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

May 10, 2011
March 15, 2012
June 2011
June 2014   (final data collection date for primary outcome measure)
6MWD [ Time Frame: Change from baseline in 6MWD at 12 weeks ] [ Designated as safety issue: Yes ]
Change in distance in meter
Same as current
Complete list of historical versions of study NCT01404520 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Patient Activation, Counseling and Exercise - Acute Leukemia (PACE-AL)
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

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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Acute Leukemia
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.
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
Intervention: Other: Exercise based multimodal intervention
Jarden M, Møller 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
106
June 2015
June 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Mary Jarden, Ph.D. mary@ucsf.dk
Denmark
 
NCT01404520
H-4-2010-046
Yes
Mary Jarden, Universitetshospitalernes Center for Sygepleje
Universitetshospitalernes Center for Sygepleje
  • University of Copenhagen
  • Novo Nordisk A/S
  • Danish Cancer Society
  • Lundbeck Foundation
Principal Investigator: Mary Jarden, Ph.D. UCSF and CIRE
Universitetshospitalernes Center for Sygepleje
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP