  • Normal EKG, blood pressure and pulse
  • Signed informed written consent

Exclusion Criteria:

  • Medical reason that contraindicates physical activity
  • Patients diagnosed with a symptomatic cardial disease within the last three months.
  • Documented bone metastasis
  • Dementia, psychotic
  • Cannot write or read Danish
  • Patients unable to carry out baseline tests
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01404520

Contacts
Contact: Mary Jarden, Ph.D. mary@ucsf.dk

Locations
Denmark
Copenhagen University Hospital Rigshospital Recruiting
Copenhagen, Denmark, DK 2100
Principal Investigator: Mary Jarden, Ph.D.         
Herlev Hospital Recruiting
Herlev, Denmark, DK 2730
Principal Investigator: Mary Jarden, Ph.D.         
Sponsors and Collaborators
Universitetshospitalernes Center for Sygepleje
University of Copenhagen
Novo Nordisk A/S
Danish Cancer Society
Lundbeck Foundation
Investigators
Principal Investigator: Mary Jarden, Ph.D. UCSF and CIRE
  More Information

No publications provided by Universitetshospitalernes Center for Sygepleje

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mary Jarden, Research Fellow, Universitetshospitalernes Center for Sygepleje
ClinicalTrials.gov Identifier: NCT01404520     History of Changes
Other Study ID Numbers: H-4-2010-046
Study First Received: May 10, 2011
Last Updated: March 15, 2012
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by Universitetshospitalernes Center for Sygepleje:
#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]

Additional relevant MeSH terms:
Leukemia
Acute Disease
Neoplasms by Histologic Type
Neoplasms
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on July 22, 2014